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.,The Lancet Oncology

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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.
The Lancet Oncology ( IF 41.6 ) Pub Date : 2020-03-20 , DOI: 10.1016/s1470-2045(20)30085-1
Madeleine T King ₁ , Emma K Link ₂ , Tim J Whelan ₃ , Ivo A Olivotto ₄ , Ian Kunkler ₅ , Antonia Helen Westenberg ₆ , Guenther Gruber ₇ , Penny Schofield ₈ , Boon H Chua ₉ ,

Affiliation

Faculty of Science, School of Psychology, The University of Sydney, Sydney, NSW, Australia.
Peter MacCallum Cancer Centre, Melbourne, VIC, Australia; Sir Peter MacCallum Department of Oncology, University of Melbourne, Parkville, VIC, Australia.
Department of Oncology, McMaster University, Hamilton, ON, Canada.
University of Calgary, Calgary, AB, Canada.
Edinburgh Cancer Research Centre, Institute of Genetic and Molecular Medicine, University of Edinburgh, Western General Hospital, Edinburgh, UK.
Radiotherapiegroep Arnhem, Arnhem, The Netherlands.
Institute for Radiotherapy, Klinik Hirslanden, Zurich, Switzerland.
Behavioural Sciences Unit, Department of Cancer Experiences Research, Melbourne, VIC, Australia; Sir Peter MacCallum Department of Oncology, University of Melbourne, Parkville, VIC, Australia; Department of Psychology, and Iverson Health Innovation Research Institute, Swinburne University, Melbourne, VIC, Australia.
University of New South Wales, UNSW Medicine, Sydney, NSW, Australia.

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.

中文翻译：

非低风险导管原位癌保乳治疗和辅助放疗后的生活质量 (BIG 3-07/TROG 07.01)：一项随机、对照、3 期试验的 2 年结果。

背景 BIG 3-07/TROG 07.01 是一项国际、多中心、随机、对照、3 期试验，用于评估非低风险原位导管癌患者在保乳手术和全乳放疗后的瘤床增强和大分割。在这里，我们报告了诊断和治疗对 2 年健康相关生活质量 (HRQOL) 的影响。方法 BIG 3-07/TROG 07.01 试验正在 11 个国家的 118 家医院进行。18 岁或以上患有完全切除的非低风险原位导管癌的女性，通过使用最小化算法，在常规全乳放疗或大分割全乳放疗后，使用最小化算法随机分配到肿瘤床增强或不增强肿瘤床。三个随机化类别之一。A 类是 4 臂随机分组，即传统全乳放疗（5 周内 25 次分次 50 Gy）和大分割全乳放疗（3·5 周内 16 次分次 42·5 Gy）后肿瘤床加强与不加强。B 类是传统全乳放疗后肿瘤床加强与不加强之间的 2 臂随机化，C 类是肿瘤床加强与大分割全乳房放疗后不加强之间的 2 臂随机化。分层因素是诊断时的年龄、计划的内分泌治疗和治疗中心。当参与者完成 5 年的随访时，将报告主要终点，即局部复发的时间。HRQOL 统计分析计划预先指定了 HRQOL 的八个方面，在基线时通过四份问卷进行评估，治疗结束和放疗后 6、12 和 24 个月：疲劳和身体功能（EORTC QLQ-C30）；美容状态、乳房特异性症状、手臂和肩部功能状态（乳腺癌治疗结果量表）；身体形象和性取向（身体形象量表）；和感知的浸润性乳腺癌风险（癌症担忧量表和研究特定问题）。对于这些措施中的每一个，通过使用广义估计方程模型，将肿瘤床加强与不加强进行比较，将常规全乳放疗与大分割全乳放疗进行比较。分析是按意向治疗进行的，并针对多重测试进行了 Hochberg 调整。该试验已在 ClinicalTrials.gov 注册，NCT00470236。2007 年 6 月 1 日至 2013 年 8 月 14 日期间的调查结果，1208 名女性被纳入并随机分配接受无瘤床加强 (n=605) 或瘤床加强 (n=603)。1208 名女性中有 396 名被分配到 A 类：常规全乳放疗加瘤床加强 (n=100) 或不加强 (n=98)，或大分割全乳放疗加瘤床加强 (n=98) 或不加强(n=100)。447 人被分配到 B 类：常规全乳放疗，肿瘤床加强（n = 223）或不加强（n = 224）。365 人被分配到 C 类：大分割全乳房放疗，肿瘤床加强（n = 182）或不加强（n = 183）。所有患者均在 2 年时进行 HRQOL 分析。1208 名患者中有 1098 名 (91%) 接受了分配的治疗，并且大多数完成了预定的 HRQOL 评估（基线时 1208 名中有 1147 名 [95%]；2 年时 1141 名中有 988 名 [87%]）。在所有时间点，肿瘤床增强的美容状态比没有增强的更差（差异 0·10 [95% CI 0·05-0·15]，全局 p=0·00014，Hochberg 调整 p=0·0016）；在治疗结束时，瘤床加强和未加强之间的估计差异为 0·13（95% CI 0·06-0·20；p=0·00021），持续 24 个月（0·13 [0· 06-0·20]；p=0·00021)。在所有时间点，臂和肩部功能也受到肿瘤床增强的不利影响（0·08 [95% CI 0·03-0·13]，全局 p=0·0033，Hochberg 调整后的 p=0·045）；治疗结束时瘤床加强和未加强之间的差异为 0·08（0·01 至 0·15，p=0·021），并且在 24 个月时并未持续（0·04 [-0·03到 0·11]，p=0·29）。HRQOL 的其他六个预先指定的方面在针对多项测试进行调整后均无显着差异。在治疗结束时，传统全乳放疗与大分割全乳放疗相比，身体形象更差（差异 -1·10 [95% CI -1·79 至 -0·42]，p=0·0016）。与大分割全乳放疗相比，传统全乳放疗在其他 PRO 方面没有报告显着差异。解释肿瘤床增加与对美容状态和手臂和肩部功能状态的持续不良影响有关，这可能会在局部复发分析未决时为共同决策提供信息。资助国家健康和医学研究委员会，Susan G Komen 治愈乳腺癌，OncoSuisse，荷兰癌症协会。

更新日期：2020-03-20

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