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.
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Data availability
The data and material used and/or analyzed during the current study are available from the corresponding author upon request.
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Acknowledgements
We would like to thank all participating patients and their families. We would like to thank AJE (https://www.aje.cn) for providing linguistic assistance during the preparation of this manuscript as well.
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Y.Z. wrote the main manuscript and did the statistical analysis. J.Y., Z.P., M.L. and X.W. helped in the acquisition of data. L.S. helped in study design and article revision. J.Z. helped in study design, article revision, and takes responsibility for the accuracy of the statistical analysis. All the authors have read and approved the article.
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The authors declare that they have no conflict of interest.
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The trial was approved by the Ethics Committee of Beijing Cancer Hospital.
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Each participant provided written informed consent.
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Yuan Zong and Jiajia Yuan contributed equally to this work.
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Zong, Y., Yuan, J., Peng, Z. et al. Nab-paclitaxel plus S-1 versus nab-paclitaxel plus gemcitabine as first-line chemotherapy in patients with advanced pancreatic ductal adenocarcinoma: a randomized study. J Cancer Res Clin Oncol 147, 1529–1536 (2021). https://doi.org/10.1007/s00432-020-03442-0
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DOI: https://doi.org/10.1007/s00432-020-03442-0