Journal of Cancer and Tumor International

Background: Cancer is listed among the leading causes of mortality and morbidity worldwide, with approx 19.97 million newly diagnosed cases and 9.74 million cancer deaths in 2022. 6,66,103 cases died out of 2.29 million new cases of breast cancer diagnosed in 2022. Radiotherapy is an integral component of the multidisciplinary management of breast cancer. Hypofractionated radiation therapy is radiation treatment in which the total dose of radiation is divided into large doses and treatments are given once a day or less often. This study is intended to compare a hypo-fractionated radiotherapy regimen delivered over 2.5 weeks as 39 Gy in 13 fractions at 3Gy per fraction against 40 Gy in 15 fractions at 2.67Gy per fraction over 3 weeks after mastectomy for early adverse reactions as radiation pneumonitis, dermatitis, dysphagia, and arm edema.

Material and Methods: The study was conducted at Acharya Tulsi Regional Cancer  Treatment and Research Institute, Sardar Patel Medical College, Bikaner. It was done on 60 histologically proven postoperative, post-chemotherapy, early breast cancer with a mean age of 50.7 years and 54.1 years respectively Arm A and Arm B. Patients were treated by radiotherapy and randomized into either of the two arms Arm A(Study) and Arm B(Control). On ARM A Hypo-fractionated radiotherapy 39Gy/13# in 3Gy/# and on ARM B Hypo-fractionated radiotherapy 40Gy/15# in 2.67Gy/# postoperative, post-chemotherapy in terms of radiation pneumonitis, dysphagia, skin reaction and arm edema were given. Toxicities were graded at 1st week, 3rd week, 1st, 3rd, 6th and 9th months. Data was analyzed using percentage, mean, and p-value.

Results: The majority of the patients were in their 51 to 60 years of life and all patients were female. Majority of the population had ECOG Performance Score of 1. Histologically, patients had infiltrating ductal carcinoma non otherwise specified. In study vs control arm where 3(10%) vs 3(10%) patients were I, 21(70%) vs 20(66.67%) in II A, 6(20%) vs 7(23.33%) in II B respectively. All 30(100%) patients in both arms completed treatment. In this study pneumonitis was not found to be statistically significant in both arms during follow-up of radiotherapy at 1st week, 3rd week,1^st month, 3rd month, 6th month, and 9th month as evident by p-value (≥ 1.000 in grade 0, 0.268 for Grade 1, ≥1.000 in grade 2). The grade of dysphagia was not statistically significant when compared to both arms. (p ≥ 1.000 in grade 0, p ≥ 0.200 in grade 1, p ≥ 0.721 in grade 2). Dysphagia grade 2 toxicity was found only in 2 patients (6.6%) in each arm. Arm edema was not statistically significant in both arms. In both arms, patients of grade 2 arm edema increased at every follow-up and maximum [8(26.6%) in Arm-A and 5 (16.6%) in Arm-B] at 9-month follow-up (P value 0.185). Grade 1st skin reaction was observed in 26.66% of patients in arm A and 20.00% of patients in arm B which is statistically significant (P value 0.049).

Conclusions: In conclusion, both hypo-fractionated arms were comparable in terms of acute toxicity. However, more such trials with a larger sample size and larger follow-up are required to have more concrete evidence for late toxicities and locoregional control.