Abstract 1215P
Background
Neoadjuvant chemoradiotherapy combined with surgery has been recommended in the treatment of locally advanced adenocarcinoma of the oesophagogastric junction (AEG). However, the local control and long-term prognosis of AEG remain suboptimal. With the development of immunotherapy, we aimed to explore the safety and efficacy of Toripalimab (PD-1 inhibitor) plus chemoradiotherapy in preoperative treatment of AEG.
Methods
cT3-T4/N+M0 AEG patients with resectable Siewert type II/III tumours were enrolled in this prospective, phase II clinical study. Patients accepted neoadjuvant chemoradiotherapy (5 cycles of concurrent chemotherapy) and 4 cycles of immunotherapy (Toripalimab), followed by radical surgery and adjuvant chemotherapy and immunotherapy (both 4 cycles). The primary endpoints of this study were major pathologic response (MPR) rate and toxicity, with disease-free survival (DFS), overall survival (OS) as secondary endpoints.
Results
We expected an enrollment of 40 patients, so far, we included 24 patients in the interim analysis. All the patients have completed neoadjuvant radiotherapy, 16 patients have accepted radical surgery, while 4 patients have been waiting for imaging examination or surgery, 3 patients rejected surgery, two of whom achieved cCR (complete response) demonstrated by imaging examination and biopsy, and 1 patient died of acute disease before surgery. All the surgery patients underwent R0 resection, CR rate was 33.3% (of all the patients with pathologic results), and 13 patients (72.2% of all the patients with pathologic results) achieved MPR. In terms of safety, only two cases of grade 3 hematologic toxicity were reported, eight cases of grade 2 radiation esophagitis were reported as major complications, there was no ≥grade 3 immune-associated complication in our study. Post-surgery chest and abdominal infection were main factors of prolonged hospitalization.
Conclusions
Chemoradiotherapy combined with immunotherapy is able to improve the pathologic response of AEG patients, without increase of post-surgery complications. Further analysis of all the patients enrolled is worth expectation.
Clinical trial identification
NCT04061928 Project Number: JS001-ISS-C091.
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.