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
Journal
Oncology (Switzerland)
Journal Volume
87
Journal Issue
2
Pages
104-113
Date Issued
2014
Author(s)
Li C.-P.
Yen C.-J.
Lin Y.-L.
Chen L.-T.
Su W.-C.
Chao Y.
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-na?ve 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-na?ve advanced gastric cancer patients. ? 2014 S. Karger AG, Basel.
SDGs
Other Subjects
cisplatin; everolimus; fluorouracil; folinic acid; cisplatin; everolimus; fluorouracil; folinic acid; adult; advanced cancer; advanced gastric cancer; aged; anorexia; article; cancer combination chemotherapy; chemotherapy induced anemia; clinical article; constipation; diarrhea; drug efficacy; drug megadose; drug safety; female; human; hyperammonemia; hyperammonemic encephalopathy; hypokalemia; hyponatremia; leukopenia; low drug dose; male; mucosa inflammation; multicenter study; multiple cycle treatment; nausea; neutropenia; open study; overall survival; phase 2 clinical trial; pneumonia; priority journal; progression free survival; sepsis; stomach cancer; stomatitis; survival rate; survival time; thrombocytopenia; vomiting; abdominal pain; anemia; Article; cancer chemotherapy; coughing; dizziness; fatigue; hand foot syndrome; hypomagnesemia; sensory neuropathy; treatment outcome; treatment response; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Cisplatin; Disease-Free Survival; Dose-Response Relationship, Drug; Drug Administration Schedule; Female; Fluorouracil; Humans; Infusions, Intravenous; Leucovorin; Male; Middle Aged; Pilot Projects; Sirolimus; Stomach Neoplasms; Taiwan; Treatment Outcome
Publisher
S. Karger AG
Type
journal article