Radiation-related quality of life parameters after targeted intraoperative radiotherapy versus whole breast radiotherapy in patients with breast cancer: results from the randomized phase III trial TARGIT-A

Radiation Oncology, Jan 2013

Background Intraoperative radiotherapy (IORT) is a new treatment approach for early stage breast cancer. This study reports on the effects of IORT on radiation-related quality of life (QoL) parameters. Methods Two hundred and thirty women with stage I-III breast cancer (age, 31 to 84 years) were entered into the study. A single-center subgroup of 87 women from the two arms of the randomized phase III trial TARGIT-A (TARGeted Intra-operative radioTherapy versus whole breast radiotherapy for breast cancer) was analyzed. Furthermore, results were compared to non-randomized control groups: n = 90 receiving IORT as a tumor bed boost followed by external beam whole breast radiotherapy (EBRT) outside of TARGIT-A (IORT-boost), and n = 53 treated with EBRT followed by an external-beam boost (EBRT-boost). QoL was collected using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaires C30 (QLQ-C30) and BR23 (QLQ-BR23). The mean follow-up period in the TARGIT-A groups was 32 versus 39 months in the non-randomized control groups. Results Patients receiving IORT alone reported less general pain (21.3 points), breast (7.0 points) and arm (15.1 points) symptoms, and better role functioning (78.7 points) as patients receiving EBRT (40.9; 19.0; 32.8; and 60.5 points, respectively, P < 0.01). Patients receiving IORT alone also had fewer breast symptoms than TARGIT-A patients receiving IORT followed by EBRT for high risk features on final pathology (IORT-EBRT; 7.0 versus 29.7 points, P < 0.01). There were no significant differences between TARGIT-A patients receiving IORT-EBRT compared to non-randomized IORT-boost or EBRT-boost patients and patients receiving EBRT without a boost. Conclusions In the randomized setting, important radiation-related QoL parameters after IORT were superior to EBRT. Non-randomized comparisons showed equivalent parameters in the IORT-EBRT group and the control groups.

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Radiation-related quality of life parameters after targeted intraoperative radiotherapy versus whole breast radiotherapy in patients with breast cancer: results from the randomized phase III trial TARGIT-A

Radiation Oncology Radiation-related quality of life parameters after targeted intraoperative radiotherapy versus whole breast radiotherapy in patients with breast cancer: results from the randomized phase III trial TARGIT-A Grit Welzel 0 Angela Boch 0 Elena Sperk 0 Frank Hofmann 0 Uta Kraus-Tiefenbacher 0 Axel Gerhardt 1 Marc Suetterlin 1 Frederik Wenz 0 0 Department of Radiation Oncology, University Medical Centre Mannheim, University of Heidelberg , Mannheim 68167 , Germany 1 Department of Gynecology, University Medical Centre Mannheim, University of Heidelberg , Mannheim 68167 , Germany Background: Intraoperative radiotherapy (IORT) is a new treatment approach for early stage breast cancer. This study reports on the effects of IORT on radiation-related quality of life (QoL) parameters. Methods: Two hundred and thirty women with stage I-III breast cancer (age, 31 to 84 years) were entered into the study. A single-center subgroup of 87 women from the two arms of the randomized phase III trial TARGIT-A (TARGeted Intra-operative radioTherapy versus whole breast radiotherapy for breast cancer) was analyzed. Furthermore, results were compared to non-randomized control groups: n = 90 receiving IORT as a tumor bed boost followed by external beam whole breast radiotherapy (EBRT) outside of TARGIT-A (IORT-boost), and n = 53 treated with EBRT followed by an external-beam boost (EBRT-boost). QoL was collected using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaires C30 (QLQ-C30) and BR23 (QLQBR23). The mean follow-up period in the TARGIT-A groups was 32 versus 39 months in the non-randomized control groups. Results: Patients receiving IORT alone reported less general pain (21.3 points), breast (7.0 points) and arm (15.1 points) symptoms, and better role functioning (78.7 points) as patients receiving EBRT (40.9; 19.0; 32.8; and 60.5 points, respectively, P < 0.01). Patients receiving IORT alone also had fewer breast symptoms than TARGIT-A patients receiving IORT followed by EBRT for high risk features on final pathology (IORT-EBRT; 7.0 versus 29.7 points, P < 0.01). There were no significant differences between TARGIT-A patients receiving IORT-EBRT compared to non-randomized IORT-boost or EBRT-boost patients and patients receiving EBRT without a boost. Conclusions: In the randomized setting, important radiation-related QoL parameters after IORT were superior to EBRT. Non-randomized comparisons showed equivalent parameters in the IORT-EBRT group and the control groups. Quality of life; Targeted intraoperative radiotherapy; Breast cancer; Boost; TARGIT-A trial - Background Intraoperative radiotherapy (IORT) is a new treatment option for women with early stage operable breast cancer, and it is increasingly used in clinical practice. In 2000, the international randomized phase III trial TARGIT-A (NCT00983684; TARGeted Intra-operative radioTherapy versus whole breast radiotherapy for breast cancer) was started to investigate the non-inferiority of targeted intraoperative radiotherapy (IORT) given in a single dose to the tumour bed during breast-conserving surgery (BCS) as compared to conventional external beam whole breast radiotherapy (EBRT) in early stage breast cancer. In the presence of risk factors identified in the final pathology (invasive lobular carcinoma, extensive intraductal component, involved margins, lymphovascular invasion) postoperative EBRT is added after IORT per protocol (IORT-EBRT). The first analysis of the trial, published in June 2010, showed a 4 year local recurrence rate of about 1% and a clinically relevant toxicity rate of about 3% in both arms [1,2]. The primary aim of the present analysis was to assess radiation-related QoL parameters in the first 123 women from a single center participating in the TARGIT-A trial. The secondary aim was to compare TARGIT-A IORTEBRT patients with two non-randomized control groups of patients treated with (i) IORT as a tumor bed boost followed by EBRT outside of TARGIT-A (IORT-boost) or (ii) EBRT followed by an external-beam boost to the tumor bed (EBRT-boost). The primary end points were the global health status, restrictions in daily activities (role functioning), and general pain subscales from the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 (QLQ-C30, version 3) [3], and the breast symptoms and arm symptoms subscales from the EORTC Quality of Life Breast Cancer Module (QLQ-BR23) [4]. Methods Treatment and patients This study was a single center cross-sectional analysis. To qualify for the analysis, patients had to be randomized in the TARGIT-A trial between 2002 and 2009 from the University Medical Centre Mannheim. The full protocol of TARGIT-A is available online [5]. All eligible TARGIT-A patients were treated as follows Arm A: IORT with 50 kV X-rays (INTRABEAM system, Carl Zeiss Surgical, Oberkochen, Germany) delivering 20 Gy at the applicator sur (...truncated)


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Grit Welzel, Angela Boch, Elena Sperk, Frank Hofmann, Uta Kraus-Tiefenbacher, Axel Gerhardt, Marc Suetterlin, Frederik Wenz. Radiation-related quality of life parameters after targeted intraoperative radiotherapy versus whole breast radiotherapy in patients with breast cancer: results from the randomized phase III trial TARGIT-A, Radiation Oncology, 2013, pp. 9, 8, DOI: 10.1186/1748-717X-8-9