Purpose: To prospectively assess and compare the quality of life (QOL) of patients with early stage breast cancer selected for either brachytherapy (BRACHY high or low dose rate) alone or external beam radiation therapy (EBRT) as their breast conserving therapy (BCT). We hypothesize that the shorter radiation treatment course associated with BRACHY may lead to an improvement in QOL. Methods And Materials: Between 3/97 and 3/98, 42 patients (18 in EBRT arm and 24 in BRACHY arm) with early stage breast cancer were asked to complete the European Organization for Treatment and Research's (EORTC) Quality of Life Questionnaire (QLQ-C30 version 2.0). EBRT patients received a standard 6 1/2 week course ofexternal radiation while BRACHY patients were part of a prospective clinical trial delivering radiation to the tumor bed region over a four day period. The QLQ-C30 is composed of 5 functional scales (physical, role, emotional, cognitive and social), 3 symptom scales (fatigue, pain, nausea and vomiting), 6 single item scales (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial impact) and 1 global health status (GHS)/QOL scale. Subjects were asked to complete the QLQ-C30 at the following intervals: simulation, first week of treatment, at week 7 and 3, 6, 9 and 12 months post-treatment. The mean scores of patients receiving EBRT and BRACHY with respect to functional scales, symptom/single item scales and GHS/QOL scale are reported for simulation, week i, week 7 and 3 months. T-tests for equal and unequal variances are also reported. Results: In the EBRT arm, 18/18 patients have completed the QLQ-C30 for the 3 month interval; 13/24 in the BRACHY arm to date. It is anticipated that 24/24 patients will have completed the 3 month interval by October 1998. At the time of simulation, no significant difference in functioning between the two arms were noted. At week i, EBRT patients demonstrated superior role functioning (~ = 0.0018) and social functioning (p = 0.0105). Role functioning is defined as the ability to work or perform daily activities. Social functioning is defined as activities that involve family life and social activities. At week i, patients in the BRACHY arm demonstrated a statistically significant difference for one symptom/single item (p < 0.01 for constipation). This may be due to the use of narcotics~analgesics related to the axillary node dissection/implant placement. At week 7, patients who underwent EBRT demonstrated an increase in fatigue and financial impact which approached statistical significance (0.0749 and 0.0797 respectively). At the 3 month interval, no functional, symptom/single item or GHS/QOL scales were significantly different for patients receiving either BRACHY alone or EBRT. Conclusions: With the exception of the responses at week I, at which EBRT patients demonstrated a statistically significant difference in role and social functional scales and BRACHY patients demonstrated a statistical improvement in a single item scale, there appears to be no difference in overall QOL when patients are treated by either BRACHY alone or EBRT. Further patient accrual is planned.
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