Neoadjuvant chemotherapy with albumin-bound paclitaxel plus cisplatin and capecitabine for locally advanced esophageal squamous cell carcinoma: a phase 2 clinical trial

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BACKGROUND: Neoadjuvant chemotherapy is recommended for locally advanced esophageal squamous cell carcinoma (ESCC), but more effective regimens are needed to improve the outcomes. This study evaluates the efficacy and safety of neoadjuvant chemotherapy with albumin-bound paclitaxel plus cisplatin and capecitabine (APC regimen) for locally advanced ESCC. MATERIALS AND METHODS: This prospective single-center phase 2 clinical study involved patients with locally advanced ESCC (T2-4aN±M0) from May 19, 2020 to September 1, 2022. Patients received neoadjuvant chemotherapy with APC regimen for four cycles and then underwent radical esophagectomy. The primary endpoints were the pathologically complete response (pCR) rate. The secondary endpoints were the major pathological response (MPR) rate, radical resection rate (R0 resection rate), disease-free survival (DFS), event-free survival (EFS), overall survival (OS), and safety. RESULTS: Eighty-two patients with locally advanced ESCC were enrolled in the trial. Of the 80 patients who underwent surgery, the R0 resection rate was 100%, and 23 patients achieved pCR, with a pCR rate of 28.7% (95% confidence interval [CI]: 18.8%-38.6%). Fifty patients achieved MPR, with an MPR rate of 62.5% (95% CI: 51.9%-73.1%). The most common grade 3-4 treatment-related adverse events were neutropenia (25.6%), leukocytosis (14.5%), nausea (7.5%), and peripheral neurotoxicity (5.5%). Five patients developed complications within 1 month after surgery, including pneumonia (five patients, 6.3%), anastomotic fistula (one patient, 1.3%), and laryngeal recurrent nerve paralysis (one patient, 1.3%), all of which were grade 2. The local recurrence was observed in 8 (8.5%) patients, and distant metastasis in 10 (12.2%) patients. The 3-year DFS rate was 81.2%, the 3-year EFS rate 77.8%, and the 3-year survival rate 90%. CONCLUSION: Neoadjuvant treatment with APC regimen for locally advanced ESCC achieved excellent pCR rates and a well-tolerated safety profile. This combination chemotherapy could serve as one optional neoadjuvant treatment. (ClinicalTrials.gov: NCT04390958).

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