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Clinical Studies

Multicenter randomised trial of two versus three courses of preoperative cisplatin and fluorouracil plus docetaxel for locally advanced oesophageal squamous cell carcinoma

British Journal of Cancer volume 126, pages 1555–1562 (2022)Cite this article

Subjects

Abstract

Background

The optimal number of neoadjuvant chemotherapy (NAC) cycles remains to be established for treating oesophageal squamous cell carcinoma (ESCC). We compared two versus three courses of NAC for treating locally advanced ESCC in a multi-institutional, randomised, Phase II trial.

Methods

We randomly assigned 180 patients with locally advanced ESCC at 6 institutions to either two (N = 91) or three (N = 89) courses of DCF (docetaxel 70 mg/m2, cisplatin 70 mg/m2 i.v. on day 1, fluorouracil 700 mg/m2 continuous infusion for 5 days) every 3 weeks, prior to surgery. The primary endpoint was 2-year progression-free survival (PFS) with an intention-to-treat analysis.

Results

Patient background parameters were well-balanced. The R0 resection rates were 98.9 and 96.5% in the two- and three-course groups, respectively (P = 0.830). In resected cases, the two- and three-course groups had comparable pN0 rates (P = 0.225) and histological responses (P = 0.898). The 2-year PFS rate was also comparable between the two groups (71.4 vs. 71.1%, P = 0.669). Among subgroups based on baseline characteristics, only patients aged under 65 years old showed a tendency for better survival with the three-course treatment (hazard ratio = 2.612, 95% confidence interval: 1.012–7.517).

Conclusions

Two courses of a DCF regimen showed potential as an optional NAC treatment for locally advanced ESCC.

Clinical trial registration

University Hospital Medical Information Network Clinical Trials Registry of Japan (identification number UMIN 000015788).

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Fig. 1: CONSORT diagram shows patient allocations, treatment and outcomes.
Fig. 2: Kaplan–Meier survival curves show progression-free and overall survival.
Fig. 3: Forest plot shows hazard ratios (dots) and 95% confidence intervals (lines) for factors that could potentially affect progression-free survival.

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Acknowledgements

The authors would like to thank the staff of all the centres that participated in the data collection process for this study.

Funding

This study was not supported by any funding.

Author information

Authors and Affiliations

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

    Tomoki Makino, Makoto Yamasaki, Koji Tanaka, Kotaro Yamashita, Shinya Urakawa, Tomo Ishida, Hidetoshi Eguchi & Yuichiro Doki

  2. Department of Surgery, Kansai Medical University, Hirakata, Japan

    Makoto Yamasaki

  3. Department of Surgery, Kindai University Faculty of Medicine, Osaka, Japan

    Osamu Shiraishi & Takushi Yasuda

  4. Department of Digestive Surgery, Osaka International Cancer Institute, Osaka, Japan

    Keijiro Sugimura, Hiroshi Miyata & Masahiko Yano

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

    Keijiro Sugimura & Atsushi Takeno

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

    Masaaki Motoori & Kazumasa Fujitani

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

    Atsushi Takeno & Motohiro Hirao

  8. Department of Surgery, Kindai University Nara Hospital, Nara, Japan

    Yutaka Kimura

  9. Department of Frontier Science for Cancer and Chemotherapy, Osaka University Graduate School of Medicine, Osaka, Japan

    Taroh Satoh

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

    Masahiko Yano

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  1. Tomoki Makino
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Contributions

TM, SU and TI contributed to the design and analysis of the results and the writing of the manuscript. MY, KT, KY, OS, KS, HM, MM, KF, AT, MH, YK and TS contributed to the implementation of the research and analysis of the results. MY, HE, YD and TY contributed to the design and implementation of the research.

Corresponding author

Correspondence to Tomoki Makino.

Ethics declarations

Ethics approval and consent to participate

All patients provided written informed consent for trial participation. The study protocol was approved by the Institutional Review Board in each of six participating hospitals, before patient enrolment.

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Not applicable.

Competing interests

The authors declare no competing interests.

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Makino, T., Yamasaki, M., Tanaka, K. et al. Multicenter randomised trial of two versus three courses of preoperative cisplatin and fluorouracil plus docetaxel for locally advanced oesophageal squamous cell carcinoma. Br J Cancer 126, 1555–1562 (2022). https://doi.org/10.1038/s41416-022-01726-5

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  • DOI: https://doi.org/10.1038/s41416-022-01726-5

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