5389 - Two-weekly accelerated BEP (aBEP) regimen as induction chemotherapy (CT) in intermediate and poor prognosis patients (pts) with nonseminomatous germ cell tumors (NSGCT): final results of phase II trial.

Background

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.

Methods

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.

Results

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).

Conclusions

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

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.