Abstract 1234P
Background
Neoadjuvant therapy followed by surgery has been recognized as an effective treatment for locally advanced ESCC. However, the pathological complete response (pCR) rate of neoadjuvant chemotherapy drugs was less than 10%. PD-1 inhibitors improve survival in patients(pts) with metastatic ESCC. Camrelizumab (anti-PD-1), has been approved as second-line treatment for ESCC. We conducted this study to evaluate the efficacy and adverse events (AEs) of camrelizumab plus docetaxel and carboplatin as neoadjuvant treatment in locally advanced ESCC.
Methods
Pts with clinically staged as T2-4aN0M0, T1-4aN+M0, aged 18–75 years, received 2 cycles of camrelizumab (200mg IV q3w) plus docetaxel (75 mg/m2 IV q3w) and carboplatin (AUC=5∼6 IV q3w) followed by surgery within 4∼8 weeks after completion of neoadjuvant therapy. The pCR rate is the primary endpoint, and the secondary endpoints include R0, ORR, DFS, OS and safety.
Results
From Oct 2019 to Feb 2022, 30 pts were enrolled. 5 pts had CR, 9 pts had PR, 16 pts had SD (tumor shrinks), ORR was 46.7% (14/30). According to postoperative pathological staging, among the16 pts with SD, 10 pts had descending stage (T,N,T and N descending stage were 3, 2, 5, respectively) except one did not underwent surgery. 25 patients underwent surgery, minimally invasive esophagectomy was conducted in 20 pts. pCR was 20% (5/25). R0 was 100% (25/25). Tumour regression grade (TRG) 0, 1, 2, and 3 was 20%(5/25), 16% (4/25), 24%(6/25 ), and 40%(10/25), respectively. None of 30 pts progressed, the DFS was not yet achieved. The average intraoperative blood loss was 128.7 ml (80-200ml) and the average hospitalization time after operation was 11.1 days (9-19 days). The average number of resected lymph nodes was 24 (10-40). Surgery-related complications: mediastinal fistula was observed in one patient (3.3%). The grade 1-2 treatment-related AEs were poor appetite (4,13.3%), reactive cutaneous capillary endothelial proliferation (4,13.3%), nausea and vomiting (3,10%), one patient had Guillain- Barre syndrome. No treatment-related mortality occurred.
Conclusions
Camrelizumab plus docetaxel and carboplatin for locally advanced ESCC produced satisfactory outcomes and good tolerance. Further study is needed.
Clinical trial identification
ChiCTR2000033252.
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.