Clinical Study Of Hyperfractionated Radiation Therapy Efficacy In The Treatment Of Squamous Cervical Cancer In Stage Ⅲb

Objective:The purpose of this study was to evaluate the efficacy and the clinical value of the proposal about hyperfractionated radiotherapy concurrently in combination with cisplatin-based chemotherapy for advanced cervical carcinoma.Methods:From March 2005 to May 2006,at the Department of female tumor of Guangxi Tumor Hospital,45 patients proven as having squamous cell carcinoma with histologically confirmed the International Federation of Gynecology and Obstetrics stageâ…¢b lesions,were randomized into hyperfractionated(HF+C)radiotherapy plus PVB chemotherapy group and conventional fractionation(CF+C)plus PVB chemotherapy group.24 patients in HF+C group were treated with hyperfractionated radiotherapy,1.2Gy/F, 10F/W,twice daily with 6-8 hours interval between the two fractions.21 patients in conventional fractionation(CF+C)group received conventional radiotherapy,1.8Gy/F,5F/W.When the time of external beam to the entire pelvis irradiation reached to 2 weeks(DT 24Gy)in HF+C group but 3 weeks (DT 27Gy)in CF+C group,high-dose-rate(HDR)intracavitary brachytherapy was administered weekly to combined with.External beam irradiation was not performed on the same days as brachytherapy.In cases of HDR,a dose of 7Gy at point A was given for total dose of 42Gy in both groups.A midline shield was inserted when total dose to pelvis in HF+C group reached to 36Gy but 30.6Gy in CF+C group,with total dose of 55.2Gy in HF+C group but 45Gy in CF+C group in 8 weeks.The patients who were delayed by festival were enforce additional 10-20%of the total dose,when the external beam radiation was completed.All of the patients received 2 cycles PVB regimen combination chemotherapy at cisplatin with a dose 100mg on day 1,vincristine 1mg on day 1,bleomycin 30mg on day 1-3,repeatly every 3 weeks.Optical colposcope was used to observe the development of the cervical lesions and to evaluate the regression state after the external beam radiation was completed. Simultaneously,the immediate response rate and clinical toxicity of both groups were also evaluated.Results:â‘ when the external beam radiation was completed,completely remission was found in 14 patients of HF+C group but 9 patients of CF+C group,while partial remission with locally erosion tumor or cauliflower tumor was found in 10 patients of HF+C group but 7 patients of CF+C group.There were still 5 patients in CF+C group having no response to the external beam radiation,but none in HF+C group.The difference between the two groups was significant(P_2tail=0.017).â‘¡In both groups,cauliflower tumor was extremely sensitive to the external radiation,but cavity tumor was insensitive,erosion tumor was partly.The time of tumor amotic was similar, either cauliflower lesion or erosion lesion in both group.But the shedding of cavity tumour in HF+C group was always more than one week earlier than that in CF+C group,but later than two types above mentioned.â‘¢Earlier period toxicity and side effect were evaluated to 2-3 scores according to the RTOG/EORTC class standardization.,and with accurate corresponding treatment,all the patients completed the treatment.45 patients were available for the acute toxcicities(RTOG criteria)and effects.Gastrointestinal toxicity and myelosuppression were the principal toxcicity.Gradeâ… -â…¡myelosuppression and proctitis,cystitis in both groups had no signigicant difference.Overall acute toxicities in both groups also had no signigicant difference(X²=7.118,P=0.130). The acute toxicities of HF+C group was appeared earlier and more serious than that of CF+C group.â‘£After completion of external radiotherapy,the local tumor eliminating rate in HF+C group was higher than that in CF+C group. There was significant difference in two groups(P_2tail=0.017).Disease-free survival(DFS),overall survival(OS)and pelvic locoregional control in HF+C group had the tendency to elevate,although immediate response and tumor control rate did not show any significant difference between the two groups(X²=2.233,P=0.135).⑤The follow-up period ranged from 11 to 27 months(calculated from the day of radiotherapy to an event).6 patients had died,of which 1 in HF+C group but 5 in CF+C group.During the follow-up period,1(4.17%)died of local recurrent,1(4.17%)had appeared distant metastatic to bilateralis lung in HF+C group.4(19.05%)died of local recurrent,1(4.17%)died of distant metastatic to all over the body,2(9.52%) had appeared local recurrent in CF+C group.Among the patients,either died or local recurrent but distant metastasis were women about 40-42 old in period of duration.The elder patients had a better survival.â‘¥The 1-year survival curve and calculated survival curve were plotted by Kaplan-Meier.(Figure 4, 5)No significant differences were found between these two groups(P=0.256,P _ç´¯=0.212).Conclusions Hyperfractionated radiotherapy concurrently in combination with cisplatin-based chemotherapy for locally advanced cervical carcinoma was safely effective and well tolerated,although acute toxicities appeared earlier and more serious.Late reaction tissue damage had no tendency to raise.Whether HF+C tended to improve the long-term disease-free survival rate and overall survival of locally advanced cervical cancer,further investigation was necessary.