AI Article Synopsis

  • The study examines the effectiveness and safety of neoadjuvant immunochemotherapy (NAIC) using toripalimab compared to traditional neoadjuvant chemotherapy (NAC) in treating locally advanced esophageal squamous cell carcinoma (ESCC).
  • Conducted as a phase III clinical trial in China, 252 patients were randomly assigned to receive either NAIC (toripalimab + chemotherapy) or NAC alone, with primary focus on event-free survival and secondary outcomes like overall survival and pathological response.
  • Results showed a significant improvement in event-free survival (77.9% vs. 64.3%) and overall survival (94.1% vs. 83.0%) for the toripalimab group

Article Abstract

Background: In the era of immunotherapy, neoadjuvant immunochemotherapy (NAIC) for the treatment of locally advanced esophageal squamous cell carcinoma (ESCC) is used clinically but lacks of high-level clinical evidence. This study aimed to compare the safety and long-term efficacy of NAIC followed by minimally invasive esophagectomy (MIE) with those of neoadjuvant chemotherapy (NAC) followed by MIE.

Methods: A prospective, single-center, open-label, randomized phase III clinical trial was conducted at Henan Cancer Hospital, Zhengzhou, China. Patients were randomly assigned to receive either neoadjuvant toripalimab (240 mg) plus paclitaxel (175 mg/m) + cisplatin (75 mg/m) (toripalimab group) or paclitaxel + cisplatin alone (chemotherapy group) every 3 weeks for 2 cycles. After surgery, the toripalimab group received toripalimab (240 mg every 3 weeks for up to 6 months). The primary endpoint was event-free survival (EFS). The pathological complete response (pCR) and overall survival (OS) were key secondary endpoints. Adverse events (AEs) and quality of life were also assessed.

Results: Between May 15, 2020 and August 13, 2021, 252 ESCC patients ranging from T1N1-3M0 to T2-3N0-3M0 were enrolled for interim analysis, with 127 in the toripalimab group and 125 in the chemotherapy group. The 1-year EFS rate was 77.9% in the toripalimab group compared to 64.3% in the chemotherapy group (hazard ratio [HR] = 0.62; 95% confidence interval [CI] = 0.39 to 1.00; P = 0.05). The 1-year OS rates were 94.1% and 83.0% in the toripalimab and chemotherapy groups, respectively (HR = 0.48; 95% CI = 0.24 to 0.97; P = 0.037). The patients in the toripalimab group had a higher pCR rate (18.6% vs. 4.6%; P = 0.001). The rates of postoperative Clavien-Dindo grade IIIb or higher morbidity were 9.8% in the toripalimab group and 6.8% in the chemotherapy group, with no significant difference observed (P = 0.460). The rates of grade 3 or 4 treatment-related AEs did not differ between the two groups (12.5% versus 12.4%).

Conclusions: The interim results of this ongoing trial showed that in resectable ESCC, the addition of perioperative toripalimab to NAC is safe, may improve OS and might change the standard treatment in the future.

Download full-text PDF

Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC11483553PMC
http://dx.doi.org/10.1002/cac2.12604DOI Listing

Publication Analysis

Top Keywords

toripalimab group
24
chemotherapy group
16
toripalimab
10
group
10
perioperative toripalimab
8
neoadjuvant chemotherapy
8
interim analysis
8
phase iii
8
clinical trial
8
toripalimab 240
8

Similar Publications

Want AI Summaries of new PubMed Abstracts delivered to your In-box?

Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!