A phase II clinical trial has demonstrated promising results for patients with unresectable locally advanced esophageal squamous cell carcinoma (ESCC) using a novel neoadjuvant approach. The study, published in Clinical Cancer Research, found that a combination of chemoradiation followed by immunochemotherapy and surgery significantly improved tumor resectability and survival outcomes.
The trial enrolled 30 patients aged 18 to 75 with unresectable locally advanced ESCC. The treatment regimen consisted of 5 weeks of radiation combined with nab-paclitaxel and cisplatin, followed by two 21-day cycles of tislelizumab plus nab-paclitaxel and cisplatin. Patients whose tumors became resectable after this treatment underwent surgery 2 to 4 weeks later.
The primary endpoint of the study was the 1-year progression-free survival rate. Key findings revealed that 24 patients received subsequent immunochemotherapy (iCT) after chemoradiotherapy (CRT). Twenty patients (66.7%) achieved resectability (R0: 95.2%; pathologic complete response: 65.0%; major pathologic response: 90.0%). The 1-year progression-free survival rate was 79.4%, and the 1-year overall survival rate was 89.6%.
Survival Benefits
The study also highlighted a significant difference in survival outcomes based on surgical resection. Patients in the R0 resection group exhibited longer progression-free survival (median, not reached vs 8.4 months; hazard ratio [HR] = 0.28; 95% confidence interval [CI] = 0.08–0.84; P = .02) and overall survival (median, not reached vs 19.2 months; HR = 0.18; 95% CI = 0.04–0.73; P < .01) compared to patients in the nonsurgery group.
Adverse Events
Grade 3 to 4 adverse events were observed in 11 patients (36.7%), and immune-related pneumonitis was observed in 5 patients (20.8%). Postchemoradiotherapy measurable residual disease before surgery was associated with unfavorable progression-free survival and overall survival rates.
Expert Commentary
"Our study met the primary endpoint. Conversion CRT and subsequent iCT followed by surgery was a promising treatment strategy for unresectable locally advanced ESCC," the study authors concluded. Further studies are warranted to evaluate the efficacy and safety of this combination regimen.
