Phase II trial of high-dose carboplatin and etoposide with autologous bone marrow transplantation in first-line therapy for patients with poor-risk germ cell tumors.

摘要: BACKGROUND Between 20% and 30% of patients with advanced germ cell tumors (GCTs) fail to have durable complete response conventional cisplatin-based induction chemotherapy. However, third-line therapy high-dose carboplatin etoposide plus autologous bone marrow transplantation (AuBMT) has induced in 10%-20% cisplatin-resistant GCT. PURPOSE We conducted a phase II trial first-line that included AuBMT untreated men GCTs unfavorable prognosis (i.e., "poor-risk" patients). METHODS Twenty-eight were treated conventional-dose, cisplatin-containing regimen (VAB-6 [cisplatin, vinblastine, bleomycin, cyclophosphamide, dactinomycin]) or without (1500 mg/m2) (1200 AuBMT. Twenty-two these selected for treatment two cycles when reduced clearance serum tumor markers (alpha-fetoprotein [AFP] human chorionic gonadotropin [HCG]), as evidenced by prolonged half-life (> 7 days AFP > 3 HCG), was observed after treatment. RESULTS Fifteen (56%) 27 considered assessable achieved (12 chemotherapy AuBMT). Sixteen (57%) are alive; 13 (46%) free disease at median follow-up 31.2 months. For 36 chemotherapy, the duration from infusion until granulocyte count 0.5/mm3 platelet 50,000/mm3 16 (range, 7-41 8-30 days, respectively). Analysis showed trend toward improved survival (P = .07) this study, compared 68 poor-risk GCT conventional-dose alone earlier studies. Toxicity not cumulative, recovery blood counts generally rapid. CONCLUSIONS Inclusion carboplatin-containing is feasible marker used predict resistance standard therapy. High-dose setting well tolerated. IMPLICATIONS Early use dose-intensive may increase alone. Further studies intensive using hematopoietic growth factor support warranted, followed randomized comparing strategy