Survival outcomes and safety of nimotuzumab combined with radiotherapy ± chemotherapy for locally advanced cervical cancer.

Objective: Chemoradiotherapy is currently the main treatment for locally advanced cervical cancer. Nevertheless, the survival profile of locally advanced cervical cancer patients remains unsatisfactory because of metastasis and recurrence. We aimed to assess the survival outcomes and safety of radiotherapy ± chemotherapy combined with nimotuzumab (a human monoclonal antibody against epidermal growth factor receptor that has anti-tumor activities) for patients with locally advanced cervical cancer.

Methods: Patients with stage IIB to IVA (International Federation of Gynecology and Obstetrics 2018) pathological and diagnosed locally advanced cervical cancer from January 2021 to December 2022 were collected in this retrospective, multi-center, and single-arm study. All patients received platinum-based radiotherapy ± chemotherapy with nimotuzumab (200 mg once a week for 6 weeks). Primary end point was overall survival. Secondary end points were progression-free survival and safety. The adverse events were recorded. Statistical analysis was performed using Statistics Analysis System software (v 9.4).

Results: A total of 60 patients were collected with a median follow-up of 17.4 months (95% CI 14.8 to 19.2). The median age was 58 years (range; 35-90). A total of 16 patients (26.7%) had stage II, 38 patients (63.3%) had stage Ⅲ, and 6 patients (10%) had stage Ⅳ. The median overall survival was not reached, and the median progression-free survival was 20.4 months (95% CI 16.3 to not evaluable). Radiotherapy ± chemotherapy with nimotuzumab achieved 90.7% 1- and 2-year overall survival. Moreover, 1-year progression-free survival was 82.1%, and the 2-year progression-free survival was 47.7%. The most common treatment-related grade 3 to 4 adverse events included neutropenia (15%), anemia (21.7%), and thrombocytopenia (5%). No drug-related severe adverse events or deaths occurred.

Conclusions: The addition of nimotuzumab to radiotherapy ± chemotherapy was associated with favorable oncologic outcomes for patients with locally advanced cervical cancer, and the toxicity was tolerable and manageable.