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Karger Publishers, Oncology, 2(87), p. 104-113, 2014

DOI: 10.1159/000362671

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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

This paper is made freely available by the publisher.
This paper is made freely available by the publisher.

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Abstract

<b><i>Objective:</i></b> 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. <b><i>Methods:</i></b> 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/m<sup>2</sup> intravenous infusion for 24 h on days 1 and 8, 5-fluorouracil 2,000 mg/m<sup>2</sup> and leucovorin 300 mg/m<sup>2</sup> 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. <b><i>Results:</i></b> 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. <b><i>Conclusion:</i></b> 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.