Clinical Observation Of Apatinib In The Treatment Of Patients With Recurrent Or Metastatic Cervical Cancer As Second-line Drug

Objective: To observe the clinical efficacy and safety of apatinib in second-line treatment of patients with recurrent or metastatic cervical cancer,and to provide new antivascular drug options for the treatment of patients with recurrent or metastatic cervical cancer.Methods: A clinical observation of 28 patients diagnosed with recurrent or metastatic cervical cancer admitted by the tumor hospital affiliated to zunyi medical university was conducted to evaluate the efficacy and safety of apatinib from May2017 to December 2019.All patients were treated with apatinib alone: 250 mg or500mg oral,once a day continuous administration until the disease progressed,the toxic side effects became intolerable or death occurs.The main study endpoint was the ORR(objective remission rate)and DCR(disease control rate)while secondary study endpoints were m PFS(median progression-free survival),m OS(median total survival)and drug safety.Follow-up was conducted by inpatient,outpatient or telephone records.All data were analyzed by SPSS 22.0.The classification variables were expressed as percentage and the continuous variables were represented by the median of the range.Kaplan-meier method was used for survival analysis and drawing the survival curve.Percentage and descriptive methods were used for safety analysis.Results: All patients had a complete follow-up record,with a median follow-up time of 7 months(1-25 months).Among the 28 patients,partial remission was achieved in4(14.3%),disease stabilization in 15(53.6%),and disease progression in 9(32.1%).The ORR was 14.3% and the DCR was 67.9%.The median time of oral apatinib in 28 patients was 3 months(1-25 months),4 months in m PFS(95%CI:2.821-5.179),and 9 months in m OS(95%CI:6.065-11.935).The most common hematological side effects were hypoproteinemia(53.6%),higher alkaline phosphatase(39.3%),anaemia(35.7%),the most common non-hematological side effects were hypertension(50%),and fatigue(53.6%),anorexia(60.7%).Most were grade I-II,and no drug-related deaths occurred.The most serious adverse reaction was 2 cases of grade III rectovaginal fistula.Conclusion: The short-term efficacy(ORR,DCR)of single-drug apatinib in second-line treatment of recurrent or metastatic cervical cancer was slightly better than other second-line treatments(traditional cytotoxic drugs or other oral targeted drugs)reported in most literatures,while the long-term efficacy(m PFS,m OS)was not significantly improved.Therefore,whether apatinib can be a second-line treatment option for patients with recurrent or metastatic cervical cancer remains to be further investigated.The overall safety of apatinib is good,and most of its side effects can be controlled by reduction or proper symptomatic treatment.However,there are also potential risks of fistula,so the risk assessment,monitoring and management of fistula need to be strengthened to ensure the safe use of apatinib.