Abstract 1220P
Background
Docetaxel-based neoadjuvant chemotherapy has been suggested to be beneficial in patients with locally advanced gastric and gastro-oesophageal junction cancer (GC/GEJC). And immunotherapy also show promising treatment efficacy for advanced GC/GEJC. Here we compared the safety and efficacy of camrelizumab combined with chemotherapy versus chemotherapy alone as the neoadjuvant therapy for patients with resectable locally advanced GC/GEJC.
Methods
Eligible patients diagnosed as resectable locally advanced GC/GEJC were randomized to receive neoadjuvant treatment, in arm A, the patients received FLOT alone, in arm B, the patients received FLOT combined with camrelizumab. Eligible patients underwent gastrectomy with D2 lymph node dissection. The primary end point of this trial was pCR rate and R0 resection rate, and the secondary end points were ORR,PFS, OS and safety profile.
Results
From January 15 2020 to January 21, 2022, 63 patients were recruited (30 patients in arm A and 33 patients in arm B). 54 patients had completed planned neoadjuvant treatment for 4 cycles ( 23 pts in the arm A, 31 ptsin the arm B). In the arm A, the median age was 63 years (45-74 years) and a total of 17 males and 6 females, ECOG PS 0 (n=4), ECOG PS 1 (n=19). In the arm B, the median age was 63 years (28-72 years) and a total of 25 males and 6 females, ECOG PS 0 (n=8), ECOG PS 1 (n=21),ECOG PS 2 (n=2). The R0 resection rate was high in arm B compared with arm A (31/31,100% vs. 21/23, 91%). The same results are also reflected in pCR:arm B compared with arm A (4/31,13% vs. 1/23, 4%). Tumour regression grade were as follows:TRG0 [arm A 4% (1/23), arm B 16% (5/31)], TRG1 [arm A 13% (3/23), arm B 6% (2/31)], TRG2 [arm A 30% (7/23), arm B 52% (16/31)], TRG3 [arm A 43% (10/23), arm B 26% (8/31)]. Treatment-related AEs neutropenia and leukopenia were manageable and there was no treatment-related death.
Conclusions
Camrelizumab combined with FLOT showed promising efficacy as neoadjuvant treatment for patients with locally advanced gastric or GEJ adenocarcinoma, with low complications and acceptable toxicity.
Clinical trial identification
ChiCTR2000030610.
Editorial acknowledgement
Legal entity responsible for the study
The Affiliated Hospital of Qingdao University.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.