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, Angela Boch, Elena Sperk, Frank Hofmann, Uta Kraus-Tiefenbacher, Axel Gerhardt, Marc Suetterlin, Frederik Wenz, Grit Welzel, Angela Boch, Elena Sperk, Frank Hofmann, Uta Kraus-Tiefenbacher, Axel Gerhardt, Marc Suetterlin, Frederik Wenz

Abstract

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.

Figures

Figure 1
Figure 1
General pain by treatment group as measured with the EORTC QLQ-C30. Higher scores are equal to severe symptoms/worse quality of life. Please note: Univariate regression analysis revealed no influence of follow-up duration on self-reported pain symptoms. Abbreviations: SD, standard deviation. * Mann–Whitney U-test. P = 0.018. ** Mann–Whitney U-test. P = 0.007.
Figure 2
Figure 2
Breast symptoms by treatment group as measured with the EORTC QLQ-BR23. Higher scores are equal to severe symptoms/worse quality of life. Please note: Univariate regression analysis revealed no influence of follow-up duration on self-reported breast symptoms. * Mann–Whitney U-test. P = 0.021. ** Mann–Whitney U-test. P = 0.001. *** Mann–Whitney U-test. P < 0.001.
Figure 3
Figure 3
Arm symptoms by treatment group as measured with the EORTC QLQ-BR23. Higher scores are equal to severe symptoms/worse quality of life. Please note: Univariate regression analysis revealed no influence of follow-up duration on self-reported arm symptoms. * Mann–Whitney U-test. P = 0.011. ** Mann–Whitney U-test. P = 0.009.
Figure 4
Figure 4
Percentage of variance in the QoL parameters accounted for by demographic and clinical variables for the TARGIT-A group. The bars show the percentage of variance explained by multiple linear regression analysis for the QoL parameters examined. The number in brackets indicates the percentage of variance explained by each factor. The sign before each term indicates whether the factor was positively or negatively related to the QoL parameter.

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