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タイトル: | Multicenter phase II study of trifluridine/tipiracil for esophageal squamous carcinoma refractory/intolerant to 5-fluorouracil, platinum compounds, and taxanes: the ECTAS study |
著者: | Mori, Yukiko Kikuchi, Osamu https://orcid.org/0000-0001-5012-5897 (unconfirmed) Horimatsu, Takahiro https://orcid.org/0000-0002-4188-9059 (unconfirmed) Hara, Hiroki Hironaka, Shuichi Kojima, Takashi Kato, Ken Tsushima, Takahiro Ishihara, Ryu Mukai, Kumi Uozumi, Ryuji Tada, Harue Kasai, Hiroi Kawaguchi, Atsushi Muto, Manabu https://orcid.org/0000-0002-3127-8203 (unconfirmed) |
著者名の別形: | 森, 由希子 菊池, 理 堀松, 高博 向井, 久美 魚住, 龍史 多田, 春江 笠井, 宏委 武藤, 学 |
キーワード: | Esophageal cancer Chemotherapy Clinical trial Trifluridine Safety |
発行日: | Jul-2022 |
出版者: | Springer Nature |
誌名: | Esophagus |
巻: | 19 |
号: | 3 |
開始ページ: | 444 |
終了ページ: | 451 |
抄録: | [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. |
著作権等: | This version of the article has been accepted for publication, after peer review (when applicable) and is subject to Springer Nature’s AM terms of use, but is not the Version of Record and does not reflect post-acceptance improvements, or any corrections. The Version of Record is available online at: http://dx.doi.org/10.1007/s10388-021-00905-2 The full-text file will be made open to the public on 20 January 2023 in accordance with publisher's 'Terms and Conditions for Self-Archiving'. This is not the published version. Please cite only the published version. この論文は出版社版でありません。引用の際には出版社版をご確認ご利用ください。 |
URI: | http://hdl.handle.net/2433/274262 |
DOI(出版社版): | 10.1007/s10388-021-00905-2 |
PubMed ID: | 35050435 |
出現コレクション: | 学術雑誌掲載論文等 |
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