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- Title
Phase II Multicentered Study of Low-Dose Everolimus plus Cisplatin and Weekly 24-Hour Infusion of High-Dose 5-Fluorouracil and Leucovorin as First-Line Treatment for Patients with Advanced Gastric Cancer.
- Authors
Shen, Ying-Chun; Li, Chung-Pin; Yen, Chia-Jui; Hsu, Chiun; Lin, Yu-Lin; Lin, Zhong-Zhe; Chen, Li-Tzong; Su, Wu-Chou; Chao, Yee; Yeh, Kun-Huei; Cheng, Ann-Lii
- Abstract
Objective: This phase II trial investigates the efficacy and safety of low-dose everolimus in combination with cisplatin-fluorouracil chemotherapy in patients with advanced gastric cancer. Methods: Eligible patients with chemotherapy-naïve advanced gastric cancer received low-dose everolimus (10 mg p.o. on days 1, 8 and 15) plus cisplatin and a weekly 24-hour infusion of high-dose 5-fluorouracil and leucovorin (HDFL) chemotherapy (cisplatin 35 mg/m2 intravenous infusion for 24 h on days 1 and 8, 5-fluorouracil 2,000 mg/m2 and leucovorin 300 mg/m2 intravenous infusion for 24 h on days 1, 8 and 15) every 28 days. The primary endpoint was objective response rate (ORR) according to the Response Evaluation Criteria in Solid Tumors version 1.0. Results: Forty patients (19 men; 21 women; median age, 54.1 years; range, 33.7-73.3 years) received a median of 6 (range, 1-30; 95% CI, 4.9-8.0) cycles of study treatment. The ORR was 52.5% (21 confirmed partial response). The median progression-free survival and overall survival were 6.9 (95% CI, 4.9-8.4) and 10.5 (95% CI, 8.6-12.3) months, respectively. Most adverse events were mild. Conclusion: Adding low-dose everolimus to cisplatin-HDFL chemotherapy failed to increase the ORR as in a preplanned statistical assumption but may prolong progression-free survival in treatment-naïve advanced gastric cancer patients. © 2014 S. Karger AG, Basel
- Subjects
TAIWAN; ACADEMIC medical centers; ANTINEOPLASTIC agents; COMBINATION drug therapy; CISPLATIN; CONFIDENCE intervals; FLUOROURACIL; MEDICAL cooperation; HEALTH outcome assessment; RESEARCH; RESEARCH funding; SAFETY; STOMACH tumors; SURVIVAL; TREATMENT effectiveness; DESCRIPTIVE statistics; EVEROLIMUS; THERAPEUTICS
- Publication
Oncology, 2014, Vol 87, Issue 2, p104
- ISSN
0030-2414
- Publication type
Article
- DOI
10.1159/000362671