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Phase II feasibility study of preoperative concurrent chemoradiotherapy with cisplatin plus 5-fluorouracil and elective lymph node irradiation for clinical stage II/III esophageal squamous cell carcinoma

  • Jun Hashimoto
  • Ken Kato
  • Yoshinori Ito
  • Takashi Kojima
  • Tetsuo Akimoto
  • Hiroyuki Daiko
  • Yasuo Hamamoto
  • Hisayuki Matsushita
  • Susumu Katano
  • Hiroki Hara
  • Yoichi Tanaka
  • Yoshihiro Saito
  • Kengo Nagashima
  • Hiroyasu Igaki
Original Article

Abstract

Background

Preoperative chemoradiotherapy (CRT) is a standard treatment for stage II/III esophageal cancer. Preoperative chemotherapy is also considered a standard treatment for stage II/III esophageal squamous cell carcinoma (ESCC) in patients who undergo radical lymph node dissection. We conducted a feasibility study of preoperative CRT with cisplatin plus 5-fluorouracil (CF) and elective lymph node irradiation followed by esophagectomy with radical lymph node dissection in patients with stage II/III ESCC.

Methods

Patients with clinical stage II/III, excluding T4, ESCC (International Union Against Cancer TNM classification system, 6th edition) were eligible. Chemotherapy comprised two courses of CF infusion repeated after 4-weeks. Radiation therapy was concurrently administered to the primary tumor, metastatic lymph nodes, and regional lymph nodes at a dose of 41.4 Gy. After the completion of CRT, transthoracic esophagectomy with 2–3 fields lymphadenectomy was performed. The primary endpoint was the completion rate of protocol treatment with R0 resection.

Results

Thirty-one eligible patients were enrolled. During CRT, the most common grade 3 or 4 toxicities were leukopenia (65%), neutropenia (65%), anemia (13%), thrombocytopenia (13%), febrile neutropenia (13%), anorexia (16%), esophagitis (16%) and hyponatremia (16%). Thirty patients (96.8%) underwent surgery. One patient received palliative chemotherapy because of appearance of lung metastasis during CRT. The completion rate of protocol treatment was 93.5% (29/31). There was one treatment-related death after surgery. Pathological complete response was achieved in 42% (13/30).

Conclusion

Preoperative CRT with CF and elective lymph node irradiation showed an acceptable toxicity and promising activity especially in ESCC.

Keywords

Esophageal cancer Preoperative chemoradiotherapy Elective lymph node irradiation Clinical trial Phase II 

Notes

Acknowledgements

We express our appreciation to Mr. Nagai, Ms. Tada, Ms. Usami, Ms. Sakamoto, Ms. Ayabe, and Ms. Shinogi for data collection and management.

Funding

This study was also supported by National Cancer Center Research and Development Funds (23-A-16, 23-A-18 and 26-A-4).

Compliance with ethical standards

Conflict of interest

No author has any conflict of interest.

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Copyright information

© Japan Society of Clinical Oncology 2018

Authors and Affiliations

  • Jun Hashimoto
    • 1
  • Ken Kato
    • 1
  • Yoshinori Ito
    • 2
  • Takashi Kojima
    • 4
  • Tetsuo Akimoto
    • 5
  • Hiroyuki Daiko
    • 6
  • Yasuo Hamamoto
    • 7
  • Hisayuki Matsushita
    • 8
  • Susumu Katano
    • 9
  • Hiroki Hara
    • 10
  • Yoichi Tanaka
    • 11
  • Yoshihiro Saito
    • 12
  • Kengo Nagashima
    • 13
  • Hiroyasu Igaki
    • 3
  1. 1.Gastrointestinal Medical Oncology DivisionNational Cancer Center HospitalTokyoJapan
  2. 2.Radiation Oncology DivisionNational Cancer Center HospitalTokyoJapan
  3. 3.Esophageal Surgery DivisionNational Cancer Center HospitalTokyoJapan
  4. 4.Gastrointestinal Oncology DivisionNational Cancer Center Hospital EastKashiwaJapan
  5. 5.Radiation Oncology DivisionNational Cancer Center Hospital EastKashiwaJapan
  6. 6.Esophageal Surgery DivisionNational Cancer Center Hospital EastKashiwaJapan
  7. 7.School of Medicine, Keio Cancer CenterKeio UniversityTokyoJapan
  8. 8.Department of SurgeryTochigi Cancer CenterUtsunomiyaJapan
  9. 9.Department of Radiation OncologyTochigi Cancer CenterUtsunomiyaJapan
  10. 10.Department of GastroenterologySaitama Cancer CenterInaJapan
  11. 11.Division of Gastroenterological SurgerySaitama Cancer CenterInaJapan
  12. 12.Department of Radiation OncologySaitama Cancer CenterInaJapan
  13. 13.Department of Global Clinical Research, Graduate School of MedicineChiba UniversityChibaJapan

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