Hypofractionated Versus Conventional Fractionated Radiotherapy After Breast-Conserving Surgery in the Modern Treatment Era: A Multicenter, Randomized Controlled Trial From China

2020 ◽  
Vol 38 (31) ◽  
pp. 3604-3614 ◽  
Author(s):  
Shu-Lian Wang ◽  
Hui Fang ◽  
Chen Hu ◽  
Yong-Wen Song ◽  
Wei-Hu Wang ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Asian Population ◽  
Skin Toxicity ◽  
Breast Conserving Surgery ◽  
Breast Cancers ◽  
Fractionated Radiotherapy ◽  
Tumor Bed ◽  
Acute Skin Toxicity ◽  
Multicenter Randomized Controlled Trial ◽  
Tumor Bed Boost

PURPOSE No randomized trials have compared hypofractionated radiotherapy (HFRT) with conventional fractionated radiotherapy (CFRT) after breast-conserving surgery in the Asian population. This study aimed to determine whether a 3.5-week schedule of HFRT is noninferior to a standard 6-week schedule of CFRT in China. PATIENTS AND METHODS Patients from 4 Chinese institutions who had undergone breast-conserving surgery and had T1-2N0-3 invasive breast cancers participated this study. Patients were randomly assigned (1:1) using a computer-generated central randomization schedule, without stratification, to receive whole-breast irradiation with or without nodal irradiation, followed by tumor-bed boost, either at a dose of 50 Gy in 25 fractions over 5 weeks with a boost of 10 Gy in five fractions over 1 week (CFRT) or 43.5 Gy in 15 fractions over 3 weeks with a boost of 8.7 Gy in three daily fractions (HFRT). The primary endpoint was 5-year local recurrence (LR), and a 5% margin of 5-year LR was used to establish noninferiority. RESULTS Between August 2010 and November 2015, 734 patients were assigned to the HFRT (n = 368) or CFRT (n = 366) group. At a median follow-up of 73.5 months (interquartile range, 60.5-91.4 months), the 5-year cumulative incidence of LR was 1.2% in the HFRT group and 2.0% in the CFRT group (hazard ratio, 0.62; 95% CI, 0.20 to 1.88; P = .017 for noninferiority). There were no significant differences in acute and late toxicities, except that the HFRT group had less grade 2-3 acute skin toxicity than the CFRT group ( P = .019). CONCLUSION CFRT and HFRT with a tumor-bed boost may have similar low LR and toxicity.

Targeted intraoperative radiotherapy tumor bed boost during breast conserving surgery after neoadjuvant chemotherapy in hormone receptor positive HER2 negative breast cancer.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e12090-e12090 ◽  
Author(s):  
Hans-Christian Kolberg ◽  
Gyoergy Loevey ◽  
Leyla Akpolat-Basci ◽  
Miltiades Stephanou ◽  
Peter A. Fasching ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Overall Survival ◽  
Neoadjuvant Chemotherapy ◽  
Hormone Receptor ◽  
Intraoperative Radiotherapy ◽  
Breast Conserving Surgery ◽  
Tumor Bed ◽  
Hormone Receptor Positive ◽  
Whole Breast Radiotherapy ◽  
Tumor Bed Boost

e12090 Background: Targeted intraoperative radiotherapy (TARGIT – IORT) as a tumor bed boost during breast conserving surgery is an established option for women with early breast cancer. In a previous study our group could show a beneficial effect of TARGIT-IORT on overall survival after neoadjuvant chemotherapy compared to an external boost in an unselected cohort. In this study we present an analysis of the hormone receptor positive HER2 negative subgroup. Methods: In this non-randomized cohort study involving 46 hormone receptor positive HER2 negative patients after NACT we compared outcomes of 21 patients who received a tumour bed boost with IORT (TARGIT-IORT) during lumpectomy versus 25 patients treated in the previous 13 months with external (EBRT) boost. All patients received whole breast radiotherapy. Disease free survival (DFS) and overall survival (OS) were compared. Results: There were no statistical differences between the two groups regarding tumor size, grading, nodal status and pCR rates. Median follow up was 49 months. Whereas DFS was not significantly different between the groups the 5-year Kaplan-Meier estimate of OS was significantly better by 21% with IORT: TARGIT-IORT 0 events 100%, EBRT 5 events 79%, log rank p = 0.028. Conclusions: Although our results have to be interpreted with caution due to a possible selection bias and the small numbers, we could show that the improved OS as previously demonstrated in our dataset for TARGIT-IORT during lumpectomy after neoadjuvant chemotherapy as a tumor bed boost compared to an external beam radiotherapy boost is driven by the hormone receptor positive HER2 negative subgroup. These data give further support to the inclusion of such patients in the TARGIT-B (Boost) randomised trial that is testing whether IORT boost is superior to EBRT boost and to the analysis of subgroups based on tumor biology in this trial.

Common variants of eNOS and XRCC1 genes may predict acute skin toxicity in breast cancer patients receiving radiotherapy after breast conserving surgery

2012 ◽  
Vol 103 (2) ◽  
pp. 199-205 ◽  
Author(s):  
Salvatore Terrazzino ◽  
Pierdaniele La Mattina ◽  
Laura Masini ◽  
Tina Caltavuturo ◽  
Giuseppina Gambaro ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cancer Patients ◽  
Skin Toxicity ◽  
Breast Conserving Surgery ◽  
Common Variants ◽  
Breast Cancer Patients ◽  
Acute Skin Toxicity

scholarly journals China Angioplasty and Stenting for Symptomatic Intracranial Severe Stenosis (CASSISS): A new, prospective, multicenter, randomized controlled trial in China

2015 ◽  
Vol 21 (2) ◽  
pp. 196-204 ◽  
Author(s):  
Peng Gao ◽  
Zhenwei Zhao ◽  
Daming Wang ◽  
Jian Wu ◽  
Yiling Cai ◽  
...  
Keyword(s):  
Medical Therapy ◽  
Controlled Trial ◽  
Asian Population ◽  
High Volume ◽  
Primary Treatment ◽  
Intracranial Artery ◽  
Inclusion Criteria ◽  
Severe Stenosis ◽  
Multicenter Randomized Controlled Trial ◽  
Angioplasty And Stenting

Background Patients with symptomatic stenosis of intradural arteries are at high risk for subsequent stroke. Since the SAMMPRIS trial, stenting is no longer recommended as primary treatment; however, the results of this trial, its inclusion criteria and its center selection received significant criticism and did not appear to reflect our experience regarding natural history nor treatment complications rate. As intracranial atherosclerosis (ICAS) is the most common cause for stroke in Asian countries, we are hereby proposing a refined prospective, randomized, multicenter study in an Asian population with strictly defined patient and participating center inclusion criteria. Methods The China Angioplasty and Stenting for Symptomatic Intracranial Severe Stenosis (CASSISS) trial is an ongoing, government-funded, prospective, multicenter, randomized trial. It recruits patients with recent TIA or stroke caused by 70%–99% stenosis of a major intracranial artery. Patients with previous stroke related to perforator ischemia will not be included. Only high-volume centers with a proven track record will enroll patients as determined by a lead-in phase. Patients will be randomized (1:1) to best medical therapy alone or medical therapy plus stenting. Primary endpoints are any stroke or death within 30 days after enrollment or after any revascularization procedure of the qualifying lesion during follow-up, or stroke in the territory of the symptomatic intracranial artery beyond 30 days. The CASSISS trial will be conducted in eight sites in China with core imaging lab review at a North American site and aims to have a sample size of 380 participants (stenting, 190; medical therapy, 190). Recruitment is expected to be finished by December 2016. Patients will be followed for at least three years. The trial is scheduled to complete in 2019. Conclusion In the proposed trial, certain shortcomings of SAMMPRIS including patient and participating center selection will be addressed. The present manuscript outlines the rationale and design of the study. We estimate that this trial will allow for a critical reappraisal of the role of intracranial stenting for selected patients in high-volume centers.

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