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

Ying Chun Shen, Chung Pin Li, Chia-Jui Yen, Chiun Hsu, Yu Lin Lin, Zhong Zhe Lin, Li Tzong Chen, Wu-Chou Su, Yee Chao, Kun Huei Yeh, Ann Lii Cheng

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9 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)104-113
Number of pages10
JournalOncology (Switzerland)
Volume87
Issue number2
DOIs
Publication statusPublished - 2014 Jan 1

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

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