Abstract 1058P
Background
Neoadjuvant chemotherapy (NAC) is the widely Immune checkpoint inaccepted treatment strategy for locally advanced ESCC and has been used in the past decades to downstage and improve the surgical resection rate for this malignancy. Immune checkpoint inhibitors (ICIs) have been shown to be efficient for advanced ESCC, while few studies focus on the neoadjuvant combination of immunotherapy and chemotherapy. To this end, we designed a trial to evaluate the safety and efficacy of toripalimab, a PD-1 inhibitor, combined with nab-paclitaxel (nab-P) and S-1 followed by radical resection surgery for resectable ESCC.
Methods
Patients histopathologically diagnosed with ESCC, TNM stages I∼Ⅲ, ECOG PS 0-1 were enrolled. 2∼4 cycles of combined therapy with toripalimab, nab-P and S-1 were given pre-operation. 2∼4 cycles of the regimen were given post-operation, followed by toripalimab monotherapy for 6 months. The primary endpoint was the major pathologic response (MPR). Secondary endpoints were pathologic complete response (PCR), overall response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS) and safety.
Results
A total of 24 patients were enrolled by April 24, 2020, which was the date for the first interim analysis. Of these patients, 18 underwent surgical resection, 4 patients were awaiting the operation, and 2 patients were unavailable for operation. The median follow-up was 7.87 months (range 6.2∼10.9 months). Of the 18 evaluable patients, 9 (50%) were MPR, 3 (16.67%) were PCR. 11 (61.11%) had tumour pathological reduction ≥50%. Imaging evaluation was feasible in all 24 patients. No patient achieved complete response (CR). Partial response (PR) was achieved in 19 (79.17%) and stable disease (SD) was observed in 5 (20.83%). The ORR and DCR were 79.17% and 100%, respectively. All patients were alive at the time of data analysis. The safety results are consistent with previous reports.
Conclusions
The combination treatment of toripalimab, nab-P and S-1 for locally advanced ESCC is effective and well tolerated and might be a promising approach for neoadjuvant treatment.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Shanghai Junshi Biosciences Co., Ltd.
Disclosure
All authors have declared no conflicts of interest.