Title: Prospective Study to Compare Outcomes Following Hypofractionated Radiotherapy versus Conventional Radiotherapy in Carcinoma Breast
Authors: Dr Vivek Kumar Pandey, Dr S.N Prasad, Dr M.Q.Baig, Dr. Jitendra Kumar Verma, Dr Pramod Kumar Singh, Dr Archana Singh, Dr Ansu Goel, Dr M. Waseem Raza
DOI: https://dx.doi.org/10.18535/jmscr/v11i7.04
Abstract
Background: Breast cancer is now the most common cancer worldwide (GLOBOCAN, 2020). It is the most common cancer among women in developed countries. The age standardized incidence rate of breast cancer in India is 25.8% per 100,000 women (GLOBOCAN, 2020). By 2020, breast cancer overtook cervical cancer as the most common type of cancer among all women in India. Breast irradiation has been shown to reduce the risk of local recurrence after breast-conserving surgery from about 30% to <10% at 10 years.
Aims & Objectives: Randomize Breast carcinoma into two arms - Arm A :- 39GY in 13 fractions over 2.3 weeks & Arm B:- 50 GY in 25 fractions over 5weeks. Compare locoregional response in two arms 4 weeks after completion of radiation therapy and at the end of six months of follow up. Compare acute and chronic toxicities in the two arms.
Method: Total 43 patients were included in the study, 21 belonged to ARM A and 22 belonged to ARM B, Patients were randomised to 50 Gy in 25 fractions over 5 weeks or to 39Gy in 13 fractions over 2.3 weeks. Randomisation was arranged via lottery system by opting chit from a box of multiple chits. Randomisation was blinded. Normal tissue effects in the breast, arm, and shoulder were assessed by RTOG criteria for skin reactions, patient self-reported assessments, and physician assessments.
ARM A = (39Gy in 13 fractions over 2.3 weeks)
ARM B = (50 Gy in 25 fractions over 5 weeks)
Result: At the end of radiotherapy all 43 patients ( 21 in Arm A and 22 in Arm B) were assessed for acute skin toxicity, in arm A, 09(42.86%) patients had grade I reaction, 11(52.38%) patients had grade II reaction,1(4.76%) patients had grade III reaction and no patients had grade IV reaction while in arm B 2(9.09%) patients had grade I reaction, 11(50%) patients had grade II reaction,7(31.82%) patients had grade III reaction and 2(9.09%) patients had grade IV reaction. Arm with 39 Gy have less no. of grade III&IV reactions 1(4.76%) as compared with 50 Gy arm 9(40.91%), which is statistically very significant (p-). At the time of analysis, 1(2.23%) patients had experienced a local-regional relapse in arm A as compared with arm B no patients had local-regional relapse, which is statistically not significant (p-). After median follow-up of 9.42 month rate of distant relapse was higher in the 39 Gy group 2(4.65%) in comparison to 50 Gy group 1(2.32%), which is statistically not significant (p-), which contributed to the higher rates of disease-free survival and overall survival in the 50 Gy group.
Conclusion: After surgery for breast cancer, a radiotherapy schedule delivering 39 Gy in 13 fractions over 2.3 weeks seems to offer significantly less acute toxicity as well as cosmetic appearance which is statistically significant. But in terms of loco regional recurrence as well as distant recurrence 39 Gy schedule appears to be less effective especially in advanced stage, although data was statistically not significant.
Keywords: Breast Cancer, Adjuvent Radiotherapy, Hypo-fractionation Radiotherapy, Coventional Radiotherapy, Acute skin toxicity.
