Background The pathologic complete response (pCR) rate occurs less than 10% of patients(pts) with neoadjuvant chemotherapy agents in locally advanced ESCC, Programmed death-1 (PD-1) blockade may induce tumor regression in pts with advanced ESCC. Camrelizumab (anti-PD-1) is standard of care as second-line therapy for advanced ESCC in China. With the potential benefit of combining Camrelizumab with neoadjuvant chemotherapy, we intended to assess the efficacy and safety of Camrelizumab combined with albumin paclitaxel and cisplatin in neoadjuvant therapy of locally advanced ESCC.
Methods 28 pts with histologically confirmed stage II-IVA ESCC were enrolled. Eligible pts were aged 18~75 years with no prior any therapy. Pts received 2~4 cycles of Camrelizumab (200mg IV q3w) plus albumin paclitaxel (260 mg/m2 IV q3w) and cisplatin (75 mg/m2 IV q3w) followed by surgery within 4~6 weeks after completion of neoadjuvant therapy. The primary endpoint was pCR, the secondary endpoints included major pathologic response (MPR), R0 resection rate, objective response rate (ORR), disease-free survival (DFS) and safety.
Results From Jul 27 2019 to Jan 29 2021, 28 eligible pts were enrolled, neoadjuvant treatment was completed in 28 pts. 12 pts (42.9%) had clinical complete response (cCR), and the ORR was 78.6% (22/28). All pts underwent surgery and surgical treatment was not delayed. The pCR was 32.1% (9/28), MPR was 53.6% (15/28). Notably, R0 resection rate was 100% (28/28). None of 28 pts progressed, the DFS was not yet achieved. The average intraoperative blood loss was 139ml (100–300ml) and the average hospitalization time after operation was 17 days (11–35 days). No patient developed anastomotic leak and other surgical treatment-related toxicity. The grade 1–2 treatment-related AEs were reactive cutaneous capillary endothelial proliferation (RCCEP) (35.7%), hepatotoxicity (21.4%), weakness (10.7%), thyroid dysfunction (10.7%). No serious AEs resulted in termination of treatment.
Conclusions Camrelizumab in combination with albumin paclitaxel and cisplatin followed by surgery for locally advanced ESCC showed promising downstaging effect and pCR with good tolerance, and further study is needed.
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