Chemoradiotherapy Combined with Nab-Paclitaxel plus Cisplatin in Patients with Locally Advanced Borderline Resectable or Unresectable Esophageal Squamous Cell Carcinoma: A Phase I/II Study

Abstract

To evaluate the efficacy and safety of nanoparticle albumin-bound paclitaxel (nab-PTX) plus cisplatin as the regimen of conversional chemoradiotherapy (cCRT) in locally advanced borderline resectable or unresectable esophageal squamous cell carcinoma (ESCC). Patients with locally advanced ESCC (cT3-4, Nany, M0-1, M1 was limited to lymph node metastasis in the supraclavicular area) were enrolled. All the patients received the cCRT of nab-PTX plus cisplatin. After the cCRT, those resectable patients received esophagectomy; those unresectable patients continued to receive the definitive chemoradiotherapy (dCRT). The locoregional control (LRC), overall survival (OS), progression-free survival (PFS), distant metastasis free survival (DMFS), pathological complete response (pCR), R0 resection rate and adverse events (AEs) were calculated. A total of 45 patients with ESCC treated from October 2019 to May 2021 were finally included. The median follow-up time was 30.3 months. The LRC, OS, EFS, DMFS at 1and 2 years were 81.5%, 86.6%, 64.3%, 73.2% and 72.4%, 68.8%, 44.8%, 52.7% respectively. 21 patients (46.7%) received conversional chemoradiotherapy plus surgery (cCRT+S). The pCR rate and R0 resection rate were 47.6% and 84.0%. The LRC rate at 1 and 2 years were 95.0%, 87.1% in cCRT+S patients and 69.3%, 58.7% in dCRT patients respectively (HR, 5.14; 95% CI, 1.10-23.94; P = 0.021). The OS rate at 1 and 2 years were 95.2% and 84.2% in resectable patients compared to 78.8% and 54.4% in unresectable patients (HR, 3.41; 95% CI, 1.10-10.61; P = 0.024). The toxicities during chemoradiotherapy were tolerated, the most common grade 3-4 toxicities were radiation esophagitis (15.6%). Nab-PTX plus cisplatin were effective and safe as the regimen of conversional chemoradiotherapy of ESCC. The patients receiving conversional chemoradiotherapy plus surgery (cCRT+S) were prone to have a better survival.