https://scholars.lib.ntu.edu.tw/handle/123456789/596681
標題: | A multicenter, phase I/II trial of biweekly S-1, leucovorin, oxaliplatin and gemcitabine in metastatic pancreatic adenocarcinoma–TCOG T1211 study | 作者: | Chiang N.-J. Tsai K.K. Hsiao C.-F. SHIH-HUNG YANG Hsiao H.-H. Shen W.-C. CHIUN HSU Lin Y.-L. Chen J.-S. Shan Y.-S. Chen L.-T. |
公開日期: | 2020 | 出版社: | Elsevier Ltd | 卷: | 124 | 起(迄)頁: | 123-130 | 來源出版物: | European Journal of Cancer | 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). ? 2019 Elsevier Ltd |
URI: | https://www.scopus.com/inward/record.uri?eid=2-s2.0-85075312362&doi=10.1016%2fj.ejca.2019.10.023&partnerID=40&md5=cb5b5734be130a470c87ef1c11fec1ab https://scholars.lib.ntu.edu.tw/handle/123456789/596681 |
ISSN: | 0959-8049 | DOI: | 10.1016/j.ejca.2019.10.023 | SDG/關鍵字: | alanine aminotransferase; aspartate aminotransferase; CA 19-9 antigen; cisplatin; erlotinib; fluorouracil; folinic acid; gamma glutamyltransferase; gemcitabine; gimeracil plus oteracil potassium plus tegafur; irinotecan; oxaliplatin; paclitaxel; antineoplastic agent; deoxycytidine; folinic acid; gemcitabine; oteracil; oxaliplatin; S 1 (combination); tegafur; adult; aged; alanine aminotransferase blood level; allergy; alopecia; anemia; anorexia; Article; aspartate aminotransferase blood level; cancer combination chemotherapy; cancer patient; diarrhea; drug dose increase; drug efficacy; drug megadose; drug safety; drug withdrawal; fatigue; febrile neutropenia; female; gamma glutamyl transferase blood level; human; hyperpigmentation; leukopenia; major clinical study; male; maximum tolerated dose; metastasis; multicenter study; multiple cycle treatment; nausea; neutropenia; oral mucositis; overall survival; pancreas adenocarcinoma; peripheral neuropathy; phase 1 clinical trial; phase 2 clinical trial; priority journal; progression free survival; pruritus; rash; sensory neuropathy; sepsis; side effect; thrombocytopenia; treatment duration; vomiting; adenocarcinoma; clinical trial; drug combination; metastasis; middle aged; pancreas carcinoma; pancreas tumor; pathology; Adenocarcinoma; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Pancreatic Ductal; Deoxycytidine; Drug Combinations; Female; Humans; Leucovorin; Male; Middle Aged; Neoplasm Metastasis; Oxaliplatin; Oxonic Acid; Pancreatic Neoplasms; Tegafur |
顯示於: | 腫瘤醫學研究所 |
在 IR 系統中的文件,除了特別指名其著作權條款之外,均受到著作權保護,並且保留所有的權利。