Phase III, international, multicenter, randomized, open-label trial of adjuvant nab-paclitaxel plus gemcitabine (nab-P/G) vs gemcitabine (G) alone for surgically resected pancreatic adenocarcinoma (APACT): Subgroup analyses

Autor: Andrew V. Biankin, Hanno Riess, Margaret A. Tempero, Michele Milella, Jordan Berlin, Mingyu Li, Philip A. Philip, Salvatore Siena, I.C. Ales-Diaz, J. Tabernero, Smitha S. Krishnamurthi, Y. Le Bruchec, Michele Reni, David Goldstein, Desmond McGovern, Stefano Ferrara, Eileen M. O'Reilly, Pia Österlund, E. Van Cutsem
Rok vydání: 2019
Předmět:
Zdroj: Annals of Oncology. 30:v259-v260
ISSN: 0923-7534
DOI: 10.1093/annonc/mdz247.010
Popis: Background The primary APACT analysis showed no significant difference in disease-free survival (DFS) by blinded, independent radiologic review with nab-P/G vs G in patients (pts) with surgically resected pancreatic cancer (PC). However, investigator-assessed DFS (prespecified sensitivity analysis) and interim overall survival (OS; secondary endpoint) trended in favor of nab-P/G. Here, we report interim OS exploratory subanalyses. Methods Treatment-naive pts with histologically confirmed PC, macroscopic complete resection (R0/R1), CA 19-9 Results 866 pts were randomized. Median age was 64 y (range, 34–86); most were male (56%) and white (78%) and had ECOG PS 0 (60%), LN+ status (72%), and R0 resection (76%). At the original data cutoff (31 December 2018; median follow-up, 38.5 mo), median OS (interim) trended in favor of nab-P/G vs G (40.5 vs 36.2 mo; HR 0.82; 95% CI, 0.680 - 0.996; nominal P = 0.045). Pts with poor characteristics had numerically longer median OS with nab-P/G vs G: 32.5 vs 27.0 mo in pts with R1 resection (n = 105 and 100) and 33.8 vs 28.9 mo in pts with LN+ status (n = 311 and 312). This is consistent with the median OS observed with nab-P/G vs G in pts whose tumors were Conclusions Final OS data may clarify the role for adjuvant nab-P/G. Interim OS analyses suggest that continued investigation of adjuvant nab-P/G for pts with suboptimally resected PC or who may not tolerate FOLFIRINOX is warranted. Clinical trial identification NCT01964430. Editorial acknowledgement Rebecca Tweedell, MediTech Media, Ltd, funded by Celgene Corporation. Legal entity responsible for the study The authors. Funding Celgene Corporation. Disclosure M.A. Tempero: Advisory / Consultancy: AbbVie, Inc., Advance Medical, Inc., BioPharm Communications, Bristol-Myers Squibb, Celgene Corporation, Eisai, Inc., Ignyta, Inc., Pharmacyslics, LLC., Pharmcyte Biotech, Tocagen, Inc., Immunovia, CPRIT, AstraZeneca. M. Reni: Research grant / Funding (self): Celgene, Baxalta, Merck Serono, Helsinn; Non-remunerated activity/ies: Celgene, Baxalta, Merck Serono, Lilly, Pfizer, AstraZeneca, Novocure, Halozyme, Novartis, Shire. H. Riess: Speaker Bureau / Expert testimony: Celgene, Roche, Shire; Advisory / Consultancy: Celgene, Shire. E.M. O’Reilly: Honoraria (self), Research grant / Funding (institution): Celgene Corporation; Research grant / Funding (self): ActaBiologica, Agios, Array, AstraZeneca, Bayer, Beigene, BMS, Casi, Exelixis, Genentech, Halozyme, Incyte, Lilly, Mabvax, Novartis, OncoQuest, Polaris Puma, QED, Roche. S. Krishnamurthi: Non-remunerated activity/ies, Research Funding: Taiho, CytomX, Regeneron, Celgene, AbbVie. P. Osterlund: Advisory / Consultancy: Amgen; Bayer; Celgene; Eisai; Lilly; Merck Serono; Roche; Sanofi; Servier/Shire; Speaker Bureau / Expert testimony: Prime Oncology; Research grant / Funding (institution): Amgen (Inst); Bristol-Myers Squibb (Inst); Celgene (Inst); Lilly (Inst); Merck Serono (Inst); MSD (Inst); Nordic Drugs (Inst); Roche (Inst); Sanofi (Inst); Servier (Inst); Travel / Accommodation / Expenses: AbbVie, Pierre Fabre. M. Milella: Advisory / Consultancy: Pfizer; Speaker Bureau / Expert testimony: AstraZeneca, EUSA Pharma. S. Siena: Advisory / Consultancy: Amgen, Bayer, BMS, CheckmAb, Celgene, Daiichi-Sankyo, Incyte, Merck, Novartis, Roche-Genentech, and Seattle Genetics. J. Tabernero: Advisory / Consultancy, Personal Financial Interest: Array Biopharma, AstraZeneca, Bayer, BeiGene, Boehringer Ingelheim, Chugai, Genentech, Inc., Genmab A/S, Halozyme, Imugene Limited, Inflection Biosciences Limited, Ipsen, Kura Oncology, Lilly, MSD, Menarini, Merck Serono, Merrimack, Merus, Molecular Part. E. Van Cutsem: Advisory / Consultancy: Bayer, Lilly, Roche, Servier, Bristol-Myers Squibb, Celgene, Merck Sharp & Dohme, Merck KGaA, Novartis, AstraZeneca; Research grant / Funding (self): Amgen, Bayer, Boehringer Ingelheim, Lilly, Novartis, Roche, Celgene, Ipsen, Merck, Merck KGaA, Servier, Bristol-Myers Squibb. P.A. Philip: Research grant / Funding (self): Celgene, Bayer, and Incyte; Speaker Bureau / Expert testimony: Roche, Sanofi, and Amgen; Advisory / Consultancy: Celgene Corporation. D. Goldstein: Advisory / Consultancy, Research grant / Funding (institution): Celgene Corporation, Pfizer. J.D. Berlin: Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Celgene Corporation. M. Li: Shareholder / Stockholder / Stock options, Full / Part-time employment: Celgene Corporation. S. Ferrara: Shareholder / Stockholder / Stock options, Full / Part-time employment: Celgene Corporation. Y. Le Bruchec: Shareholder / Stockholder / Stock options, Full / Part-time employment: Celgene Corporation. D. McGovern: Shareholder / Stockholder / Stock options, Full / Part-time employment: Celgene Corporation. A. Biankin: Leadership role: Gene Forward Inc; Research grant / Funding (self): Celgene, AstraZeneca; Licensing / Royalties: Agilent; Honoraria (self): Celgene, AstraZeneca, Tusk, Astar; Travel / Accommodation / Expenses: Celegene, AstraZeneca, Roche; Speaker Bureau / Expert testimony: Celgene, AstraZeneca, Tusk, Astar, Roche. All other authors have declared no conflicts of interest.
Databáze: OpenAIRE
Externí odkaz: