Abstract
OBJECTIVES: This study aimed to compare the survival outcomes of paclitaxel liposome-based chemoradiotherapy, with or without rhEndostatin, in patients with unresectable locally advanced esophageal squamous cell carcinoma (ESCC). METHODS: Patients with ESCC treated with paclitaxel liposome-based definitive chemoradiotherapy (dCRT), with or without rhEndostatin (E), between February 2015 and June 2020 were included. Patients received induction chemotherapy followed by concurrent chemoradiotherapy, with or without rhEndostatin. The chemotherapy regimen consisted of platinum-based doublet (paclitaxel liposome + cisplatin/nedaplatin). RhEndostatin was administered at a dose of 30 mg/d from day 1 to day 5 of each chemotherapy cycle. Total radiotherapy dose was 66-68 Gy, delivered in fractions of 2.0-2.2 Gy/d. Follow-up continued until December 2023. The primary endpoints were 3-year progression-free survival (PFS) rate. Secondary endpoints included 3-year overall survival (OS) rate, objective response rate (ORR), disease control rate (DCR), and toxicity. RESULTS: A total of 80 patients were included, with 34 in the dCRT group and 46 in the E + dCRT group. The 3-year PFS was 26.47% (95% confidence interval [CI] 13.19-41.81) in the dCRT group and 56.29% (95% CI 40.79-69.20) in the E + dCRT group (Hazard ratio (HR), 0.50; 95% CI 0.28-0.89, P = 0.012). Patients in the E + dCRT group had a superior 3-year OS compared to those in the dCRT group (80.44% [95% CI 65.77-89.30] vs. 47.06% [95% CI 29.83-62.52]; HR, 0.40; 95% CI 0.21-0.72; P = 0.003). The ORR was 91.18% in the dCRT group and 95.65% in the E + dCRT group. The most common grade 3-4 toxicities were leukopenia, neutropenia, and thrombocytopenia. CONCLUSION: The addition of rhEndostatin to paclitaxel liposome-based dCRT may improve clinical outcomes for patients with unresectable ESCC while maintaining manageable toxicities. However, further prospective randomized controlled studies are necessary to confirm the survival benefits of this treatment strategy.