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

作者：Margaret A. Tempero, Uwe Pelzer, Eileen M. O’Reilly, Jordan M. Winter, Do‐Youn Oh, Chung‐Pin Li, Giampaolo Tortora, Heung-Moon Chang, Charles D. Lopez, Tanios Bekaii‐Saab, Andrew H. Ko, Armando Santoro, Joon Oh Park, Marcus Smith Noel, Giovanni Luca Frassineti, Yan‐Shen Shan, Andrew Dean, Hanno Riess, Eric Van Cutsem, Jordan Berlin, Philip Philip, Malcolm J. Moore, David Goldstein, Josep Tabernero, Mingyu Li, Stefano Ferrara, Yvan Le Bruchec, George Zhang, Brian Lu, Andrew V. Biankin, Michele Reni, Richard A. Epstein, Paul L. Vasey, Jeremy Shapiro, Matthew Burge, Yu Jo Chua, Marion Harris, Nick Pavlakis, Niall C. Tebbutt, Gerald W. Prager, Christian Dittrich, Friedrich Längle, Kathrin Philipp‐Abbrederis, Richard Greil, Herbert Stöger, Michael Girschikofsky, Thomas Kuehr, Jean–Luc Van Laethem, Stéphanie Laurent, Neesha C. Dhani, Yoo Joung Ko, Scot Dowden, Petr Kavan, Mustapha Édouard Tehfe, Eugen Kubala, Milan Kohoutek, Per Pfeiffer, Mette Yilmaz, Vibeke K. Parner, Tapio Salminen, Leena‐Maija Soveri, Eija Korkeila, Pia Österlund, Julien Taı̈eb, David Tougeron, Pascal Artru, François‐Xavier Caroli‐Bosc, Rosine Guimbaud, Antony Turpin, Thomas Walter, Jean‐Baptiste Bachet, Volker Kunzmann, Florian Kreth, Andreas De Block, Marino Venerito, Helmut Oettle, Meinolf Karthaus, Jörg Trojan, Gunnar Folprecht, Markus M. Lerch, Frank Kullmann, Marcel Reiser, Volker Heinemann, Marcus‐Alexander Wörns, H. Schulz, Benjamin Garlipp, Thomas Yau, Lam Stephen Chan, Balázs Juhász, László Landherr, Tamás Pintér, G. Bodoky, Zsuzsanna Kahán, Raymond McDermott, Derek G. Power, Luca Gianni, Salvatore Siena, Michèle Milella, Alfredo Falcone, Rossana Berardi, Cinzia Bagalá, Francesco Di Costanzo, Fausto Roila, Andrea Ardizzoni, Evaristo Maiello, Silvia Fanello, Johanna W. Wilmink, Jan Willem de Groot, G.J. Creemers, Eduardo Barroso, Tânia Rodrigues, Cristina Montalvão Sarmento, Cheng Ean Chee, David Tai, T. Macarulla Mercadé, Manuel Hidalgo Medina, Alfredo Carrato Mena, Joan Maurel Santasusana, Maria Jose Flor Oncala, Carlos Gómez Martín, Rafael López‐López, Andrés Muñoz, Ruth Vera García, Inmaculada Alés, Berta Sáez, Fernando Rivera, Javier Sastre, Cheng‐Chung Wu, Yu‐Wen Tien, De-Chuan Chan, Tsann‐Long Hwang, Jeffry Evans, Jonathan Wadsley, Pippa Corrie, Andrew V. Biankin, Andrew H. Ko, Dana B. Cardin, E. Gabriela Chiorean, Johanna C. Bendell, Anne M. Noonan, Hedy L. Kindler, Nishan H. Fernando, Muhammad Shaalan Beg, Thomas J. George, Marcus Smith Noel, Noelle K. LoConte, Francis P. Arena, James Posey, Rajat Malhotra, Charles D. Lopez, Davendra Sohal, Robert R. McWilliams, Warren Brenner, Mark Womack, Rahul Seth, Renuka lyer, Nathan Bahary, Robert Marsh, Robert A. Ramirez, Cynthia C. Chua, J. N. Reeves, Gulam A. Manji, Anthony B. El-Khoueiry, Robert J. Weaver, Vaibhav Sahai, Wells A. Messersmith, Robert Dreicer, Ahmed Zakari, Andrea J. Bullock, Benjamin Musher, Mitesh J. Borad, Edward Kim, David J. Bajor, Tim Huyck, Hassan Hatoum, Henry Xiong, Boris Pasche, Jill Lacy, Olugbenga Olowokure, Allen Lee Cohn, Donald Richards, Robert C.G. Martin, Andrew Scott Paulson, Paul T. Fanta, Smitha Krishnamurthi, Paul E. Oberstein, Jyotsna Fuloria · 发表于：Journal of Clinical Oncology · 年份：2022 · DOI：10.1200/jco.22.01134 · 被引用次数：135 · 研究领域：Pancreatic and Hepatic Oncology Research、Neuroendocrine Tumor Research Advances、Cholangiocarcinoma and Gallbladder Cancer Studies

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/m 2 ) + gemcitabine (1,000 mg/m 2 ) 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 me...