Document Type
Article
Publication Date
12-15-2022
Abstract
PURPOSE
This randomized, open-label trial compared the efficacy and safety of adjuvant nab-paclitaxel + gemcitabine with those of gemcitabine for resected pancreatic ductal adenocarcinoma (ClinicalTrials.gov identifier: NCT01964430). METHODS
We assigned 866 treatment-naive patients with pancreatic ductal adenocarcinoma to nab-paclitaxel (125 mg/m2) + gemcitabine (1,000 mg/m2) or gemcitabine alone to one 30-40 infusion on days 1, 8, and 15 of six 28-day cycles. The primary end point was independently assessed disease-free survival (DFS). Additional end points included investigator-assessed DFS, overall survival (OS), and safety. RESULTS
Two hundred eighty-seven of 432 patients and 310 of 434 patients completed nab-paclitaxel + gemcitabine and gemcitabine treatment, respectively. At primary data cutoff (December 31, 2018; median follow-up, 38.5 [interquartile range [IQR], 33.8-43 months), the median independently assessed DFS was 19.4 (nab-paclitaxel + gemcitabine) versus 18.8 months (gemcitabine; hazard ratio [HR], 0.88; 95% CI, 0.729 to 1.063; P = .18). The median investigator-assessed DFS was 16.6 (IQR, 8.4-47.0) and 13.7 (IQR, 8.3-44.1) months, respectively (HR, 0.82; 95% CI, 0.694 to 0.965; P = .02). The median OS (427 events; 68% mature) was 40.5 (IQR, 20.7 to not reached) and 36.2 (IQR, 17.7-53.3) months, respectively (HR, 0.82; 95% CI, 0.680 to 0.996; P = .045). At a 16-month follow-up (cutoff, April 3, 2020; median follow-up, 51.4 months [IQR, 47.0-57.0]), the median OS (511 events; 81% mature) was 41.8 (nab-paclitaxel + gemcitabine) versus 37.7 months (gemcitabine; HR, 0.82; 95% CI, 0.687 to 0.973; P = .0232). At the 5-year follow-up (cutoff, April 9, 2021; median follow-up, 63.2 months [IQR, 60.1-68.7]), the median OS (555 events; 88% mature) was 41.8 versus 37.7 months, respectively (HR, 0.80; 95% CI, 0.678 to 0.947; P = .0091). Eighty-six percent (nab-paclitaxel + gemcitabine) and 68% (gemcitabine) of patients experienced grade ≥ 3 treatment-emergent adverse events. Two patients per study arm died of treatment-emergent adverse events. CONCLUSION
The primary end point (independently assessed DFS) was not met despite favorable OS seen with nab-paclitaxel + gemcitabine.
Recommended Citation
Tempero, Margaret A.; Pelzer, Uwe; O'Reilly, Eileen M.; Winter, Jordan; Oh, Do-Youn; Li, Chung-Pin; Tortora, Giampaolo; Chang, Heung-Moon; Lopez, Charles D.; Bekaii-Saab, Tanios; Ko, Andrew H.; Santoro, Armando; Park, Joon Oh; Noel, Marcus S.; Frassineti, Giovanni Luca; Shan, Yan-Shen; Dean, Andrew; Riess, Hanno; Van Cutsem, Eric; Berlin, Jordan; Philip, Philip; Moore, Malcolm; Goldstein, David; Tabernero, Josep; Li, Mingyu; Ferrara, Stefano; Le Bruchec, Yvan; Zhang, George; Lu, Brian; Biankin, Andrew V.; and Reni, Michele, "Adjuvant nab-Paclitaxel + Gemcitabine in Resected Pancreatic Ductal Adenocarcinoma: Results from a Randomized, Open-Label, Phase III Trial" (2022). Department of Surgery Faculty Papers. Paper 243.
https://jdc.jefferson.edu/surgeryfp/243
Creative Commons License
This work is licensed under a Creative Commons Attribution-Noncommercial-No Derivative Works 4.0 License.
PubMed ID
36521097
Language
English
Comments
This article is the author's final published version in the Journal of Clinical Oncology, Volume 41, Issue 11, April 2023, Pg. 2007 - 2019.
The published version is available at https://doi.org/10.1200/JCO.22.01134. Copyright © 2022 by American Society of Clinical Oncology.