APACT was a geographically diverse trial with study sites worldwide, including in Asia; here, we report outcomes from Asian sites.
Treatment-naive pts with histologically confirmed PC, R0/R1 resection, CA 19-9 < 100 U/mL, and ECOG PS ≤ 1 received 6 cycles of nab-P 125 mg/m2 + G 1000 mg/m2 or G 1000 mg/m2 on days 1, 8, and 15. Stratification factors were resection (R0/R1) and lymph node (LN+/−) status. The primary endpoint was disease-free survival (DFS) by independent review. Secondary endpoints were overall survival (OS) and safety.
At Asian sites (Hong Kong, Korea, Singapore, and Taiwan), 108 pts (of 866 pts from the ITT population) were randomized to nab-P/G (n = 55) or G (n = 53). Median age was 61 years. Most pts had ECOG PS 0 (64%), LN+ disease (61%), and R0 resection (86%). Six treatment cycles were administered in 76% (nab-P/G) vs 77% (G) of pts. Data cutoff was April 3, 2020; median follow-up for OS was 52.6 months. Median independently assessed DFS was 27.6 (nab-P/G) vs 22.6 (G) months (Table); investigator-assessed DFS was 18.0 vs 11.9 months. Median OS was 46.8 (nab-P/G) vs 40.6 (G) months. Analgesics (nab-P/G) and treatments for indigestion (G) were the most common concomitant medications. The most common grade ≥ 3 hematologic and nonhematologic treatment-emergent adverse events (AEs) with nab-P/G vs G were neutropenia (36.4% vs 26.9%) and peripheral neuropathy (10.9% vs 0%). All dose reductions (36 [nab-P/G] vs 21 [G]) were due to AEs (most common, neutropenia); 4 (nab-P/G) vs 0 (G) pts discontinued treatment due to AEs a Pts were from sites in Hong Kong (n = 4), Republic of Korea (n = 51), Singapore (n = 6), and Taiwan (n = 47). b Based on an April 3, 2020 data cutoff.CI, confidence interval; G, gemcitabine; HR, hazard ratio; Ind. DFS, disease-free survival by independent radiological review; Inv. DFS, disease-free survival by investigator review; ITT, intention-to-treat; NA, not achieved; nab-P, nab-paclitaxel; OS, overall survival.
Outcome nab-P/G G HR (95% CI) P Value n/N Median (95% CI), months n/N Median (95% CI), months Asian populationa Ind. DFS 21/55 27.6 (16.36-NA) 24/53 22.6 (10.84-NA) 0.73 (0.405-1.331) – Inv. DFS 34/55 18.0 (11.96-27.63) 35/53 11.9 (8.28-21.88) 0.73 (0.453-1.178) – OSb 30/ 55 46.8 (27.01-NA) 32/53 40.6 (24.21-48.03) 0.85 (0.513-1.398) – ITT population Ind. DFS 226/ 432 19.4 (16.62-21.91) 213/ 434 18.8 (13.83-20.30) 0.88 (0.729-1.063) .1824 Inv. DFS 282/ 432 16.6 (14.55-19.29) 289/434 13.7 (11.24-16.00) 0.82 (0.694-0.965) .0168 OSb 248/432 41.8 (35.55-47.28) 263/434 37.7 (31.11-40.51) 0.82 (0.687-0.973) .0232
Consistent with outcomes in the ITT population, DFS and OS were numerically longer with nab-P/G vs G in the Asian cohort. The nab-P/G safety profile was consistent with that seen in the overall treated population.
2013-003398-91; NCT01964430.
Writing assistance was provided by Mohan Harihar, of MediTech Media, Ltd., and funded by Bristol-Myers Squibb Company. The authors are fully responsible for all content and editorial decisions for this manuscript.
Bristol-Myers Squibb Company.
Bristol-Myers Squibb Company.
J. Bendell: Research grant/Funding (institution): Gilead, Genentech-Roche, Bristol-Myers Squibb, Five Prime, Eli Lilly & Co., Merck, MedImmune, Celgene, EMD Serono, Taiho, Macrogenics, GlaxoSmithKline, Novartis, OncoMed, LEAP, TG Therapeutics, AstraZeneca, BI, Daiichi Sankyo, Bayer, Incyte, Apexigen, Kol; Advisory/Consultancy: Gilead, Genentech-Roche, Bristol-Myers Squibb, Five Prime, Eli Lilly & Co., Merck, MedImmune, Celgene, Taiho, Macrogenics, GlaxoSmithKline, Novartis, OncoMed, LEAP, TG Therapeutics, AstraZeneca, BI, Daiichi Sankyo, Bayer, Incyte, Apexigen, Array, Sanofi,. B. Garlipp: Research grant/Funding (self): Sirtex; Honoraria (self): Sirtex, Roche, Amgen, Pfizer, Celgene, Merck and Novartis; Advisory/Consultancy: Sirtex, Roche and Amgen; Travel/Accommodation/Expenses: Merck, Amgen, Celgene, B. Braun Travacare. M. Karthaus: Advisory/Consultancy, Travel/Accommodation/Expenses: Helsinn and Riemser. B. Lu: Shareholder/Stockholder/Stock options, Full/Part-time employment: Bristol-Myers Squibb. D. McGovern: Shareholder/Stockholder/Stock options, Full/Part-time employment: Bristol-Myers Squibb. S. Banerjee: Shareholder/Stockholder/Stock options, Full/Part-time employment: Bristol-Myers Squibb. M. Tempero: Research grant/Funding (self): AbbVie, AstraZeneca, Advance Medical, BioPharm Communications, Bristol-Myers Squibb, CPRIT, Eisai, Halozyme, Ignyta, Immunovia, Pharmacyclics LLC, PharmaCyte Biotech, Tocagen. D-Y. Oh: Research grant/Funding (self): AstraZeneca. All other authors have declared no conflicts of interest.