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
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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)