Study of Bendamustine, Gemcitabine and Vinorelbine Regimen in Relapsed/Refractory Classical Hodgkin Lymphoma

Overview

The goal of this phase III clinical trial was to make a direct head to head comparison between the chemotherapeutics; Bendamustine, Gemcitabine and Vinorelbine (BEGEV) and the the Gemcitabine, Dexamethasone and Cisplatin (GDP) regimens in the settings of relapsed and refractory classical Hodgkin lymphoma. Patients were allocated and randomly assigned to either arm. Cycles were received as out-patient setting, every 21 days. Patients were assessed by clinical and routine labs, before receiving the cycle. Efficacy was assessed by performing Positron Emission Tomography (PET-CT) after three cycles. Toxicity was reported according to the National Cancer Institute Common Terminology Criteria of AEs v4.0 and was dealt with accordingly. Patients attained at least partial response (PR) was sent for high dose chemotherapy followed by autologous stem cell rescue(HDC/ASCR). Patients were followed up for a total of 1 year

Patients with primary refractory and relapsed classical Hodgkin lymphoma attended the medical oncology department at the National Cancer Institute, Cairo University, Egypt during the period from April, 2024 to October, 2024 were randomly assigned in the 2 treatment groups using online random number generator. Exclusion criteria include age less than 18 year, Eastern Cooperative Oncology Group(ECOG) performance status less than 2, pregnancy, second cancers chronic kidney disease, end stage renal disease, liver cell failure, HIV, HCV, HBV, and autoimmune diseases. The basic, epidemiological, clinical, laboratory, pathological, and radiological data, and complete staging was recorded at the baseline. The BEGEV regimen was administered as follows: gemcitabine 800 mg/m2 and prednisolone 100 mg per day on days 1 and 4, vinorelbine 20 mg/m2 on day 1, and bendamustine 90 mg/m2 on days 2 and 3. The GDP regimen was administered as follows: Gemcitabine 1000 mg/m2 days 1 and 8, dexamethasone 20 mg/m2 days 1-4 and days 11-14 and cisplatin 25 mg/m2 days 1-3. Cycles were repeated every 21 days for a total of 4 cycles, guided by the clinical situation. Side effects were reported according to National Cancer Institute Common Terminology Criteria of AEs v4.0 and was dealt with accordingly. Interim evaluation was done after 3 cycles and response was reported according to the International Workshop for Response Criteria for non-Hodgkin lymphomas. Patients who attained at least partial response were sent for autologous stem cell transplantation and the same evaluation was repeated post-transplant. Patients was followed every 3 months for a total of 1 year and relapse, mortality, progression free survival, disease free survival, and overall survival, were recorded. Sample size calculation: A study conducted by Stefoni et al. (2023) assessed the effectiveness of BEGEV regimen and reported that the overall response rate was 76.7%, another study by Rybka et al. (2015) assessed the effectiveness of GDP regimen and reported that the overall response rate was 31% in Hodgkin lymphoma patients. A total sample size of 44 (22 in each group) was needed for this study with alpha 5% and power 80%. Sample size calculation was done using MedCalc program version 18.2.1.