Three-weekly BEP has been a standard of CT of advanced NSGCT for last two decades. We performed a phase II study to assess the efficacy and toxicity of two-weekly aBEP regimen in the first line treatment of NSGCT. Here we report final efficacy and safety results.
CT-naïve NSGCT pts with intermediate or poor prognosis (IGCCCG) received aBEP as follows: cisplatin 20 mg/m2 days 1-5, etoposide 100 mg/m2 days 1-5, bleomycin 30 IU days 1,3,5 with G-CSF support 300 mcg days 6-10. Four cycles of aBEP were administered every 2 weeks. The primary endpoint was the progression free rate.
From 2010 to 2014, 67 pts were treated. Intermediate and poor prognosis according IGCCCG had 35 (59%) and 32 (41%) of pts, respectively. In poor prognostic group mediastinal primary tumor had 11 (34%) pts, nonpulmonary visceral metastases - 16 (50%) pts. All pts were assessed for toxicity, which included (grade 3/4, per patient) neutropenia 72%, febrile neutropenia 26%, thrombocytopenia 18%, non-neutropenic infection 3%, anemia 31%. There were no toxic deaths. Dose reduction of cisplatin, etoposide and bleomycin were done on 16 (6.4%), 22 (8.9%) and 19 (7.7%) of 247 cycles, respectively. Median number of cycles was 4 (3-5). Two pts could not receive 4-th cycle due to toxicity. Median duration of treatment (from the first to the last doses of CT) was 7.4 (6.7-10.4) weeks. Totally 44 (72%) pts were able to start 4-th cycle of aBEP by day 50 (<1 week of delay). Median time of f.-up was 74 (5-108) months. Five-years PFS and OS were 88% and 85% (intermediate risk), 63% and 53% (poor risk). There were a trend to improvement of OS in poor risk group over 3-weekly BEP regimen in our center (n = 79, 5-y OS 45%, p = 0.09).
Two-weekly BEP regimen can be safely administered to NSGCT pts with intermediate and poor prognosis. Promising efficacy of aBEP warrants confirmation in ongoing randomized trial.
Clinical trial identification
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All authors have declared no conflicts of interest.