Abstract 913
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 < 100 U/mL, and ECOG PS 0 or 1 were enrolled. Stratification factors included resection (R0/R1), lymph node (LN) status (positive [+]/negative), and geographic region. Pts were treated ≤ 12 weeks after surgery with nab-P 125 mg/m2 + G 1000 mg/m2 or G 1000 mg/m2 alone on days 1, 8, and 15 every 28 days for 6 cycles. For the primary endpoint assessment, independent reviewers received only baseline clinical data and scans. OS and safety were secondary endpoints. Ten prespecified subanalyses were performed.
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 < 1 mm to the closest margin (32.5 vs 29.7 mo; n = 114 and 112). Pts with both R1 resection and LN+ status had numerically longer median OS with nab-P/G vs G (30.7 vs 24.9 mo; n = 87 and 83).
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. Österlund: 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.
Resources from the same session
2107 - Role of Individualized Intervention(s) on Quality of Life (QOL) and Adherence to Adjuvant Endocrine Therapy in Premenopausal Women with Early-Stage Breast Cancer (BC): MyChoice Study
Presenter: Shahid Ahmed
Session: Poster Display session 2
Resources:
Abstract
5812 - Correlation between the density of tumor-infiltrating lymphocytes, immune cell subsets in tumor stroma and response to systemic therapy in breast cancer
Presenter: Cvetka Grasic Kuhar
Session: Poster Display session 2
Resources:
Abstract
4734 - BRCA1/2 Testing in HER2- Advanced Breast Cancer (ABC): Results from the European Component of a Multi-Country Real World Study
Presenter: Michael Patrick Lux
Session: Poster Display session 2
Resources:
Abstract
1686 - In vitro and in vivo rescue of resistance to BET inhibitors by targeting PLK1 in triple negative breast cancer.
Presenter: Cristina Nieto-jiménez
Session: Poster Display session 2
Resources:
Abstract
5020 - Neoadjuvant endocrine therapy in combination with melatonin and metformin in locally advanced breast cancer
Presenter: Tatiana Semiglazova
Session: Poster Display session 2
Resources:
Abstract
5082 - Melatonin and metformin in neoadjuvant chemotherapy in locally advanced breast cancer
Presenter: Tatiana Semiglazova
Session: Poster Display session 2
Resources:
Abstract
2642 - Patient-tailored tamoxifen dosing based on an increased quantitative understanding of its complex pharmacokinetics: A novel integrative modelling approach
Presenter: Anna Mueller-Schoell
Session: Poster Display session 2
Resources:
Abstract
2461 - Lack of benefit of neoadjuvant pertuzumab in high risk HER2 positive breast cancer. A retrospective case-control study of 355 cases with biomarker analysis.
Presenter: Manuela Tiako Meyo
Session: Poster Display session 2
Resources:
Abstract
4776 - Targeting CDCA3 to improve chemotherapy response in triple-negative breast cancer patients
Presenter: Kenneth O'Byrne
Session: Poster Display session 2
Resources:
Abstract
1674 - Activity of BET-proteolysis targeting chimeric (PROTAC) compounds in triple negative breast cancer
Presenter: María Del Mar Noblejas López
Session: Poster Display session 2
Resources:
Abstract