Safety and efficacy of nimotuzumab combined with chemoradiotherapy in Chinese patients with locally advanced cervical cancer

Abstract

ObjectiveTo evaluate efficacy and safety of nimotuzumab combined with chemotherapy and radiotherapy in women with locally advanced cervical cancer.Materials and methodsWomen with locally advanced cervical cancer (stage IIB, III, or IVA) who experienced relapse after first-line chemoradiotherapy and one or more lines of palliative chemotherapy were enrolled. All patients received nimotuzumab weekly at 200 mg/m2 as single agent for 4 weeks (induction phase), then concurrent with 6 cycles (21-day per cycle) of gemcitabine (800 mg/m2) or cisplatin (50 mg/m2) for 18 weeks (concurrent phase) and then once every 2 weeks (maintenance phase). Overall response rate (ORR) was assessed after 4 weeks of induction therapy and then every 3 months according to response evaluation criteria in solid tumors version 1.1 (primary end point). Secondary end points include progression-free survival (PFS), overall survival (OS), and drug toxicity. Descriptive statistics was used for ORR, and Kaplan–Meier curves were generated for OS and PFS.ResultsA total of 80 women with locally advanced cervical cancer were enrolled and evaluated for safety and efficacy. Our results demonstrated that none of the patients had a complete response (0%), 11 patients had a partial response (14%), and 10 patients had progressive disease (13%), giving a tumor response rate of 14%. A total of 59 patients had stable disease (74%), giving a disease control rate of 88% (70/80). Median PFS was 8.21 months (95% confidence interval [CI]: 5.09–12.45). Median OS was 11.96 months (95% CI: 8.11–23.95). The most common adverse events were mucositis, myelosuppression, and gastrointestinal disturbance.ConclusionOur study results suggested that nimotuzumab in combination with chemotherapy and radiotherapy is well tolerated, and could be a better treatment alternative in patients with locally advanced cervical cancer.

Efficacy and safety of Nimotuzumab combined with chemoradiotherapy in the treatment of locally advanced cervical cancer

“…Nimotuzumab, as China's rst humanized anti-EGFR monoclonal antibody, can signi cantly improve the 3-year OS for nasopharyngeal carcinoma in combination with CCRT (9). Furthermore, the same trend of increasing e cacy can also be seen in some other clinical studies (9)(10)(11).…”

Nimotuzumab Combined With Irradiation Enhances the Inhibition to the HPV16 E6-Promoted Growth of Cervical Squamous Cell Carcinoma

“…The results showed that 11 patients had partial relief of symptoms; 59 patients were stable; the rate of disease control reached 88%. Drug side effects and safety were also within acceptable limits ( 33 ). In another study, 28 patients with locally advanced cervical cancer received preoperative neoadjuvant therapy.…”

“…Because of its ability to bind EGFR, nimotuzumab can competitively interfere with the binding of EGF to EGFR, resulting in the blockade of downstream signaling pathways, inhibiting tumor cell proliferation, promoting tumor cell apoptosis, and enhancing the efficacy of radio- and/or chemotherapy. Although nimotuzumab has been used less frequently in treating cervical cancer, several studies have shown that the combination of nimotuzumab with radio-chemotherapy for locally advanced cervical cancer has a very reliable treatment effect ( 31 – 33 ). Nimotuzumab is therefore a promising option for preoperative neoadjuvant treatment.…”

Efficacy and safety of nimotuzumab combined with chemoradiotherapy in the treatment of locally advanced cervical cancer

“…As China's first humanized anti-EGFR monoclonal antibody, nimotuzumab has been shown to significantly improve the 3-year OS for nasopharyngeal carcinoma in combination with CCRT (9). Furthermore, the same trend of increasing efficacy can also be seen in other clinical studies of LACC (9)(10)(11), but these studies have some limitations such as single arm study or small sample size, which needs more clinical studies to prove this conclusion. In our study, we obtained the efficacy and safety data of 120 patients with LACC who received CCRT with or without nimotuzumab, observed and compared the efficacy and safety of the two groups of patients.…”