Summary
Purpose. This study aimed to evaluate the effectiveness and safety of gemcitabine (GEM) plus nab-paclitaxel (GnP) in patients aged ≥ 75 years with advanced pancreatic cancer and compare it with monotherapy (GEM or S-1). Methods. We retrospectively reviewed the data of consecutive patients with advanced pancreatic cancer aged ≥ 75 years who received either GnP or monotherapy (GEM or S-1) between January 2014 and May 2020. The primary efficacy outcome was overall survival (OS). Results. A total of 96 patients were included in this study; 51 were treated with GnP and 45 with monotherapy (31 with GEM and 14 with S-1). The median OS and progression-free survival were 10.8 and 6.7 months in the GnP group and 10.7 and 4.3 months in the monotherapy group, respectively. The treatment effect on OS was consistently favorable in the GnP group across most subgroups, particularly in patients with locally advanced cancer, modified Glasgow prognostic score of 0 or 1, and neutrophil/lymphocyte ratio < 3.1. The disease control rates were 76% and 48% in the GnP and monotherapy groups, respectively, and grade 3 or 4 neutropenia occurred in 23 (45%) and 11 (24%) patients of the GnP and monotherapy groups, respectively. Conclusions. This study demonstrated that GnP was not superior to monotherapy with regard to OS. However, multivariate analysis showed that GnP treatment positively affected the OS and could be considered as a treatment option, even for elderly patients.
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All authors contributed to the study conception and design. Data collection and analysis was performed by Sae Ohwada. The first draft of the manuscript was written by Sae Ohwada and Akiko Todaka. All authors commented on previous versions of the manuscript. All authors read and approved the final version of the manuscript.
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This research study was conducted in accordance with the Declaration of Helsinki (as revised in Fortaleza, Brazil in October 2013). The study design was approved by the Institutional Review Board of the Shizuoka Cancer Center (IRB No. J2020-128–2020-1–3). Patients were not required to give informed consent to the study because the analysis used anonymous clinical data that were obtained after each patient agreed to treatment by written consent.
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Patients were not required to give informed consent to the study because the analysis used anonymous clinical data that were obtained after each patient agreed to treatment by written consent.
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This research study was conducted in accordance with the Declaration of Helsinki (as revised in Fortaleza, Brazil in October 2013). The study design was approved by the Institutional Review Board of the Shizuoka Cancer Center (IRB No. J2020-128–2020-1–3).
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Ohwada, S., Todaka, A., Nakase, H. et al. Effectiveness and safety of gemcitabine plus nab-paclitaxel in elderly patients with advanced pancreatic cancer: a single-center retrospective cohort study. Invest New Drugs 40, 1106–1116 (2022). https://doi.org/10.1007/s10637-022-01221-x
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DOI: https://doi.org/10.1007/s10637-022-01221-x