Results of Interim Analysis of Prospective Randomized Multicenter Open-Label Study in Comparison of Efficacy and Toxicity of Beacopp-14 and Beacopp-Esc Regimens in Patients with Hodgkin'S Lymphoma from Poor-Prognosis Group

Abstract

ABSTRACT Aim: The aim of the study was to evaluate overall response rate (ORR), complete response rate (CRR), 3-year overall survival (OS), and toxicity of BEACOPP-14 and BEACOPP-esc regimens. Methods: Since September 2008 until December 2013 215 patients from 18 to 65 years old (median 30 years), 90 male and 125 female with stage ІІВ with 1 unfavorable factor and stage III-IV. Patients were randomized to receive ВЕАСОРР-14 (98 patients) or ВЕАСОРР-esc (117 patients). The treatment efficacy in both groups was evaluated by Сheson criterion (1999, 2007). Toxicity rates were evaluated according to NCI-CTC V.3.0. After completion of chemotherapy patients with initial sites >5 cm, residual lymph nodes >2 cm and PET-positive sites received radiotherapy (30-36 Gy). Results: Both groups were similar by clinical and laboratory characteristics. ORR was 98.0% in the group of BEACOPP-14 and 98.3% in the group of BEACOPP-esc. CRR was 81% in the group of BEACOPP-14 and 73.5%, in the group of BEACOPP-esc, р > 0.05. Maximal observation period was 72 months, median 32 months. 3-year OS in the group of BEACOPP-14 was 94.2% vs 92.6% in the group of BEACOPP-esc, p > 0.05. Toxicity was observed in 62.4% of cycles in the group of BEACOPP-14 and in 57.8% cycles in the group of BEACOPP-esc, p > 0.05. 3 patients had died in the group of BEACOPP-esc due to toxicity. There was no difference in haematological toxicity grade 3-4 in both groups: anemia was observed in 16% of cases in the group of BEACOPP-14 vs 14% of cases in the group of BEACOPP-esc, thrombocytopenia – in 3% of cases in both groups (p> 0.05), neutropenia – in 45% vs 41% of cases, respectively (p Conclusions: During the interim analysis of our study any significant difference in efficacy of BEACOPP-14 and BEACOPP-esc regimens were not revealed. The rate of neutropenia gr. 3-4 was significantly higher in the group of BEACOPP-14 than in the group of BEACOPP-esc. This didn't influence the rate of febrile neutropenia and infections. The further analysis will allow making the final conclusion in comparison of the efficacy and toxicity of BEACOPP-14 and BEACOPP-esc. Disclosure: All authors have declared no conflicts of interest.