The UK Standardisation of Breast Radiotherapy (START) trials of radiotherapy hypofractionation for treatment of early breast cancer: 10-year follow-up results of two randomised controlled trials

Haviland, J.S.; Owen, John R.; Dewar, John; Agrawal, Rajiv; Barrett, Jane; Barrett-Lee, Peter; Dobbs, H.J.; Hopwood, Penelope; Lawton, P.A.; Magee, Brian; Mills, Judith; Simmons, Sandra F.; Sydenham, M.; Venables, Karen; Bliss, Judith; Yarnold, John

doi:10.1016/s1470-2045(13)70386-3

Cited by 1,217 publications

(1,152 citation statements)

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“…It is important to have a study that will improve care without increasing complications. Randomized studies in breast cancer have shown that delivery can be given in a shorter period of time without effect on overall survival, local control or toxicities compared to standard fractionation (Haviland et al, 2013, Whelan et al, 2010, Owen et al, 2006). Similar findings are being reported in prostate cancer (Kupelian et al, 2007, Hoffman et al, 2014, Pollack et al, 2013).…”

Section: High Priority Topics For Lmicsmentioning

confidence: 99%

Clinical trials in low and middle-income countries — Successes and challenges

Grover

Jhingran

et al. 2017

Gynecologic Oncology Reports

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Gynecologic malignancies affect women in low and middle-income countries (LMICs) at equal or higher rates compared to high income countries (HICs), yet practice guidelines based on clinical trials performed in HICs do not routinely account for resource disparities between these regions. There is a need and growing interest for executing clinical trials in LMICs. This has led to the creation of multinational cooperative groups and the initiation of several ongoing clinical trials in Mexico, China, and Korea. In this article we describe the challenges involved in initiating clinical trials in LMICs, review current efforts within surgical, medical, and radiation oncology, and introduce high priority topics for future research.

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Section: High Priority Topics For Lmicsmentioning

confidence: 99%

Clinical trials in low and middle-income countries — Successes and challenges

Grover

Jhingran

et al. 2017

Gynecologic Oncology Reports

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“…The START 10-year paper reports 5-year and 10-year clinical assessments of late adverse effects, 2 whereas the results published in 2008 and 2010 related to photographic Dr P Marszzi/Science Photo Library exceeding the likely effect. We are surprised that Kaul and Wolf do not mention this rather obvious limitation in their discussion of the results.…”

Section: Late Eff Ects Of Breast Radiotherapymentioning

confidence: 99%

“…It is not expected to have an immediate effect on youth smoking rates, but rather, as with other tobacco control interventions, to have a long-term eff ect on youth uptake. 2 Tobacco industry misrepresentation of the evidence in order to try to block public health interventions by manipulating policy making and public opinion is well documented. 3 Recently, Philip Morris International funded an analysis of smoking among Australian adolescents aged 14-17 years showing "an absence of any plain packaging eff ect".…”

Section: Late Eff Ects Of Breast Radiotherapymentioning

confidence: 99%

“…Between 2001 and 2013 smoking prevalence was falling by 0·44% per year, during a period when a range of interventions had been implemented. 2 At the time standardised packaging was introduced, smoking prevalence was 6%. In the previous year, mean deviation from this trend was -0·6%, whereas in the year after it was -0·4%.…”

Section: Late Eff Ects Of Breast Radiotherapymentioning

confidence: 99%

“…The occurrence of bone necrosis was not collected in the trials although rib fractures were reassuringly rare. We acknowledged in our paper 2 that the timescale for some adverse eff ects such as cardiac events is long, and that we are continuing to receive follow-up data on the START patients. However, recent analysis suggests that hypofractionation might be gentler on the heart than is standard fractionation, but the real priority is to protect the heart whatever dose schedule is used, and heart-sparing protocols are now widely practised.…”

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Late effects of breast radiotherapy

et al. 2014

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Uptake and Costs of Hypofractionated vs Conventional Whole Breast Irradiation After Breast Conserving Surgery in the United States, 2008–2013

Bekelman

Sylwestrzak

Barron

et al. 2014

JAMA

197

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IMPORTANCE Based on randomized evidence, expert guidelines in 2011 endorsed shorter, hypofractionated whole breast irradiation (WBI) for selected patients with early-stage breast cancer and permitted hypofractionated WBI for other patients. OBJECTIVES To examine the uptake and costs of hypofractionated WBI among commercially insured patients in the United States. DESIGN, SETTING, AND PARTICIPANTS Retrospective, observational cohort study, using administrative claims data from 14 commercial health care plans covering 7.4%of US adult women in 2013, we classified patients with incident early-stage breast cancer treated with lumpectomy and WBI from 2008 and 2013 into 2 cohorts: (1) the hypofractionation-endorsed cohort (n = 8924) included patients aged 50 years or older without prior chemotherapy or axillary lymph node involvement and (2) the hypofractionation-permitted cohort (n = 6719) included patients younger than 50 years or those with prior chemotherapy or axillary lymph node involvement. EXPOSURES Hypofractionated WBI (3–5 weeks of treatment) vs conventional WBI (5–7 weeks of treatment). MAIN OUTCOMES AND MEASURES Use of hypofractionated and conventional WBI, total and radiotherapy-related health care expenditures, and patient out-of-pocket expenses. Patient and clinical characteristics included year of treatment, age, comorbid disease, prior chemotherapy, axillary lymph node involvement, intensity-modulated radiotherapy, practice setting, and other contextual variables. RESULTS Hypofractionated WBI increased from 10.6%(95%CI, 8.8%–12.5%) in 2008 to 34.5%(95%CI, 32.2%–36.8%) in 2013 in the hypofractionation-endorsed cohort and from 8.1% (95%CI, 6.0%–10.2%) in 2008 to 21.2%(95%CI, 18.9%–23.6%) in 2013 in the hypofractionation-permitted cohort. Adjusted mean total health care expenditures in the 1 year after diagnosis were $28 747 for hypofractionated and $31 641 for conventional WBI in the hypofractionation-endorsed cohort (difference, $2894; 95%CI, $1610–$4234; P < .001) and $64 273 for hypofractionated and $72 860 for conventional WBI in the hypofractionation-permitted cohort (difference, $8587; 95%CI, $5316–$12 017; P < .001). Adjusted mean total 1-year patient out-of-pocket expenses were not significantly different between hypofractionated vs conventional WBI in either cohort. CONCLUSIONS AND RELEVANCE Hypofractionated WBI after breast conserving surgery increased among women with early-stage breast cancer in 14 US commercial health care plans between 2008 and 2013. However, only 34.5%of patients with hypofractionation-endorsed and 21.2%with hypofractionation-permitted early-stage breast cancer received hypofractionated WBI in 2013.

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The UK Standardisation of Breast Radiotherapy (START) trials of radiotherapy hypofractionation for treatment of early breast cancer: 10-year follow-up results of two randomised controlled trials

Cited by 1,217 publications

References 19 publications

Clinical trials in low and middle-income countries — Successes and challenges

Clinical trials in low and middle-income countries — Successes and challenges

Late effects of breast radiotherapy

Uptake and Costs of Hypofractionated vs Conventional Whole Breast Irradiation After Breast Conserving Surgery in the United States, 2008–2013

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