Temozolomide (TMZ) in Patients with Brain Metastases from NSCLC in Combination with Gemcitabine-Cisplatin (GEM-CDDP) or Gemcitabine-Vinorelbine (GEM+VNB). Alessandra Mangiameli, Giuseppe Mineo, Guglielmo M Trovato, Casa di Cura Musumeci-Gecas, Catania, Italy; Università di Catania, Catania, Italy.
Presented at the American Society Of Clinical Oncology, 2001 Conference

Temozolomide (TMZ) is a new orally-administered alkilating agent with pre-clinical evidence of activity against a variety of solid tumours. TMZ in combination with Gemcitabine-Cisplatin (GEM+CDDP) or Gemcitabine-Vinorelbine (GEM+VNB) has demonstrated activity in pre-treated advanced non-small-cell-lung-cancer (NSCLC) (with brain metastases). We evaluated the feasibility, efficacy and tolerability of 2 therapeutic schedules with rHu-EPO support in the CDDP containing regimen. From December 1999 to November 2000 we treated 8 patients with brain metastases of NSCLC. Demography was: M/F = 6/2; median age = 58,9 (range 48-69); PS 0/1/2 = 6/1/1. Four patients received TMZ 150 mg/m2 day 1-5 in combination with GEM 1000 mg/m2 day 1,8 plus CDDP 50 mg/m2 day 1,8 every 21 days. Four patients received TMZ 150 mg/m2 day 1-5 GEM 1000mg/m2 day 1,8 plus VNB 25 mg/m2 day 1,8 every 21 days. Five patients (62,5 %) had a major response with 3 complete remissions (CR). One patient progressed (P) and two are too early for response evaluation. Two of three patients performing complete remission received TMZ + GEM-CDDP and one received TMZ + GEM-VNB. The treatment was generally well tolerated. Grade 2-3 neutropenia occurred in two cases; grade 2-3 anaemia in three cases; grade 2 neurotoxicity was observed in three cases; grade 1 nausea in one case.
Conclusions: In our preliminary experience chemotherapy with Temozolomide plus Gemcitabine-Cisplatin or Gemcitabine-Vinorelbine is feasible and well tolerated, and showed high activity with low toxicity.