Nab-paclitaxel plus S-1 versus nab-paclitaxel plus gemcitabine as first-line chemotherapy in patients with advanced panc
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ORIGINAL ARTICLE – CLINICAL ONCOLOGY
Nab‑paclitaxel plus S‑1 versus nab‑paclitaxel plus gemcitabine as first‑line chemotherapy in patients with advanced pancreatic ductal adenocarcinoma: a randomized study Yuan Zong1 · Jiajia Yuan1 · Zhi Peng1 · Ming Lu1 · Xicheng Wang1 · Lin Shen1 · Jun Zhou1 Received: 15 September 2020 / Accepted: 27 October 2020 © Springer-Verlag GmbH Germany, part of Springer Nature 2020
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://clinicaltr ials.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. Keywords Advanced pancreatic ductal adenocarcinoma · Chemotherapy · Nab-paclitaxel · S-1 · Gemcitabine · Objective response rate
Background Pancreatic cancer is a highly lethal malignant neoplasm with a poor prognosis, and it is the fourth leading cause of cancer death in the USA and the sixth in China (Siegel et al. 2018; This work was presented as a poster presentation at Gastrointestinal Cancers Symposium (#GI20) held in San Francisco, California, January 23–25, 2020. Yuan Zong and Jiajia Yuan contributed equally to this work. * Jun Zhou [email protected] 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
Chen et al. 2016). Nearly 80% of patients are ineligible for surgical resection at the time of diagnosis because of an advanced stage (Kamisawa et al. 2016). The 5-year survival rate for distant disease is as low as 3% (Siegel et al. 2018). Chemotherapy remains the mainstay for advanced pancreatic du
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