scholarly journals Phase 2 Study of Neoadjuvant Chemoradiation Therapy With Cisplatin Plus 5-Fluorouracil and Elective Nodal Irradiation Followed by Surgery for Stage II/III Esophageal Squamous Cell Carcinoma

2016 ◽  
Vol 96 (2) ◽  
pp. E172
Author(s):  
Y. Ito ◽  
K. Kato ◽  
J. Hashimoto ◽  
T. Akimoto ◽  
S. Katano ◽  
...  
Keyword(s):  
Squamous Cell Carcinoma ◽  
Esophageal Squamous Cell Carcinoma ◽  
Cell Carcinoma ◽  
Squamous Cell ◽  
Neoadjuvant Chemoradiation ◽  
Chemoradiation Therapy ◽  
Stage Ii ◽  
Phase 2 ◽  
Elective Nodal Irradiation ◽  
Phase 2 Study

Feasibility study of neoadjuvant chemoradiotherapy with cisplatin plus 5-fluorouracil and elective nodal irradiation for stage II/III esophageal squamous cell carcinoma.

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 130-130 ◽  
Author(s):  
Takashi Kojima ◽  
Jun Hashimoto ◽  
Ken Kato ◽  
Yoshinori Ito ◽  
Hiroyasu Igaki ◽  
...  
Keyword(s):  
Squamous Cell Carcinoma ◽  
Neoadjuvant Chemotherapy ◽  
Esophageal Squamous Cell Carcinoma ◽  
Lymph Nodes ◽  
Cell Carcinoma ◽  
Feasibility Study ◽  
Squamous Cell ◽  
Neoadjuvant Chemoradiotherapy ◽  
Stage Ii ◽  
Elective Nodal Irradiation

130 Background: Based on the JCOG 9907 trial results, neoadjuvant chemotherapy with cisplatin (CDDP) plus 5-fluorouracil (5-FU) is considered a standard treatment for stage II/III esophageal squamous cell carcinoma (ESCC) in Japan. However, patient survival remains unsatisfactory. We conducted a feasibility study of neoadjuvant chemoradiotherapy (NeoCRT) with CDDP plus 5-FU and elective nodal irradiation for stage II/III ESCC. Methods: Eligibility criteria included clinical stage II/III (UICC 6th, non-T4) ESCC, PS 0-1, and age 20–75 years. Chemotherapy consisted of 2 courses of 5-FU infusion (1000 mg/m2, days 1–4) and a 2-h CDDP infusion (75 mg/m2, day 1), with a 4-week interval. Radiotherapy was concurrently administered to a total 41.4 Gy in 23 fractions for primary tumor, metastatic lymph nodes and regional lymph nodes. After completion of CRT, transthoracic esophagectomy with extensive lymphadenectomy (>D2) was performed. The primary endpoint was the completion rate of NeoCRT and R0 resection. Results: From July 2010 to June 2011, 33 patients were enrolled, including 2 ineligibles. In 31 eligible patients, the median age was 63 years (range, 40–73); male/female: 28/3; PS0/1: 19/12; cStage IIA/IIB/III: 2/10/19. 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%). In total, 31 patients (100%) underwent CRT and 25 (81%) underwent surgery; 1 patient (3%) did not undergo surgery due to disease progression, and the other 5 patients (16%) are scheduled for surgery. Among patients who underwent surgery, there was 1 treatment-related death, and the incidence of operative morbidity was similar to that in previous studies. According to RECIST, the overall response rate was 63% after CRT completion. Pathological complete response was achieved in 11 patients (44%) who underwent esophagectomy. Conclusions: NeoCRT was well tolerated and appears to be highly promising. The randomized controlled trial compared with neoadjuvant chemotherapy is needed and will be started.

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