Yuan Zong1, Jiajia Yuan1, Zhi Peng1, Ming Lu1, Xicheng Wang1, Lin Shen1, Jun Zhou2. 1. Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Gastrointestinal Oncology, Peking University Cancer Hospital & Institute, Fucheng Road 52, Haidian District, Beijing, 100142, China. 2. Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Gastrointestinal Oncology, Peking University Cancer Hospital & Institute, Fucheng Road 52, Haidian District, Beijing, 100142, China. 13366152815@126.com.
Abstract
PURPOSE: To investigate the efficacy and safety of nab-paclitaxel plus S-1 (nab-P/S) versus nab-paclitaxel plus gemcitabine (nab-P/G) as first-line chemotherapy in patients with advanced pancreatic ductal adenocarcinoma (PDAC). METHODS:Treatment-naïve patients with advanced PDAC were equally randomized to receive nab-P/S or nab-P/G. The primary endpoint was the objective response rate (ORR). The secondary endpoints were ORR of the primary lesion, disease control rate, progression-free survival (PFS), overall survival (OS) and safety. The trial was registered at https://clinicaltrials.gov as NCT03636308. RESULTS: A total of 110 patients were planned for enrollment, but the trial was prematurely closed because no better ORR was observed with nab-P/S among the first 40 patients assigned between 08/2018 and 06/2019. The ORR was numerically higher with nab-P/S versus nab-P/G (35.0% vs 25.0%, P = 0.49). The ORRs of the primary lesion for both arms were similar (30.0% and 25.0%, P = 0.72). Disease control rate was 70.0% in each arm. There was no significant difference in PFS and OS between the two arms (median PFS, 6.3 vs 5.7 months, P = 0.34; median OS, 10.2 vs 10.2 months, P = 0.92). Risks of hematological toxicity, liver injury and rash were significantly decreased in the nab-P/S arm. CONCLUSIONS: A biweekly combination of nab-P/S yielded comparable efficacy with nab-P/G but improved safety profile. It may be a promising and convenient alternative as first-line and neoadjuvant settings for advanced PDAC.
RCT Entities:
PURPOSE: To investigate the efficacy and safety of nab-paclitaxel plus S-1 (nab-P/S) versus nab-paclitaxel plus gemcitabine (nab-P/G) as first-line chemotherapy in patients with advanced pancreatic ductal adenocarcinoma (PDAC). METHODS: Treatment-naïve patients with advanced PDAC were equally randomized to receive nab-P/S or nab-P/G. The primary endpoint was the objective response rate (ORR). The secondary endpoints were ORR of the primary lesion, disease control rate, progression-free survival (PFS), overall survival (OS) and safety. The trial was registered at https://clinicaltrials.gov as NCT03636308. RESULTS: A total of 110 patients were planned for enrollment, but the trial was prematurely closed because no better ORR was observed with nab-P/S among the first 40 patients assigned between 08/2018 and 06/2019. The ORR was numerically higher with nab-P/S versus nab-P/G (35.0% vs 25.0%, P = 0.49). The ORRs of the primary lesion for both arms were similar (30.0% and 25.0%, P = 0.72). Disease control rate was 70.0% in each arm. There was no significant difference in PFS and OS between the two arms (median PFS, 6.3 vs 5.7 months, P = 0.34; median OS, 10.2 vs 10.2 months, P = 0.92). Risks of hematological toxicity, liver injury and rash were significantly decreased in the nab-P/S arm. CONCLUSIONS: A biweekly combination of nab-P/S yielded comparable efficacy with nab-P/G but improved safety profile. It may be a promising and convenient alternative as first-line and neoadjuvant settings for advanced PDAC.
Authors: Anabela G Barros; Catarina F Pulido; Manuela Machado; Maria José Brito; Nuno Couto; Olga Sousa; Sónia A Melo; Hélder Mansinho Journal: Int J Oncol Date: 2021-12-03 Impact factor: 5.650