KEY TAKEAWAYS
- The phase II study aimed to evaluate the efficacy of adding PD-1 antibody to perioperative chemotherapy in patients with locally advanced gastric or GEJ cancer.
- The primary endpoint was TRG 0/1, and the secondary endpoints were PCR, R0 resection rate, survival rates, response rates, and safety. The mantel-Haenszel test was used to test the difference.
- The study found that perioperative toripalimab and chemotherapy improved gastric cancer pathological regression.
PD-1 antibody plus chemotherapy is effective in advanced gastric or GEJ cancer but not yet in locally advanced patients. Researchers aimed to evaluate the efficacy of adding PD-1 antibody to perioperative chemotherapy in patients with locally advanced gastric or GEJ cancer.
The study randomized patients (pts) with advanced gastric cancer to receive toripalimab + chemo or chemo alone with TRG 0/1 as the primary endpoint. Secondary endpoints were pathological complete response (pCR), R0 resection rate, recurrence-free survival, event-free survival, objective response rate, disease control rate, overall survival (OS), and treatment safety. Enrollment was completed, and the primary endpoint analysis was conducted using the Mantel-Haenszel test.
Around 108 patients (C+T arm, n=54; C arm, n=54) were enrolled and were assessed using intention-to-treat analysis. Pts in the toripalimab plus chemotherapy arm achieved a higher proportion of TRG 0/1 than those in the chemotherapy arm (44.4% [24/54, 95% CI: 30.9%-58.6%] vs 20.4% [11/54, 95% CI: 10.6%-33.5%]; P=0.009). A higher pCR rate was observed in the C+T arm (24.1% [13/54, 95% CI: 13.5%-37.6%] vs 9.3% [5/54, 95% CI: 3.1%-20.3%]; P=0.039). Preoperative therapies (3 cycles) were completed in 96.3% of patients, and postoperative cycles (>3 cycles) in 81.5%, with no significant differences observed between these two arms. A higher proportion of downstaging was observed in the C+T arm (ypT0-2: 46.3% vs 22.2% [P=0.002]; ypstage 0-1: 38.9% vs 16.7% [P=0.024]). Surgical morbidity (11.8% in the C+T arm vs 13.5% in the C arm) and mortality (1.9% vs 0%), and treatment-related grade 3-4 adverse events (27.8% vs 25.9%) were comparable between the arms.
The study concluded that perioperative toripalimab and chemotherapy may be promising for locally advanced gastric cancer.
Source: https://ascopubs.org/doi/abs/10.1200/JCO.2023.41.16_suppl.4001
Clinical Trial: https://classic.clinicaltrials.gov/ct2/show/NCT04250948
Shuqiang Yuan, Run-Cong Nie, Ying Jin, Cheng-cai Liang, Rui Jian, Yuan-fang Li, Haibo Qiu, Wei Wang, Shi Chen, Dong-sheng Zhang, Chun-yu Huang, Yi-hong Ling, Qiu-xia Yang, Zi-Xian Wang, Wen-long Guan, Ying-bo Chen, Xiao-wei Sun, Zhi-wei Zhou, Feng Wang, and Rui-Hua Xu. DOI: 10.1200/JCO.2023.41.16_suppl.4001 Journal of Clinical Oncology 41, no. 16_suppl (June 01, 2023) 4001-4001.
