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Abstract This prospective randomized two arm study included 116 female stage I and II breast cancer patients who completed their postoperative radiotherapy in the Radiation therapy and Nuclear Medicine department, South Egypt Cancer Institute, in the period of time from January 2003 to February 2005. All patients were randomized into two groups, namely A and B. group A included 54 patients who received conventional fractionation i.e. 2 Gy/ fraction, one fraction per day, five fractions per week for 5 weeks aiming at 50 Gy total dose. group B consisted of 62 patients who received hypofractionated radiotherapy in the form of 2.66 Gy per fraction, one fraction per day, 5 fractions per week for 16 fractions given over 22 days aiming to complete 42.5 Gy. All patients who had undergone CBS, in either group, received an electron boost of 14 Gy, 2 Gy per fraction for seven fractions a with 9-12 MV beam, except for those over fifty with a negative margin. For a median follow up of 24 months, survival and several acute and late toxicity criteria were observed and analyzed for the two groups. Five, 9.3%, of group A, the conventional group, had local recurrence of the disease and four, 7.4%, had distant metastases. For the hypofractionated group, B, the results were similar having local recurrence occur in six patients, 9.7% of the group, and distant metastases in four patients, 6.5% of the group. The actuarial disease free survival was 83.3%±0.850 for the conventionally treated group versus 83.9%±0.956 for the hypofractionated radiotherapy group. None of this data showed a statistically significant difference between the two groups. Skin changes were observed. Acute radiation dermatitis was observed and graded in the two groups. The results were comparable in the two groups showing no statistical difference. Grade 1 radiation dermatitis was apparent in 26 patients of group 1, constituting 48.1% of the conventional group, while it was manifested in 27, 43.5%, patients from the hypofractionated therapy group. Grade 2 radiation dermatitis was found in 8 patients of group A, 14.8%, and 7 patients of group B, 11.3%. Pulmonary toxicity was assessed by pulmonary function tests (PFT), chest radiographs, and chest C.T. Fourty-five patients in group A (81.5%) and 53 patients of group B, (85.4% of the group) showed less than 10% reduction of the pretreatment value of FVC and FEVı during the follow up period, i.e. grade 0 toxicity. Four patients in each group showed chest radiographic changes, making up 7.4% of group A and 6.5% of group B. Nine patients in group A showed the infiltrates in the radiation fields (16.7 %). Also nine patients in group B showed radiation pneumonitis, 14.5%. There was no statistical significant difference between the two groups regarding the number of patients who manifested pulmonary toxicity. Cardiac toxicity determined by function, assessed by the ejection fraction measured by echocardiography, for left-sided breast cancer patients who were 20 in group A and 30 in group B. The patients who experienced cardiac toxicity were 4 in group A, constituting 20% of the group and 5 group B, 18% of the group. They were all graded as grade 1, (less than 10% decrease in the ejection fraction value), and were nonsymptomatic. These results showed no statistically significant difference between group A and B. |