Yang H, et al. - Researchers compared two treatment approaches for patients with locally advanced esophageal squamous cell carcinoma (ESCC): neoadjuvant chemoradiotherapy (NCRT) plus surgery vs surgery alone, focusing on survival and safety offered by these treatments. They found that, with acceptable and manageable adverse events, NCRT plus surgery vs surgery alone offered a greater improvement in survival among patients with locally advanced ESCC.

Methods

• This study included 451 patients with potentially resectable thoracic ESCC, clinically staged as T1-4N1M0/T4N0M0.
• From June 2007 to December 2014, these patients were randomized to NCRT plus surgery (group CRT; n=224) or surgery alone (group S; n=227).
• The CRT group received vinorelbine 25 mg/m²intravenously (IV) on days 1 and 8 and cisplatin 75 mg/m² IV day 1, or 25 mg/m² IV on days 1 to 4 every 3 weeks for two cycles, with a total concurrent radiation dose of 40.0 Gy administered in 20 fractions of 2.0 Gy on 5 days per week.
• McKeown or Ivor Lewis esophagectomy was performed on patients in both groups.
• Overall survival was assessed as primary end point.

Results

• The group CRT showed a pathologic complete response rate of 43.2%.
• According to findings, the group CRT vs group S showed a higher R0 resection rate (98.4% v 91.2%; P=.002), a better median overall survival (100.1 months v 66.5 months; hazard ratio, 0.71; 95% CI, 0.53 to 0.96; P=.025), and a prolonged disease-free survival (100.1 months v 41.7 months; hazard ratio, 0.58; 95% CI, 0.43 to 0.78; P < .001).
• The most common grade 3 or 4 adverse events documented during chemoradiotherapy were leukopenia (48.9%) and neutropenia (45.7%).
• The groups had similar incidences of postoperative complications, except arrhythmia (group CRT: 13% v group S: 4.0%; P=.001).
• In group CRT vs in group S, the observed peritreatment mortality was 2.2% vs 0.4%, respectively (P=.212).