Adjuvant nab-Paclitaxel + Gemcitabine in Resected Pancreatic Ductal Adenocarcinoma: Results From a Randomized, Open-Label, Phase III Trial

Media type: E-Article
Title: Adjuvant nab-Paclitaxel + Gemcitabine in Resected Pancreatic Ductal Adenocarcinoma: Results From a Randomized, Open-Label, Phase III Trial
Contributor: 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; [...]
Published: American Society of Clinical Oncology (ASCO), 2023
Published in: Journal of Clinical Oncology
Extent: 2007-2019
Language: English
DOI: 10.1200/jco.22.01134
ISSN: 0732-183X; 1527-7755
Keywords: Cancer Research ; Oncology
Abstract: <jats:sec><jats:title>PURPOSE</jats:title><jats:p> 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 ). </jats:p></jats:sec><jats:sec><jats:title>METHODS</jats:title><jats:p> We assigned 866 treatment-naive patients with pancreatic ductal adenocarcinoma to nab-paclitaxel (125 mg/m<jats:sup>2</jats:sup>) + gemcitabine (1,000 mg/m<jats:sup>2</jats:sup>) 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. </jats:p></jats:sec><jats:sec><jats:title>RESULTS</jats:title><jats:p> 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. </jats:p></jats:sec><jats:sec><jats:title>CONCLUSION</jats:title><jats:p> The primary end point (independently assessed DFS) was not met despite favorable OS seen with nab-paclitaxel + gemcitabine. </jats:p></jats:sec>
Description: <jats:sec><jats:title>PURPOSE</jats:title><jats:p> 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 ). </jats:p></jats:sec><jats:sec><jats:title>METHODS</jats:title><jats:p> We assigned 866 treatment-naive patients with pancreatic ductal adenocarcinoma to nab-paclitaxel (125 mg/m<jats:sup>2</jats:sup>) + gemcitabine (1,000 mg/m<jats:sup>2</jats:sup>) 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. </jats:p></jats:sec><jats:sec><jats:title>RESULTS</jats:title><jats:p> 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. </jats:p></jats:sec><jats:sec><jats:title>CONCLUSION</jats:title><jats:p> The primary end point (independently assessed DFS) was not met despite favorable OS seen with nab-paclitaxel + gemcitabine. </jats:p></jats:sec>
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