From clinical trials to clinical practice: outcome of NSABP-B27 neoadjuvant chemotherapy regimen for high-risk early-stage breast cancer

2017 ◽  
Vol 165 (3) ◽  
pp. 771-777 ◽  
Author(s):  
Hikmat Abdel-Razeq ◽  
Lina Marei ◽  
Salwa S. Saadeh ◽  
Hazem Abdulelah ◽  
Mahmoud Abu-Nasser ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trials ◽  
Clinical Practice ◽  
High Risk ◽  
Neoadjuvant Chemotherapy ◽  
Chemotherapy Regimen ◽  
Early Stage ◽  
Early Stage Breast Cancer

scholarly journals Corrigendum to ‘VP1-2021: Efficacy of everolimus in patients with HR+/HER2- high risk early stage breast cancer’

2021 ◽  
Author(s):  
T. Bachelot ◽  
F. Dalenc ◽  
S. Chabaud ◽  
P. Cottu ◽  
D. Allouache ◽  
...  
Keyword(s):  
Breast Cancer ◽  
High Risk ◽  
Early Stage ◽  
Early Stage Breast Cancer

scholarly journals The prophylactic and therapeutic effects of moxibustion combined with traditional Chinese medicine decoction for treating chemotherapy-induced myelosuppression in early-stage breast cancer: study protocol for a randomized controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Yajie Ji ◽  
Siyu Li ◽  
Xinyue Zhang ◽  
Yu Liu ◽  
Qing Lu ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Chemotherapy Regimen ◽  
Early Stage ◽  
Controlled Trial ◽  
Early Stage Breast Cancer ◽  
Therapeutic Effects ◽  
Breast Cancer Patients ◽  
Randomized Controlled

Abstract Background Traditional Chinese medicine (TCM) has a long history of use in breast cancer, but lacking systematic evidence to support its clinical benefits. In this study, we evaluated the prophylactic and therapeutic effects of moxibustion combined with decoctions for treating chemotherapy-induced myelosuppression (CIM) in early-stage breast cancer patients. Methods This is a randomized controlled clinical trial single-blinded for TCM decoction but not moxibustion. Patients are equally divided into the control group without decoction and moxibustion treatment (control), the decoction+moxibustion group (MD), and the placebo+moxibustion group (MP), according to the following stratification factors: age (below 40s, 40s, 50s, and 60s or above), chemotherapy regimen (anthracyclines, taxanes, anthracyclines+taxane, and others), and chemotherapy strategy (adjuvant and neoadjuvant). The TCM decoction is Wenshen Shengbai Decoction. The anticipated sample size is 462 cases (154 cases in each group). All participants are expected to treat with chemotherapy and recombinant human granulocyte colony-stimulating factor (rhG-CSF). The primary outcomes include the proportion of patients with relief of leukopenia and/or neutropenia, the myelosuppression-associated serious adverse event including grade 3–4 leukopenia and/or neutropenia, and febrile neutropenia, and the dose of rhG-CSF. The secondary outcomes include chemotherapy adherence, stratified analysis, adverse reactions, quality of life by EORTC Breast-Cancer-Specific Quality of Life Questionnaire including EORTC QLQ-C30 (V3.0) and QLQ-BR23, TCM Constitution, and 3-year disease-free survival and overall survival. Baseline information including age, surgical approach, chemotherapy regimen and strategy, pathological stage, and molecular subtype will be recorded. Discussion This will be the first randomized controlled trial to evaluate the efficacy of moxibustion combined with TCM decoction in treating CIM in early-stage breast cancer patients, aiming to standardize the TCM decoction and moxibustion method, thus providing evidence for its clinical benefit. Trial registration chictr.org.cn ChiCTR-INR-16009557. Registered on 23 October 2016.

The relationship between treatment intensity and characteristics of patients with early-stage breast cancer.

2020 ◽  
Vol 38 (29_suppl) ◽  
pp. 125-125
Author(s):  
Jeffrey Franks ◽  
Nicole Caston ◽  
Courtney Williams ◽  
Andres Azuero ◽  
Monica S. Aswani ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trials ◽  
High Intensity ◽  
Early Stage ◽  
Standard Of Care ◽  
Early Stage Breast Cancer ◽  
Treatment Intensity ◽  
Low Intensity ◽  
Her2 Breast Cancer ◽  
To Receive

125 Background: Clinical trials are used to generate standard-of-care, yet often do not reflect patient populations treated in real-world settings. Elderly patients or patients of color who are often underrepresented in trials, which may impact what types of treatments are prescribed. This study examines how patient characteristics are associated with treatment intensity in early stage breast cancer. Methods: This retrospective cross-sectional study included women with a stage I-III breast cancer from American Society of Clinical Oncology’s CancerLinQ database treated by chemotherapy from 2005-2019. Seven standard-of-care regimens were characterized by intensity. For patients with ER+/- HER2- breast cancer, low-intensity regimens were Taxol and Cyclophosphamide or Adriamycin and Cyclophosphamide; while Taxol, Adriamycin, and Cyclophosphamide was considered high intensity. For patients with HER2+ breast cancer, the low intensity regimen was Taxol and Herceptin; while Adriamycin and Cyclophosphamide followed by Taxol and Herceptin; Taxol, Carboplatin, and Herceptin; or Taxol, Carboplatin, Herceptin, and Pertuzumab were considered high intensity. A model estimating the likelihood of intensity was calculated using log-binomial regression, in order to produce relative risks. The models were adjusted for patient demographics and cancer stage. Results: Of 24,383 patients, 51% had ER+HER2-, 20% ER-HER2-, and 29% HER2+ breast cancer. Most patients were White (60%), age 40-69 (80%), had stage II breast cancer (39%), and received higher intensity treatment (65%). Adjusted for the other covariates, patient who were Black were more likely to receive high-intensity treatment than patients who were White (61% vs 58%; RR 1.05, 95%CI 1.02-1.06. Additionally, older adults were more likely to receive low-intensity treatment, with 42% of patients over 70 receiving low intensity treatment, and 29% of patients between the ages 40 and 69 received low intensity treatment (RR 1.5, 95% CI 1.44 -1.54). Conclusions: Differences in treatment intensity were observed for patients with differing demographic characteristics. Further research is needed to determine lack of representation in clinical trials impacts on prescribing patterns, regimen intensity, and survival.

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