Real‐world evidence of adjuvant gemcitabine plus capecitabine vs gemcitabine monotherapy for pancreatic ductal adenocarcinoma. Issue 10 (31st December 2021)

• Record Type: Journal Article
• Authors: de Jong, Evelien J. M.; Janssen, Quisette P.; Simons, Tessa F. A.; Besselink, Marc G.; Bonsing, Bert A.; Bouwense, Stefan A. W.; Geurts, Sandra M. E.; Homs, Marjolein Y. V.; de Meijer, Vincent E.; Tjan‐Heijnen, Vivianne C. G.; van Laarhoven, Hanneke W. M.; Valkenburg‐van Iersel, Liselot B. J.; Wilmink, Johanna W.; van der Geest, Lydia G.; Koerkamp, Bas Groot; de Vos‐Geelen, Judith
• Is Part Of: International journal of cancer. Volume 150:Issue 10(2022)
• Page Start: 1654
• Page End: 1663
• Publication Date: 2021-12-31
• Subjects: chemotherapy -- pancreatic cancer -- survival; Cancer -- Periodicals; Cancer -- Prevention -- Periodicals; 616.994
• DOI: 10.1002/ijc.33916
• Languages: English
• ISSNs: 0020-7136

Abstract

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. Abstract : What's new? The benefit of treating pancreatic ductal adenocarcinoma (PDAC) with a combination of gemcitabine plus capecitabine (vs gemcitabine alone) was previously shown in a carefully controlled clinical trial. But does this approach work as well in the real world? In this study, the authors found that the answer is yes—patients had significantly better overall survival (OS) with the combined therapy than with gemcitabine alone. These results may aid in the selection of adjuvant chemotherapy for patients who are not eligible for modified FOLFIRINOX (fluorouracil, leucovorin, irinotecan and oxaliplatin).