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Annals of Surgical Oncology

, Volume 22, Issue 11, pp 3653–3658 | Cite as

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

  • Tatsuya Miyazaki
  • Hitoshi Ojima
  • Minoru Fukuchi
  • Makoto Sakai
  • Makoto Sohda
  • Naritaka Tanaka
  • Shigemasa Suzuki
  • Keisuke Ieta
  • Kana Saito
  • Akihiko Sano
  • Takehiko Yokobori
  • Takanori Inose
  • Masanobu Nakajima
  • Hiroyuki Kato
  • Hiroyuki Kuwano
Gastrointestinal Oncology

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.

Keywords

Docetaxel Esophageal Cancer Acute Kidney Injury CDDP Complete Response Rate 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Notes

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).

References

  1. 1.
    Kato H, Fukuchi M, Miyazaki T, et al. Surgical treatment for esophageal cancer. Current issues. Digest Surg. 2007;24(2):88–95.CrossRefGoogle Scholar
  2. 2.
    Kuwano H, Nakajima M, Miyazaki T, Kato H. Distinctive clinicopathological characteristics in esophageal squamous cell carcinoma. Ann Thor Cardiovasc Surg. 2003;9(1):6–13.Google Scholar
  3. 3.
    Ajani JA. Contributions of chemotherapy in the treatment of carcinoma of the esophagus: results and commentary. Semin Oncol. 1994;21(4):474–82.PubMedGoogle Scholar
  4. 4.
    Ajani JA, Ryan B, Rich TA, et al. Prolonged chemotherapy for localised squamous carcinoma of the oesophagus. Eur J Cancer. 1992;28A(4–5):880–4.CrossRefPubMedGoogle Scholar
  5. 5.
    Hilgenberg AD, Carey RW, Wilkins EW, Jr., Choi NC, Mathisen DJ, Grillo HC. Preoperative chemotherapy, surgical resection, and selective postoperative therapy for squamous cell carcinoma of the esophagus. Ann Thorac Surg. 1988;45(4):357–63.CrossRefPubMedGoogle Scholar
  6. 6.
    Iizuka T, Kakegawa T, Ide H, et al. Phase II evaluation of cisplatin and 5-fluorouracil in advanced squamous cell carcinoma of the esophagus: a Japanese Esophageal Oncology Group Trial. Jpn J Clin Oncol. 1992;22(3):172–6.PubMedGoogle Scholar
  7. 7.
    Hayashi K, Ando N, Watanabe H, et al. Phase II evaluation of protracted infusion of cisplatin and 5-fluorouracil in advanced squamous cell carcinoma of the esophagus: a Japan Esophageal Oncology Group (JEOG) Trial (JCOG9407). Jpn J Clin Oncol. 2001;31(9):419–23.CrossRefPubMedGoogle Scholar
  8. 8.
    Osaka Y, Shinohara M, Hoshino S, et al. Phase II study of combined chemotherapy with docetaxel, CDDP and 5-FU for highly advanced esophageal cancer. Anticancer Res. 2011;31(2):633–8.PubMedGoogle Scholar
  9. 9.
    Watanabe M, Baba Y, Yoshida N, et al. Outcomes of preoperative chemotherapy with docetaxel, cisplatin, and 5-fluorouracil followed by esophagectomy in patients with resectable node-positive esophageal cancer. Ann Surg Oncol. 2014;21:2838–3844.CrossRefPubMedGoogle Scholar
  10. 10.
    Sasaki Y, Tamura T, Eguchi K, et al. Pharmacokinetics of (glycolate-0,0′)-diammine platinum (II), a new platinum derivative, in comparison with cisplatin and carboplatin. Cancer Chemother Pharmacol. 1989;23(4):243–6.CrossRefPubMedGoogle Scholar
  11. 11.
    Suzumura Y, Kato T, Ueda R, Ota K. Effect of treatment schedule on antitumor activity of glycolate-0,0′-diammineplatinum(II), a new platinum derivative: comparison with cis-diamminedichloroplatinum(II). Anticancer Res. 1989;9(4):1083–8.PubMedGoogle Scholar
  12. 12.
    Sasaki Y, Fukuda M, Morita M, et al. Prediction from creatinine clearance of thrombocytopenia and recommended dose in patients receiving (glycolato-O,O’)-diammine platinum (II) (NSC 375101D). Jpn J Cancer Res. 1990;81(2):196–200.CrossRefPubMedGoogle Scholar
  13. 13.
    Fukuda M, Shinkai T, Eguchi K, et al. Phase II study of (glycolate-O,O′) diammineplatinum(II), a novel platinum complex, in the treatment of non-small-cell lung cancer. Cancer Chemother Pharmacol. 1990;26(6):393–6.CrossRefPubMedGoogle Scholar
  14. 14.
    Akaza H, Togashi M, Nishio Y, et al. Phase II study of cis-diammine(glycolato)platinum, 254-S, in patients with advanced germ-cell testicular cancer, prostatic cancer, and transitional-cell carcinoma of the urinary tract. 254-S Urological Cancer Study Group. Cancer Chemother Pharmacol. 1992;31(3):187–92.CrossRefPubMedGoogle Scholar
  15. 15.
    Guo JF, Zhang B, Wu F, et al. A phase II trial of docetaxel plus nedaplatin and 5-fluorouracil in treating advanced esophageal carcinoma. Chinese J Cancer. 2010;29(3):321–324.CrossRefGoogle Scholar
  16. 16.
    Miyazaki T, Sohda M, Tanaka N, et al. Phase I dose-escalation study of docetaxel, nedaplatin, and 5-fluorouracil combination chemotherapy in patients with advanced esophageal cancer. Cancer Chemother Pharmacol. 2013;71(4):853–7.CrossRefPubMedGoogle Scholar
  17. 17.
    Yamasaki M, Miyata H, Tanaka K, et al. Multicenter phase I/II study of docetaxel, cisplatin and fluorouracil combination chemotherapy in patients with advanced or recurrent squamous cell carcinoma of the esophagus. Oncology. 2011;80(5–6):307–13.CrossRefPubMedGoogle Scholar
  18. 18.
    Posner MR, Hershock DM, Blajman CR, et al. Cisplatin and fluorouracil alone or with docetaxel in head and neck cancer. N Engl J Med. 2007;357(17):1705–15.CrossRefPubMedGoogle Scholar
  19. 19.
    Minamide J, Aoyama N, Takada K, Oota Y. Evaluation of docetaxel, CDDP and 5-FU combined therapy as second-line chemotherapy for esophagus cancer. Gan to kagaku ryoho. Cancer Chemother. 2007;34(1):49–52.Google Scholar

Copyright information

© Society of Surgical Oncology 2015

Authors and Affiliations

  • Tatsuya Miyazaki
    • 1
  • Hitoshi Ojima
    • 1
    • 2
  • Minoru Fukuchi
    • 1
    • 3
  • Makoto Sakai
    • 1
    • 4
  • Makoto Sohda
    • 1
  • Naritaka Tanaka
    • 1
  • Shigemasa Suzuki
    • 1
  • Keisuke Ieta
    • 1
    • 4
  • Kana Saito
    • 1
    • 3
    • 4
  • Akihiko Sano
    • 1
    • 2
  • Takehiko Yokobori
    • 1
  • Takanori Inose
    • 1
  • Masanobu Nakajima
    • 5
  • Hiroyuki Kato
    • 5
  • Hiroyuki Kuwano
    • 1
  1. 1.Department of General Surgical Science (Surgery 1)Gunma University Graduate SchoolMaebashiJapan
  2. 2.Department of Gastroenterological SurgeryGunma Prefectural Cancer CenterOtaJapan
  3. 3.Department of SurgeryGunma Chuo HospitalMaebashiJapan
  4. 4.Department of SurgeryIsesaki Municipal HospitalIsesakiJapan
  5. 5.Department of Surgery IDokkyo Medical UniversityTsuga-gunJapan

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