Nimotuzumab combined with chemotherapy in the first-line treatment for patients with stage IVB, recurrent or persistent cervical squamous cell carcinoma: A multi-center, randomized, double-blind, and controlled study.

5510 Background: Stage IVb, recurrent or persistent cervical cancer patients have limited treatment options and poor survival prognosis. Additionally, 70-90% of cervical cancers have overexpression of EGFR (epidermal growth factor receptor), a promising therapeutic target. Nimotuzumab (nimo), an EGFR antibody, 95% humanization degree, had applied in the treatment of various advanced solid tumors. So, we conducted the study to investigate its efficacy and safety. Methods: This trial is a prospective study with a total of 118 patients enrolled. There were 55 patients (pts) in the experimental group (nimo+chemotherapy) and 63 pts in the control group (chemotherapy alone). Primary efficacy endpoint is overall survival (OS). Secondary endpoints included progression-free survival (PFS), objective response rate (ORR), quality of life (QoL) and exploratory endpoints including the relationship between EGFR expression level and clinical efficacy and prognosis. The study of NCT approval number is 06781073. Results: The median age of the study population was 51.3 (range, 24.7-69.5) years. The average number of organs involved in the lesion was 2. The disease stage at initial diagnosis (2018 FIGO stage) was Ia-IVb. According to the disease status at the time of enrollment, IVB/recurrence/persistence accounted for 14.4%, 92.4%, and 9.3%, respectively. The results showed that the median OS was 15.7 (95% CI, 11.8-26.9) months in the nimo arm and 12.4 (95% CI, 7.9-21.0) months in the control arm. For recurrence pts, median OS was 21.7 (95% CI, 21.1-32.9) months vs. 12.4 (95% CI, 8.0-21.4) months for both groups. Median PFS was 7.4 (95% CI, 4.9-8.9) months in the nimo arm and 5.6 (95% CI, 4.1-6.1) months in the control arm. For recurrence pts, median PFS was 7.9 (95% CI, 5.6-12.0) months vs. 5.2 (95% CI, 3.7-8.0) months for both groups. In terms of safety, SAEs occur as follows. There were 8 pts (14.5%) in the nimo and 13 pts (23.6%) in the control group, respectively. For AEs above grade 3, there were 43 pts in the nimo and 45 pts in the control group. Adverse events related to the study drug, there were 6 cases in the nimo group with neutropenia. Among all AEs, the highest frequency was in the nimo group with 20 cases of leukopenia, 16 cases of nausea, 23 cases of anemia, and 11 cases of alopecia. In the control group, there were 17 cases of leukopenia, 21 cases of nausea, 23 cases of vomiting and 20 cases of alopecia. There was no significant difference between the two groups for adverse events. Conclusions: Adding nimotuzumab to chemotherapy in the first-line treatment for stage IVB, recurrent or persistent cervical squamous cell carcinoma could have an improvement trend on progression-free and overall survival with well tolerated toxicity, and should be considered as a new first-line therapy option.