Title: A comparison of Dosimetry and Efficacy between two fractionation schedules of HDR brachytherapy using Fletcher–suit-delclos-applicator in patients with locally advanced Carcinoma Cervix- ASingle Institution Randomised Prospective Study
Authors: Subhendu Gangopadhyay, Bidyut Mandal, Janmenjoy Mondal, Shinjini Chakrabarty. Debjit Ghosh, Abhishek Basu
DOI: https://dx.doi.org/10.18535/jmscr/v7i12.14
Abstract
Purpose: Cervical cancer is the second most common cancer in women in India with annual mortality of around 60,000. Brachytherapy is an integral part of treatment of CA Cervix. Single Institutional, Open label randomised clinical trial was performed to compare & evaluate clinical outcomes using two different dose fractionation but same applicator in ICBT for Cancer Cervix in term of better locoregional control with acceptable bladder, rectal toxicity & late toxicity.
Material & Methods: 60 patients were accrued between January 2018 & June 2019 & treated with ICBT using FLETCHER – SUIT – DELCLOS applicator with HDR after loader unit. All patients received 50Gy/25# whole pelvis EBRT with concurrent Inj Cisplatin. They were allotted in 2 arms (n= 30) & received 9 Gy ×2# and 7 Gy ×3 # respectively. Response and Radiation induced toxicities were assessed and graded. Disease free survival was estimated based on the duration from the date of completion of treatment to the date of last follow up/recurrence of tumour/ death in the patients who have achieved Complete Response. During treatment, patients were reviewed weekly. After treatment completion, patients were reviewed at 6 weeks, 3 months, 6 months, 9 months and 12 months.
Results: Patients in both the arms had equivalent response (local control) with 80% local control in study arm as compared to 63.3% in control arm. 1 year actuarial DFS in study arm is 60% as compared to 52% in control arm. Median DFS was better in study arm (14 months v/s 12 months) with a trend of significant benefit. Improved DFS in the study arm was probably be explained by reduction of overall treatment time. Few Grade 1 & 2 late rectal, bladder and vaginal toxicities were present over there without any Grade 3 or 4 toxicity.
Conclusion: 9 Gy/# × 2 HDR Brachytherapy is an effective and safe alternative to equivalent response in terms of dose fractionation and manageable toxicity for treating locally advanced CA cervix that can be used in developing countries with excessive patient load.
Keywords: Carcinoma Cervix, Intracavitary Brachytherapy, Fractionation, Fletcher applicator.
