A multicenter, phase I/II trial of biweekly S-1, leucovorin, oxaliplatin and gemcitabine in metastatic pancreatic adenocarcinoma–TCOG T1211 study

Nai Jung Chiang, Kelvin K. Tsai, Chin Fu Hsiao, Shih Hung Yang, Hui Hua Hsiao, Wen Chi Shen, Chiun Hsu, Yu Lin Lin, Jen Shi Chen, Yan Shen Shan, Li Tzong Chen

研究成果: 雜誌貢獻文章

1 引文 斯高帕斯(Scopus)

摘要

Background: This phase I/II study evaluated the feasibility and efficacy of S-1, leucovorin, oxaliplatin and gemcitabine (SLOG), a triplet regimen, for treating patients with metastatic pancreatic ductal adenocarcinoma (PDAC). Methods: Patients with chemo-naive, metastatic PDAC were eligible to receive fixed-rate infusion (10 mg/m2/min) of gemcitabine of 800 mg/m2 followed by 85 mg/m oxaliplatin of 85 mg/m2 on day 1 plus oral S-1 and leucovorin (20 mg/m2) twice daily from days 1 to 7 in a 2-week cycle. The dose of S-1 would be escalated from 20, 30, 35 to 40 mg/m2 in a 3 + 3 designed phase I part to determine the maximum tolerated dose (MTD) for phase II study, in which the primary end-point was objective response rate (ORR). The recommended dose of S-1 was from phase I. This trial is registered at ClinicalTrials.gov: NCT01415713. Results: Seventy-three patients were enrolled. In the phase I study (n = 19), the MTD of S-1 was 35 mg/m2 twice daily. Of 54 patients in phase II, the ORR was 40.7% (95% confidence interval [CI], 28%–55%). The median progression-free survival and overall survival were 7.6 (95% CI, 5.6–11.0) and 11.4 (95% CI, 8.1–16.3) months, respectively. The most common grade III/IV adverse event was neutropenia (40.7%). Twenty-four percent of patients had SLOG treatment for more than 1 year. The mean relative dose intensities of gemcitabine, oxaliplatin, and S-1 were 92%, 92% and 89%, respectively. Conclusion: Biweekly SLOG is a feasible regimen with promising activity and safety profiles. A randomised study comparing SLOG versus modified folinic acid, fluorouracil, irinotecan, and oxaliplatin (FOLFIRINOX) in advanced PDAC is ongoing (ClinicalTrials.gov: NCT03443492).

原文英語
頁(從 - 到)123-130
頁數8
期刊European Journal of Cancer
124
DOIs
出版狀態已發佈 - 一月 2020

    指紋

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

引用此

Chiang, N. J., Tsai, K. K., Hsiao, C. F., Yang, S. H., Hsiao, H. H., Shen, W. C., Hsu, C., Lin, Y. L., Chen, J. S., Shan, Y. S., & Chen, L. T. (2020). A multicenter, phase I/II trial of biweekly S-1, leucovorin, oxaliplatin and gemcitabine in metastatic pancreatic adenocarcinoma–TCOG T1211 study. European Journal of Cancer, 124, 123-130. https://doi.org/10.1016/j.ejca.2019.10.023