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Phase II Study of Docetaxel, Nedaplatin, and 5-Fluorouracil Combined Chemotherapy for Advanced Esophageal Cancer

  • Gastrointestinal Oncology
  • Published:
Annals of Surgical Oncology Aims and scope Submit manuscript

Abstract

Background

We performed a prospective, multi-institutional, phase-II, clinical trial of a docetaxel, nedaplatin, and 5-fluorouracil (DNF) regimen in patients with unresectable esophageal cancer. Our goal was to determine the efficacy and feasibility of this DNF protocol.

Methods

Thirty-four patients with unresectable esophageal cancer were enrolled and received DNF therapy. The DNF regimen was repeated every 4 weeks for up to 8 weeks, based on the following recommended doses: docetaxel, 60 mg/m2 (day 1); nedaplatin, 70 mg/m2 (day 1); and 5-fluorouracil, 700 mg/m2 (days 1–5). The primary endpoint was the response rate. The secondary endpoints were overall survival and chemotherapy toxicities.

Results

The complete response rate and response rate were 5.9 and 47.1 %, respectively. The 2-year overall survival rate and progression-free survival rate were 44.3 and 27.3 %, respectively. The median survival time was 594 days. The median progression-free time was 277 days. No treatment-related deaths occurred. Thirty patients (30/34) with grade 3, 4 neutropenia improved relatively quickly with administration of granulocyte colony-stimulating factor.

Conclusions

DNF combination chemotherapy is a useful regimen with relatively minor adverse events and may serve as an effective protocol in patients with unresectable esophageal cancer.

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Acknowledgment

The authors thank Ms. Tomoko Yano, Ms. Ayaka Ishida, Ms. Ishikubo Ayaka, Ms. Yuka Matsui, and Ms. Yukie Saito for their excellent assistance.

Disclosure

This work was supported in part by Grants-in-Aid for Scientific Research from the Japan Society for the Promotion of Science (JSPS) (Grant Numbers 22591450 and 23591857).

Author information

Authors and Affiliations

  1. Department of General Surgical Science (Surgery 1), Gunma University Graduate School, Maebashi, Gunma, Japan

    Tatsuya Miyazaki MD, PhD, FACS, Hitoshi Ojima MD, PhD, Minoru Fukuchi MD, PhD, FACS, Makoto Sakai MD, PhD, Makoto Sohda MD, PhD, Naritaka Tanaka MD, PhD, Shigemasa Suzuki MD, PhD, Keisuke Ieta MD, PhD, Kana Saito MD, PhD, Akihiko Sano MD, PhD, Takehiko Yokobori MD, PhD, Takanori Inose MD, PhD & Hiroyuki Kuwano MD, PhD, FACS

  2. Department of Gastroenterological Surgery, Gunma Prefectural Cancer Center, Ota, Japan

    Hitoshi Ojima MD, PhD & Akihiko Sano MD, PhD

  3. Department of Surgery, Gunma Chuo Hospital, Maebashi, Gunma, Japan

    Minoru Fukuchi MD, PhD, FACS & Kana Saito MD, PhD

  4. Department of Surgery, Isesaki Municipal Hospital, Isesaki, Gunma, Japan

    Makoto Sakai MD, PhD, Keisuke Ieta MD, PhD & Kana Saito MD, PhD

  5. Department of Surgery I, Dokkyo Medical University, Tsuga-gun, Tochigi, Japan

    Masanobu Nakajima MD, PhD, FACS & Hiroyuki Kato MD, PhD, FACS

Authors
  1. Tatsuya Miyazaki MD, PhD, FACS
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  2. Hitoshi Ojima MD, PhD
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  3. Minoru Fukuchi MD, PhD, FACS
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  4. Makoto Sakai MD, PhD
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  5. Makoto Sohda MD, PhD
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  6. Naritaka Tanaka MD, PhD
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  7. Shigemasa Suzuki MD, PhD
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  8. Keisuke Ieta MD, PhD
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  9. Kana Saito MD, PhD
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  10. Akihiko Sano MD, PhD
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  11. Takehiko Yokobori MD, PhD
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  12. Takanori Inose MD, PhD
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  13. Masanobu Nakajima MD, PhD, FACS
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  14. Hiroyuki Kato MD, PhD, FACS
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  15. Hiroyuki Kuwano MD, PhD, FACS
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Corresponding author

Correspondence to Tatsuya Miyazaki MD, PhD, FACS.

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Miyazaki, T., Ojima, H., Fukuchi, M. et al. Phase II Study of Docetaxel, Nedaplatin, and 5-Fluorouracil Combined Chemotherapy for Advanced Esophageal Cancer. Ann Surg Oncol 22, 3653–3658 (2015). https://doi.org/10.1245/s10434-015-4440-4

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  • DOI: https://doi.org/10.1245/s10434-015-4440-4

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