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Paclitaxel plus cisplatin and 5-fluorouracil induction chemotherapy for locally advanced borderline-resectable esophageal squamous cell carcinoma: a phase II clinical trial

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Abstract

Purpose

This phase II trial aimed to assess the safety and efficacy of paclitaxel in combination with cisplatin and 5-fluorouracil (TPF) induction chemotherapy followed by surgery for locally advanced borderline-resectable esophageal squamous cell carcinoma (BR-ESCC).

Methods

Patients with primary tumor or bulky lymph nodes that might invade nearby organs were eligible. Treatment started with 2–3 cycles of TPF induction chemotherapy, followed by surgery if the tumor was assessed resectable, or by radical concurrent chemoradiotherapy if unresectable. The primary endpoint was pathologically proven complete resection (R0) rate.

Results

From July 2014 to February 2019, a total of 47 patients were enrolled. After TPF chemotherapy, 27 patients (57.4%) received surgery and 11 patients (23.4%) received radical concurrent chemoradiotherapy. R0 resection was confirmed in 25 patients (53.2%, 95% confidence interval (CI) 38.9–67.5%). Pathologic complete response was confirmed in four patients (8.5%). The median overall survival (OS) and progression-free survival (PFS) for all patients were 33.3 months and 20.3 months, respectively. The median OS was significantly more favorable in surgery group than in chemoradiotherapy and chemotherapy alone group [33.3 months vs 14.1 months, hazard ratio 0.32 (95% CI 0.12–0.88), p = 0.027]. During induction chemotherapy, the most common grade 3 or 4 toxicities were neutropenia (29.8%), leucopenia (21.3%) and stomatitis (4.3%). No serious postoperative complications were observed in patients undergoing surgery.

Conclusions

The treatment strategy of induction chemotherapy followed by surgery is promising for patients with locally advanced BR-ESCC. To further improve the R0 resection rate, more effective induction chemotherapy regimens need to be explored.

Trial registration

ClinicalTrials.gov identifier: NCT02976909.

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Acknowledgements

We thank all the patients for the participation in this study. We thank the contribution of the esophageal cancer multidisciplinary consultation of Sun Yat-sen Cancer Center.

Funding

This project was supported by the Science and Technology Project of Guangdong Esophageal Cancer Research Institute (Q201509); the National Natural Science Foundation of China (81972614).

Author information

Author notes

  1. Zhiqiang Wang, Mingtao Hu and Yihuai Hu contributed equally.

Authors and Affiliations

  1. State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-Sen University Cancer Center, Guangzhou, China

    Zhiqiang Wang, Mingtao Hu, Yihuai Hu, Qiaoqiao Li, Jiadi Wu, William Pat Fong, Chao Ren, Deshen Wang, Qiong Tan, Hong Yang & Yuhong Li

  2. Department of Medical Oncology, Sun Yat-Sen University Cancer Center, Guangzhou, China

    Zhiqiang Wang, Mingtao Hu, William Pat Fong, Chao Ren, Deshen Wang, Qiong Tan & Yuhong Li

  3. Department of Thoracic Surgery, Sun Yat-Sen University Cancer Center, Guangzhou, China

    Yihuai Hu, Jiadi Wu & Hong Yang

  4. Department of Radiation Oncology, Cancer Center, Sun Yat-Sen University, Guangzhou, China

    Qiaoqiao Li

  5. Department of Medical Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, No. 651, Dong-Feng-Dong Street, Guangzhou, 510060, China

    Yuhong Li

  6. Department of Thoracic Surgery, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, No. 651, Dong-Feng-Dong Street, Guangzhou, 510060, China

    Hong Yang

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  1. Zhiqiang Wang
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Contributions

YL and HY planed and decided the whole study design and protocol development. ZW designed the specific implementation steps and drafted the article. ZW , MH and YH contributed to statistical analysis and wrote the manuscript. YL, ZW, CR and DW contributed the perform chemotherapy. QL contributed the perform radiotherapy for patients. HY, YH and JW contributed to perform surgery. WPF and QT contributed to acquisition of data, literature search and manuscript revision. All authors read and gave the final approval of the version.

Corresponding authors

Correspondence to Hong Yang or Yuhong Li.

Ethics declarations

Ethical statement

All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1964 and later versions. Informed consent or substitute for it was obtained from all patients for being included in the study.

Conflict of interest

The authors declare no conflict of interest.

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Wang, Z., Hu, M., Hu, Y. et al. Paclitaxel plus cisplatin and 5-fluorouracil induction chemotherapy for locally advanced borderline-resectable esophageal squamous cell carcinoma: a phase II clinical trial. Esophagus 19, 120–128 (2022). https://doi.org/10.1007/s10388-021-00864-8

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  • DOI: https://doi.org/10.1007/s10388-021-00864-8

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