Quality of life after breast-conserving therapy and adjuvant radiotherapy for non-low-risk ductal carcinoma in situ (BIG 3-07/TROG 07.01): 2-year results of a randomised, controlled, phase 3 trial
Autor: | Madeleine T King, Emma K Link, Tim J Whelan, Ivo A Olivotto, Ian Kunkler, Antonia Helen Westenberg, Guenther Gruber, Penny Schofield, Boon H Chua, Claire Phillips, Guy Bryant, Helen Westenberg, Om Pra-Kesh Purohit, Verity Ahern, Peter Graham, Mohamed Akra, Orla McArdle, Peter O'Brien, Jane Ludbrook, Jennifer Harvey, John H Maduro, Isabelle Gabelle-Flandin, Carine Kirkove, Carolyn Bedi, Joseph Martin, Tony Vu, Theirry Muanza, Anthony Neal, Adel Courdi, Juliette Thariat, Eileen Rakovitch, Laurien Daniels, Marjan van Hezewijk, Wlasyslawa Cwajna, Adelheid Roelstraete, Angela van Baardwijk, Nicola Russel, Anne Koch, Jennifer Croke, Imogen Locke, Peter Jeal, Quenten Walker, Kandeepeepan Thuraisingham, Anupam Chauduri, David Joseph, Mandy Taylor, Sabine Vanderkam, Tony Woo, Johann Tang, Michael Yassa, Elaine Wai, Susan Hewitt, Shazia Mahmood, Jennifer Gilmore, Bolante Ofi, Amit Bahl, Olga Vujovic, Edward Yu, Duc Le, Iwa Kong, Alan Nichol, Nina Bijker, Geoff Delaney, Malcolm Feigen, Adeline Lim, Michael Chao, Margaret Latham, Hafiz Algurafi, Christoph Tausch, Eric Khoo, Sam Leung, Karen Taylor, Sasha Senthi, Andrea Stevens, Abhro Chaudhuri, Susan Cleator, Adrian Murray Brunt, Scott Babington, David Christie, Daniel Zwahlen, Ulrich Schratzenstaller, Laurence Masson, Nicola Storey, Eshwar Kumar, Liz Sherwin, Reinhilde Weytjens, Sharma Ravi, Patricia Lawton, Ruth Angell, Glenys Round, Angela Allen, Ziad Thotathil, Margaret Anthes, Christiane Reuter, Laura Pettit, Yvonne Zissiadis, Christine Elder, Antoinette Verbeek-de Kanter, Andree Lirette, Ludwig Plasswilm, David Spooner, Fiona Hoar, Islam Mohamed, Kristina Lossl, Vivienne Loo, Antonella Richetti, Tamasin Evans, Aisling Hennessy, Medhat El-Mallah, Marketa Skala, Raef Awad, Isabelle Germain, Carine Mitine, Hilde Van Parijs, Mark Churn, Nawaz Walji, Michael Francis, Karin Stellamans, Gunther Gruber, Giovanni Ivaldi, Abdulla Alhasso, Lizbeth Kenny, Ken Tiver, Matthew Griffin, Gillian Lamoury, Marco Trovo, Hafiz Algufarfi, Minjae Lah, Scott Carruthers, George Papadatos, Gabriel Paardekooper, Mojca Persic, Bernadette Lavery |
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Přispěvatelé: | Radiotherapy, CCA - Cancer Treatment and Quality of Life |
Rok vydání: | 2020 |
Předmět: |
Oncology
medicine.medical_specialty medicine.medical_treatment Breast surgery Brachytherapy Breast Neoplasms Mastectomy Segmental law.invention 03 medical and health sciences 0302 clinical medicine Breast cancer Randomized controlled trial law Internal medicine medicine Clinical endpoint Humans Breast 030212 general & internal medicine Neoplasm Staging Intention-to-treat analysis business.industry Middle Aged medicine.disease Radiation therapy Carcinoma Intraductal Noninfiltrating Treatment Outcome 030220 oncology & carcinogenesis Quality of Life Female Radiotherapy Adjuvant Neoplasm Recurrence Local business Mastectomy |
Zdroj: | lancet oncology, 21(5), 685-698. Lancet Publishing Group |
ISSN: | 1470-2045 0047-0236 |
DOI: | 10.1016/s1470-2045(20)30085-1 |
Popis: | Summary Background BIG 3-07/TROG 07.01 is an international, multicentre, randomised, controlled, phase 3 trial evaluating tumour bed boost and hypofractionation in patients with non-low-risk ductal carcinoma in situ following breast-conserving surgery and whole breast radiotherapy. Here, we report the effects of diagnosis and treatment on health-related quality of life (HRQOL) at 2 years. Methods The BIG 3-07/TROG 07.01 trial is ongoing at 118 hospitals in 11 countries. Women aged 18 years or older with completely excised non-low-risk ductal carcinoma in situ were randomly assigned, by use of a minimisation algorithm, to tumour bed boost or no tumour bed boost, following conventional whole breast radiotherapy or hypofractionated whole breast radiotherapy using one of three randomisation categories. Category A was a 4-arm randomisation of tumour bed boost versus no boost following conventional whole breast radiotherapy (50 Gy in 25 fractions over 5 weeks) versus hypofractionated whole breast radiotherapy (42·5 Gy in 16 fractions over 3·5 weeks). Category B was a 2-arm randomisation between tumour bed boost versus no boost following conventional whole breast radiotherapy, and category C was a 2-arm randomisation between tumour bed boost versus no boost following hypofractionated whole breast radiotherapy. Stratification factors were age at diagnosis, planned endocrine therapy, and treating centre. The primary endpoint, time to local recurrence, will be reported when participants have completed 5 years of follow-up. The HRQOL statistical analysis plan prespecified eight aspects of HRQOL, assessed by four questionnaires at baseline, end of treatment, and at 6, 12, and 24 months after radiotherapy: fatigue and physical functioning (EORTC QLQ-C30); cosmetic status, breast-specific symptoms, arm and shoulder functional status (Breast Cancer Treatment Outcome Scale); body image and sexuality (Body Image Scale); and perceived risk of invasive breast cancer (Cancer Worry Scale and a study-specific question). For each of these measures, tumour bed boost was compared with no boost, and conventional whole breast radiotherapy compared with hypofractionated whole breast radiotherapy, by use of generalised estimating equation models. Analyses were by intention to treat, with Hochberg adjustment for multiple testing. This trial is registered with ClinicalTrials.gov , NCT00470236 . Findings Between June 1, 2007, and Aug 14, 2013, 1208 women were enrolled and randomly assigned to receive no tumour bed boost (n=605) or tumour bed boost (n=603). 396 of 1208 women were assigned to category A: conventional whole breast radiotherapy with tumour bed boost (n=100) or no boost (n=98), or to hypofractionated whole breast radiotherapy with tumour bed boost (n=98) or no boost (n=100). 447 were assigned to category B: conventional whole breast radiotherapy with tumour bed boost (n=223) or no boost (n=224). 365 were assigned to category C: hypofractionated whole breast radiotherapy with tumour bed boost (n=182) or no boost (n=183). All patients were followed up at 2 years for the HRQOL analysis. 1098 (91%) of 1208 patients received their allocated treatment, and most completed their scheduled HRQOL assessments (1147 [95%] of 1208 at baseline; 988 [87%] of 1141 at 2 years). Cosmetic status was worse with tumour bed boost than with no boost across all timepoints (difference 0·10 [95% CI 0·05–0·15], global p=0·00014, Hochberg-adjusted p=0·0016); at the end of treatment, the estimated difference between tumour bed boost and no boost was 0·13 (95% CI 0·06–0·20; p=0·00021), persisting at 24 months (0·13 [0·06–0·20]; p=0·00021). Arm and shoulder function was also adversely affected by tumour bed boost across all timepoints (0·08 [95% CI 0·03–0·13], global p=0·0033, Hochberg adjusted p=0·045); the difference between tumour bed boost and no boost at the end of treatment was 0·08 (0·01 to 0·15, p=0·021), and did not persist at 24 months (0·04 [–0·03 to 0·11], p=0·29). None of the other six prespecified aspects of HRQOL differed significantly after adjustment for multiple testing. Conventional whole breast radiotherapy was associated with worse body image than hypofractionated whole breast radiotherapy at the end of treatment (difference –1·10 [95% CI –1·79 to –0·42], p=0·0016). No significant differences were reported in the other PROs between conventional whole breast radiotherapy compared with hypofractionated whole breast radiotherapy. Interpretation Tumour bed boost was associated with persistent adverse effects on cosmetic status and arm and shoulder functional status, which might inform shared decision making while local recurrence analysis is pending. Funding National Health and Medical Research Council, Susan G Komen for the Cure, Breast Cancer Now, OncoSuisse, Dutch Cancer Society. |
Databáze: | OpenAIRE |
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