作者
T Ebata, S Hirano, M Konishi, K Uesaka, Y Tsuchiya, M Ohtsuka, Y Kaneoka, M Yamamoto, Y Ambo, Y Shimizu, F Ozawa, A Fukutomi, M Ando, Y Nimura, M Nagino, S Nakamori, T Ajiki, H Baba, R Yamaguchi, M Kawai, H Nagano, F Miura, T Arai, Y Nishiwaki, S Kawasaki, H Shinchi, M Shimoda, Y Yamamoto, I Endo, S Isaji, T Otsubo, S Ishihara, T Takahara, M Shimada, M Unno, M Imamura, N Ohkochi, Y Murakami, J Fujimoto, S Ikuta, Y Fujino, M Uebayashi, S Ishiyama, N Takakura, Y Kumamoto, T Kato, I Yoshioka, S Uemoto, K Yanaga
发表日期
2018/2
期刊
Journal of British Surgery
卷号
105
期号
3
页码范围
192-202
出版商
Oxford University Press
简介
Background
Although some retrospective studies have suggested the value of adjuvant therapy, no recommended standard exists in bile duct cancer. The aim of this study was to test the hypothesis that adjuvant gemcitabine chemotherapy would improve survival probability in resected bile duct cancer.
Methods
This was a randomized phase III trial. Patients with resected bile duct cancer were assigned randomly to gemcitabine and observation groups, which were balanced with respect to lymph node status, residual tumour status and tumour location. Gemcitabine was given intravenously at a dose of 1000 mg/m2, administered on days 1, 8 and 15 every 4 weeks for six cycles. The primary endpoint was overall survival, and secondary endpoints were relapse-free survival, subgroup analysis and toxicity.
Results
Some 225 patients were included (117 …
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T Ebata, S Hirano, M Konishi, K Uesaka, Y Tsuchiya… - Journal of British Surgery, 2018