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 CancerShen Y.-C.a, b · Li C.-P.e, g · Yen C.-J.h · Hsu C.b-d · Lin Y.-L.b · Lin Z.-Z.a-c · Chen L.-T.h-j · Su W.-C.h · Chao Y.f, g · Yeh K.-H.a,b,d · Cheng A.-L.a-d
aNational Center of Excellence for Clinical Trial and Research and Departments of bOncology and cInternal Medicine, National Taiwan University Hospital, dGraduate Institute of Oncology, School of Medicine, National Taiwan University, eDivision of Gastroenterology, Department of Medicine, and fCancer Center, Taipei Veterans General Hospital, and gNational Yang-Ming University School of Medicine, Taipei, hDivision of Hematology/Oncology, Department of Internal Medicine, National Cheng Kung University Hospital, and iNational Institute of Cancer Research, National Health Research Institute, Tainan, and jDepartment of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan, ROC
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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
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