Chemotherapy intensification for first-line treatment of poor-prognosis metastatic germ cell cancer is not yet ready for prime time

摘要

The standard treatment for metastatic, poor-risk nonseminomatous germ cell tumor (NSGCT) based on International Germ Cell Cancer Collaborative Group (IGCCCG) risk stratification is four cycles of bleomycin, etoposide, cisplatin (BEP) or ifosfamide, etoposide, and cisplatin (VIP) chemotherapy in patients who are not suitable for bleomycin. Rate of tumor marker decline during initial chemotherapy is prognostic for survival and may help identify patients who may be resistant to standard chemotherapy. GETUG-13 was a phase 3, multicenter, randomized trial including patients with untreated, metastatic, poor-risk NSGCT. Following one cycle of BEP, marker decline kinetics, defined by a logarithmic formula, were calculated. Among 254 patients, 203 (80%) with unfavorable decline (estimated time to normalization above pre-defined cutoffs or rising levels at cycle 2) were randomized to continue standard BEP for an additional three cycles, or switch to dosedense chemotherapy consisting of two cycles of paclitaxel, BEP, oxaliplatin (T-BEP-O) followed by two cycles of cisplatin, bleomycin, ifosfamide (PBI) with granulocyte colony stimulating factor support.