Abstract 14P
Background
Cervical cancer is the 4th most common cancer in women in the world, and the 9th overall. External beam radiotherapy (EBRT) with concurrent cisplatin followed by brachytherapy forms the standard of care for advanced cervical carcinoma. High dose-rate (HDR) intracavitary brachytherapy (ICBT) for cervical cancer is now well established because of its numerous advantages. This study aimed to assess and compare the local control and toxicities between HDR ICBT with 7.5 Gy per fraction in three fractions (Control Arm) and 9 Gy per fraction in two fractions (Study Arm) after EBRT in treatment of carcinoma cervix.
Methods
A total of 180 patients meeting the inclusion criteria were included in the study and randomly assigned to the 2 arms of 90 patients each. Arm A received HDR ICBT with a dose of 7.5 Gy per fraction, 1 fraction per week for 3 fractions and Arm B received HDR brachytherapy 9 Gy per fraction , 1 fraction per week for 2 fractions. Patients were evaluated monthly for assessment of local control and toxicities. Statistical evaluation was done with mean, percentage and frequency using Chi Square, and Student T test.
Results
A total of 180 patients were analysed with 90 patients in each arm. All patients had received EBRT with a dose of 50 Gy in 25 fractions. 91% of the patients received concurrent chemotherapy to a mean of 4 cycles. Complete response was seen in 80 patients (89%) in arm A and in 87 patients (96.7%) in arm B. 4 patients in arm A and 2 patients in arm B has local recurrence. Grade 2 and above proctitis was seen in 3.3 % of the patients in arm A and in 6.6 % of the patients arm B. 1 patient in arm A and 1 patient in arm B had grade 1 hematuria.
Conclusions
This study, with 9 Gy in 2 fractions showed a better local control of the tumour till 6 months when compared to 7.5 Gy in 3 fractions. Although there was no statistical significance, our study also suggested that the rate of rectal toxicities was slightly higher in the 9 Gy arm when compared with 7.5 Gy arm, which could be managed medically. The study also highlighted the need for completion of total treatment of EBRT and brachytherapy within 60 days to reduce recurrence rates.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.