Nimotuzumab plus image-guided radiotherapy for elderly patients with locally advanced cervical squamous cell carcinoma: Interim analysis of a prospective multi-center phase
Mené sur 118 patientes âgées atteintes d’un carcinome épidermoïde du col de l’utérus de stade localement avancé (durée médiane de suivi : 24 mois ; âge : au moins 65 ans), cet essai multicentrique de phase II évalue l'efficacité, du point de vue de la survie sans maladie, et la toxicité d'un traitement combinant nimotuzumab et radiothérapie guidée par l'image
Purpose: 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.
Methods and materials: 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.
Results: 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.
Conclusions: 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.
International Journal of Radiation Oncology, Biology, Physics , article en libre accès, 2025