| Objective and purpose:Cervical cancer remains the fourth most common female malignancy worldwide.Currently,the average 5-year survival rate of cervical cancer has reached 66%in developed countries,yet less than half patients from developing countries could live longer than 5 years.Several controversies still exist for the treatment of locally advanced cervical cancer(LACC;International Federation of Gynecology and Obstetrics[FIGO]stages IB2-IVA),which represents about 60%of all diagnosed cervical cancers,with a 3-year overall survival(OS)about 81%for stage IB2,51%for stage IIIB and 28%for stage IVA,respectively.Many trials have shown that concurrent chemoradiotherapy(CCRT)reduces the risk of death for LACC by 30%to 50%compared with radiotherapy(RT)alone.In 1999,the National Cancer Institute suggested that strong consideration should be given to using CCRT instead of RT alone for LACC.However,25%to 40%of patients still experience relapse,and some experience distant failure despite local control after CCRT.Therefore,many studies focused on the efficacy of neoadjuvant chemotherapy for LACC,most of which were based on phase II clinical trials and retrospective analysis.Therefore,we conducted this clinical study to compare the efficacy and safety of neoadjuvant chemotherapy plus CCRT with CCRT alone in LACC.Methods:This study is a retrospective analysis.Patients were selected in two affiliated Hospitals of Wuhan University between January 2012 and January 2017,diagnosed as LACC by pathology.There are 155 patients meet the inclusion criteria and exclusion criteria,and divided into neoadjuvant chemotherapy plus CCRT(group A)and CCRT group(group B).In both two groups,patients were all treated with external beam radiotherapy(EBRT)between 45.0 and 50.4 Gy in 1.8-to 2.0-Gy daily fractions.In group A(n=103),paclitaxel was administered intravenously at a dose of135 mg/m~2on day 1,and cisplatin was administered by intravenous infusion at a dose of 70 mg/m~2on day 1.The treatment was repeated every 3 weeks for a total of 1 to 2courses.Then,cisplatin(40mg/m~2)or nedaplatin(30mg/m~2)was dissolved in 500m L of 0.9%sodium chloride and infused intravenously,repeated weekly for 5 times.In group B(n=52),cisplatin(40mg/m~2)or nedaplatin(30mg/m~2)was dissolved in500m L of 0.9%sodium chloride and infused intravenously,repeated weekly for 5times.The primary end point was progression-free survival(PFS).Secondary end points were response rate,OS,and safety.Data was analyzed by Kaplan-Meier and Cox’s proportional hazards regression models to evaluate the OS and PFS.Propensity score matching(PSM)was used to balance the numerous factors of exposure that are not controlled by humans.Results:Propensity score matching identified 44 patients in each group.After matching,the results showed that the objective response rate(ORR)of A group was81.8%and that of B group was 86.4%in LACC patients,and the difference between the two groups was not statistically significant.The mean OS was 56.9 months(95%CI:50.6-63.3 months)in A group,53.6 months in the B group(95% CI 46.5-60.7months),and the difference was not statistically significant(P=0.3473).The mean PFS was 50.9 months(95%CI:43.2-58.6 months)in A group,45.4 months in the B group(95%CI 37.3-53.5 months),and the difference was statistically significant(P=0.2250).There was no difference in the toxicities between the 2 groups.The most common grade 1-2 adverse reactions in the A group were anemia(52.3%),leukopenia(50%),nausea and vomiting(34.1%)and radiation proctitis(31.8%),while grade 3-4adverse reactions were leukopenia(27.3%).The most common grade 1-2 adverse reactions in the B group were nemia(47.7%),leukopenia(52.3%),nausea and vomiting(31.8%)and radiation proctitis(31.8%),while grade 3-4 adverse reactions were leukopenia(29.5%).Conclusion:The clinical outcome shows that the addition of neoadjuvant chemotherapy consisting of cisplatin and paclitaxel to standard CCRT is not superior to CCRT alone for the treatment of LACC.Toxicities and response rate are similar in both arms.However,evidence from phase III clinical trials is still needed.Clinicians should be cautious of using neoadjuvant chemotherapy. |
