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
- 123 Downloads
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.
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.
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).
Preoperative CRT with CF and elective lymph node irradiation showed an acceptable toxicity and promising activity especially in ESCC.
KeywordsEsophageal cancer Preoperative chemoradiotherapy Elective lymph node irradiation Clinical trial Phase II
We express our appreciation to Mr. Nagai, Ms. Tada, Ms. Usami, Ms. Sakamoto, Ms. Ayabe, and Ms. Shinogi for data collection and management.
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.
- 4.Kidane B, Coughlin S, Vogt K et al (2015) Preoperative chemotherapy for resectable thoracic esophageal cancer. Cochrane Database Syst Rev 19:CD001556Google Scholar
- 11.Inokuchi K (1992) Milestones along the road to improvement of results in the treatment of squamous cell carcinoma of the esophagus. In: Color atlas of surgical anatomy for esophageal cancer. Springer, Tokyo, pp 1–8Google Scholar
- 12.Ando N, Kato H, Igaki H et al (2012) A randomized trial comparing postoperative adjuvant chemotherapy with cisplatin and 5-fluorouracil versus preoperative chemotherapy for localized advanced squamous cell carcinoma of the thoracic esophagus (JCOG9907). Ann Surg Oncol 19:68–74CrossRefPubMedGoogle Scholar
- 14.Japanese Society for Esophageal Diseases (2004) Guidelines for clinical and pathologic studies on carcinoma of the esophagus ninth edition: part II. Esophagus 1:107–125Google Scholar
- 24.Nakamura K, Kato K, Igaki H et al (2013) Three-arm phase III trial comparing cisplatin plus 5-FU (CF) versus docetaxel, cisplatin plus 5-FU (DCF) versus radiotherapy with CF (CF-RT) as preoperative therapy for locally advanced esophageal cancer (JCOG1109, NExT study). Jpn J Clin Oncol 43:752–755CrossRefPubMedGoogle Scholar