T-BEP-ANOTHER ANTICIPATED FAILURE

Urology. 2011 Jul 14. [Epub ahead of print]

Paclitaxel + BEP (T-BEP) Regimen as Induction Chemotherapy in Poor Prognosis Patients With Nonseminomatous Germ Cell Tumors: A Phase II Study.

Tryakin A, Fedyanin M, Kanagavel D, Fainstein I, Sergeev J, Polockij B, Matveev V, Zakharova T, Garin A, Tjulandin S.

Source

NN Blokhin Russian Cancer Research Center, Moscow, Russia.

Abstract

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/m(2) [day 2], cisplatin 20 mg/m(2) [days 1-5], etoposide 100 mg/m(2) [days 1-5], bleomycin 30 IU [days 1, 3, and 5]), and granulocyte colony-stimulating factor 300 μg (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 ≥1 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.