Abstract 198P
Background
The CheckMate 577 trial showed the superiority of adjuvant nivolumab (adjNivo) therapy to placebo in terms of disease-free survival (DFS) in patients with esophageal cancer who underwent surgery after not having a pathological complete response to neoadjuvant chemoradiotherapy. In Japan, neoadjuvant docetaxel plus cisplatin, 5-FU (neoDCF) therapy is the standard of care for resectable locally advanced esophageal squamous cell carcinoma (LA-ESCC) based on the results of the JCOG1109 trial. There are no data on adjNivo after neoadjuvant triplet chemotherapy followed by surgery for LA-ESCC worldwide, and its efficacy and safety are unclear.
Methods
This retrospective study included patients with histologically confirmed resectable LA-ESCC treated with adjNivo (480 mg, every 4 weeks for 1 year) in our hospital from January 2022 to March 2024 after neoDCF followed by surgery. Efficacy was evaluated by DFS and, distant metastasis-free survival (DMFS), overall survival (OS). To evaluate safety, adverse events were assessed according to the CTCAE ver. 5.0.
Results
Forty-two patients were included (median age, 63 [46–76] years; male/female, 67/33%; performance status 0/1, 79/21%; tumor location Ce/Ut/Mt/Lt, 9/12/50/29%; clinical stage II/III/IVA/IVB (UICC TNM 8th), 14/62/7/17%; pathological stage IIB/IIIA/IIIB/IVA/IVB, 38/7/40/5/10%). Median time from surgery to adjNivo was 10 (4-22) weeks. Median follow-up time was 18.6 (5-28) months. Twelve-month DFS, DMFS, and OS were 68.1% (95%CI, 50.4-80.6%), 78.1% (95%CI, 60.8-88.5%), and 91.7% (95%CI, 76.3-97.2%), respectively. Recurrence was observed in 17 patients (40%) (regional lymph nodes, n=12; distal lymph nodes, n=4; liver, n=4). Eight patients (19%) with recurrence received definitive chemoradiotherapy. Any grade adverse events included fatigue (24%) and pruritus (24%), rash (24%). Grade 3 AST/ALT elevation and CPK elevation were observed in 1 patient each (3%).
Conclusions
The efficacy of adjNivo after neoDCF was comparable to the results of the Checkmate 577 trial. No new safety signals were shown.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
S. Yamamoto: Financial Interests, Personal, Invited Speaker: Ono Pharmaceuticals and Bristol Myers Squibb, Merck Sharp & Dohme, Taiho; Financial Interests, Personal, Writing Engagement: M3, Hokuto; Financial Interests, Personal, Expert Testimony: Ono Pharmaceuticals, Hokuto. Y. Honma: Financial Interests, Personal, Advisory Board: Janssen, Rakuten Medical Japan; Financial Interests, Personal and Institutional, Coordinating PI: Taiho Pharmaceutical, Chugai Pharma, MSD, Janssen, Merck Biopharma; Financial Interests, Institutional, Coordinating PI: GSK, Adlai Nortye Biopharma, Maruho, Genmab, Astellas pharma, AstraZeneca; Financial Interests, Institutional, Funding: Rakuten Medical Japan. K. Kato: Financial Interests, Personal, Invited Speaker: Ono Pharmaceutical, Bristol Myers Squibb, Merck and Co; Financial Interests, Personal, Advisory Board: Ono Pharmaceutical, Bristol Myers Squibb, Merck and Co, BAYER, AstraZeneca, Beigene, Taiho, Merck BioPharma, Daiichi Sankyo; Financial Interests, Institutional, Coordinating PI: Ono Pharmaceuticals, Merck & Co; Financial Interests, Institutional, Local PI: BAYER, AstraZeneca, Beigene, Taiho, Oncolys Biopharma, Merck Biopharma. All other authors have declared no conflicts of interest.