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

King, Madeleine; Link, Emma; Whelan, Timothy J.; Olivotto, Ivo A.; Kunkler, Ian; Westenberg, A. Helen; Gruber, Guenther; Schofield, Penny; Chua, Boon; Phillips, Claire; Bryant, Guy; Westenberg, Helen; Purohit, Om Pra-Kesh; Ahern, Verity; Graham, Peter; Akra, Mohamed; McArdle, O.; O’Brien, Peter C.; Ludbrook, Jane; Harvey, Jennifer A.; Maduro, John H.; Gabelle-Flandin, Isabelle; Kirkove, Carine; Bedi, Carolyn; Martin, Joseph D.; Vu, T Trinh T; Muanza, T.; Neal, Anthony; Courdi, A.; Thariat, Juliette; Rakovitch, Eileen; Daniëls, Laurien A.; Hezewijk, Marjan van; Cwajna, Wlasyslawa; Roelstraete, A.; Baardwijk, Angela van; Russel, N.; Koch, Anne; Croke, Jennifer; Locke, Imogen; Jeal, P. N.; Walker, Quenten; Thuraisingham, Kandeepeepan; Chauduri, Anupam; Joseph, David; Taylor, Mandy; Vanderkam, S.; Woo, Tony; Tang, Johann I.; Yassa, M.; Wai, Elaine S.; Hewitt, Susan; Mahmood, Shazia; Gilmore, Jennifer; Ofi, Bolante; Bahl, Amit; Vujovic, Olga; Yu, Edward; Le, Duc; Kong, Iwa; Nichol, Alan; Bijker, Nina; Delaney, Geoff P.; Feigen, M.; Lim, Adeline; Chao, Michael; Latham, Margaret; Algurafi, Hafiz; Tausch, Christoph; Khoo, Eric Yin-Hao; Leung, Sam; Taylor, Karen; Senthi, Sashendra; Stevens, Andrea; Cleator, Susan; Brunt, Adrian Murray; Babington, Scott; Zwahlen, Daniel R.; Schratzenstaller, U; Masson, L.; Storey, Nicola; Kumar, Eshwar; Sherwin, Liz; Weytjens, R.; Sharma, Richa; Lawton, Patricia A.; Angell, Ruth; Round, Glenys; Allen, Angela; Thotathil, Ziad; Anthes, Margaret; Reuter, Christiane; Pettit, Laura; Zissiadis, Yvonne; Elder, Christine; Kanter, Antoinette Verbeek-de; Lirette, A.; Plaßwilm, Ludwig; Spooner, D.; Hoar, Fiona; Mohamed, Islam; Lössl, Kristina; Loo, Vivienne; Richetti, A.; Evans, Tamasin; Hennessy, Aisling; El-Mallah, Medhat; Skala, Marketa; Awad, Raef; Germain, Isabelle; Mitine, C.; Parijs, Hilde Van; Churn, Mark; Francis, Michael; Stellamans, Karin; Gruber, Günther; Ivaldi, Giovanni Battista; Kenny, Lizbeth; Tiver, K. W.; Griffin, Matthew; Lamoury, Gillian; Trovò, Marco; Algufarfi, Hafiz; Walji, Nawaz; Lah, Minjae; Christie, David; Alhasso, Abdulla; Carruthers, Scott; Papadatos, George; Paardekooper, G.; Chaudhuri, Abhro; Persic, Mojca; Lavery, Bernadette

doi:10.1016/s1470-2045(20)30085-1

Cited by 35 publications

(22 citation statements)

References 24 publications

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“…Boost radiation is known to adversely affect toxicities and the cosmetic results (23,24). Coles et al compared the RAPID and NSABP B-39/RTOG 0413 trials and suggested that the use of boost radiation in the whole-breast irradiation group might have contributed to the observed differences in toxicity (25).…”

Section: Discussionmentioning

confidence: 99%

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The Acute and Late Toxicities of MRI-Guided External Beam Partial Breast Irradiation Delivered Using a Once-Per-Day Regimen

Lee

Kim

et al. 2021

Front. Oncol.

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Background and PurposeThe use of external beam accelerated partial breast irradiation (APBI) using a twice-per-day regimen has raised concerns about increase rates of late toxicities. We compared toxicity outcomes of external beam APBI using a once-per-day regimen and accelerated hypofractionated whole breast irradiation (AWBI) in patients with early-stage breast cancer.Materials and MethodsThis was a single-institution, retrospective cohort study. Patients aged ≥50 years with pTisN0 or pT1N0 breast cancer who underwent breast-conserving surgery and adjuvant radiotherapy were included. APBI was delivered at 38.5 Gy in 10 fractions once daily using magnetic resonance imaging (MRI)-guided radiotherapy only to patients who were strictly “suitable”, according to the ASTRO-APBI guidelines. AWBI was delivered at 40.5–43.2 Gy in 15 or 16 fractions with or without a boost.ResultsBetween October 2015 and December 2018, 173 and 300 patients underwent APBI and AWBI, respectively. At a median follow-up of 34.9 months (range 7.1 to 55.4 months), the 3-year recurrence-free survival rates of the APBI and AWBI groups were both 99.2% (p=0.63). Acute toxicities were less frequent in the APBI than AWBI group (grade 1: 95 [54.9%] vs. 233 [77.7%] patients; grade 2: 7 [4.0%] vs. 44 [14.7%] patients; no grade ≥3 toxicities were observed in either group, p<0.001). Late toxicities were less common in the APBI than AWBI group (grade 1: 112 [64.7%] vs. 197 [65.7%] patients; grade 2: 9 [5.2%] vs. 64 [21.3%] patients; grade 3: 0 vs. 5 [1.7%] patients, p<0.001). Multivariate analysis showed that APBI was significantly associated with fewer late toxicities of grade ≥2 compared with AWBI (odds ratio 4.17, p=0.006).ConclusionOnce-per-day APBI afforded excellent locoregional control and fewer toxicities compared with AWBI. This scheme could be an attractive alternative to AWBI in patients who meet the ASTRO-APBI guidelines.

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Section: Discussionmentioning

confidence: 99%

“…Boost radiation is known to adversely affect toxicities and the cosmetic results ( 23 , 24 ). Coles et al.…”

Section: Discussionmentioning

confidence: 99%

The Acute and Late Toxicities of MRI-Guided External Beam Partial Breast Irradiation Delivered Using a Once-Per-Day Regimen

Lee

Kim

et al. 2021

Front. Oncol.

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“…To allow for attrition at a rate of 5% per year, 1020 patients are required to participate in the quality of life study.' 49…”

Section: Pro Endpoints: 2°tmentioning

confidence: 99%

SPIRIT-PRO Extension explanation and elaboration: guidelines for inclusion of patient-reported outcomes in protocols of clinical trials

et al. 2021

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Patient-reported outcomes (PROs) are used in clinical trials to provide valuable evidence on the impact of disease and treatment on patients’ symptoms, function and quality of life. High-quality PRO data from trials can inform shared decision-making, regulatory and economic analyses and health policy. Recent evidence suggests the PRO content of past trial protocols was often incomplete or unclear, leading to research waste. To address this issue, international, consensus-based, PRO-specific guidelines were developed: the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT)-PRO Extension. The SPIRIT-PRO Extension is a 16-item checklist which aims to improve the content and quality of aspects of clinical trial protocols relating to PRO data collection to minimise research waste, and ultimately better inform patient-centred care. This SPIRIT-PRO explanation and elaboration (E&E) paper provides information to promote understanding and facilitate uptake of the recommended checklist items, including a comprehensive protocol template. For each SPIRIT-PRO item, we provide a detailed description, one or more examples from existing trial protocols and supporting empirical evidence of the item’s importance. We recommend this paper and protocol template be used alongside the SPIRIT 2013 and SPIRIT-PRO Extension paper to optimise the transparent development and review of trial protocols with PROs.

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“…The merits of administering boost radiation therapy for DCIS need to be carefully weighed up. Improvements in local control are offset by the fact that giving a boost is detrimental to cosmetic outcomes and arm and shoulder functionality 10 , 11 .…”

Section: Ductal Carcinoma In Situmentioning

confidence: 99%

“…Die Entscheidung für den Einsatz einer Bestrahlung mit Boost beim DCIS sollte gründlich abgewogen werden. Der Verbesserung der lokalen Kontrolle steht ein negativer Einfluss des Boost auf die Kosmetik sowie die Funktionalität von Arm und Schulter gegenüber 10 , 11 .…”

Section: Duktales Carcinoma In Situunclassified

Update Breast Cancer 2021 Part 3 – Current Developments in the Treatment of Early Breast Cancer: Review and Assessment of Specialised Treatment Scenarios by an International Expert Panel

Fehm

Stickeler

Fasching

et al. 2021

Geburtshilfe Frauenheilkd

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The continuous availability of findings from new studies repeatedly results in updated treatment recommendations and guidelines. In the case of breast carcinoma in particular, several studies have been published in the last few years that have transformed how early and advanced breast carcinoma is being treated. However, this by no means means implies that there is agreement among all experts on specific issues. It is precisely the diversity of interpretation of guidelines and study findings that reflects the constantly changing available data and its complexity, as well as the availability of new drugs. In recent years, new substances such as pertuzumab, T-DM1, neratinib and capecitabine have become available to treat patients with early stages of breast carcinoma. Furthermore, the first results on the use of CDK4/6 inhibitors for adjuvant treatment have now been published. Last but not least, the use of multigene tests to avoid the necessity of chemotherapy in certain patients is still under discussion. This review summarises the state of the data and publishes the results of the survey completed by experts at the 2021 St. Gallen Breast Cancer Conference on early-stage breast cancer.

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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

Cited by 35 publications

References 24 publications

The Acute and Late Toxicities of MRI-Guided External Beam Partial Breast Irradiation Delivered Using a Once-Per-Day Regimen

The Acute and Late Toxicities of MRI-Guided External Beam Partial Breast Irradiation Delivered Using a Once-Per-Day Regimen

SPIRIT-PRO Extension explanation and elaboration: guidelines for inclusion of patient-reported outcomes in protocols of clinical trials

Update Breast Cancer 2021 Part 3 – Current Developments in the Treatment of Early Breast Cancer: Review and Assessment of Specialised Treatment Scenarios by an International Expert Panel

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