Preoperative chemotherapy in patients with resectable esophageal carcinoma: a single center Phase II study

• Published in: Japanese journal of clinical oncology 2016-07, Vol.46 (7), p.610-614
• Main Authors: Tryakin, Alexey, Pokataev, Ilya, Kononets, Pavel, Fedyanin, Mikhail, Bokhyan, Vagan, Malikhova, Olga, Minin, Kirill, Shogenov, M, Stilidi, Ivan, Vybarava, Anna, Davydov, Mikhail, Tjulandin, Sergei
• Format: Article
• Language: English
• Subjects: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols - administration & dosage; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Carcinoma, Squamous Cell - drug therapy; Carcinoma, Squamous Cell - mortality; Carcinoma, Squamous Cell - surgery; Cisplatin - administration & dosage; Cisplatin - therapeutic use; Combined Modality Therapy; Disease-Free Survival; Esophageal Neoplasms - drug therapy; Esophageal Neoplasms - mortality; Esophageal Neoplasms - surgery; Esophagectomy; Etoposide - administration & dosage; Etoposide - therapeutic use; Female; Fluorouracil - administration & dosage; Fluorouracil - therapeutic use; Humans; Leucovorin - administration & dosage; Leucovorin - therapeutic use; Male; Middle Aged; Neoadjuvant Therapy - methods; Prospective Studies
• ISSN: 0368-2811; 1465-3621
• DOI: 10.1093/jjco/hyw039

The role of preoperative chemotherapy in squamous cell esophageal carcinoma remains controversial. A prospective trial was initiated to investigate whether preoperative chemotherapy followed by surgery results in increased progression-free survival in patients with resectable thoracic esophageal carcinoma. Patients with Stage IIb-IIIa/b resectable esophageal carcinoma were eligible for the study. They received two cycles of FLEP regimen chemotherapy (cisplatin, etoposide, leucovorine, 5-fluorouracil) followed by transthoracic extended 2- or 3-field esophagectomy. Two-year progression-free survival was the primary endpoint. To evaluate the potential benefit of the dual-modality approach we compared these results with the outcome of patients who were treated in our center in the same period of time and were non-randomly allocated to surgery alone. From 2001 to 2008, 63 patients were included in the study (bimodality group) and 58 patients into the surgery-alone group. Median follow-up was 68 (range, 4-123) months. Squamous cell carcinoma had 93% patients. Two-year progression-free survival for all patients was 45.3 and 30.7% (hazard ratio 0.71, 95% confidence interval 0.46-1.08) and median overall survival was 26.5 months and 18.0 months (hazard ratio 0.67, 95% confidence interval 0.41-1.01) in bimodality- and surgery-alone groups, respectively. Patients who underwent R0-resection after bimodality treatment had significantly better overall survival (40.9 months) than after surgery alone (19.0 months, hazard ratio 0.51, 95% confidence interval 0.30-0.81). Two cycles of preoperative chemotherapy did not improve progression-free survival of patients with resectable thoracic esophageal carcinoma in intent-to-treat population. However, significantly better results of bimodality approach was seen in R0-resected patients which warrants further trials with more effective chemotherapy combinations.