Adjuvant Immunotherapy for Patients with Positive Lymph Nodes after Neoadjuvant Chemotherapy for Esophageal Squamous Cell Carcinoma: A Prospective, Single-Center, Controlled Phase II Study
Presented During:
Sunday, May 4, 2025: 9:00AM - 4:00PM
Seattle Convention Center | Summit
Posted Room Name:
Poster Area, Exhibit Hall
Abstract No:
P0165
Submission Type:
Abstract Submission
Authors:
Liang Dai (1), Keneng Chen (2), Yaya Wu (3)
Institutions:
(1) Peking University Cancer Hospital, Beijing, Beijing, (2) Peking University Cancer Hospital, Hai Dian District, Bei Jing, (3) Peking University Cancer Hospital, Bei Jing, Bei Jing
Submitting Author:
Liang Dai
-
Contact Me
Peking University Cancer Hospital
Peking University Cancer Hospital
Co-Author(s):
*Ke-Neng Chen
-
Contact Me
Peking University Cancer Hospital
Peking University Cancer Hospital
Yaya Wu
-
Contact Me
Peking University Cancer Hospital
Peking University Cancer Hospital
Presenting Author:
Liang Dai
-
Contact Me
Peking University Cancer Hospital
Peking University Cancer Hospital
Abstract:
Background: For locally advanced esophageal squamous cell carcinoma, patients with positive lymph nodes after neoadjuvant chemotherapy combined with surgery often have a high recurrence rate and poor prognosis. Currently, there is no recommended adjuvant treatment.
Methods: We conducted a prospective, non-randomized, open-label, controlled clinical study to evaluate the value of checkpoint inhibitors as adjuvant treatment for patients with squamous esophageal carcinoma. Stage II or III esophageal squamous cell carcinoma patients who received neoadjuvant chemotherapy and R0 resection with positive lymph nodes were enrolled and allocated to receive Toripalimab (240 mg every 3 weeks) or the clinical observation group at a 1:1 ratio. The study period lasted up to 1 year. The primary endpoint of the study was disease-free survival. Survival analysis was described using Kaplan-Meier curves, and Log-rank test was used to compare differences in clinical characteristics between groups.
Results: The median follow-up time for the entire group was 37 months (from the time of surgery to the last follow-up time in July 2024). The 1-year and 3-year DFS rates were 75.0% vs. 46.2% and 57.8% vs. 37.8% (P = 0.043) in the immunotherapy group and the clinical observation group, respectively; the corresponding OS rates were 92.9% vs. 80.4% and 85.6% vs. 43.5% (P = 0.031). The mean duration of toripalimab intervention in the immunotherapy group was 6 months (0.7-12.0 months). The incidence of any-grade TRAEs was 71.4% in the immunotherapy group, higher than 46.2% in the clinical observation group, but the difference was not statistically significant (P = 0.059). TRAEs were mainly grade 1-2, and the proportion of grade ≥3 TRAEs was 25.0% and 11.5% (P = 0.298) in the two groups, respectively; no patients in either group died due to adverse reactions.
Conclusion: In patients with positive lymph nodes after esophageal squamous cell carcinoma resection who have undergone neoadjuvant chemotherapy, patients who receive adjuvant treatment with Toripalimab have significantly longer disease-free survival and overall survival compared to patients in the clinical observation group, with manageable safety.
Methods: We conducted a prospective, non-randomized, open-label, controlled clinical study to evaluate the value of checkpoint inhibitors as adjuvant treatment for patients with squamous esophageal carcinoma. Stage II or III esophageal squamous cell carcinoma patients who received neoadjuvant chemotherapy and R0 resection with positive lymph nodes were enrolled and allocated to receive Toripalimab (240 mg every 3 weeks) or the clinical observation group at a 1:1 ratio. The study period lasted up to 1 year. The primary endpoint of the study was disease-free survival. Survival analysis was described using Kaplan-Meier curves, and Log-rank test was used to compare differences in clinical characteristics between groups.
Results: The median follow-up time for the entire group was 37 months (from the time of surgery to the last follow-up time in July 2024). The 1-year and 3-year DFS rates were 75.0% vs. 46.2% and 57.8% vs. 37.8% (P = 0.043) in the immunotherapy group and the clinical observation group, respectively; the corresponding OS rates were 92.9% vs. 80.4% and 85.6% vs. 43.5% (P = 0.031). The mean duration of toripalimab intervention in the immunotherapy group was 6 months (0.7-12.0 months). The incidence of any-grade TRAEs was 71.4% in the immunotherapy group, higher than 46.2% in the clinical observation group, but the difference was not statistically significant (P = 0.059). TRAEs were mainly grade 1-2, and the proportion of grade ≥3 TRAEs was 25.0% and 11.5% (P = 0.298) in the two groups, respectively; no patients in either group died due to adverse reactions.
Conclusion: In patients with positive lymph nodes after esophageal squamous cell carcinoma resection who have undergone neoadjuvant chemotherapy, patients who receive adjuvant treatment with Toripalimab have significantly longer disease-free survival and overall survival compared to patients in the clinical observation group, with manageable safety.
THORACIC:
Esophageal Cancer
Image or Table
