Clinical outcomes of second‑line chemotherapy after gemcitabine and cisplatin plus S‑1 treatment for patients with advanced biliary tract cancer in the KHBO1401‑3A study

Shindo,Yoshitaro; Nagano,Hiroaki; Kanai,Masashi; Kobayashi,Shogo; Wada,Hiroshi; Sakai,Daisuke; Eguchi,Hidetoshi; Baba,Hideo; Kamachi,Hirofumi; Takayama,Tadatoshi; Ueno,Masaki; Takahashi,Masahiro; Nakagami,Yuki; Yoshimura,Kenichi; Hatano,Etsuro; Ioka,Tatsuya

doi:10.3892/or.2023.8478

Clinical outcomes of second‑line chemotherapy after gemcitabine and cisplatin plus S‑1 treatment for patients with advanced biliary tract cancer in the KHBO1401‑3A study

Authors:
- Yoshitaro Shindo
- Hiroaki Nagano
- Masashi Kanai
- Shogo Kobayashi
- Hiroshi Wada
- Daisuke Sakai
- Hidetoshi Eguchi
- Hideo Baba
- Hirofumi Kamachi
- Tadatoshi Takayama
- Masaki Ueno
- Masahiro Takahashi
- Yuki Nakagami
- Kenichi Yoshimura
- Etsuro Hatano
- Tatsuya Ioka
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Affiliations: Department of Gastroenterological, Breast and Endocrine Surgery, Yamaguchi University Graduate School of Medicine, Ube, Yamaguchi 755‑8505, Japan, Department of Medical Oncology, Kyoto University Hospital, Kyoto 606‑8501, Japan, Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Suita, Osaka 565‑0871, Japan, Department of Gastroenterological Surgery, Osaka International Cancer Institute, Suita, Osaka 565‑0871, Japan, Department of Frontier Science for Cancer and Chemotherapy, Osaka University, Suita, Osaka 565‑0871, Japan, Department of Gastroenterological Surgery, Graduate School of Medical Science, Kumamoto University, Kumamoto 860‑8556, Japan, Department of Gastroenterological Surgery I, Hokkaido University Graduate School of Medicine, Sapporo, Hokkaido 060‑8648, Japan, Department of Digestive Surgery, Nihon University School of Medicine, Tokyo 173‑8610, Japan, Second Department of Surgery, School of Medicine, Wakayama Medical University, Wakayama 641‑8509, Japan, Department of Medical Oncology, Tohoku University Hospital, Sendai, Miyagi 980‑8574, Japan, Medical Center for Clinical and Translational Research, Hiroshima University Hospital, Hiroshima 734‑8551, Japan, Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto 606‑8501, Japan, Department of Oncology Center, Yamaguchi University Hospital, Ube, Yamaguchi 755‑8505, Japan
Published online on: January 11, 2023 https://doi.org/10.3892/or.2023.8478
Article Number: 41
Copyright: © Shindo et al. This is an open access article distributed under the terms of Creative Commons Attribution License.

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Abstract

Since the completion of the KHBO1401 study, which evaluated the efficacy of the combination of gemcitabine (GEM) and cisplatin (GC) compared with GC plus S‑1 (GCS), GCS has become a standard chemotherapy for patients with advanced biliary tract cancer (BTC). However, there are currently no data revealing second‑line therapy options after GCS. The present study aimed to evaluate the survival outcomes of patients receiving second‑line chemotherapy for advanced BTC, refractory or intolerant to GCS, using data from the KHBO1401 study. Patients who received a second‑line treatment after GCS chemotherapy between July 2014 and February 2016 were retrospectively studied. Overall survival (OS) was calculated from the day of GCS treatment failure or the first day of second‑line chemotherapy to the final follow‑up date or until death from any cause. Among 83 patients refractory or intolerant to GCS chemotherapy, 51 (61%) received second‑line chemotherapy, including GCS (n=8), GC (n=15), GEM (n=6), GEM plus S‑1 (GS) (n=4) and S‑1 (n=18). The 6‑ and 12‑month OS rates were 66.7 and 44.4%, respectively, following second‑line chemotherapy, and 6.3 and 3.1%, respectively, in the best supportive care group (P<0.0001). In addition, the 12‑ and 24‑month OS rates were 59.3 and 36.2%, respectively, in the multidrug chemotherapy group, and 26.9 and 9.0%, respectively, in the single‑agent chemotherapy group (P=0.0191). These results suggested that second‑line combination chemotherapy is a viable treatment option for patients with advanced BTC that is refractory or intolerant to first‑line GCS therapy.

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