Objectives:
To evaluate paclitaxel, bleomycin, etoposide, and cisplatin (t-bep) in patients with poor-prognosis nonseminomatous germ cell tumor (nsgct). paclitaxel is an active treatment of nonseminomatous germ cell tumors.
Methods:
The present study was an open-label, single-center, phase ii study. chemotherapy-naive patients received t-bep (paclitaxel 175 mg/m2 [day 2], cisplatin 20 mg/m2 [days 1-5], etoposide 100 mg/m2 [days 1-5], bleomycin 30 iu [days 1, 3, and 5]), and granulocyte colony-stimulating factor 300 ฮผg (days 6-10). the number of cycles (range 4-6) was dependent on the normalization of tumor markers. secondary resection was planned for patients with tumor marker-negative partial remission. assessments included radiologic response, tumor markers, and safety. the primary endpoint was progression-free survival (pfs) 1 year after chemotherapy.
Results:
Of 51 patients, 49 completed chemotherapy and were evaluable for response: 12 (25%) had a complete response, 29 (59%) were marker-negative (tumor marker normalization) and 3 (6%) were marker-positive (tumor marker decrease for โฅ1 month) incomplete responders, and 5 (10%) had progressive disease. a total of 37 patients underwent secondary resection. after the treatment of 27 patients, an unplanned analysis showed inappropriate toxicity at cycle 1 (grade 3-4 infection [6 patients] resulting in 2 toxic deaths), which led to treatment modification (bep [cycle 1], t-bep [subsequent cycles]), with no further toxic deaths observed. grade 3-4 adverse events included neutropenia (71%), febrile neutropenia (33%), and infection (14%). during the first year after chemotherapy, 1 patient was lost to follow-up, and 21 patients relapsed. the pfs rate at 1 year after chemotherapy was 58% (29 of 50 patients).
Conclusions:
T-bep did not improve pfs in patients with poor-prognosis nsgct. the administration of t-bep from cycle 1 resulted in excessive toxicity but was administered safely from cycle 2.