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Phase II trial of
radiosurgery (RS) for 1 to 3 newly diagnosed brain metastases from renal cell,
melanoma, and sarcoma: An Eastern Cooperative Oncology Group Study (E6397)
R. R. Mañon, A. Oneill, M. Mehta, J. Knisely, M. Werner-Wasik, H. Lazarus,
H. Wagner, M. Gilbert
University of Wisconsin, Madison, WI; Dana Farber Cancer
Institute, Boston, MA; Yale School of Medicine, New Haven, CT; Thomas Jefferson
University Hospital, Philadelphia, PA; University Hospitals of Cleveland,
Cleveland, OH; Penn State Cancer Institute, Hershey, PA; M. D. Anderson Cancer
Center, Houston, TX.
Background.
Whole brain radiation therapy (WBRT) is considered standard
therapy for patients (pts.) w/ brain metastasis.
Long term survivors are at risk for CNS morbidity, and the value of low doses of
WBRT in radioresistant tumors is suspect.
RS emerged as a treatment modality, and retrospective analyses found no
difference in survival when RS is given up front.
Prior to evaluating RS w/ delayed WBRT in a Phase III trial, the feasibility of
RS alone was prospectively tested in this phase II trial.
Methods.
Pts. w/ histologically confirmed renal cell carcinoma, melanoma,
or sarcoma, w/ 1-3 brain metastases, ECOG performance status (PS) of 0-2, and no
previous cranial RT were enrolled.
Exclusion criteria were: leptomeningeal disease; metastases in medulla, pons, or
midbrain; multiple liver metastases.
Based on tumor size, pts. received 24, 18, or 15 Gy RS dose.
At recurrence, treatment was at the discretion of treating physicians.
Results.
Between 7/98 and 8/03, 36 pts. accrued; to date, 32 eligible by
entry criteria; 28/32 were male and the median number of lesions was 1.
ECOG PS was: 44% PS 0; 34% PS 1; 19% PS 2.
With median F/U of 25 mo., median survival (MS) was 8.3 mo. (95% CI 6.8-13.7);
22/ 32 pts. died, 7/22 (32%) from CNS death; 3% had PR, 34% had stable disease,
41% had PD, and 13% were unevaluable (scans not performed).
Three and 6 month in-field failures were 28 and 45% (includes simultaneous
failures in-field and outside field), and failure rates outside the
radiosurgery volume at 3 and 6 months were 4 and 17%.
There were 3 ≥ grade 3 CNS toxicities, possibly related to RS.
Conclusions.
In this study, MS was equivalent to published surgical and
concurrent RS +WBRT series and better than WBRT alone.
Failures outside RS field were low and treatment was well tolerated.
Response rates and failures w/ in the RS volume were higher than historic
controls.
Delaying WBRT may be appropriate for some subgroups of patients w/
radioresistant tumors, but failures beyond 6 mo. have not been addressed
yet.
Based on these results, a phase III randomized study evaluating the RS alone in
some subsets of patients is warranted.
Copyright 2004 American Society of Clinical Oncology All rights
reserved worldwide.
Source: http://www.asco.org/ac/1,1003,_12-002636-00_18-0026-00_19-001665,00.asp
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