Abstract 793P
Background
Chemoradiation with external beam radiation therapy (EBRT) followed by high dose-rate (HDR) intracavitary brachytherapy (ICBT) is the standard treatment for locally advanced cervical cancer. HDR ICBT for cervical cancer is now well established because of its numerous advantages. Although there are decades of published literature and research on the efficacy of HDR brachytherapy, optimum treatment time, dose, and fractionation still need to be defined. The aim of this study was 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 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’st-test.
Results
All 180 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. The total duration was significant less in Arm B compared to Arm A (59 days vs 68 days, p<0.00001). In arm A out of the 90 patients 80 (89%) had complete response at 6 months. 2 (2.2%) patients had partial response. 4 (4.4%) patients had local recurrence. In Arm B, after 6 months, 87 (96.7%) of the patients had complete response and was statistically significant (p=0.040). 2 (2.2%) patients had local recurrence in the cervix. Grade 2/3 diarrhea was seen in 4.4% of the patients in Arm A and in 7.7% of patients in Arm B. Grade 2/3 proctitis was seen in 3.3 % of the patient in the 7.5-Gy arm and in 6.6 % of the patients in the 9-Gy arm.
Conclusions
This study showed that HDR ICBT with 9 Gy in 2 fractions had a better local control of the tumour when compared to 7.5 Gy in 3 fractions.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The author.
Funding
Has not received any funding.
Disclosure
The author has declared no conflicts of interest.