FILGRASTIM DURING COMBINATION CHEMOTHERAPY OF PATIENTS WITH POOR-PROGNOSIS METASTATIC GERM-CELL MALIGNANCY

Purpose: To determine the effect of r-metHu granulocyte colony-stimula ting factor (G-CSF) on the proportion of patients with metastatic poor -prognosis malignant germ cell tumors who receive full dose-intensity combination chemotherapy. Patients and Methods: In a phase ill study p atients received six cycles of BEP/EP (etoposide, and cisplatin, plus or minus bleomycin) or six cycles of BOP/VIP-B (bleomycin, vincristine , cisplatin/etoposide, ifosfamide, cisplatin, bleomycin). A subset wer e secondarily randomized to receive or not receive filgrastim. Filgras tim 5 mu g/kg/day was administered subcutaneously on days 3 through 9 after each BOP and on days 6 through 19 after each VIP, BEP, or EP cyc le. Results: Eighty five percent of 120 eligible patients randomized t o filgrastim received at least six chemotherapy cycles compared with 7 0% of 130 patients randomized to not receive filgrastim (VCP = .003). Patients in the filgrastim-arm achieved significantly higher dose-inte nsities. Neutropenic fever occurred in 25 of 128 filgrastim-patients a nd in 38 of 129 non filgrastim-patients (P = .052). Twelve and three t oxic deaths occurred in the non-filgrastim- and filgrastim-arms, respe ctively. Nine of the 12 toxic deaths and all of the three toxic deaths were associated with febrile grade 4 neutropenia. Failure-free and ov erall survival were similar in both arms. Conclusion: During combinati on chemotherapy in patients with malignant germ cell tumors, the routi ne use of filgrastim significantly improved the delivery of the planne d treatment schedule without effect on failure-free or overall surviva l. The use of filgrastim was associated with a clinically important re duction in the number of toxic deaths, confined to the experimental in tensified-chemotherapy schedule. This study does not support the routi ne use of filgrastim during standard chemotherapy with BEP. (C) 1998 b y American Society of Clinical Oncology.