Nimotuzumab plus image-guided radiotherapy for elderly patients with locally advanced cervical squamous cell carcinoma: Interim analysis of a prospective multi-center phase Ⅱ trial.
prospective_cohort · Level II
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- Also identified by DOI 10.1016/j.ijrobp.2025.10.029.
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Abstract
Elderly patients with locally advanced cervical squamous cell carcinoma (LACSCC) generally have fewer therapeutic choices. Nimotuzumab, as an epidermal growth factor receptor (EGFR)-targeted humanized monoclonal antibody, has low toxicity, and shown antitumor efficacy in cervical cancer in preliminary study. So we wanted to explore efficacy and safety of nimotuzumab and image-guided radiotherapy for elderly patients with LACSCC. This is a prospective, multicenter, open-label, single-arm, and phase II trial. LACSCC patients aged ≥65 years not receiving chemotherapy were enrolled. All of the patients received intensity-modulated radiotherapy and image-guided brachytherapy. Nimotuzumab was administration of 200 mg once a week for 6 weeks. Disease-free survival (DFS) is the primary endpoint. Secondary endpoints included overall survival (OS), complete response rate (CRR), objective response rate (ORR), and safety. From Nov 2021 to Jan 2023, a total of 118 elder patients with stage IB3-IVA were enrolled. The median follow-up was 24 months (95% CI: 21.78, 25.53). The CRR was 61.86% (95% CI: 0.53, 0.71), ORR was 91.53% (95% CI: 0.85, 0.96). The 1 year-DFS and 2 year-DFS were 92.42% (95% CI: 85.40, 96.14) and 84.61% (95% CI: 75.07, 90.72), respectively, the median DFS was 36.99 months (95% CI: NA, NA). The 1 year-OS was 96.19% (95% CI: 90.15, 98.55), 2 year-OS was 88.22% (95% CI: 78.87, 93.60), the median OS was not reached. The most common Grade 3 adverse events (AEs) included leukopenia (4/30.77%), neutropenia (3/23.08%), lymphopenia (2/15.38%), diarrhea (1/7.69%), and anemia (3/23.08%). No drug-related severe AEs or deaths were recorded. Among elderly LACSCC patients, nimotuzumab plus image-guided radiotherapy and brachytherapy was well tolerated and indicated promising clinical survival benefits. The robustness of efficacy and toxicity results might provide a novel treatment option for this population.