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Tamoxifen
and carboplatin combinational treatment of high-grade gliomas.
Results of a
clinical trial on newly diagnosed patients
Mastronardi
L, Puzzilli F, Couldwell WT, Farah JO, Lunardi P.
Department
of Neurological Sciences, Civilian Hospital of Terni, Italy
Between
April, 1992 and December, 1995, forty consecutive patients with a cerebral
malignant glioma (WHO Grade III and IV) were enrolled in a trial consisting in
surgery and post-operative administration of radiotherapy (4500-6000 cGy),
carboplatin (CBDCA; dose of 450-600 mg/m2), and oral tamoxifen (TAM; at doses of
40, 80 or 120 mg/day).
Two patients of the TAM group died in the postoperative period from a pulmonary
embolism and myocardial infarction, respectively.
The patients (all dosages combined) had a median survival time of 13 months from
the time of diagnosis.
The 12-month and 24-month survival rates were 52% and 32%, respectively.
The median relapse-free survival time was 7 months.
Patients treated with higher doses of TAM (80-120 mg/day) demonstrated a longer
median survival rate (13 months both) and a longer 12-month survival result (58%
and 76%, respectively).
Patients who assumed TAM for a period longer than 3 months (group +3) have a
higher median survival rate (16 months) and better 12-month and 24-month results
(62% and 40%, respectively).
Moreover, the median relapse-free survival time was 10 months (versus 6 months
in group -3; p = 0.0038).
However, it is not possible to exclude that patients of group +3 had a slower
growing or a stable tumor and were well enough to assume TAM for a longer
period.
The results observed in the TAM-group have been compared with those of 40
matched controls treated with surgery, radiotherapy and CBDCA.
These patients had a median survival time of 9 months (p = 0.04) and the
12-month and 24-month survival rates were 30% and 0%, respectively.
The median relapse-free survival time was 4 months (p = 0.0014).
These data suggest a potential role for combinational TAM-CBDCA therapy in the
post-operative treatment of cerebral malignant gliomas; further clinical phase
III trials, especially those with higher dosages of TAM are warranted.
PMID:
9540058 [PubMed - indexed for MEDLINE]
Source:
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=9540058&dopt=Abstract
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