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大学・研究所にある論文を検索できる 「Multicenter phase II study of trifluridine/tipiracil for esophageal squamous carcinoma refractory/intolerant to 5-fluorouracil, platinum compounds, and taxanes: the ECTAS study」の論文概要。リケラボ論文検索は、全国の大学リポジトリにある学位論文・教授論文を一括検索できる論文検索サービスです。
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Multicenter phase II study of trifluridine/tipiracil for esophageal squamous carcinoma refractory/intolerant to 5-fluorouracil, platinum compounds, and taxanes: the ECTAS study

Mori, Yukiko Kikuchi, Osamu Horimatsu, Takahiro Hara, Hiroki Hironaka, Shuichi Kojima, Takashi Kato, Ken Tsushima, Takahiro Ishihara, Ryu Mukai, Kumi Uozumi, Ryuji Tada, Harue Kasai, Hiroi Kawaguchi, Atsushi Muto, Manabu 京都大学 DOI:10.1007/s10388-021-00905-2

2022.07

概要

[Background] The standard treatment for unresectable advanced/recurrent esophageal cancer in Japan is 5-fluorouracil plus platinum-containing drugs as first-line chemotherapy and taxanes as second-line chemotherapy. However, the standard regimen after patients become refractory to these treatments remains to be established. Therefore, we investigated the efficacy of trifluridine/tipiracil (FTD/TPI) in patients with esophageal cancer who are refractory or intolerant to 5-fluorouracil, platinum-containing drugs, and taxanes. [Methods] This single-arm phase II trial was conducted in seven hospitals in Japan. Eligible patients were those with unresectable advanced/recurrent esophageal cancer that was refractory or intolerant to 5-fluorouracil, platinum-containing drugs, and taxanes. The primary endpoint was the 3-month progression-free survival rate, and the secondary endpoints were the 6-month progression-free survival rate, progression-free survival, overall survival, response rate, disease control rate, and toxicity. [Results] Forty-two patients were enrolled between October 2015 and June 2016. All tumors were squamous cell carcinomas. The progression-free survival rates at 3 and 6 months were 15.4% (90% confidence interval 7.4–26.0%) and 7.7% (90% confidence interval 2.6–16.6%), respectively. The median progression-free survival and median overall survival were 1.3 (95% confidence interval 1.0–1.8) months and 4.5 (95% confidence interval 3.6–5.7) months, respectively. The response rate was 0%, and the disease control rate was 23.8% (95% confidence interval 13.5–38.5%). The major grade 3/4 toxicities were neutropenia (47.6%), leukocytopenia (35.7%), and anemia (21.4%). No treatment-related deaths occurred. Exploratory subgroup analyses showed better progression-free survival in the subgroup without distant metastasis at diagnosis. [Conclusions] Trifluridine/tipiracil monotherapy is feasible and shows modest activity in patients with refractory esophageal squamous cell carcinoma.

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参考文献

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