Quality-of-life results for accelerated partial breast irradiation with interstitial brachytherapy versus whole-breast irradiation in early breast cancer after breast-conserving surgery (GEC-ESTRO): 5-year results of a randomised, phase 3 trial

• Published in: The lancet oncology 2018-06, Vol.19 (6), p.834-844
• Main Authors: Schäfer, Rebekka, Strnad, Vratislav, Polgár, Csaba, Uter, Wolfgang, Hildebrandt, Guido, Ott, Oliver J, Kauer-Dorner, Daniela, Knauerhase, Hellen, Major, Tibor, Lyczek, Jaroslaw, Guinot, Jose Luis, Dunst, Jürgen, Miguelez, Cristina Gutierrez, Slampa, Pavel, Allgäuer, Michael, Lössl, Kristina, Kovács, György, Fischedick, Arnt-René, Fietkau, Rainer, Resch, Alexandra, Kulik, Anna, Arribas, Leo, Niehoff, Peter, Guedea, Ferran, Schlamann, Annika, Gall, Christine, Polat, Bülent, Wendt, Thomas G, Hindemith, Marion, Pötter, Richard, Malzer, Martina
• Format: Article
• Language: English
• Subjects: Biopsy; Brachytherapy; Breast cancer; Cancer therapies; Data processing; Patients; Quality of life; Radiation therapy; Studies; Surgery; Tumors
• ISSN: 1470-2045; 1474-5488
• DOI: 10.1016/S1470-2045(18)30195-5

Previous results from the GEC-ESTRO trial showed that accelerated partial breast irradiation (APBI) using multicatheter brachytherapy in the treatment of early breast cancer after breast-conserving surgery was non-inferior to whole-breast irradiation in terms of local control and overall survival. Here, we present 5-year results of patient-reported quality of life. We did this randomised controlled phase 3 trial at 16 hospitals and medical centres in seven European countries. Patients aged 40 years or older with 0–IIA breast cancer were randomly assigned (1:1) after 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. Randomisation was stratified by study centre, tumour type, and menopausal status, with a block size of ten and an automated dynamic algorithm. There was no masking of patients or investigators. The primary endpoint of the trial was ipsilateral local recurrence. Here, we present 5-year results of quality of life (a prespecified secondary endpoint). Quality-of-life questionnaires (European Organisation for Research and Treatment of Cancer QLQ-C30, breast cancer module QLQ-BR23) were completed before radiotherapy (baseline 1), immediately after radiotherapy (baseline 2), and during follow-up. We analysed the data according to treatment received (as-treated population). Recruitment was completed in 2009, and long-term follow-up is continuing. The trial is registered at ClinicalTrials.gov, number NCT00402519. Between April 20, 2004, and July 30, 2009, 633 patients had accelerated partial breast irradiation and 551 patients had whole-breast irradiation. 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; the response rate was similar during follow-up. Global health status (range 0–100) was stable in both groups: at baseline 1, APBI group mean score 65·5 (SD 20·6) versus whole-breast irradiation group 64·6 (19·6), p=0·37; at 5 years, APBI group 66·2 (22·2) versus whole-breast irradiation group 66·0 (21·8), p=0·94. The only moderate, significant difference (difference of 10–20 points) between the groups was found in the breast symptoms scale. Breast symptom scores were significantly higher (ie, worse) after whole-breast irradiation than after APBI at baseline 2 (difference of means 13·6, 95% CI 9·7–17·5; p