NRG Oncology/NSABP B-51/RTOG 1304: Phase III trial to determine if chest wall and regional nodal radiotherapy (CWRNRT) post mastectomy (Mx) or the addition of RNRT to whole breast RT post breast-conserving surgery (BCS) reduces invasive breast cancer recurrence-free interval (IBCR-FI) in patients (pts) with pathologically positive axillary (PPAx) nodes who are ypN0 after neoadjuvant chemotherapy (NC).

Mamounas, Eleftherios P.; Bandos, Hanna; White, Julia; Julian, Thomas B.; Khan, Atif J.; Shaitelman, Simona F.; Torres, Mylin A.; Vicini, Frank A.; Ganz, Patricia A.; McCloskey, Susan A.; Paik, Soonmyung; Gupta, Nilendu; Li, X. Allen; DiCostanzo, D.J.; Wolmark, Norman

doi:10.1200/jco.2019.37.15_suppl.tps600

Cited by 54 publications

(29 citation statements)

References 0 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…[38][39][40] As this search did not yield a comprehensive list, we reviewed a wider collection of adjuvant phase III local therapy trials in breast cancer (Data Supplement). 38,[41][42][43][44][45][46][47][48][49][50][51][52] Surgical and radiotherapy trials. As improvements in systemic therapy have reduced the risk of distant recurrence, many recent trials have focused on optimizing local therapy.…”

Section: Local Therapy Trialsmentioning

confidence: 99%

Updated Standardized Definitions for Efficacy End Points (STEEP) in Adjuvant Breast Cancer Clinical Trials: STEEP Version 2.0

Tolaney

Garrett‐Mayer

White

et al. 2021

JCO

View full text Add to dashboard Cite

PURPOSE The Standardized Definitions for Efficacy End Points (STEEP) criteria, established in 2007, provide standardized definitions of adjuvant breast cancer clinical trial end points. Given the evolution of breast cancer clinical trials and improvements in outcomes, a panel of experts reviewed the STEEP criteria to determine whether modifications are needed. METHODS We conducted systematic searches of ClinicalTrials.gov for adjuvant systemic and local-regional therapy trials for breast cancer to investigate if the primary end points reported met STEEP criteria. On the basis of common STEEP deviations, we performed a series of simulations to evaluate the effect of excluding non–breast cancer deaths and new nonbreast primary cancers from the invasive disease–free survival end point. RESULTS Among 11 phase III breast cancer trials with primary efficacy end points, three had primary end points that followed STEEP criteria, four used STEEP definitions but not the corresponding end point names, and four used end points that were not included in the original STEEP manuscript. Simulation modeling demonstrated that inclusion of second nonbreast primary cancer can increase the probability of incorrect inferences, can decrease power to detect clinically relevant efficacy effects, and may mask differences in recurrence rates, especially when recurrence rates are low. CONCLUSION We recommend an additional end point, invasive breast cancer–free survival, which includes all invasive disease–free survival events except second nonbreast primary cancers. This end point should be considered for trials in which the toxicities of agents are well-known and where the risk of second primary cancer is small. Additionally, we provide end point recommendations for local therapy trials, low-risk populations, noninferiority trials, and trials incorporating patient-reported outcomes.

show abstract

Section: Local Therapy Trialsmentioning

confidence: 99%

Updated Standardized Definitions for Efficacy End Points (STEEP) in Adjuvant Breast Cancer Clinical Trials: STEEP Version 2.0

Tolaney

Garrett‐Mayer

White

et al. 2021

JCO

View full text Add to dashboard Cite

show abstract

“…In patients with an axillary pCR following NAC or NET, an ALND or adjuvant radiotherapy to the lymph nodes appears to be overtreatment, which is currently investigated in the NSABP B-51/RTOG 1304 trial [24]. The optimal adjuvant treatment of cN þ patients with residual disease in the axilla is also a matter of debate, especially in patients with HR þ HER2-grade 1e2 breast cancer.…”

Section: Discussionmentioning

confidence: 99%

Rate and predictors of nodal pathological complete response following neoadjuvant endocrine treatment in clinically biopsy-proven node-positive breast cancer patients

Schipper

Bruijn

Voogd

et al. 2021

European Journal of Surgical Oncology

View full text Add to dashboard Cite

“…Even though clinicians have to give particular attention to these complications, anthracycline treatment [60][61][62]) is an additional major risk factor for additional cardiotoxicity during radiotherapy with a synergistic effect. However, the use of anthracycline, other cardiotoxic chemotherapies, immunotherapy [63][64][65] and targeted therapies [66,67] should only be used with great caution and only after carrying out a careful treatment plan and optimization [1,30,40]. There is a wealth of evidence from retrospective and planning studies demonstrating reduction in dose to the heart and coronary arteries with DIBH treatment of left-sided breast cancers [10,14,15].…”

Section: Discussionmentioning

confidence: 99%

5 years of experience with DIBH (Deep inspiration breath-hold) combined with SGRT (Surface-Guided Radiation Therapy) in left-sided breast cancer

Steffal

Schratter-Sehn

Brinda-Raitmayr

et al. 2020

Senologie - Zeitschrift für Mammadiagnostik und -therapie

View full text Add to dashboard Cite

Background Radiation treatment to the left breast is associated with increased cardiac morbidity as well as mortality. Deep inspiration breath-hold (DIBH) technique with Surface Guided Radiation Therapy (SGRT) could have dosimetric advantages over the free breathing technique (NB, normal breathing) in cardiac (heart and LAD) and ipsilateral lung sparing in patients with left-sided breast cancer after surgery. Therefore this technique was implemented in 2013 at the institute of radiooncology at the KFJ/SMZ-South – Hospital Vienna. Methods From Oct 2013 – December 2018 548 patients were referred to radiotherapy following conservative operation of left-sided invasive breast cancer. All patients gave their informed consent and underwent training sessions for the DIBH-technique independent of age or breathing activity or respiratory disorders. Patients who turned out to be unfit for DIBH were enrolled for NB. The relative reduction in Dmean heart and left lung dose was compared between the two cohorts. Acute radiation induced side effects were classified according to the Radiation Therapy Oncology Group/The European Organisation for Research (RTOG) 37; late toxicity rates according to the Common Terminology Criteria for Adverse Events (CTCAE Version 4.03) Results The median age of the DIBH-patients was 58 years (27–90), of the NB-patients 65 (30–80) years. Follow-up was obtained until June 2019. The median follow-up was 52 months (range 7–73 m). The average coverage of Dmean left lung was 6.91 Gy (1.44 Gy – 12.4 Gy). The average coverage of Dmean heart was 1.17 Gy (0.12 Gy – 3.19 Gy) in the DIBH-cohort. The NB – plans had a Dmean of 8.92 Gy (5.23–16.9 Gy) at the ipsilateral lung and a Dmean of 2.31 Gy (0.71–4.21 Gy) at the heart. This shows that the DIBH-technique halved the Dmean of the heart. The amount of acute side effects was comparable between the two groups: RTOG 1: 70.8 % vs. 64 %, RTOG 3 6.6 % vs. 5.6 %, no reaction 3.2 % vs. 1.4 %. There were more CTCAE 1-late events in the NB-group (51.6 % vs. 12.67 %). Conclusion Deep inspiration breath-hold (DIBH) technique with Surface Guided Radiation Therapy (SGRT) is a rather simple, reproducable method with a high acceptance of the patients who can actively participate in the whole treatment process. The mean dose at the heart and the left lung can be reduced, at the heart even by as much as 50 %.

show abstract

Cited by 54 publications

References 0 publications

Updated Standardized Definitions for Efficacy End Points (STEEP) in Adjuvant Breast Cancer Clinical Trials: STEEP Version 2.0

Updated Standardized Definitions for Efficacy End Points (STEEP) in Adjuvant Breast Cancer Clinical Trials: STEEP Version 2.0

Rate and predictors of nodal pathological complete response following neoadjuvant endocrine treatment in clinically biopsy-proven node-positive breast cancer patients

5 years of experience with DIBH (Deep inspiration breath-hold) combined with SGRT (Surface-Guided Radiation Therapy) in left-sided breast cancer

Contact Info

Product

Resources

About