Session Item

Carcinoma of the uterine cervix is one of the common malignancies among Indian women. Radiation therapy including external beam radiotherapy(EBRT) and intracavitary brachytherapy (ICBT)  plays a pivotal role in patients with locally advanced disease. HDR ICBT for carcinoma of the cervix is now well established because of its various advantages. Although there are three decades of published literature on the efficacy of HDR brachytherapy, optimum time, dose, and fractionation is not very well defined. Two fractions of high-dose-rate brachytherapy are convenient for patients, but most radiation oncologists fear that they could lead to excessive rectal or bladder toxicity.

The objective of this study was to assess and compare the local control and toxicities between HDR Intracavitary Brachytherapy with 7.5 Gy per fraction in three fractions (Arm A) and 9 Gy per fraction in two fractions (Arm B) post EBRT in treatment of carcinoma cervix.

A total of 180 patients meeting the inclusion criteria were included in the  study and randomly assigned to 2 arms of 90 patients each. All patients received concurrent chemoradiation to a dose of 50 Gy in 25 fractions along with weekly cisplatin. Post chemoradiation, 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 ICBT 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 , Student T test.

180 patients were included in the study with 90 patients in each arm. The total duration of treatment was significant less in Arm B compared to Arm A (59 days vs 68 days, p<0.0001).  80 (89%) patients in arm A, had complete response at 6 months. 2(2.2%)  patients had partial response and 4(4.4%) patients had local recurrence. In Arm B, 87 (96.7%) of the patients had complete response and was statistically significant (p=0.040). 2(2.2%) patient had local recurrence in the cervix. 

Grade 2 and above diarrhea was seen in 4.4% of the patients in arm A and in 7.7% of patients in arm B. Grade 2 and above proctitis was seen in 3.3 % of the patient in arm A and in 6.6 % of the patients in arm B. One patient in arm B had Grade 4 proctitis. Grade 2 urinary tract pain was seen in 10 (11.1%) patients in arm A and in 6 (6.7%) patients in arm B. One patient each in arm A and arm B had grade 1 hematuria. 

This study, with intracavitary brachytherapy with 9 Gy in 2 fractions showed a better local control of tumour compared to 7.5 Gy in 3 fractions. Although there was no statistical significance, our study showed a slightly higher rate of rectal toxicities in the 9 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 the recurrence rates.