Real-world evidence of adjuvant gemcitabine plus capecitabine vs gemcitabine monotherapy for pancreatic ductal adenocarcinoma

Evelien J.M. de Jong, Quisette P. Janssen, the Dutch Pancreatic Cancer Group, Tessa F.A. Simons, Marc G. Besselink, Bert A. Bonsing, Stefan A.W. Bouwense, Sandra M.E. Geurts, Marjolein Y.V. Homs, Vincent E. de Meijer, Vivianne C.G. Tjan-Heijnen, Hanneke W.M. van Laarhoven, Liselot B.J. Valkenburg-van Iersel, Johanna W. Wilmink, Lydia G. van der Geest, Bas Groot Koerkamp, Judith de Vos-Geelen*

*Corresponding author for this work

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Abstract

The added value of capecitabine to adjuvant gemcitabine monotherapy (GEM) in pancreatic ductal adenocarcinoma (PDAC) was shown by the ESPAC-4 trial. Real-world data on the effectiveness of gemcitabine plus capecitabine (GEMCAP), in patients ineligible for mFOLFIRINOX, are lacking. Our study assessed whether adjuvant GEMCAP is superior to GEM in a nationwide cohort. Patients treated with adjuvant GEMCAP or GEM after resection of PDAC without preoperative treatment were identified from The Netherlands Cancer Registry (2015-2019). The primary outcome was overall survival (OS), measured from start of chemotherapy. The treatment effect of GEMCAP vs GEM was adjusted for sex, age, performance status, tumor size, lymph node involvement, resection margin and tumor differentiation in a multivariable Cox regression analysis. Secondary outcome was the percentage of patients who completed the planned six adjuvant treatment cycles. Overall, 778 patients were included, of whom 21.1% received GEMCAP and 78.9% received GEM. The median OS was 31.4 months (95% CI 26.8-40.7) for GEMCAP and 22.1 months (95% CI 20.6-25.0) for GEM (HR: 0.71, 95% CI 0.56-0.90; logrank P =.004). After adjustment for prognostic factors, survival remained superior for patients treated with GEMCAP (HR: 0.73, 95% CI 0.57-0.92, logrank P =.009). Survival with GEMCAP was superior to GEM in most subgroups of prognostic factors. Adjuvant chemotherapy was completed in 69.5% of the patients treated with GEMCAP and 62.7% with GEM (P =.11). In this nationwide cohort of patients with PDAC, adjuvant GEMCAP was associated with superior survival as compared to GEM monotherapy and number of cycles was similar.

Original languageEnglish
Pages (from-to)1654-1663
Number of pages10
JournalInternational Journal of Cancer
Volume150
Issue number10
Early online date22 Dec 2021
DOIs
Publication statusPublished - 15 May 2022

Bibliographical note

Funding Information:
This work was supported by the Dutch Cancer Society (KWF) (10955) and by ZonMw (843004108). No funding agency was involved in the design of the study or the collection, analysis and interpretation of data. The authors are solely responsible for the content of the study and do not necessarily represent the viewpoint of the Dutch Cancer Society or ZonMw. Funding information

Funding Information:
JDV has served as a consultant for Amgen, AstraZeneca, MSD, Pierre Fabre and Servier, and has received institutional research funding from Servier. All outside the submitted work; SG reports grants from Roche, grants from Pfizer, grants from Novartis, grants from Lilly, grants from Daiichi Sankyo, personal fees from AstraZeneca. All outside the submitted work; HVL reports research funding and/or medication supply from Bayer, BMS, Celgene, Janssen, Incyte, Lilly, Merck, Nordic Pharma, Philips, Roche, Servier and reports consult or advisory role from BMS, Dragonfly, Lilly, Merck, Nordic Pharma and Servier. All outside the submitted work; VM reports a VENI grant by the Netherlands Organization for Scientific Research (NWO; grant #09150161810030) and a grant from the Dutch Ministry of Economic Affairs (Health~Holland Public Private Partnership grant #PPP‐2019‐024). All outside the submitted work; VT‐H reports grants and personal fees from Roche, grants and personal fees from Novartis, grants and personal fees from Pfizer, grants and personal fees from Lilly, grants from AstraZeneca, grants from Eisai, grants from Daiichi Sankyo, grants from Gilead. All outside the submitted work; LV‐VI reports nonfinancial support from Servier, nonfinancial support from Pierre Fabre, nonfinancial support from Roche. All outside the submitted work; JW reports grants and nonfinancial support from Servier, nonfinancial support from MSD, nonfinancial support from AstraZeneca, grants and nonfinancial support from Celgene, grants from Halozyme, grants from Merck, grants from Roche, grants from Pfizer, grants from Amgen, grants from Novartis. All outside the submitted work. The other authors have declared no conflicts of interests.

Publisher Copyright:
© 2021 The Authors. International Journal of Cancer published by John Wiley & Sons Ltd on behalf of UICC.

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