Schafer R, et al. - Researchers determined quality of life, as reported by patients, over a period of 5 years in those who underwent accelerated partial breast irradiation (APBI) with multicatheter brachytherapy vs whole-breast irradiation for early breast cancer after breast-conserving surgery. Previously, it has been demonstrated in the GEC-ESTRO trial that APBI using multicatheter brachytherapy was non-inferior to whole-breast irradiation in terms of local control and overall survival. APBI with multicatheter brachytherapy vs whole-breast irradiation was not found to be related to worse quality of life. APBI was supported as an alternative treatment option after breast-conserving surgery for patients with early breast cancer.

Methods

• Researchers conducted this randomized controlled phase 3 trial at 16 hospitals and medical centers in seven European countries.
• They randomized (1:1) patients aged 40 years or older with 0–IIA breast cancer who underwent breast-conserving surgery (resection margins ≥2 mm) to receive either whole-breast irradiation of 50 Gy with a boost of 10 Gy or APBI using multicatheter brachytherapy.
• They stratified randomization by study center, tumor type, and menopausal status, with a block size of ten and an automated dynamic algorithm.
• There was no masking of patients or investigators.
• Ipsilateral local recurrence was primary endpoint.
• Five-year results of quality of life (secondary endpoint) were determined.
• Before radiotherapy (baseline 1), immediately after radiotherapy (baseline 2), and during follow-up, participants were asked to complete quality-of-life questionnaires (European Organization for Research and Treatment of Cancer QLQ-C30, breast cancer module QLQ-BR23).
• In 2009, recruitment was completed and long-term follow-up is continuing.

Results

• Between April 20, 2004, and July 30, 2009, accelerated partial breast irradiation was used to treat 633 patients and whole-breast irradiation to treat 551 patients.
• Data showed that quality-of-life questionnaires at baseline 1 were available for 334 (53%) of 663 patients in the APBI group and 314 (57%) of 551 patients in the whole-breast irradiation group; follow-up revealed similar response rate.
• Both groups had stable global health status (range 0–100). At baseline 1, APBI group mean score 65.5 (SD 20.6) vs whole-breast irradiation group 64.6 (19·6), p=0·37; at 5 years, APBI group 66.2 (22.2) vs whole-breast irradiation group 66.0 (21.8), p=0.94.
• The breast symptoms scale was the only moderate, significant difference (difference of 10–20 points) between the groups.
• Breast symptom scores were significantly higher (ie, worse) following whole-breast irradiation vs after APBI at baseline 2 (difference of means 13.6, 95% CI 9.7–17.5; p<0.0001) and at 3-month follow-up (difference of means 12.7, 95% CI 9.8–15.6; p<0.0001).