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

Margaret A. Tempero; APACT Investigators; Johanna Wilmink

doi:10.1200/JCO.22.01134

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

Margaret A. Tempero^*
, APACT Investigators
, Johanna Wilmink

^*Corresponding author for this work

University of California at San Francisco
Berlin Institute of Health, Comprehensive Allergy Center, Department of Dermatology and Allergy, Berlin
Memorial Sloan-Kettering Cancer Center
Thomas Jefferson University
Seoul National University
Veterans General Hospital-Taipei
National Yang-Ming University
Ospedale Policlinico
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
University of Ulsan
Oregon Health and Science University
Mayo Clinic Scottsdale, AZ
Humanitas University
IRCCS Istituto Clinico Humanitas - Rozzano (Milano)
Sungkyunkwan University
Georgetown University
IRCCS Istituto scientifico romagnolo per lo studio e la cura dei tumori - Meldola (FC)
National Cheng Kung University
St. John of God Subiaco Hospital, Subiaco, WA, Australia
KU Leuven
Vanderbilt University
Wayne State University
Henry Ford Cancer Institute, Detroit, Michigan
Princess Margaret Cancer Centre
University of New South Wales
Hospital Universitari Vall d'Hebron
Bristol-Myers Squibb
University of Glasgow
Glasgow Royal Infirmary
Vita-Salute San Raffaele University

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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).METHODSWe 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.RESULTSTwo 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.CONCLUSIONThe primary end point (independently assessed DFS) was not met despite favorable OS seen with nab-paclitaxel + gemcitabine.

Original language	English
Pages (from-to)	2007-2019
Number of pages	13
Journal	Journal of clinical oncology
Volume	41
Issue number	11
DOIs	https://doi.org/10.1200/JCO.22.01134
Publication status	Published - 10 Apr 2023

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Adjuvant-nab-paclitaxel--gemcitabine-in-resected-pancreatic-ductal-adenocarcinoma.pdfFinal published version, 801 KBLicence: CC BY

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@article{13e14b9267a648e293f96424c0b9af5c,

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

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).METHODSWe 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.RESULTSTwo 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.CONCLUSIONThe primary end point (independently assessed DFS) was not met despite favorable OS seen with nab-paclitaxel + gemcitabine.",

author = "Tempero, \{Margaret A.\} and Uwe Pelzer and O'Reilly, \{Eileen M.\} and Jordan Winter and Do-Youn Oh and Chung-Pin Li and Giampaolo Tortora and Heung-Moon Chang and Lopez, \{Charles D.\} and Tanios Bekaii-Saab and Ko, \{Andrew H.\} and Armando Santoro and Park, \{Joon Oh\} and Noel, \{Marcus S.\} and Frassineti, \{Giovanni Luca\} and Yan-Shen Shan and Andrew Dean and Hanno Riess and \{van Cutsem\}, Eric and Jordan Berlin and Philip Philip and Malcolm Moore and David Goldstein and Josep Tabernero and Mingyu Li and Stefano Ferrara and \{le Bruchec\}, Yvan and George Zhang and Brian Lu and Biankin, \{Andrew V.\} and Michele Reni and \{APACT Investigators\} and Richard Epstein and Paul Vasey and Jeremy Shapiro and Matthew Burge and Chua, \{Yu Jo\} and Marion Harris and Nick Pavlakis and Niall Tebbutt and Gerald Prager and Christian Dittrich and Friedrich L{\"a}ngle and Kathrin Philipp-Abbrederis and Richard Greil and Herbert St{\"o}ger and Michael Girschikofsky and Thomas Kuehr and \{van Laethem\}, Jean-Luc and St{\'e}phanie Laurent and Neesha Dhani and Ko, \{Yoo Joung\} and Scot Dowden and Petr Kavan and Tehfe, \{Mustapha {\'E}douard\} and Eugen Kubala and Milan Kohoutek and Per Pfeiffer and Mette Yilmaz and Vibeke Parner and Tapio Salminen and Leena-Maija Soveri and Eija Korkeila and Pia Osterlund and Julien Taieb and David Tougeron and Pascal Artru and Caroli-Bosc, \{Fran{\c c}ois Xavier\} and Rosine Guimbaud and Antony Turpin and Thomas Walter and Bachet, \{Jean Baptiste\} and Volker Kunzmann and Florian Kreth and Andreas Block and Marino Venerito and Helmut Oettle and Meinolf Karthaus and Trojan, \{J. rg\} and Gunnar Folprecht and Markus Lerch and Frank Kullmann and Marcel Reiser and Volker Heinemann and Marcus-Alexander W{\"o}rns and Holger Schulz and Benjamin Garlipp and Thomas Yau and Chan, \{Lam Stephen\} and Balazs Juhasz and Landherr, \{L. szl{\'o}\} and Tamas Pinter and Gy{\"o}rgy Bodoky and Zsuzsanna Kah{\'a}n and Raymond McDermott and Derek Power and Luca Gianni and Salvatore Siena and Michele Milella and Alfredo Falcone and Rossana Berardi and Cinzia Bagal{\`a} and \{di Costanzo\}, Francesco and Fausto Roila and Andrea Ardizzoni and Evaristo Maiello and Silvia Fanello and Johanna Wilmink and \{Willem de Groot\}, Jan and Geert Creemers and Eduardo Barroso and Rodrigues, \{T. nia\} and Cristina Sarmento and Chee, \{Cheng Ean\} and David Tai and Mercade, \{Teresa Macarulla\} and Medina, \{Manuel Hidalgo\} and Mena, \{Alfredo Carrato\} and Santasusana, \{Joan Maurel\} and \{Flor Oncala\}, \{Maria Jose\} and Martin, \{Carlos Gomez\} and Rafael Lopez and Andres Mu{\~n}oz and Garcia, \{Ruth Vera\} and Inmaculada Ales and S{\'a}ez, \{Berta Laquente\} and Fernando Rivera and Javier Sastre and Cheng-Chung Wu and Yu-Wen Tien and De-Chuan Chan and Tsann-Long Hwang and Jeffry Evans and Jonathan Wadsley and Pippa Corrie and Andrew Biankin and Andrew Ko and Dana Cardin and Elena Chiorean and Johanna Bendell and Anne Noonan and Hedy Kindler and Nishan Fernando and Muhammad Beg and Thomas George and Marcus Noel and Noelle Loconte and Francis Arena and James Posey and Rajat Malhotra and Charles Lopez and Davendra Sohal and Robert McWilliams and Warren Brenner and Mark Womack and Rahul Seth and Renuka Lyer and Nathan Bahary and Robert Marsh and Robert Ramirez and Cynthia Chua and James Reeves and Gulam Manji and Anthony el-Khoueiry and Robert Weaver and Vaibhav Sahai and Wells Messersmith and Robert Dreicer and Ahmed Zakari and Andrea Bullock and Benjamin Musher and Mitesh Borad and Edward Kim and David Bajor and Tim Huyck and Hassan Hatoum and Henry Xiong and Boris Pasche and Jill Lacy and Olugbenga Olowokure and Allen Cohn and Donald Richards and Robert Martin and Andrew Paulson and Paul Fanta and Smitha Krishnamurthi and Paul Oberstein and Jyotsna Fuloria",

note = "Funding Information: Supported by Bristol Myers Squibb and by Celgene, a Bristol Myers Squibb Company, Princeton, NJ. Professional medical writing and editorial assistance was provided by Narender Dhingra, MBBS, PhD, CMPP, of Meditech Media, Ltd; Aaron Runkle, PhD, CMPP, of Meditech Media, Ltd; and Krystin Tran, PharmD, of Chrysalis Medical Communications LLC and funded by Bristol Myers Squibb. Medical review was supported by Julie Jeanes, Emily Mantovani, Desmond McGovern, Alfredo Romano, David Eardley, and Lotus Yung. Publisher Copyright: {\textcopyright} American Society of Clinical Oncology.",

year = "2023",

month = apr,

day = "10",

doi = "10.1200/JCO.22.01134",

language = "English",

volume = "41",

pages = "2007--2019",

journal = "Journal of clinical oncology",

issn = "0732-183X",

publisher = "American Society of Clinical Oncology",

number = "11",

}

TY - JOUR

T1 - Adjuvant nab-Paclitaxel + Gemcitabine in Resected Pancreatic Ductal Adenocarcinoma

T2 - Results from a Randomized, Open-Label, Phase III Trial

AU - Tempero, Margaret A.

AU - Pelzer, Uwe

AU - O'Reilly, Eileen M.

AU - Winter, Jordan

AU - Oh, Do-Youn

AU - Li, Chung-Pin

AU - Tortora, Giampaolo

AU - Chang, Heung-Moon

AU - Lopez, Charles D.

AU - Bekaii-Saab, Tanios

AU - Ko, Andrew H.

AU - Santoro, Armando

AU - Park, Joon Oh

AU - Noel, Marcus S.

AU - Frassineti, Giovanni Luca

AU - Shan, Yan-Shen

AU - Dean, Andrew

AU - Riess, Hanno

AU - van Cutsem, Eric

AU - Berlin, Jordan

AU - Philip, Philip

AU - Moore, Malcolm

AU - Goldstein, David

AU - Tabernero, Josep

AU - Li, Mingyu

AU - Ferrara, Stefano

AU - le Bruchec, Yvan

AU - Zhang, George

AU - Lu, Brian

AU - Biankin, Andrew V.

AU - Reni, Michele

AU - APACT Investigators

AU - Epstein, Richard

AU - Vasey, Paul

AU - Shapiro, Jeremy

AU - Burge, Matthew

AU - Chua, Yu Jo

AU - Harris, Marion

AU - Pavlakis, Nick

AU - Tebbutt, Niall

AU - Prager, Gerald

AU - Dittrich, Christian

AU - Längle, Friedrich

AU - Philipp-Abbrederis, Kathrin

AU - Greil, Richard

AU - Stöger, Herbert

AU - Girschikofsky, Michael

AU - Kuehr, Thomas

AU - van Laethem, Jean-Luc

AU - Laurent, Stéphanie

AU - Dhani, Neesha

AU - Ko, Yoo Joung

AU - Dowden, Scot

AU - Kavan, Petr

AU - Tehfe, Mustapha Édouard

AU - Kubala, Eugen

AU - Kohoutek, Milan

AU - Pfeiffer, Per

AU - Yilmaz, Mette

AU - Parner, Vibeke

AU - Salminen, Tapio

AU - Soveri, Leena-Maija

AU - Korkeila, Eija

AU - Osterlund, Pia

AU - Taieb, Julien

AU - Tougeron, David

AU - Artru, Pascal

AU - Caroli-Bosc, François Xavier

AU - Guimbaud, Rosine

AU - Turpin, Antony

AU - Walter, Thomas

AU - Bachet, Jean Baptiste

AU - Kunzmann, Volker

AU - Kreth, Florian

AU - Block, Andreas

AU - Venerito, Marino

AU - Oettle, Helmut

AU - Karthaus, Meinolf

AU - Trojan, J. rg

AU - Folprecht, Gunnar

AU - Lerch, Markus

AU - Kullmann, Frank

AU - Reiser, Marcel

AU - Heinemann, Volker

AU - Wörns, Marcus-Alexander

AU - Schulz, Holger

AU - Garlipp, Benjamin

AU - Yau, Thomas

AU - Chan, Lam Stephen

AU - Juhasz, Balazs

AU - Landherr, L. szló

AU - Pinter, Tamas

AU - Bodoky, György

AU - Kahán, Zsuzsanna

AU - McDermott, Raymond

AU - Power, Derek

AU - Gianni, Luca

AU - Siena, Salvatore

AU - Milella, Michele

AU - Falcone, Alfredo

AU - Berardi, Rossana

AU - Bagalà, Cinzia

AU - di Costanzo, Francesco

AU - Roila, Fausto

AU - Ardizzoni, Andrea

AU - Maiello, Evaristo

AU - Fanello, Silvia

AU - Wilmink, Johanna

AU - Willem de Groot, Jan

AU - Creemers, Geert

AU - Barroso, Eduardo

AU - Rodrigues, T. nia

AU - Sarmento, Cristina

AU - Chee, Cheng Ean

AU - Tai, David

AU - Mercade, Teresa Macarulla

AU - Medina, Manuel Hidalgo

AU - Mena, Alfredo Carrato

AU - Santasusana, Joan Maurel

AU - Flor Oncala, Maria Jose

AU - Martin, Carlos Gomez

AU - Lopez, Rafael

AU - Muñoz, Andres

AU - Garcia, Ruth Vera

AU - Ales, Inmaculada

AU - Sáez, Berta Laquente

AU - Rivera, Fernando

AU - Sastre, Javier

AU - Wu, Cheng-Chung

AU - Tien, Yu-Wen

AU - Chan, De-Chuan

AU - Hwang, Tsann-Long

AU - Evans, Jeffry

AU - Wadsley, Jonathan

AU - Corrie, Pippa

AU - Biankin, Andrew

AU - Ko, Andrew

AU - Cardin, Dana

AU - Chiorean, Elena

AU - Bendell, Johanna

AU - Noonan, Anne

AU - Kindler, Hedy

AU - Fernando, Nishan

AU - Beg, Muhammad

AU - George, Thomas

AU - Noel, Marcus

AU - Loconte, Noelle

AU - Arena, Francis

AU - Posey, James

AU - Malhotra, Rajat

AU - Lopez, Charles

AU - Sohal, Davendra

AU - McWilliams, Robert

AU - Brenner, Warren

AU - Womack, Mark

AU - Seth, Rahul

AU - Lyer, Renuka

AU - Bahary, Nathan

AU - Marsh, Robert

AU - Ramirez, Robert

AU - Chua, Cynthia

AU - Reeves, James

AU - Manji, Gulam

AU - el-Khoueiry, Anthony

AU - Weaver, Robert

AU - Sahai, Vaibhav

AU - Messersmith, Wells

AU - Dreicer, Robert

AU - Zakari, Ahmed

AU - Bullock, Andrea

AU - Musher, Benjamin

AU - Borad, Mitesh

AU - Kim, Edward

AU - Bajor, David

AU - Huyck, Tim

AU - Hatoum, Hassan

AU - Xiong, Henry

AU - Pasche, Boris

AU - Lacy, Jill

AU - Olowokure, Olugbenga

AU - Cohn, Allen

AU - Richards, Donald

AU - Martin, Robert

AU - Paulson, Andrew

AU - Fanta, Paul

AU - Krishnamurthi, Smitha

AU - Oberstein, Paul

AU - Fuloria, Jyotsna

N1 - Funding Information: Supported by Bristol Myers Squibb and by Celgene, a Bristol Myers Squibb Company, Princeton, NJ. Professional medical writing and editorial assistance was provided by Narender Dhingra, MBBS, PhD, CMPP, of Meditech Media, Ltd; Aaron Runkle, PhD, CMPP, of Meditech Media, Ltd; and Krystin Tran, PharmD, of Chrysalis Medical Communications LLC and funded by Bristol Myers Squibb. Medical review was supported by Julie Jeanes, Emily Mantovani, Desmond McGovern, Alfredo Romano, David Eardley, and Lotus Yung. Publisher Copyright: © American Society of Clinical Oncology.

PY - 2023/4/10

Y1 - 2023/4/10

N2 - 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).METHODSWe 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.RESULTSTwo 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.CONCLUSIONThe primary end point (independently assessed DFS) was not met despite favorable OS seen with nab-paclitaxel + gemcitabine.

AB - 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).METHODSWe 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.RESULTSTwo 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.CONCLUSIONThe primary end point (independently assessed DFS) was not met despite favorable OS seen with nab-paclitaxel + gemcitabine.

UR - https://www.scopus.com/pages/publications/85151492442

U2 - 10.1200/JCO.22.01134

DO - 10.1200/JCO.22.01134

M3 - Article

C2 - 36521097

SN - 0732-183X

VL - 41

SP - 2007

EP - 2019

JO - Journal of clinical oncology

JF - Journal of clinical oncology

IS - 11

ER -

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

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