760P - Efficacy and safety of nimotuzumab plus radiotherapy for elderly patients with locally advanced cervical squamous cell carcinoma

Background

Although concurrent chemoradiotherapy is the standard treatment for locally advanced cervical cancer, elderly patients are often intolerable to chemotherapy. It’s urgent to explore a suitable regimen for these population. Cervical squamous cell carcinoma (CSCC) is characterized by the high expression of epidermal growth factor receptor (EGFR). Nimotuzumab is a recombinant humanized anti-EGFR monoclonal antibody with good safety. This study aimed to investigate the efficacy and safety of nimotuzumab plus radiotherapy in the treatment of elderly patients with locally advanced cervical squamous cell carcinoma (LACSCC).

Methods

It’s a prospective, multicenter, and single-arm trial. Key inclusion criteria included aged ≥ 65 years, histologically diagnosed CSCC with clinical stage IB3-ⅣA, ECOG 0-2, and refusing chemotherapy. Patients received nimotuzumab with 200mg/w for 6 weeks, underwent radiotherapy, including intensity-modulated radiotherapy (IMRT), volumetric intensity modulated arc therapy (VMAT) (45-50.4Gy, 1.8-2.0Gy/f, 25-28f), and brachytherapy (HR-CTV D90, 80-85Gy). Brachytherapy combined with external beam radiotherapy was completed within 8 weeks. The current endpoints include objective response rate (ORR), complete response rate (CRR), disease control rate (DCR), and safety.

Results

This trial enrolled 122 elderly LACSCC patients from Nov 2021 to Jan 2023. The median age was 72.5 years old (range from 65 to 92) with clinical stage IB3-ⅣA. The addition of nimotuzumab to radiotherapy exhibited a significant improvement in short-term efficacy with ORR of 87.70% (107/122), CRR of 42.62% (52/122), and DCR of 92.62% (113/122). The partial response was 45.08% (55/122), progressive disease was 2.50% (3/122), and stable disease was 4.92% (6/122). So far, no drug-related adverse events have occurred.

Conclusions

Nimotuzumab plus radiotherapy provided significant improvements in ORR, CRR, and DCR in elderly patients with LACSCC. No drug-related adverse events were observed. Our results demonstrate that nimotuzumab combined with radiotherapy may provide a choice for this population with better efficacy and tolerance.

Clinical trial identification

NCT04976478.

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.