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Clinical Studies

Chemoradiotherapy versus triplet chemotherapy as initial therapy for T4b esophageal cancer: survival results from a multicenter randomized Phase 2 trial

British Journal of Cancer volume 129, pages 54–60 (2023)Cite this article

Subjects

Abstract

Background

We report the long-term results as primary endpoint in a multicentre randomized prospective Phase 2 trial which compared chemoradiotherapy (CRT) and triplet chemotherapy (CT) as the initial therapy for conversion surgery (CS) in T4b esophageal cancer (EC).

Methods

Patients with T4b EC were randomly assigned to the CRT group or CT group as initial treatment. CS was performed if resectable after initial or secondary treatment. The primary endpoint was 2-year overall survival, analysed by intention-to-treat.

Results

The median follow-up period was 43.8 months. The 2-year survival rate was higher in the CRT group (55.1%; 95% CI: 41.1–68.3%) compared to the CT group (34.7%; 95% CI: 22.8–48.9%), although the difference was not significant (P = 0.11). Local and regional lymph node recurrence in patients undergoing R0 resection was significantly higher in the CT group compared to the CRT group (local: 30% versus 8%, respectively, P = 0.03; regional: 37% versus 8%, respectively, P = 0.002).

Conclusions

Upfront CT was not superior to upfront CRT as induction therapy for T4b EC in terms of 2-year survival and was significantly inferior to upfront CRT in terms of local and regional control.

Registration

The Japan Registry of Clinical Trials (s051180164).

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Fig. 1: CONSORT diagram.
Fig. 2: Kaplan-Meier curves.
Fig. 3: Kaplan–Meier curves.
Fig. 4: Forest plot for survival.

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Data availability

The datasets generated and/or analysed during the current study are available from the corresponding author on reasonable request.

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Acknowledgements

The authors thank the staff from all centers that participated in data collection.

Funding

This work was supported by a grant-in-aid from Japanese Foundation for Multidisciplinary Treatment of Cancer (KS), a grant-in-aid from The Osaka Community Foundation (KS), a grant-in-aid from The Public Trust Fund for Clinical Cancer Research (KS) and a grant-in-aid from Japan Research Foundation for Clinical Pharmacology (KS).

Author information

Authors and Affiliations

  1. Department of Surgery, Kansai Medical University, Hirakata, Osaka, Japan

    Makoto Yamasaki

  2. Department of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, Suita, Osaka, Japan

    Makoto Yamasaki, Kotaro Yamashita, Koji Tanaka, Tomoki Makino, Hidetoshi Eguchi & Yuichiro Doki

  3. Department of Surgery, Osaka International Cancer Institute, Osaka, Japan

    Hiroshi Miyata

  4. Department of Surgery, National Hospital Organization, Osaka National Hospital, Osaka, Japan

    Takuya Hamakawa, Atsushi Takeno & Motohiro Hirao

  5. Department of Surgery, Kansai Rosai Hospital, Hyogo, Japan

    Keijiro Sugimura

  6. Department of Surgery, Kindai University Faculty of Medicine, Osaka Sayama, Osaka, Japan

    Osamu Shiraishi, Yutaka Kimura & Takusi Yasuda

  7. Department of Surgery, Osaka General Medical Center, Osaka, Japan

    Masaaki Motoori & Kazumasa Fujitani

  8. Department of Surgery, Suita Municipal Hospital, Osaka, Japan

    Masahiko Yano

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Contributions

Study concepts: M Yano, YD and TY. Development of the methodology, data analysis and interpretation: M Yamasaki, KS, HM, KT, TM, AT, OS, M Motoori, YK, MH, KF, TY, HE, YD and M Yano. Manuscript preparation, editing and review: M Yamasaki. All authors had access to the study data and have reviewed and approved the final manuscript.

Corresponding author

Correspondence to Makoto Yamasaki.

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Competing interests

The authors declare no competing interests.

Ethics approval and consent to participate

The human ethics review committee of each institution approved the study protocol. Subjects provided written informed consent. This study was performed in accordance with the Declarations of Helsinki.

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Yamasaki, M., Miyata, H., Yamashita, K. et al. Chemoradiotherapy versus triplet chemotherapy as initial therapy for T4b esophageal cancer: survival results from a multicenter randomized Phase 2 trial. Br J Cancer 129, 54–60 (2023). https://doi.org/10.1038/s41416-023-02286-y

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