Management of = single brain metastasis: a practice guideline

4. RESULTS

4.1 Literature Search = Results

Table I outlines, = by=20 question, the type and number of studies included in this practice = guideline.

4.2 Outcomes

4.2.1 Should=20 Patients with Confirmed Single Brain Metastasis Undergo Surgical=20 Resection?

Three rcts compared surgery plus wbrt with wbrt alone=20 in the treatment of single brain metastasis ⁵^,⁶^,⁸ (Table II). All = three trials=20 required patients to have histologically verified extracranial = cancer and=20 radiographic evidence of a surgically resectable single brain = metastasis.=20 Patients with certain radiosensitive tumours such as lymphoma and=20 small-cell lung cancer were excluded from all trials. In the trial = by=20 Patchell et al.⁵, patients were stratified by = tumour=20 location, extent of disease, and type of primary tumour. = Stratification in=20 the trial by Vecht et al.⁸ was by centre, site of = extracranial=20 disease, and status of extracranial disease. Mintz et = al.⁶ stratified patients by type of = cancer,=20 size of metastasis, and extent of primary cancer. In all trials, = most=20 patients had non-small-cell lung cancer; other primary tumours = types=20 included breast, gastrointestinal, genitourinary, and melanoma. = All=20 patients randomized to the surgery plus wbrt=20 groups in the trials by Patchell et al.⁵ and Vecht et al.⁸ underwent surgical resection, = but=20 treatment compliance with wbrt was = not=20 reported. In the trial by Mintz and colleagues⁶, 6 patients in the surgery plus = wbrt group did not receive wbrt and 2 patients did not undergo = surgery. In=20 the wbrt alone group, 1 patient = did not=20 receive wbrt, and 10 patients = underwent a=20 surgical procedure.

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TABLE=20 I

Studies = included in=20 the present systematic review

Analyses for all three = rcts used the intent-to-treat = principle.

Survival =

Two randomized trials = demonstrated a=20 significant survival benefit for patients who received surgery = plus wbrt as compared with patients who = received wbrt alone⁵^,⁸, and one randomized trial = detected no=20 significant survival difference between the treatment = groups⁶. In the trial by Patchell et = al.⁵, median survival was 9.2 months = for=20 patients who received surgery as compared with 3.5 months for = patients who=20 received wbrt alone (p = < 0.01);=20 in the trial by Vecht et al.⁸, median survival was 10 months = as compared=20 with 6 months (p =3D 0.04). Also in the trial by Vecht = et=20 al., the difference in survival was most robust in a subgroup = of=20 patients with stable or absent extracranial disease (median = survival: 12=20 months vs. 7 months; p =3D 0.02). No significant survival = difference was observed in patients with active extracranial = disease=20 (median survival: 5 months in both treatment groups; p = =3D=20 0.88).

In the rct by=20 Mintz et al.⁶, median survival was not = statistically=20 different between the surgery plus wbrt arm=20 and the wbrt-only arm (5.6 months = and 6.3=20 months respectively, p =3D 0.24). In addition, most = patients died=20 within the first year (69.8% in the wbrt=20 arm, 87.8% in the surgery plus wbrt arm). In=20 a univariate Cox proportional hazard model, the systemic extent of = primary=20 disease was identified as a major contributing factor and = predictor of=20 mortality (relative risk:1.86; p =3D 0.006).

A Cochrane collaboration=20 meta-analysis of the published survival data from the three trials = indicated no significant difference in overall survival, with a = hazard=20 ratio of 0.74 [95% confidence interval (CI): 0.39 to 1.4; = p =3D=20 0.35]⁹. A high degree of heterogeneity = for=20 survival was detected between trials.

Neurologic = Control of=20 Disease

Local recurrence of = disease was=20 reported in only one randomized trial⁵. In the trial by Patchell et = al.,=20 recurrence or progression at the site of the original metastasis = was less=20 frequent in the surgery plus wbrt = group than=20 in the wbrt-only group (20% vs. = 52%,=20 p < 0.02). The median length of time from treatment to = recurrence of the brain metastasis was significantly longer in = patients=20 who underwent surgery than in patients who received wbrt alone (>59 weeks vs. 21 weeks; = p=20 < 0.0001).

None of the three = randomized trials=20 reported a significant difference between neurologic and systemic = causes=20 of death between the treatment groups. Mintz et = al.⁶ reported that the cause of death = was=20 systemic disease in 46% of the surgical group and in 35% of the = radiation=20 group (p =3D 0.42). Death from neurologic causes alone = was 15% in=20 the surgical group and 28% in the radiation group (p =3D = 0.30). The=20 remaining patients died of a combination of neurologic and = systemic causes=20 or an unknown cause. Vecht et al.⁸ reported no difference in = systemic or=20 neurologic causes of death between the treatment groups, with = neurologic=20 death being approximately one third in both treatment groups. = Patchell=20 et al.⁵ reported that 71% of patients in = the=20 surgical group and 50% in the wbrt-only=20 group died of systemic causes (p =3D 0.26). The Cochrane=20 meta-analysis indicated that patients who were treated with = surgery were=20 somewhat less likely to die from neurologic causes [odds ratio = (or): 0.57; 95% ci:=20 0.29 to 1.10; p =3D 0.09], but this trend was not = statistically=20 significant⁹.

Quality of = Life and=20 Performance Status

Two randomized trials = demonstrated a=20 benefit in quality of life for patients who received surgery plus = wbrt as compared with patients who = received wbrt alone⁵^,⁸, and one randomized trial showed = no=20 significant difference between the groups⁶. In the trial by Patchell et = al.⁵, the length of functional = independence=20 (defined as a kps =E2=89=A5 70), = was significantly=20 improved in the surgical group (8.8 months vs. 1.8 months, = p <=20 0.005). Multivariate analysis showed that surgical treatment was = the only=20 factor associated with a better quality of life (p < = 0.007).=20 In the trial by Vecht et al.⁸, median functionally independent = survival=20 (defined in that trial as a World Health Organization performance = status =E2=89=A4=20 1) was somewhat longer in patients who received surgery than in = patients=20 who received wbrt alone (7.5 = months vs. 3.5=20 months, p =3D 0.06).

The analysis of patients = with=20 progressive extracranial disease demonstrated no difference in=20 functionally independent survival between treatment groups = (p =3D=20 0.88), but the analysis of patients with stable extracranial = disease=20 demonstrated a significant benefit for patients who received = surgery as=20 compared with patients who received wbrt=20 alone (p =3D 0.01). In the trial by Mintz et = al.⁶, no statistically significant = differences=20 were observed in the mean Spitzer quality-of-life score or the = kps between treatment = groups.

Adverse=20 Effects

In the trials by = Patchell et=20 al.⁵ and Mintz et al.⁶, surgical mortality (defined as = death=20 within 30 days following surgery) did not differ significantly = from 30-day=20 mortality in the wbrt-only groups. = In the=20 trial by Vecht et al.⁸, 30-day mortality was 9% in the = combined=20 treatment group and 0% in the wbrt-only=20 group; however, death within 2 months did not differ between the = groups.=20 In one trial⁶, 30-day morbidity was 8% in the = surgery=20 plus wbrt group and 17% in the = wbrt-only group, and in another = trial⁶, it did not differ between the=20 groups.

In the trial by Vecht = et=20 al.⁸, postoperative complications = included=20 respiratory problems in 4 patients, intracerebral hemorrhage in 1 = patient,=20 infectious disease in 3 patients, and other complications in 9 = patients.=20 Postoperative morbidity affected 13 patients, and those = complications were=20 serious in 4 patients. Complications of radiotherapy, including = nausea,=20 vomiting, and headache, did not differ between the treatment = groups (10=20 patients in the surgery plus wbrt = group vs.=20 9 patients in the wbrt-only = group). In the=20 Cochrane meta-analysis, no significant difference in adverse = effects was=20 detected between the groups (or: = 1.25; 95%=20 ci: 0.68 to 2.66; p =3D = 0.39)⁹.

4.2.2 = Should Patients=20 with Single Brain Metastasis Undergoing Surgical Resection Receive = Adjuvant WBRT?

Although all three rcts examining the efficacy of surgery = for single=20 brain metastasis also administered wbrt to=20 the surgical treatment arm⁵^,⁶^,⁸, the need for postoperative = wbrt had not been established through = randomized=20 trials. Patchell et al.¹⁰ conducted a follow-up rct comparing surgery plus wbrt with surgery alone to determine = whether=20 postoperative wbrt increases = survival or the=20 neurologic control of disease. The researchers randomly assigned = 49=20 patients to postoperative wbrt and = 46=20 patients to observation after complete resection of a single brain = metastasis. Contrast-enhanced mri = was=20 performed after resection to confirm complete resection and to = rule out=20 additional lesions, and resected tissue was examined to confirm = that all=20 patients had metastatic tumours. Patients were required to have a = kps of =E2=89=A570. Patients with = small-cell lung cancer,=20 germ-cell tumours, lymphoma, leukemia, or multiple myeloma were = excluded,=20 and the included patients were stratified by type and extent of=20 extracranial disease.

Recurrence of a tumour at = the site of=20 the original metastasis (10% vs. 46%, p < 0.001) or = anywhere=20 else in the brain (18% vs. 70%, p < 0.001) was less = frequent=20 in the wbrt group than in the = observation=20 group¹⁰. Patients in the radiation = group were=20 less likely to die of neurologic causes than were patients in the=20 observation group (14% vs. 44%, p =3D 0.003); however, no = significant difference was observed in overall length of survival = or=20 length of time that patients remained functionally=20 independent.

4.2.3 What Is=20 the Role of SRS in the Management of Patients with Single Brain=20 Metastasis?

WBRT With or=20 Without SRS

One rct compared the use of wbrt plus srs boost=20 with wbrt alone in patients with = brain=20 metastases¹¹. The Radiation Therapy = Oncology Group=20 9508 rct by Andrews et = al.=20 randomized patients with 1=E2=80=933 brain metastases, including = 186 patients with=20 a single metastasis, to receive either wbrt=20 plus srs or wbrt alone. The target sample size was = calculated=20 to provide sufficient statistical power to detect a survival = difference=20 between treatment arms in patients with single brain = metastasis.

Patients with a kps of <70, with lesions greater than = 4 cm in=20 diameter, or with known active extracranial disease were excluded = from the=20 study. Patients randomized to srs = boost=20 received srs within 1 week after = wbrt. Fourteen patients with a single = metastasis=20 (15%) randomized to srs boost did = not=20 receive radiosurgery, but were included in the analysis in an=20 intent-to-treat approach. As compared with patients receiving = wbrt alone, patients receiving both = wbrt and srs in=20 cases of single brain metastasis showed a significant improvement = in=20 median survival (6.5 months vs. 4.9 months, p =3D 0.039). = The=20 causes of death and the rates of adverse effects did not differ = between=20 treatment groups. Local control and quality-of-life results were = not=20 reported separately for patients with a single brain=20 metastasis.

SRS Versus = Surgical=20 Resection

No randomized trials = compared srs with traditional surgical resection; = however,=20 three retrospective reviews compared those treatment = modalities¹⁸^,¹⁹^,²¹.

The study by Muacevic et = al.¹⁸ reviewed 108 patients with a = single=20 metastasis no larger than 3.5 cm in diameter and stable systemic = disease=20 who received srs alone or surgery = plus wbrt. Patients in the srs group had significantly smaller = tumours than=20 did the patients in the surgery plus wbrt=20 group (mean size: 2.07 cm vs. 2.7 cm; p < 0.001). The = srs group also contained a higher = proportion of=20 patients with melanoma. Although median survival was 15.7 months = in the=20 surgery plus wbrt group and 8.1 = months in=20 the srs group, that survival = difference was=20 not statistically significant. No significant differences in local = control=20 or complications were observed between the groups, but a higher = incidence=20 of distant recurrences was reported in the srs group.

The review by Sch=C3=B6ggl et = al.¹⁹ retrospectively matched 133 = patients who=20 received wbrt and either = GammaKnife (Elekta,=20 Stockholm, Sweden) srs or surgery = for the=20 treatment of a single brain metastasis less than 3 cm in diameter. = Median=20 survival and 1-year overall survival did not differ significantly = between=20 the groups; however, the authors reported that srs was superior for local control and=20 morbidity.

To be included in the review by = O=E2=80=99Neill et=20 al.²¹, patients had to be candidates = for both=20 srs and surgical resection. Tumour = size had=20 to be no larger than 3.5 cm in diameter, and patients with = deep-seated=20 tumours or ventricular obstruction were excluded. These inclusion = criteria=20 were met by 23 patients who had received srs=20 and 74 patients who had received surgery, most of whom had also = received=20 wbrt. Significantly fewer patients = in the=20 srs group had a good performance = score=20 (p =3D 0.0016). No significant differences in survival or = cause of=20 death were detected between the groups, and the authors concluded = that=20 neither srs nor surgical resection = was=20 superior in that study.

No conclusions can be = drawn from the=20 results of the foregoing studies because of the inherent = limitations=20 associated with comparisons that use retrospective data. Those = reviews=20 were subject to selection bias, and the patients in the two groups = differed in important prognostic factors such as performance = status and=20 tumour size. In addition, small sample sizes limited the ability = of the=20 studies to detect significant differences between treatment groups = for key=20 outcomes.

SRS With or=20 Without WBRT

No randomized trials = compared srs plus wbrt to=20 srs alone; however, several = retrospective=20 reviews addressed the efficacy of srs with=20 or without wbrt. A subgroup = analysis of the=20 largest review by Sneed et al.²⁰ compared 168 patients with = single brain=20 metastasis who received srs alone = with 175=20 patients who received srs with = wbrt as initial treatment. To be = included in the=20 srs plus wbrt=20 arm of the study, patients had to have received both radiosurgery = and=20 wbrt within a period of 1 month, = although=20 the order of treatment was not specified. Overall, patients who = received=20 srs alone included a higher = percentage of=20 patients more than 65 years old and with a kps of <70, but whether that = imbalance was also=20 present in patients with single metastasis is unclear. A number of = patients, particularly those who initially received srs alone, underwent one or more salvage = therapies=20 for recurrence or new metastases. No significant survival = difference was=20 detected between the groups (Table III). Tumour = control=20 results were not reported for patients with single brain = metastasis.

<= /DIV>

TABLE=20 II

Randomized trials=20 of surgery plus radiation therapy as compared with radiation = therapy=20 alone

Flickinger et al.¹⁵ reviewed 116 patients with = single=20 metastasis treated with linear accelerator srs. Of those patients, 56% also = received=20 fractionated radiation therapy. In that study population, 45 = patients=20 (39%) had tumours that recurred after previous wbrt, and 71 (61%) were treated with = srs as initial management for their = metastasis.=20 The median survival was 11 months, with local tumour control in = 85% of=20 patients. Recurrence was documented in 15%. In a multivariate = analysis,=20 local tumour control was significantly better in patients = receiving both=20 fractionated radiation therapy and srs as=20 compared with srs alone = (p =3D=20 0.011), but no effect on survival was observed.

Two non-comparative retrospective=20 reviews¹⁶^,¹⁷ and one single-arm prospective = case=20 series¹² investigated the efficacy of = srs plus wbrt. The=20 study by Auchter et al.¹⁷ retrospectively reviewed 122 = patients=20 who matched the eligibility criteria for entry into the randomized = trial=20 by Patchell et al.⁶ and who had been treated with = srs followed by wbrt. None of those patients had = received prior=20 surgery or radiation therapy. Median survival was 12.9 months, and = the 1-=20 and 2-year survival rates were 53% and 30% respectively. Complete = response=20 was observed in 25% of patients, and partial response in 34%. = Local=20 control rates at 1 and 2 years were 85% and 77% respectively. = Intracranial=20 recurrence outside the srs volume = was=20 experienced by 22% of patients. Median duration of functionally=20 independent survival, defined as a kps >=20 70, was 10.2 months.

A second retrospective review by = Alexander=20 et al.¹⁶ included 171 patients with = single brain=20 metastasis. Most of the patients in that review received srs to treat recurrent lesions. All = patients=20 received wbrt, either as part of = their=20 initial therapy or in combination with srs.=20 Median survival for patients with single brain metastasis was 10.3 = months.=20 A small prospective case series of 24 patients who received srs plus wbrt¹² reported a median survival of = 10 months=20 and tumour shrinkage in 58% of patients for whom data were=20 available.

Two single-arm = prospective=20 studies¹³^,¹⁴ investigated the efficacy of = srs alone. The case series by Sturm = et=20 al.¹³ of 30 patients with inoperable = single=20 brain metastasis reported mean survival of 6.5 months, improvement = of=20 clinical symptoms in 18 of 27 patients, and tumour regression in = 13 of 22=20 patients. A subgroup analysis of the study by Lutterbach et=20 al.¹⁴ reported median survival of = 7.7 months=20 for patients with single brain=20 metastasis.

5. DISCUSSION

5.1 Should Patients with = Confirmed Single=20 Brain Metastasis Undergo Surgical Resection Before Radiation=20 Therapy?

Definitive conclusions = about using=20 resection before radiation therapy are difficult to reach. The = three rcts that compared surgery plus wbrt with wbrt alone=20 were relatively small, and they varied with respect to important = baseline=20 patient characteristics. The largest trial by Mintz et = al.⁶ was calculated to have only 50%=20 statistical power to detect a 50% difference in median survival = between=20 treatment arms²². The two major differences = between the=20 results of the three rcts are the = reduced=20 survival time for the surgery plus wbrt=20 group in the Mintz et al. rct⁶ and the diminished survival time = reported=20 by Patchell et al.⁵ for the wbrt-only group.

Several factors may have = contributed to the=20 reduced survival time for the wbrt-only=20 group in the Patchell et al.⁵ trial.

Macdonald and Cairncross²³ suggest that that trial may = have had a=20 referral bias. Patients in the trial were recruited from a cohort = of=20 patients referred to the neurosurgery service; thus, they = represented a=20 selected group of patients who were thought to be likely to = benefit from=20 surgery or who required more urgent surgery. Referral bias of that = kind=20 was minimized in the trial by Mintz et al.⁶, in which eligible patients were = identified by oncologists, neurologists, and surgeons rather than = being=20 identified from among patients referred to the neurosurgery = service.

Differences in the proportions of = primary=20 tumour histologies are another explanation for the lower survival = for the=20 radiation-only group in the Patchell et al.⁵ trial. That trial had a large = proportion=20 of patients with non-small-cell lung cancer (77.0%) as compared = with the=20 trials by Vecht et al. (52.3%)⁸ and Mintz et al. = (53.6%)⁶. Because non-small-cell lung = cancer is a=20 relatively radioresistant tumour, the higher proportion of that = tumour=20 type may have biased the results against wbrt alone. Patchell et al. = reported that=20 lung cancer was not found to be a significant variable in a = multivariate=20 analysis of survival, but their small sample size may have had low = statistical power to detect a difference.

The benefit of surgery may be lost = in patients=20 with poor prognostic factors such as advanced extracranial disease = or=20 lower performance status. Decreased median survival was reported = in two=20 randomized trials⁶^,⁸ in patients with greater = systemic=20 involvement for their primary malignancy. Of the patients in the = study by=20 Mintz et al.⁶, 45% had extracranial = metastases; in the=20 trial by Patchell et al.⁵, this number was only 37.5%, and = in the=20 trial by Vecht et al.⁸, it was 31.7%. In the report by = Mintz=20 et al., the univariate Cox regression model identified = extent of=20 disease as the most significant variable, with a relative risk of = 1.86=20 (p =3D 0.006). Vecht et al. reported no = difference in=20 median survival for patients with progressive extracranial disease = in the=20 two groups; however, a significant survival advantage was reported = for=20 patients with stable disease who received surgery plus wbrt as compared with patients who = received wbrt alone.

In the trial by Mintz et = al.⁶, 21% of patients had a kps of <70, but patients in the = trials by=20 Patchell et al.⁵ and Vecht et al.⁸ had performance scores = equivalent to a=20 kps of =E2=89=A5 70. In addition, = patients in the=20 trials by Patchell et al. and Vecht et al. were = required=20 to have a minimum life expectancy of 6 months, but that = expectation was=20 not required by Mintz et al.⁶ in their trial. The increased = proportion=20 of patients with poor prognoses in the Mintz et al. = trial, and=20 the fact that 10 patients in the wbrt-only=20 arm underwent a surgical procedure may have made it more difficult = to=20 detect a survival advantage for surgery.

A pooled analysis of the three = trials showed=20 no significant overall survival advantage for the surgical group = as=20 compared with the wbrt-only = group⁹. However, the key differences in = patient=20 baseline characteristics between the studies and the wide = confidence=20 limits around the pooled estimate of effect allow for the = possibility that=20 surgery may have a beneficial effect on survival in selected = groups of=20 patients and may provide no survival benefit for others. The = pooled=20 results suggest that surgery may reduce mortality from neurologic = causes,=20 but in those studies, the difference with surgery was not = statistically=20 significant.

The evidence to determine whether = surgical=20 resection, as compared with treatment with wbrt alone, has a benefit on quality of = life is=20 limited. However, two rcts⁵^,⁸ reported that surgery plus wbrt significantly prolonged = functionally=20 independent survival as compared with wbrt=20 alone. The published meta-analysis reported no significant = increase in=20 adverse effects for patients who underwent surgical resection as = compared=20 with those who received wbrt = alone.

Surgical excision should = be=20 considered for patients with prognostic factors that would = increase the=20 potential benefit of such aggressive treatment, because randomized = trials=20 have demonstrated a benefit in those patients. The applicable = prognostic=20 factors include good performance status, minimal or no evidence of = extracranial disease, and a surgically accessible single brain = metastasis=20 amenable to complete excision. Because treatment in this disease = is=20 considered palliative, invasive local treatments must be=20 individualized.

5.2 Should Patients with Single = Brain=20 Metastasis Undergoing Surgical Resection Receive Adjuvant = WBRT?

The one randomized trial = examining=20 surgery plus wbrt versus surgery=20 alone¹⁰ supports the use of = post-operative wbrt. Tumour recurrence was = significantly reduced=20 at the original and distant sites alike, and patients were less = likely to=20 die of neurologic causes if radiation therapy was used = postoperatively.=20 However, no significant differences were observed in overall = survival or=20 in maintenance of functional independence between the two groups. = The use=20 of postoperative radiation is supported by that trial as a = preventive for=20 central nervous system relapse and neurologic death rather than as = a=20 contributor to survival time or maintenance of functional=20 independence.

In its radiation = component, the trial=20 by Patchell et al.¹⁰ used 5040 cGy in 28 fractions, = where the=20 current standard management of patients with single brain = metastasis in=20 the United States is 3000 cGy in 10 fractions. The latter dosage = is=20 typically used in the standard arm of randomized studies of = radiation in=20 patients with brain metastases. Based solely on evidence, no = reason exists=20 to choose 3000 cGy in 10 fractions over 2000 cGy in 5 fractions, = but=20 fraction size is believed to be important and 300 cGy daily = (3000/10) is=20 believed to be associated with fewer long-term neurocognitive = effects than=20 is 400 cGy daily (2000/5) in the occasional long-term survivor, = which is=20 the reason that many radiation oncologists in Ontario prefer 3000 = cGy in=20 10 fractions. Because no data exist to either support or refute = that=20 preference, there is no way to resolve this question of = fractionation at=20 present. More randomized trials examining various radiation = therapy doses=20 for patients with single brain metastasis are necessary to = determine the=20 optimal dose to maximize survival and minimize toxicity. The=20 Neuro-oncology dsg will update the = recommendations as new evidence becomes available.

5.3 What Is the Role of SRS in = the=20 Management of Patients with Single Brain Metastasis?

The randomized trial by = Andrews=20 et al.¹¹ demonstrated a significant = survival=20 benefit for patients with single brain metastasis who received = wbrt plus srs boost=20 as compared with patients who received wbrt=20 alone. With that evidence, it is reasonable to conclude that srs should be considered for patients = with a small=20 single brain metastasis, good performance status, and controlled=20 extracranial disease who also meet additional eligibility criteria = for=20 srs.

The evidence comparing the = efficacy of srs with that of surgery in the = treatment of=20 single brain metastasis is limited to retrospective reviews. = Radiosurgery=20 has been used increasingly in recent years because of minimal=20 invasiveness, low risk, and ability to treat metastases considered = surgically unresectable. No significant difference in survival was = detected for patients receiving srs as=20 compared with surgery in the three studies included in the present = review¹⁸^,¹⁹^,²¹; however, one study suggested = a benefit=20 for srs in local control and=20 morbidity¹⁹. Those studies were limited by = small=20 sample size and differences between treatment cohorts in key = prognostic=20 factors such as tumour size and performance status. Patients in = those=20 studies represent a highly selected study population, and the = results=20 therefore need to be interpreted cautiously. Preliminary evidence = suggests=20 a similar efficacy for srs and = surgery, but=20 direct comparisons using random patient allocation are needed to = determine=20 which treatment should be administered to patients who are = candidates for=20 both modalities.

The evidence comparing srs plus wbrt with=20 srs alone is of poor quality and = should be=20 viewed only as hypothesis-generating. The addition of wbrt to srs has yet=20 to be clarified through randomized trials. The rationale for using = wbrt in addition to srs over srs alone=20 is similar to the reasons presented for the use of radiation = therapy=20 following surgery. Use of wbrt = allows for=20 irradiation of any microscopic intracranial tumour deposits not = revealed=20 by neuro-imaging studies²⁴ and metastases that have = infiltrated=20 into the brain beyond the srs = margins. An=20 additional theoretic consideration for using combined srs and wbrt relates=20 to tumour shrinkage, which may occur after initial treatment with=20 fractionated wbrt. The smaller = radiosurgical=20 target may provide better local control and reduced complication = rates.=20 Although the addition of wbrt to = srs appears to increase local and = distant=20 intracranial control, wbrt may be = associated=20 with adverse effects such as radiation-induced dementia, = particularly in=20 long-term survivors. No quality data exist to help determine = whether wbrt should be given before or after = srs or whether selected patients should = receive=20 wbrt at recurrence or progression=20 only.

A recent rct by=20 Aoyama et al. ²⁵ that compared srs plus wbrt with=20 srs alone in patients with = 1=E2=80=934 brain=20 metastases did not meet the inclusion criteria for the present = systematic=20 review because it did not separately report results for patients = with=20 single metastasis; however, 64 of 132 patients had single brain=20 metastasis. The study did not detect a significant difference in = overall=20 survival between the treatment groups, but 1-year rates of brain = tumour=20 recurrence (46.8% vs. 76.4%, p < 0.001) and = development of new=20 brain metastases (41.5% vs. 63.7%, p =3D 0.003) were = lower in=20 patients who received srs plus = wbrt than in those who received srs alone. Salvage treatment for brain = tumour=20 progression was required more frequently in patients who received = srs alone than in those who received = srs plus wbrt=20 (p < 0.001).

The maximum size of = lesions treatable=20 with srs is not well established, = although=20 larger tumour volumes seem to be associated with poorer response = and local=20 control, and with higher complication rates. Radiosurgical = treatment of=20 larger metastases may increase the risk for development of = necrotic=20 lesions. Most studies included in the present review set limits = for lesion=20 diameter up to a maximum of 3 cm or 4 cm.

6. NEURO-ONCOLOGY DSG CONSENSUS PROCESS

The Neuro-oncology dsg decided to limit the target = population for the=20 present guideline by excluding patients with metastatic lymphoma,=20 small-cell lung cancer, germ-cell tumour, leukemia, and sarcoma = because=20 these primary tumours are radiosensitive and respond differently = to=20 radiation therapy than do other tumours.

After reviewing the = guideline report,=20 the dsg members discussed the role = of=20 postoperative wbrt in terms of = increased=20 survival. Other issues addressed included srs versus surgical resection and the = use of wbrt plus srs. The=20 Neuro-oncology dsg drafted = recommendations=20 based on the evidence and attempted to draft recommendations based = on=20 perceived practice variations within Ontario.

7. EXTERNAL REVIEW OF THE PRACTICE GUIDELINE

7.1 Report Approval Panel = Process

Before the present = practice=20 guideline was submitted for external review, the report was = reviewed and=20 approved by the pebc rap, which = consists of=20 two members, including an oncologist with expertise in clinical = and=20 methodology issues. Key issues raised by the rap included these points:

For the first question on surgical resection, three = small=20 rcts were included. Analyses by = both=20 intent to treat and actual treatment received would be helpful. = The=20 dsg should indicate compliance = with the=20 assigned therapy and expand the interpretations in the = Discussion=20 section if the data demonstrate compliance problems.
The subsection on quality of life cites only data = regarding=20 performance status. If these are the only data available, the = dsg should consider renaming the = section and=20 address the topic as a performance-status outcome evaluation = rather than=20 as an assessment of quality of life.
The dsg should = consider a more=20 definitive recommendation stating that the data are insufficient = to=20 recommend srs as single-modality = therapy.

In response to this = feedback, the=20 Neuro-oncology dsg made the = following=20 modifications to the report and guideline:

Information regarding treatment compliance was added = to the=20 Results section and to the Discussion of the systematic review. = The=20 three rcts did not perform = analyses=20 according to treatment received.
The authors changed the title of the quality of life=20 subsection to Quality of Life and Performance Status to reflect = the=20 performance status focus of most of the data.
The dsg added a = statement to the=20 recommendations to emphasize that the evidence is insufficient = to=20 recommend srs as single-modality = therapy.

7.2 Practitioner Feedback

7.2.1=20 Methods

Practitioner = feedback on the=20 draft practice guideline report was obtained through an electronic = survey=20 of 98 practitioners in Ontario (medical oncologists, radiation=20 oncologists, neurologists, and neurosurgeons). The survey = consisted of=20 items evaluating the methods, results, and discussion used to = inform the=20 draft recommendations and whether the draft recommendations should = be=20 approved as a practice guideline. Written comments were invited. = Follow-up=20 reminders were sent at 4 weeks and 6 weeks.

7.2.2 = Results

Of the 23 practitioners = who=20 responded, 16 indicated that the report was relevant to their = clinical=20 practice, and they completed the survey. The other 7 practitioners = indicated that they were not able to complete the survey or that = the=20 report was not relevant to their clinical practice. These were the = key=20 results of the practitioner feedback survey:

Number surveyed: 98

Number of responses: 23 = (23%)

Number who completed the survey: = 16=20 (70%)

Written comments attached: 6 = (38%)

Agreement with the summary of the = evidence: 14=20 (88%)

Agreement with the = recommendations: 12=20 (75%)

Approval of the = recommendation as a=20 practice guideline: 12 (75%)

7.2.3 = Summary of Main=20 Findings

Of respondents who = completed=20 the survey, 6 (38%) provided written comments. The main points = contained=20 in the written comments are summarized below.

One respondent commented that the draft was very = good.
One respondent stated that the recommendations were as = clear=20 as possible given the vagueness of the literature. This = respondent felt=20 that the data regarding surgical excision and adjuvant radiation = were=20 clear enough and agreed fully with this aspect of the = report.
One respondent commented that implementation of srs would require significant resource = allocation.
Two respondents stated that the rct by Aoyama et al.²⁵ comparing srs plus wbrt with=20 srs alone should be included in = the=20 systematic review. Although the full publication was outside the = scope=20 of the literature review, results were available in abstracts = from the=20 2004 American Society of Clinical Oncology annual = meeting.
One respondent suggested that the study by Auchter = et=20 al.¹⁷ would be more appropriately = included=20 and discussed in the SRS Versus Surgical Resection subsection, = because=20 it describes a patient population that would have been eligible = for=20 surgery but that was treated with radiosurgery.
One respondent commented that few high quality data = support=20 the statements made in the report and that the data comparing = srs with surgery are as good as any of = these.=20 The limited evidence suggests that srs and=20 surgery are roughly equivalent, and srs=20 (with or without wbrt) should be = strongly=20 considered for single lesions that are not amenable to surgery. = The=20 report should mention this consideration.
One respondent found it difficult to comment on the = draft=20 recommendations because they were not clear and because no = definitive=20 recommendation was made for each of the questions. The = respondent=20 suggested that a summary of the recommendations would be=20 helpful.

7.2.4=20 Modifications or Actions

Based on the = practitioner=20 feedback survey, the following actions were taken or modifications = made:

The text was amended to state that issues of cost of = treatment=20 and resource allocation are beyond the scope of this = evidence-based=20 guideline.
The rct by Aoyama = et=20 al. ²⁵ was still excluded from the = systematic=20 review because it did not report results for patients with = single brain=20 metastasis separately from those for patients with multiple = metastases.=20 A paragraph regarding this rct = was added=20 to the Discussion section of the systematic review.
The study by Auchter et al.¹⁷ was a single-arm study of = srs plus wbrt for=20 patients whose tumours were considered resectable. This study = was not=20 included in the surgery versus srs=20 subsection because it was not a comparative study and patients = did not=20 undergo surgical resection.
The recommendations state that srs following wbrt=20 should be considered for any patients with a tumour whose size = and=20 location are suitable for srs. = The authors=20 did not feel that a separate recommendation for srs specifically in patients with a = single=20 lesion not amenable to surgery was=20 necessary.

8. PRACTICE GUIDELINE

The present = practice guideline=20 integrates the draft recommendations with the feedback obtained = from the=20 external review process. It has been approved by the = Neuro-oncology dsg and the pebc=20 rap.

8.1 Target Population

The recommendations = that follow=20 apply to adults with confirmed cancer and a single brain = metastasis. This=20 practice guideline does not apply to patients with metastatic = lymphoma,=20 small-cell lung cancer, germ-cell tumour, leukemia, or=20 sarcoma.

8.2 Recommendations

Surgical excision should = be=20 considered for patients with good performance status, minimal or = no=20 evidence of extracranial disease, and a surgically accessible = single brain=20 metastasis amenable to complete excision. Because treatment in = cases of=20 single brain metastasis is considered palliative, invasive local=20 treatments must be individualized. Patients with lesions requiring = emergency decompression because of intracranial hypertension were = excluded=20 from the rcts, but should be = considered=20 candidates for surgery.

Postoperative wbrt should be considered to reduce the = risk of=20 tumour recurrence for patients who have undergone resection of a = single=20 brain metastasis. The optimal dose and fractionation schedule for = wbrt is 3000 cGy in 10 fractions or 2000 = cGy in 5=20 fractions.

As an alternative to = surgical=20 resection, wbrt followed by srs boost should be considered for = patients with=20 single brain metastasis. The evidence is insufficient to recommend = srs alone as single-modality = therapy.

8.3 Qualifying Statements

No high-quality data are = available=20 regarding the choice of surgery versus radiosurgery for single = brain=20 metastasis. In general, size and location of the metastasis = determine the=20 optimal approach.

The standard wbrt regimen for management of patients = with=20 single brain metastasis in the United States is 3000 cGy in 10 = fractions,=20 and this treatment is usually the standard arm in randomized = studies of=20 radiation in patients with brain metastases. Based solely on = evidence, the=20 understanding that no reason exists to choose 3000 cGy in 10 = fractions=20 over 2000 cGy in 5 fractions is correct; however, fraction size is = believed to be important, and therefore 300 cGy daily (3000/10) is = believed to be associated with fewer long-term neurocognitive = effects than=20 is 400 cGy daily (2000/5) in the occasional long-term survivor. = For that=20 reason, many radiation oncologists in Ontario prefer 3000 cGy in = 10=20 fractions. No data exist to either support or refute that = preference;=20 therefore, finding a resolution to this issue is not currently = possible.=20 The Neuro-oncology dsg will update = the=20 recommendations as new evidence becomes = available.

9. PRACTICE GUIDELINE DATE

Approved on August = 16, 2006.=20 Practice guidelines developed by Cancer Care Ontario=E2=80=99s = pebc are regularly reviewed and updated. = Please=20 visit the Web site of Cancer Care Ontario=E2=80=99s pebc (http://www.ncbi.nlm.nih.gov/pmc/articles= /PMC1948870/www.cancercare.on.ca/index_AboutthePEBC.htm)=20 for updates of this guideline.

Footnotes

The Cancer Care = Ontario=20 Practice Guidelines Initiative is sponsored by Cancer Care Ontario = and the=20 Ontario Ministry of Health and Long-Term = Care

10. REFERENCES

1.=20 Posner JB.=20 Diagnosis and treatment of metastases to the brain. Clin Bull. 1974;4:47=E2=80=9357. [PubMed]

2.=20 Delattre=20 JY, Krol G, Thaler HT, Posner JB. Distribution of brain = metastases.=20 Arch Neurol. 1988;45:741=E2=80=934. [PubMed]

3.=20 Walker AE,=20 Robins M, Weinfeld FD. Epidemiology of brain tumors: the national = survey=20 of intracranial neoplasms. Neurology.=20 1985;35:219=E2=80=9326. = [PubMed]

4.=20 Zimm S,=20 Wampler GL, Stablein D, Hazra T, Young HF. Intracerebral = metastases in=20 solid-tumor patients: natural history and results of treatment.=20 Cancer. 1981;48:384=E2=80=9394. [PubMed]

5.=20 Patchell=20 RA, Tibbs PA, Walsh JW, et al. A randomized trial of surgery in = the=20 treatment of single metastases to the brain. N Engl J Med. 1990;322:494=E2=80=93500. [PubMed]

6.=20 Mintz AH,=20 Kestle J, Rathbone MP, et al. A randomized trial to assess the = efficacy of=20 surgery in addition to radiotherapy in patients with a single = brain=20 metastasis. Cancer. = 1996;78:1470=E2=80=936. [PubMed]

7.=20 Browman GP,=20 Levine MN, Mohide EA, et al. The practice guidelines development = cycle: a=20 conceptual tool for practice guidelines development and = implementation.=20 J Clin Oncol. 1995;13:502=E2=80=9312. [PubMed]

8.=20 Vecht CJ,=20 Haaxma=E2=80=93Reiche H, Noordijk EM, et al. Treatment of single = brain metastasis:=20 radiotherapy alone or combined with neurosurgery? Ann Neurol. 1993;33:583=E2=80=9390. [PubMed]

9.=20 Hart MG,=20 Grant R, Walker M, Dickinson H. Surgical resection and whole brain = radiation therapy versus whole brain radiation therapy alone for = single=20 brain metastases [electronic resource]. Cochrane Database Syst Rev. 2004 [CD003292]

10.=20 Patchell=20 RA, Tibbs PA, Regine WF, et al. Postoperative radiotherapy in the=20 treatment of single metastases to the brain: a randomized trial.=20 JAMA. 1998;280:1485=E2=80=939. [PubMed]

11.=20 Andrews DW,=20 Scott CB, Sperduto PW, et al. Whole brain radiation therapy with = or=20 without stereotactic radiosurgery boost for patients with one to = three=20 brain metastases: phase iii results of the rtog 9508 randomised = trial.=20 Lancet. 2004;363:1665=E2=80=9372. [PubMed]

12.=20 Coffey RJ,=20 Flickinger JC, Bissonette DJ, Lunsford LD. Radiosurgery for = solitary brain=20 metastases using the cobalt-60 gamma unit: methods and results in = 24=20 patients. Int J Radiat Oncol Biol = Phys.=20 1991;20:1287=E2=80=9395. [PubMed]

13.=20 Sturm V,=20 Kimmig B, Engenhardt R, et al. Radiosurgical treatment of cerebral = metastases. Method, indications and results. Stereotact Func Neurosurg. 1991;57:7=E2=80=9310.

14.=20 Lutterbach=20 J, Cyron D, Henne K, Ostertag CB. Radiosurgery followed by planned = observation in patients with one to three brain metastases. = Neurosurgery. 2003;52:1066=E2=80=9374. [PubMed]

15.=20 Flickinger=20 JC, Kondziolka D, Lunsford LD, et al. A multi-institutional = experience=20 with stereotactic radiosurgery for solitary brain metastasis. = Int J Radiat Oncol Biol Phys. = 1994;28:797=E2=80=93802. [PubMed]

16.=20 Alexander=20 E, Moriarty TM, Davis RB, et al. Stereotactic radiosurgery for the = definitive, noninvasive treatment of brain metastases. J Natl Cancer Inst. 1995;87:34=E2=80=9340. [PubMed]

17.=20 Auchter RM,=20 Lamond JP, Alexander E, et al. A multi-institutional outcome and=20 prognostic factor analysis of radiosurgery for resectable single = brain=20 metastasis. Int J Radiat Oncol = Biol Phys.=20 1996;35:27=E2=80=9335. = [PubMed]

18.=20 Muacevic A,=20 Kreth FW, Horstmann GA, et al. Surgery and radiotherapy compared = with=20 GammaKnife radiosurgery in the treatment of solitary cerebral = metastases=20 of small diameter. J Neurosurg.=20 1999;91:35=E2=80=9343. = [PubMed]

19.=20 Sch=C3=B6ggl A,=20 Kitz K, Reddy M, et al. Defining the role of stereotactic = radiosurgery=20 versus microsurgery in the treatment of single brain metastases.=20 Acta Neurochir (Wien). = 2000;142:621=E2=80=936. [PubMed]

20.=20 Sneed PK,=20 Suh JH, Goetsch SJ, et al. A multi-institutional review of = radiosurgery=20 alone vs. radiosurgery with whole brain radiotherapy as the = initial=20 management of brain metastases. Int J Radiat=20 Oncol Biol Phys. 2002;53:519=E2=80=9326.=20 [PubMed]

21.=20 O=E2=80=99Neill BP,=20 Iturria NJ, Link MJ, Pollock BE, Ballman KV, O=E2=80=99Fallon JR. = A comparison of=20 surgical resection and stereo-tactic radiosurgery in the treatment = of=20 solitary brain metastases. Int J = Radiat=20 Oncol Biol Phys. 2003;55:1169=E2=80=9376.=20 [PubMed]

22.=20 George SL,=20 Desu MM. Planning the size and duration of a clinical trial = studying the=20 time to some critical event. J = Chronic Dis.=20 1974;27:15=E2=80=9324. = [PubMed]

23.=20 Macdonald=20 DR, Cairncross JG. Surgery for single brain metastasis. = N Engl J Med. 1990;323:132=E2=80=933. [PubMed]

24.=20 Flickinger=20 JC, Loeffler JS, Larson DA. Stereotactic radiosurgery for = intracranial=20 malignancies. Oncology (Williston = Park).=20 1994;8:81=E2=80=936,94=E2=80=9397=E2=80=938. = [PubMed]

25.=20 Aoyama H,=20 Shirato H, Tago M, et al. Stereotactic radiosurgery plus = whole-brain=20 radiation therapy vs stereotactic radiosurgery alone for treatment = of=20 brain metastases: a randomized controlled trial. JAMA. 2006;295:2483=E2=80=9391. [PubMed]

<= /DIV>

TABLE=20 III

Studies=20 investigating stereotactic radiosurgery (srs)

PubMed articles by these = authors

Mintz,=20 A.
Perry,=20 J.
Spithoff,=20 K.
Laperriere,=20 N.

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PubMed=20

Diagnosis=20 and treatment of metastases to the brain.
Clin Bull. 1974; = 4(2):47-57.
[Clin Bull. 1974]
Epidemiology=20 of brain tumors: the national survey of intracranial neoplasms.
Neurology. 1985 Feb; = 35(2):219-26.
[Neurology. 1985]
Distribution=20 of brain metastases.
Arch Neurol. 1988 Jul; = 45(7):741-4.
[Arch Neurol. 1988]
Intracerebral=20 metastases in solid-tumor patients: natural history and results of=20 treatment.
Cancer. 1981 Jul 15; = 48(2):384-94.
[Cancer. 1981]

See=20 more articles cited in this paragraph

A=20 randomized trial of surgery in the treatment of single metastases to = the=20 brain.
N Engl J Med. 1990 Feb 22;=20 322(8):494-500.
[N Engl J Med. = 1990]
A=20 randomized trial to assess the efficacy of surgery in addition to = radiotherapy=20 in patients with a single cerebral metastasis.
Cancer. 1996 Oct 1; = 78(7):1470-6.
[Cancer. 1996]

See=20 more articles cited in this paragraph

The=20 practice guidelines development cycle: a conceptual tool for practice=20 guidelines development and implementation.
J Clin Oncol. 1995 Feb;=20 13(2):502-12.
[J Clin Oncol. = 1995]

See=20 more articles cited in this paragraph

A=20 randomized trial of surgery in the treatment of single metastases to = the=20 brain.
N Engl J Med. 1990 Feb 22;=20 322(8):494-500.
[N Engl J Med. = 1990]
A=20 randomized trial to assess the efficacy of surgery in addition to = radiotherapy=20 in patients with a single cerebral metastasis.
Cancer. 1996 Oct 1; = 78(7):1470-6.
[Cancer. 1996]
Treatment=20 of single brain metastasis: radiotherapy alone or combined with=20 neurosurgery?
Ann Neurol. 1993 Jun; = 33(6):583-90.
[Ann Neurol. 1993]

See=20 more articles cited in this paragraph

A=20 randomized trial of surgery in the treatment of single metastases to = the=20 brain.
N Engl J Med. 1990 Feb 22;=20 322(8):494-500.
[N Engl J Med. = 1990]
A=20 randomized trial to assess the efficacy of surgery in addition to = radiotherapy=20 in patients with a single cerebral metastasis.
Cancer. 1996 Oct 1; = 78(7):1470-6.
[Cancer. 1996]
Treatment=20 of single brain metastasis: radiotherapy alone or combined with=20 neurosurgery?
Ann Neurol. 1993 Jun; = 33(6):583-90.
[Ann Neurol. 1993]

See=20 more articles cited in this paragraph

A=20 randomized trial of surgery in the treatment of single metastases to = the=20 brain.
N Engl J Med. 1990 Feb 22;=20 322(8):494-500.
[N Engl J Med. = 1990]
Treatment=20 of single brain metastasis: radiotherapy alone or combined with=20 neurosurgery?
Ann Neurol. 1993 Jun; = 33(6):583-90.
[Ann Neurol. 1993]
A=20 randomized trial to assess the efficacy of surgery in addition to = radiotherapy=20 in patients with a single cerebral metastasis.
Cancer. 1996 Oct 1; = 78(7):1470-6.
[Cancer. 1996]

See=20 more articles cited in this paragraph

A=20 randomized trial to assess the efficacy of surgery in addition to = radiotherapy=20 in patients with a single cerebral metastasis.
Cancer. 1996 Oct 1; = 78(7):1470-6.
[Cancer. 1996]

See=20 more articles cited in this paragraph

A=20 randomized trial of surgery in the treatment of single metastases to = the=20 brain.
N Engl J Med. 1990 Feb 22;=20 322(8):494-500.
[N Engl J Med. = 1990]

See=20 more articles cited in this paragraph

A=20 randomized trial to assess the efficacy of surgery in addition to = radiotherapy=20 in patients with a single cerebral metastasis.
Cancer. 1996 Oct 1; = 78(7):1470-6.
[Cancer. 1996]
Treatment=20 of single brain metastasis: radiotherapy alone or combined with=20 neurosurgery?
Ann Neurol. 1993 Jun; = 33(6):583-90.
[Ann Neurol. 1993]
A=20 randomized trial of surgery in the treatment of single metastases to = the=20 brain.
N Engl J Med. 1990 Feb 22;=20 322(8):494-500.
[N Engl J Med. = 1990]

See=20 more articles cited in this paragraph

A=20 randomized trial of surgery in the treatment of single metastases to = the=20 brain.
N Engl J Med. 1990 Feb 22;=20 322(8):494-500.
[N Engl J Med. = 1990]
Treatment=20 of single brain metastasis: radiotherapy alone or combined with=20 neurosurgery?
Ann Neurol. 1993 Jun; = 33(6):583-90.
[Ann Neurol. 1993]
A=20 randomized trial to assess the efficacy of surgery in addition to = radiotherapy=20 in patients with a single cerebral metastasis.
Cancer. 1996 Oct 1; = 78(7):1470-6.
[Cancer. 1996]

See=20 more articles cited in this paragraph

A=20 randomized trial to assess the efficacy of surgery in addition to = radiotherapy=20 in patients with a single cerebral metastasis.
Cancer. 1996 Oct 1; = 78(7):1470-6.
[Cancer. 1996]

See=20 more articles cited in this paragraph

A=20 randomized trial of surgery in the treatment of single metastases to = the=20 brain.
N Engl J Med. 1990 Feb 22;=20 322(8):494-500.
[N Engl J Med. = 1990]
A=20 randomized trial to assess the efficacy of surgery in addition to = radiotherapy=20 in patients with a single cerebral metastasis.
Cancer. 1996 Oct 1; = 78(7):1470-6.
[Cancer. 1996]
Treatment=20 of single brain metastasis: radiotherapy alone or combined with=20 neurosurgery?
Ann Neurol. 1993 Jun; = 33(6):583-90.
[Ann Neurol. 1993]

See=20 more articles cited in this paragraph

Treatment=20 of single brain metastasis: radiotherapy alone or combined with=20 neurosurgery?
Ann Neurol. 1993 Jun; = 33(6):583-90.
[Ann Neurol. 1993]

See=20 more articles cited in this paragraph

A=20 randomized trial of surgery in the treatment of single metastases to = the=20 brain.
N Engl J Med. 1990 Feb 22;=20 322(8):494-500.
[N Engl J Med. = 1990]
A=20 randomized trial to assess the efficacy of surgery in addition to = radiotherapy=20 in patients with a single cerebral metastasis.
Cancer. 1996 Oct 1; = 78(7):1470-6.
[Cancer. 1996]
Treatment=20 of single brain metastasis: radiotherapy alone or combined with=20 neurosurgery?
Ann Neurol. 1993 Jun; = 33(6):583-90.
[Ann Neurol. 1993]
Postoperative=20 radiotherapy in the treatment of single metastases to the brain: a = randomized=20 trial.
JAMA. 1998 Nov 4; = 280(17):1485-9.
[JAMA. 1998]

See=20 more articles cited in this paragraph

Postoperative=20 radiotherapy in the treatment of single metastases to the brain: a = randomized=20 trial.
JAMA. 1998 Nov 4; = 280(17):1485-9.
[JAMA. 1998]

See=20 more articles cited in this paragraph

Whole=20 brain radiation therapy with or without stereotactic radiosurgery = boost for=20 patients with one to three brain metastases: phase III results of the = RTOG=20 9508 randomised trial.
Lancet. 2004 May 22;=20 363(9422):1665-72.
[Lancet. = 2004]

See=20 more articles cited in this paragraph

Surgery=20 and radiotherapy compared with gamma knife radiosurgery in the = treatment of=20 solitary cerebral metastases of small diameter.
J Neurosurg. 1999 Jul; = 91(1):35-43.
[J Neurosurg. 1999]
Defining=20 the role of stereotactic radiosurgery versus microsurgery in the = treatment of=20 single brain metastases.
Acta Neurochir (Wien). 2000;=20 142(6):621-6.
[Acta Neurochir (Wien).=20 2000]
ReviewA comparison of surgical resection and = stereotactic=20 radiosurgery in the treatment of solitary brain metastases.
Int J Radiat Oncol Biol Phys. 2003 Apr = 1;=20 55(5):1169-76.
[Int J Radiat Oncol Biol = Phys.=20 2003]

See=20 more articles cited in this paragraph

Surgery=20 and radiotherapy compared with gamma knife radiosurgery in the = treatment of=20 solitary cerebral metastases of small diameter.
J Neurosurg. 1999 Jul; = 91(1):35-43.
[J Neurosurg. 1999]

See=20 more articles cited in this paragraph

Defining=20 the role of stereotactic radiosurgery versus microsurgery in the = treatment of=20 single brain metastases.
Acta Neurochir (Wien). 2000;=20 142(6):621-6.
[Acta Neurochir (Wien).=20 2000]

See=20 more articles cited in this paragraph

ReviewA comparison of surgical resection and = stereotactic=20 radiosurgery in the treatment of solitary brain metastases.
Int J Radiat Oncol Biol Phys. 2003 Apr = 1;=20 55(5):1169-76.
[Int J Radiat Oncol Biol = Phys.=20 2003]

See=20 more articles cited in this paragraph

A=20 multi-institutional review of radiosurgery alone vs. radiosurgery with = whole=20 brain radiotherapy as the initial management of brain metastases.
Int J Radiat Oncol Biol Phys. 2002 Jul = 1;=20 53(3):519-26.
[Int J Radiat Oncol Biol Phys. = 2002]

See=20 more articles cited in this paragraph

A=20 multi-institutional experience with stereotactic radiosurgery for = solitary=20 brain metastasis.
Int J Radiat Oncol Biol Phys. 1994 Mar = 1;=20 28(4):797-802.
[Int J Radiat Oncol Biol = Phys.=20 1994]

See=20 more articles cited in this paragraph

Stereotactic=20 radiosurgery for the definitive, noninvasive treatment of brain=20 metastases.
J Natl Cancer Inst. 1995 Jan 4;=20 87(1):34-40.
[J Natl Cancer Inst. = 1995]
A=20 multiinstitutional outcome and prognostic factor analysis of = radiosurgery for=20 resectable single brain metastasis.
Int J Radiat Oncol Biol Phys. 1996 Apr = 1;=20 35(1):27-35.
[Int J Radiat Oncol Biol Phys.=20 1996]
Radiosurgery=20 for solitary brain metastases using the cobalt-60 gamma unit: methods = and=20 results in 24 patients.
Int J Radiat Oncol Biol Phys. 1991 = Jun;=20 20(6):1287-95.
[Int J Radiat Oncol Biol = Phys.=20 1991]
A=20 randomized trial to assess the efficacy of surgery in addition to = radiotherapy=20 in patients with a single cerebral metastasis.
Cancer. 1996 Oct 1; = 78(7):1470-6.
[Cancer. 1996]

See=20 more articles cited in this paragraph

Stereotactic=20 radiosurgery for the definitive, noninvasive treatment of brain=20 metastases.
J Natl Cancer Inst. 1995 Jan 4;=20 87(1):34-40.
[J Natl Cancer Inst. = 1995]
Radiosurgery=20 for solitary brain metastases using the cobalt-60 gamma unit: methods = and=20 results in 24 patients.
Int J Radiat Oncol Biol Phys. 1991 = Jun;=20 20(6):1287-95.
[Int J Radiat Oncol Biol = Phys.=20 1991]

See=20 more articles cited in this paragraph

Radiosurgery=20 followed by planned observation in patients with one to three brain=20 metastases.
Neurosurgery. 2003 May; 52(5):1066-73; = discussion=20 1073-4.
[Neurosurgery. = 2003]

See=20 more articles cited in this paragraph

A=20 randomized trial to assess the efficacy of surgery in addition to = radiotherapy=20 in patients with a single cerebral metastasis.
Cancer. 1996 Oct 1; = 78(7):1470-6.
[Cancer. 1996]
Planning=20 the size and duration of a clinical trial studying the time to some = critical=20 event.
J Chronic Dis. 1974 Feb;=20 27(1):15-24.
[J Chronic Dis. = 1974]
A=20 randomized trial of surgery in the treatment of single metastases to = the=20 brain.
N Engl J Med. 1990 Feb 22;=20 322(8):494-500.
[N Engl J Med. = 1990]

See=20 more articles cited in this paragraph

A=20 randomized trial of surgery in the treatment of single metastases to = the=20 brain.
N Engl J Med. 1990 Feb 22;=20 322(8):494-500.
[N Engl J Med. = 1990]

See=20 more articles cited in this paragraph

Surgery=20 for single brain metastasis.
N Engl J Med. 1990 Jul 12;=20 323(2):132-3.
[N Engl J Med. = 1990]
A=20 randomized trial to assess the efficacy of surgery in addition to = radiotherapy=20 in patients with a single cerebral metastasis.
Cancer. 1996 Oct 1; = 78(7):1470-6.
[Cancer. 1996]

See=20 more articles cited in this paragraph

A=20 randomized trial of surgery in the treatment of single metastases to = the=20 brain.
N Engl J Med. 1990 Feb 22;=20 322(8):494-500.
[N Engl J Med. = 1990]
Treatment=20 of single brain metastasis: radiotherapy alone or combined with=20 neurosurgery?
Ann Neurol. 1993 Jun; = 33(6):583-90.
[Ann Neurol. 1993]
A=20 randomized trial to assess the efficacy of surgery in addition to = radiotherapy=20 in patients with a single cerebral metastasis.
Cancer. 1996 Oct 1; = 78(7):1470-6.
[Cancer. 1996]

See=20 more articles cited in this paragraph

A=20 randomized trial to assess the efficacy of surgery in addition to = radiotherapy=20 in patients with a single cerebral metastasis.
Cancer. 1996 Oct 1; = 78(7):1470-6.
[Cancer. 1996]
Treatment=20 of single brain metastasis: radiotherapy alone or combined with=20 neurosurgery?
Ann Neurol. 1993 Jun; = 33(6):583-90.
[Ann Neurol. 1993]
A=20 randomized trial of surgery in the treatment of single metastases to = the=20 brain.
N Engl J Med. 1990 Feb 22;=20 322(8):494-500.
[N Engl J Med. = 1990]

See=20 more articles cited in this paragraph

A=20 randomized trial to assess the efficacy of surgery in addition to = radiotherapy=20 in patients with a single cerebral metastasis.
Cancer. 1996 Oct 1; = 78(7):1470-6.
[Cancer. 1996]
A=20 randomized trial of surgery in the treatment of single metastases to = the=20 brain.
N Engl J Med. 1990 Feb 22;=20 322(8):494-500.
[N Engl J Med. = 1990]
Treatment=20 of single brain metastasis: radiotherapy alone or combined with=20 neurosurgery?
Ann Neurol. 1993 Jun; = 33(6):583-90.
[Ann Neurol. 1993]

See=20 more articles cited in this paragraph

A=20 randomized trial of surgery in the treatment of single metastases to = the=20 brain.
N Engl J Med. 1990 Feb 22;=20 322(8):494-500.
[N Engl J Med. = 1990]
Treatment=20 of single brain metastasis: radiotherapy alone or combined with=20 neurosurgery?
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Stereotactic=20 radiosurgery plus whole-brain radiation therapy vs stereotactic = radiosurgery=20 alone for treatment of brain metastases: a randomized controlled = trial.
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Stereotactic=20 radiosurgery plus whole-brain radiation therapy vs stereotactic = radiosurgery=20 alone for treatment of brain metastases: a randomized controlled = trial.
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A=20 multiinstitutional outcome and prognostic factor analysis of = radiosurgery for=20 resectable single brain metastasis.
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BORDER-LEFT-WIDTH: 0px; BORDER-BOTTOM-WIDTH: 0px; PADDING-BOTTOM: 0px; = PADDING-TOP: 0px; BORDER-RIGHT-WIDTH: 0px } .x-panel-btns-ct .x-panel-btns-right TABLE { CLEAR: none; FLOAT: right } .x-panel-btns-ct .x-panel-btns-left TABLE { CLEAR: none; FLOAT: left } .x-panel-btns-ct .x-panel-btns-center { TEXT-ALIGN: center } .x-panel-btns-ct .x-panel-btns-center TABLE { MARGIN: 0px auto } .x-panel-btns-ct TABLE TD.x-panel-btn-td { PADDING-RIGHT: 3px; PADDING-LEFT: 3px; PADDING-BOTTOM: 3px; = PADDING-TOP: 3px } .x-panel-btns-ct .x-btn-focus .x-btn-left { BACKGROUND-POSITION: 0px -147px } .x-panel-btns-ct .x-btn-focus .x-btn-right { BACKGROUND-POSITION: 0px -168px } .x-panel-btns-ct .x-btn-focus .x-btn-center { BACKGROUND-POSITION: 0px -189px } .x-panel-btns-ct .x-btn-over .x-btn-left { BACKGROUND-POSITION: 0px -63px } .x-panel-btns-ct .x-btn-over .x-btn-right { BACKGROUND-POSITION: 0px -84px } .x-panel-btns-ct .x-btn-over .x-btn-center { BACKGROUND-POSITION: 0px -105px } .x-panel-btns-ct .x-btn-click .x-btn-center { BACKGROUND-POSITION: 0px -126px } .x-panel-btns-ct .x-btn-click .x-btn-right { BACKGROUND-POSITION: 0px -84px } .x-panel-btns-ct .x-btn-click .x-btn-left { BACKGROUND-POSITION: 0px -63px } ------=_NextPart_000_0007_01CA6D1D.CD7D4AA0 Content-Type: text/css; charset="iso-8859-1" Content-Transfer-Encoding: quoted-printable Content-Location: http://www.ncbi.nlm.nih.gov/core/ext.ncbi/1/css/themes/xtheme-oldentrez.css .x-panel { BORDER-LEFT-COLOR: #d0d0d0; BORDER-BOTTOM-COLOR: #d0d0d0; = BORDER-TOP-STYLE: solid; BORDER-TOP-COLOR: #d0d0d0; BORDER-RIGHT-STYLE: = solid; BORDER-LEFT-STYLE: solid; BORDER-RIGHT-COLOR: #d0d0d0; = BORDER-BOTTOM-STYLE: solid } .x-panel-header { BORDER-RIGHT: #d0d0d0 1px solid; BORDER-TOP: #d0d0d0 1px solid; = BACKGROUND-IMAGE: url(../../img/oldentrez/panel/white-top-bottom.gif); = BORDER-LEFT: #d0d0d0 1px solid; COLOR: #333; BORDER-BOTTOM: #d0d0d0 1px = solid } .x-panel-body { BORDER-LEFT-COLOR: #d0d0d0; BORDER-BOTTOM-COLOR: #d0d0d0; = BORDER-TOP-COLOR: #d0d0d0; BORDER-RIGHT-COLOR: #d0d0d0 } .x-panel-bbar .x-toolbar { BORDER-LEFT-COLOR: #d0d0d0; BORDER-BOTTOM-COLOR: #d0d0d0; = BORDER-TOP-COLOR: #d0d0d0; BORDER-RIGHT-COLOR: #d0d0d0 } .x-panel-tbar .x-toolbar { BORDER-LEFT-COLOR: #d0d0d0; BORDER-BOTTOM-COLOR: #d0d0d0; = BORDER-TOP-COLOR: #d0d0d0; BORDER-RIGHT-COLOR: #d0d0d0 } .x-panel-tbar-noheader .x-toolbar { BORDER-LEFT-COLOR: #d0d0d0; BORDER-BOTTOM-COLOR: #d0d0d0; = BORDER-TOP-COLOR: #d0d0d0; BORDER-RIGHT-COLOR: #d0d0d0 } .x-panel-mc .x-panel-tbar .x-toolbar { BORDER-LEFT-COLOR: #d0d0d0; BORDER-BOTTOM-COLOR: #d0d0d0; = BORDER-TOP-COLOR: #d0d0d0; BORDER-RIGHT-COLOR: #d0d0d0 } .x-panel-body-noheader { BORDER-LEFT-COLOR: #d0d0d0; BORDER-BOTTOM-COLOR: #d0d0d0; = BORDER-TOP-COLOR: #d0d0d0; BORDER-RIGHT-COLOR: #d0d0d0 } .x-panel-mc .x-panel-body { BORDER-LEFT-COLOR: #d0d0d0; BORDER-BOTTOM-COLOR: #d0d0d0; = BORDER-TOP-COLOR: #d0d0d0; BORDER-RIGHT-COLOR: #d0d0d0 } .x-panel-tl .x-panel-header { COLOR: #333 } .x-panel-tc { BACKGROUND-IMAGE: url(../../img/oldentrez/panel/top-bottom.gif) } .x-panel-tl { BORDER-LEFT-COLOR: #d0d0d0; BACKGROUND-IMAGE: = url(../../img/oldentrez/panel/corners-sprite.gif); BORDER-BOTTOM-COLOR: = #d0d0d0; BORDER-TOP-COLOR: #d0d0d0; BORDER-RIGHT-COLOR: #d0d0d0 } .x-panel-tr { BACKGROUND-IMAGE: url(../../img/oldentrez/panel/corners-sprite.gif) } .x-panel-bc { BACKGROUND-IMAGE: url(../../img/oldentrez/panel/top-bottom.gif) } .x-panel-bl { BACKGROUND-IMAGE: url(../../img/oldentrez/panel/corners-sprite.gif) } .x-panel-br { BACKGROUND-IMAGE: url(../../img/oldentrez/panel/corners-sprite.gif) } .x-panel-mc { BACKGROUND: #f1f1f1 } .x-panel-mc .x-panel-body { BORDER-RIGHT: 0px; BORDER-TOP: 0px; BACKGROUND: none transparent scroll = repeat 0% 0%; BORDER-LEFT: 0px; BORDER-BOTTOM: 0px } .x-panel-ml { BACKGROUND-IMAGE: url(../../img/oldentrez/panel/left-right.gif) } .x-panel-mr { BACKGROUND-IMAGE: url(../../img/oldentrez/panel/left-right.gif) } .x-tool { BACKGROUND-IMAGE: url(../../img/oldentrez/panel/tool-sprites.gif) } .x-panel-ghost { BACKGROUND: #e0e0e0 } .x-panel-ghost UL { BORDER-LEFT-COLOR: #b0b0b0; BORDER-BOTTOM-COLOR: #b0b0b0; = BORDER-TOP-COLOR: #b0b0b0; BORDER-RIGHT-COLOR: #b0b0b0 } .x-grid-panel .x-panel-mc .x-panel-body { BORDER-RIGHT: #d0d0d0 1px solid; BORDER-TOP: #d0d0d0 1px solid; = BORDER-LEFT: #d0d0d0 1px solid; BORDER-BOTTOM: #d0d0d0 1px solid } .x-btn-left { BACKGROUND-IMAGE: url(../../img/oldentrez/button/btn-sprite.gif) } .x-btn-right { BACKGROUND-IMAGE: url(../../img/oldentrez/button/btn-sprite.gif) } .x-btn-center { BACKGROUND-IMAGE: url(../../img/oldentrez/button/btn-sprite.gif) } .x-border-layout-ct { BACKGROUND: #f0f0f0 } .x-accordion-hd { BACKGROUND-IMAGE: url(../../img/oldentrez/panel/light-hd.gif) } .x-layout-collapsed { BORDER-LEFT-COLOR: #e0e0e0; BORDER-BOTTOM-COLOR: #e0e0e0; = BORDER-TOP-COLOR: #e0e0e0; BACKGROUND-COLOR: #eee; BORDER-RIGHT-COLOR: = #e0e0e0 } .x-layout-collapsed-over { BACKGROUND-COLOR: #fbfbfb } .x-tip 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BUTTON { BACKGROUND-IMAGE: url(../../img/oldentrez/toolbar/btn-arrow.gif) } .x-toolbar .x-btn-text-icon .x-btn-menu-arrow-wrap .x-btn-center BUTTON = { BACKGROUND-IMAGE: url(../../img/oldentrez/toolbar/btn-arrow.gif) } .x-toolbar .x-btn-over .x-btn-left { BACKGROUND-IMAGE: url(../../img/oldentrez/toolbar/tb-btn-sprite.gif) } .x-toolbar .x-btn-over .x-btn-right { BACKGROUND-IMAGE: url(../../img/oldentrez/toolbar/tb-btn-sprite.gif) } .x-toolbar .x-btn-over .x-btn-center { BACKGROUND-IMAGE: url(../../img/oldentrez/toolbar/tb-btn-sprite.gif) } .x-toolbar .x-btn-over BUTTON { COLOR: #111 } .x-toolbar .x-btn-click .x-btn-left { BACKGROUND-IMAGE: url(../../img/oldentrez/toolbar/tb-btn-sprite.gif) } .x-toolbar .x-btn-pressed .x-btn-left { BACKGROUND-IMAGE: url(../../img/oldentrez/toolbar/tb-btn-sprite.gif) } .x-toolbar .x-btn-menu-active .x-btn-left { BACKGROUND-IMAGE: url(../../img/oldentrez/toolbar/tb-btn-sprite.gif) } .x-toolbar .x-btn-click .x-btn-right { BACKGROUND-IMAGE: url(../../img/oldentrez/toolbar/tb-btn-sprite.gif) } .x-toolbar .x-btn-pressed .x-btn-right { BACKGROUND-IMAGE: url(../../img/oldentrez/toolbar/tb-btn-sprite.gif) } .x-toolbar .x-btn-menu-active .x-btn-right { BACKGROUND-IMAGE: url(../../img/oldentrez/toolbar/tb-btn-sprite.gif) } .x-toolbar .x-btn-click .x-btn-center { BACKGROUND-IMAGE: url(../../img/oldentrez/toolbar/tb-btn-sprite.gif) } .x-toolbar .x-btn-pressed .x-btn-center { BACKGROUND-IMAGE: url(../../img/oldentrez/toolbar/tb-btn-sprite.gif) } .x-toolbar .x-btn-menu-active .x-btn-center { BACKGROUND-IMAGE: url(../../img/oldentrez/toolbar/tb-btn-sprite.gif) } .x-toolbar .ytb-sep { BACKGROUND-IMAGE: url(../images/default/grid/grid-split.gif) } .x-tab-panel-header { BORDER-LEFT-COLOR: #d0d0d0; BACKGROUND: #eaeaea; BORDER-BOTTOM-COLOR: = #d0d0d0; BORDER-TOP-COLOR: #d0d0d0; BORDER-RIGHT-COLOR: #d0d0d0 } .x-tab-panel-footer { BORDER-LEFT-COLOR: #d0d0d0; BACKGROUND: #eaeaea; BORDER-BOTTOM-COLOR: = #d0d0d0; BORDER-TOP-COLOR: #d0d0d0; BORDER-RIGHT-COLOR: #d0d0d0 } .x-tab-panel-header { BORDER-LEFT-COLOR: #d0d0d0; BORDER-BOTTOM-COLOR: #d0d0d0; = BORDER-TOP-COLOR: #d0d0d0; BORDER-RIGHT-COLOR: #d0d0d0 } .x-tab-panel-footer { BORDER-LEFT-COLOR: #d0d0d0; BORDER-BOTTOM-COLOR: #d0d0d0; = BORDER-TOP-COLOR: #d0d0d0; BORDER-RIGHT-COLOR: #d0d0d0 } UL.x-tab-strip-top { BORDER-LEFT-COLOR: #d0d0d0; BACKGROUND: = url(../../img/oldentrez/tabs/tab-strip-bg.gif) #dbdbdb repeat-x left = top; BORDER-BOTTOM-COLOR: #d0d0d0; BORDER-TOP-COLOR: #d0d0d0; = PADDING-TOP: 2px; BORDER-RIGHT-COLOR: #d0d0d0 } UL.x-tab-strip-bottom { BORDER-LEFT-COLOR: #d0d0d0; BACKGROUND-IMAGE: = url(../../img/oldentrez/tabs/tab-strip-btm-bg.gif); BORDER-BOTTOM-COLOR: = #d0d0d0; BORDER-TOP-COLOR: #d0d0d0; BORDER-RIGHT-COLOR: #d0d0d0 } .x-tab-strip SPAN.x-tab-strip-text { COLOR: #333 } .x-tab-strip-over SPAN.x-tab-strip-text { COLOR: #111 } .x-tab-strip-active SPAN.x-tab-strip-text { COLOR: #333 } .x-tab-strip-disabled .x-tabs-text { COLOR: #aaaaaa } 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url(../../img/oldentrez/tabs/tab-close.gif) } .x-tab-panel-body { BORDER-LEFT-COLOR: #d0d0d0; BACKGROUND: #fff; BORDER-BOTTOM-COLOR: = #d0d0d0; BORDER-TOP-COLOR: #d0d0d0; BORDER-RIGHT-COLOR: #d0d0d0 } .x-tab-panel-bbar .x-toolbar { BORDER-LEFT-COLOR: #d0d0d0; BORDER-BOTTOM-COLOR: #d0d0d0; = BORDER-TOP-COLOR: #d0d0d0; BORDER-RIGHT-COLOR: #d0d0d0 } .x-tab-panel-tbar .x-toolbar { BORDER-LEFT-COLOR: #d0d0d0; BORDER-BOTTOM-COLOR: #d0d0d0; = BORDER-TOP-COLOR: #d0d0d0; BORDER-RIGHT-COLOR: #d0d0d0 } .x-tab-panel-header-plain .x-tab-strip-spacer { BORDER-LEFT-COLOR: #d0d0d0; BACKGROUND: #eaeaea; BORDER-BOTTOM-COLOR: = #d0d0d0; BORDER-TOP-COLOR: #d0d0d0; BORDER-RIGHT-COLOR: #d0d0d0 } .x-tab-scroller-left { BORDER-LEFT-COLOR: #aeaeae; BACKGROUND-IMAGE: = url(../../img/oldentrez/tabs/scroll-left.gif); BORDER-BOTTOM-COLOR: = #aeaeae; BORDER-TOP-COLOR: #aeaeae; BORDER-RIGHT-COLOR: #aeaeae } .x-tab-scroller-right { BORDER-LEFT-COLOR: #aeaeae; BACKGROUND-IMAGE: = url(../../img/oldentrez/tabs/scroll-right.gif); BORDER-BOTTOM-COLOR: = #aeaeae; BORDER-TOP-COLOR: #aeaeae; BORDER-RIGHT-COLOR: #aeaeae } .x-window-proxy { BORDER-LEFT-COLOR: #b0b0b0; BACKGROUND: #e0e0e0; BORDER-BOTTOM-COLOR: = #b0b0b0; BORDER-TOP-COLOR: #b0b0b0; BORDER-RIGHT-COLOR: #b0b0b0 } .x-window-tl .x-window-header { COLOR: #555 } .x-window-tc { BACKGROUND-IMAGE: url(../../img/oldentrez/window/top-bottom.png) } .x-window-tl { BACKGROUND-IMAGE: url(../../img/oldentrez/window/left-corners.png) } .x-window-tr { BACKGROUND-IMAGE: url(../../img/oldentrez/window/right-corners.png) } .x-window-bc { BACKGROUND-IMAGE: url(../../img/oldentrez/window/top-bottom.png) } .x-window-bl { BACKGROUND-IMAGE: url(../../img/oldentrez/window/left-corners.png) } .x-window-br { BACKGROUND-IMAGE: url(../../img/oldentrez/window/right-corners.png) } .x-window-mc { BORDER-RIGHT: #d0d0d0 1px solid; BORDER-TOP: #d0d0d0 1px solid; = BACKGROUND: #e8e8e8; BORDER-LEFT: #d0d0d0 1px solid; BORDER-BOTTOM: = #d0d0d0 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