• Br J Surg · Jan 2024

    Recurrence-free survival as a surrogate endpoint for overall survival after neoadjuvant chemotherapy and surgery for oesophageal squamous cell carcinoma.

    • Jun Okui, Kengo Nagashima, Satoru Matsuda, Yasunori Sato, Akihiko Okamura, Hirofumi Kawakubo, Manabu Muto, Yoshihiro Kakeji, Koji Kono, Hiroya Takeuchi, Masayuki Watanabe, Yuichiro Doki, Takeo Bamba, Takashi Fukuda, Hitoshi Fujiwara, Shinsuke Sato, Kazuhiro Noma, Hiroshi Miyata, Takeo Fujita, and Yuko Kitagawa.
    • Department of Surgery, Keio University School of Medicine, Tokyo, Japan.
    • Br J Surg. 2024 Jan 31; 111 (2).

    BackgroundOverall survival is considered as one of the most important endpoints of treatment efficacy but often requires long follow-up. This study aimed to determine the validity of recurrence-free survival as a surrogate endpoint for overall survival in patients with surgically resectable advanced oesophageal squamous cell carcinoma (OSCC).MethodsPatients with OSCC who received neoadjuvant cisplatin and 5-fluorouracil, or docetaxel, cisplatin and 5-fluorouracil, at 58 Japanese oesophageal centres certified by the Japan Esophageal Society were reviewed retrospectively. The correlation between recurrence-free and overall survival was assessed using Kendall's τ.ResultsThe study included 3154 patients. The 5-year overall and recurrence-free survival rates were 56.6 and 47.7% respectively. The primary analysis revealed a strong correlation between recurrence-free and overall survival (Kendall's τ 0.797, 95% c.i. 0.782 to 0.812) at the individual level. Subgroup analysis showed a positive relationship between a more favourable pathological response to neoadjuvant chemotherapy and a higher τ value. In the meta-regression model, the adjusted R2 value at the institutional level was 100 (95% c.i. 40.2 to 100)%. The surrogate threshold effect was 0.703.ConclusionThere was a strong correlation between recurrence-free and overall survival in patients with surgically resectable OSCC who underwent neoadjuvant chemotherapy, and this was more pronounced in patients with a better response to neoadjuvant chemotherapy.© The Author(s) 2024. Published by Oxford University Press on behalf of BJS Foundation Ltd.

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