Journal of Clinical Oncology, 2005 ASCO Annual Meeting Proceedings.
Vol 23, No 16S (June 1 Supplement), 2005: 1575
© 2005 American Society of Clinical Oncology

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Abstract

Phase II trial of thalidomide (TD), tamoxifen (TX), and temozolomide (T) for patients with advanced malignant gliomas (MG)

New York Medcl Coll, Valhalla, NY

1575

Background: Patients with MG have a poor survival despite surgery, radiation therapy (RT). Chemotherapy (CTX) is often used but the overall impact on survival is poor. Methods: We studied the combination of TD, TX and T in a phase II trial for patients with MG. Standard response criteria and NCI toxicity criteria were used. We also assessed quality-of-life (QoL). Eligibility criteria included histologic confirmation of Glioblastoma (GBM) or Anaplastic astrocytoma (AA), no chemo or RT for 3 weeks and ECOG PS of 2. 20 patients entered the trial: 8 were female; median age 51 years (r 24–84); 17 had GBM and 3 had AA. 9 patients had prior RT and 5 prior CTX. 28-day treatment cycles consisted of daily TD 100 mg PO and TX 100 mg PO for the full duration of each cycle and T 75 mg/m2 PO) for the first 21 days of each cycle. Treatment continued until disease progression. Primary outcomes measures were patient survival, response, toxicity and changes in QoL. Results: 6 patients discontinued therapy prior to response evaluation. 9 of 14 patients had disease stabilization and response (64%, 95% CI, 39%–89%), lasting 8–135 weeks (median 12 weeks) documented by MRI scan. No CR was seen. One patient remained progression free for 2 years. By Kaplan Meier analysis, mean survival was 75 ± 18 weeks (95% CI, 41–110 weeks) with a median time to progression of 47 weeks (95% CI, 15–79 weeks). One patient had a sustained decrease in WBC and T was held. Mean WBC was 9.4 x10e3/ul, which fell to a mean of 5.58 x 10e3/ul. Hgb and platelets were not significantly affected. 4 patients developed deep vein thrombosis (DVT): subsequent patients were given prophylactic warfarin. 2 patients had pulmonary embolism. No other grade 3 or 4 toxicities were noted. Changes in QoL scores during treatment did not significantly correlate with disease progression. Conclusions: Outpatient therapy with temozolomide, thalidomide, and tamoxifen is well tolerated and results in stabilization/response in 64% of patients. Prophylaxis with warfarin may prevent DVT in patients on tamoxifen. The overall impact on survival will require further study. Supported by the ZA Arlin Cancer Research Institute, Schering-Plough Corp. and Celgene Corp

Author Disclosure

Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Celgene, Schering-Plough