RESUMO
AIMS: The standard of care for carcinoma cervix stage IB2-IVA is five fractions per week of radiotherapy (RT) with concurrent cisplatin. We compared the standard treatment with six fractions per week of RT with concurrent Cisplatin to see whether the later had improved survival outcomes with comparable toxicities. SETTINGS AND DESIGN: 46 patients of carcinoma cervix with stage IB2-IVAwere randomized into two arms. MATERIALS AND METHODS: Study arm: 46 Gy/23 fractions/26 days, 6 fractions/week with injection CDDP 40 mg/m2 and Control arm: 46 Gy/23 fractions/31 days, 5 fractions/week with injection Cisplatin 40mg/m2. Patients in both the arms received LDR brachytherapy to a dose of 29 Gy at point A. STATISTICAL ANALYSIS USED: The primary end points were disease-free survival (DFS) and overall survival (OS). Compliance to treatment and treatment toxicities were the secondary end points. P value ≤0.05 were considered significant. RESULTS: The study was carried out during June, 2014-April, 2015. Statistical analysis was done in May, 2019. Of 46 patients, 39 patients completed the treatment. The study and control arms had 17 and 22 patients, respectively. Median follow-up period is 45 months (range: 1-54 months). 3-year DFS rates and OS was 69.5% vs. 72.7% (P = 0.73) and 63% vs. 68% (P = 0.45) in study and in control arm, respectively. There was no significant difference in acute and late radiation toxicities between two arms. CONCLUSION: Chemoradiotherapy with six fractions per week seems feasible and equally efficacious in terms of survival outcomes and toxicity profile. Further prospective randomized controlled study is required to prove the merit of altered fractionation with concurrent cisplatin.
