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

Research output: Contribution to journalArticle

4 Citations (Scopus)

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.

Original languageEnglish
JournalInternational Journal of Clinical Oncology
DOIs
Publication statusAccepted/In press - 2018 Jan 1

Fingerprint

Feasibility Studies
Chemoradiotherapy
Fluorouracil
Cisplatin
Lymph Nodes
Lymph Node Excision
Esophagectomy
Clinical Protocols
Drug Therapy
Febrile Neutropenia
Esophagitis
Hyponatremia
Neoplasm Staging
Leukopenia
Anorexia
Esophageal Neoplasms
Neutropenia
Thrombocytopenia
Esophageal Squamous Cell Carcinoma
Anemia

Keywords

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

ASJC Scopus subject areas

  • Surgery
  • Hematology
  • Oncology

Cite this

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

In: International Journal of Clinical Oncology, 01.01.2018.

Research output: Contribution to journalArticle

Hashimoto, Jun ; Kato, Ken ; Ito, Yoshinori ; Kojima, Takashi ; Akimoto, Tetsuo ; Daiko, Hiroyuki ; Hamamoto, Yasuo ; Matsushita, Hisayuki ; Katano, Susumu ; Hara, Hiroki ; Tanaka, Yoichi ; Saito, Yoshihiro ; Nagashima, Kengo ; Igaki, Hiroyasu. / 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. In: International Journal of Clinical Oncology. 2018.
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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.",
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T1 - 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

AU - Hashimoto, Jun

AU - Kato, Ken

AU - Ito, Yoshinori

AU - Kojima, Takashi

AU - Akimoto, Tetsuo

AU - Daiko, Hiroyuki

AU - Hamamoto, Yasuo

AU - Matsushita, Hisayuki

AU - Katano, Susumu

AU - Hara, Hiroki

AU - Tanaka, Yoichi

AU - Saito, Yoshihiro

AU - Nagashima, Kengo

AU - Igaki, Hiroyasu

PY - 2018/1/1

Y1 - 2018/1/1

N2 - 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.

AB - 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.

KW - Clinical trial

KW - Elective lymph node irradiation

KW - Esophageal cancer

KW - Phase II

KW - Preoperative chemoradiotherapy

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