759P - Nimotuzumab combined with concurrent chemo-radiotherapy in patients with locally advanced cervical squamous cell carcinoma: A randomized, controlled, open-label, multicenter study

Background

Concurrent chemo-radiotherapy (CCRT) with platinum-based regimen is the standard treatment for locally advanced cervical cancer (LACC), however, 30% of patients developed recurrence and metastasis. Epidermal growth factor receptor (EGFR) is highly expressed in most cervical squamous cell carcinomas with poor survival prognosis. Nimotuzumab combined with CCRT had good antitumor activity and safety in LACC. In order to evaluate the efficacy and safety of nimotuzumab combined with CCRT in locally advanced cervical squamous cell carcinoma patients, we conducted a randomized, controlled, open-label, multicenter study (NCT04678791).

Methods

All patients with locally advanced cervical squamous cell carcinoma were randomized (1:1) to receive nimotuzumab (400mg, iv, weekly, for 6 weeks) combined with CCRT (cisplatin: 40 mg/m², weekly, for 6 weeks; IMRT/VMAT: 45-50.4 Gy/25-28f; high-dose rate brachytherapy: 30-40 Gy, in 8 weeks) or CCRT alone. The primary endpoint was 3-year progression free survival (PFS) per RECIST v1.1. The secondary endpoints were 3-year overall survival (OS), objective response rate (ORR), complete response (CR) rate per RECIST v1.1, and safety per CTCAE v5.0.

Results

Totally 291 patients were enrolled. 147 patients in the Nimo group (nimotuzumab combined with CCRT) and 144 in the CCRT group (CCRT alone). The median follow-up time was 1.8 months, and follow-up is ongoing. The baseline characteristics were balanced between the two groups. The median PFS of the Nimo group was longer than that of CCRT group (9.5 vs. 7.0 months, P=0.129), the 3-year PFS and 3-year OS were not reached. A total of 28 (19.05%) patients achieved partial response (PR) and 99 (67.35%) achieved CR in the Nimo group, 17 (11.81%) and 93 (64.58%) in the CCRT group, respectively. The ORR was 86.39% vs. 76.39% (P=0.028). The incidence of grade 3 or higher adverse reactions had no significant difference between the two groups (P＞0.05).

Conclusions

Nimotuzumab combined with concurrent chemo-radiotherapy showed longer survival trend and significantly improved the ORR in patients of locally advanced cervical squamous cell carcinoma with a good tolerance.

Clinical trial identification

NCT04678791.

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.