scholarly journals Final results from the prospective phase III WSG-ARA trial: impact of adjuvant darbepoetin alfa on event-free survival in early breast cancer

2014 ◽  
Vol 25 (1) ◽  
pp. 75-80 ◽  
Author(s):  
U. Nitz ◽  
O. Gluz ◽  
I. Zuna ◽  
C. Oberhoff ◽  
T. Reimer ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Early Breast Cancer ◽  
Darbepoetin Alfa ◽  
Phase Iii ◽  
Event Free Survival ◽  
Free Survival ◽  
Prospective Phase

Event-free survival analysis of the prospectively randomized phase III ETNA study with neoadjuvant nab-paclitaxel (nab-P) versus paclitaxel (P) followed by anthracycline regimens in women with HER2-negative high-risk breast cancer.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 515-515 ◽  
Author(s):  
Luca Gianni ◽  
Mauro Mansutti ◽  
Antonio Anton ◽  
Lourdes Calvo Martínez ◽  
Giancarlo Bisagni ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Statistical Significance ◽  
Secondary Endpoint ◽  
Phase Iii ◽  
Primary Therapy ◽  
Event Free Survival ◽  
Open Label ◽  
Serious Adverse Events ◽  
Free Survival ◽  
Luminal B

515 Background: The ETNA study showed that substituting P with nab-P did not significantly increase the overall rate of pathological complete response (pCR) (P 18.6%, nab-P 22.5%, p = 0.19). The multivariate analysis revealed that tumor subtype (triple negative vs luminal B-like) was the most significant factor (OR 4.85) influencing treatment outcome (Gianni L et al, JAMA Oncol 2018). Methods: This multicenter open label study (NCT01822314) in collaboration with GEICAM and BCRC-WA randomized 695 patients with centrally-confirmed HER2-negative breast cancer to nab-P 125 mg/m2 (346 patients) or P 90 mg/m2 (349 patients). The two drugs were given on weeks 1, 2 and 3 followed by 1-week rest for 4 cycles before 4 cycles of an anthracycline regimen as per investigator choice. The primary endpoint was pCR (absence of invasive cells in breast and nodes). A secondary endpoint is event-free survival (EFS) defined as the time from randomization to the first date of disease progression while on primary therapy or disease recurrence (local, regional, distant, invasive contralateral breast cancer) after surgery or death due to any cause. Results: The ITT analysis of the secondary endpoint EFS at 5 years is reported below: Clinical trial information: NCT01822314. Overall 5-year survival was 84.8% after P and 87.3% for nab-P. No serious adverse events were documented during the follow-up. Conclusions: The improved 5-year EFS after nab-P failed to reach statistical significance (unadjusted P = 0.245). In the analysis by subgroup the numerical improvement was almost exclusively observed in luminal B and not in TN tumors. So far the data do not support substitution of P with nab-P in the schedule and doses adopted in the ETNA trial. Additional analyses will be based on ongoing molecular studies.[Table: see text]

Intense Dose-Dense Sequential Chemotherapy With Epirubicin, Paclitaxel, and Cyclophosphamide Compared With Conventionally Scheduled Chemotherapy in High-Risk Primary Breast Cancer: Mature Results of an AGO Phase III Study

2010 ◽  
Vol 28 (17) ◽  
pp. 2874-2880 ◽  
Author(s):  
Volker Moebus ◽  
Christian Jackisch ◽  
Hans-Joachim Lueck ◽  
Andreas du Bois ◽  
Christoph Thomssen ◽  
...  
Keyword(s):  
Breast Cancer ◽  
High Risk ◽  
Primary Breast Cancer ◽  
Survival Rates ◽  
Phase Iii ◽  
Axillary Lymph Nodes ◽  
Axillary Lymph ◽  
Event Free Survival ◽  
Free Survival ◽  
Dose Dense

Purpose Patients with primary breast cancer who have extensive axillary lymph node involvement have a poor prognosis after conventional adjuvant therapy. We compared intense dose-dense (IDD) adjuvant chemotherapy with conventionally scheduled adjuvant chemotherapy in patients with high-risk primary breast cancer. Patients and Methods In this randomized, phase III trial, a total of 1,284 eligible patients with four or more involved axillary lymph nodes were randomly assigned to receive IDD sequential epirubicin, paclitaxel, and cyclophosphamide (IDD-ETC) every 2 weeks or conventionally scheduled epirubicin/cyclophosphamide followed by paclitaxel every three weeks. The primary end point was event-free survival (EFS). Results At a median follow-up of 62 months, 5-year event-free survival rates were 62% in the conventional arm and 70% in the IDD-ETC arm, representing a 28% reduction of the relative risk of relapse (P < .001). This benefit was independent of menopausal, hormone receptor, or human epidermal growth factor receptor 2 status. The 5-year overall survival rates were 77% versus 82%, representing a 24% reduction of the relative risk of death (P = .0285). IDD therapy was associated with significantly more nonhematologic and hematologic toxicities, but no treatment-related death occurred. Four occurrences of acute myeloid leukemia or myelodysplastic syndrome (MDS) were observed in the IDD-ETC arm. No severe congestive heart failure was reported. Conclusion IDD-ETC was less well tolerated compared with conventional chemotherapy but significantly improved event-free and overall survivals in patients with high-risk primary breast cancer who had four or more positive axillary lymph nodes.

scholarly journals Biopsychosocial approach in the rehabilitation of patients with operable breast cancer

2020 ◽  
pp. 196-204
Author(s):  
V. A. Kluge ◽  
T. Yu. Semiglazova ◽  
P. V. Krivorotko ◽  
E. V. Melnikova ◽  
V. V. Semiglazov ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Early Breast Cancer ◽  
Control Group ◽  
Concomitant Disease ◽  
Complex Treatment ◽  
Event Free Survival ◽  
Free Survival ◽  
Biopsychosocial Approach ◽  
Psychosocial Disorders ◽  
Rehabilitation Measures

The relevance: more than 60% of cases are due to early breast cancer (EBC). Priority is the treatment of patients with early breast cancer, provided that the maximum quality of life (QL) is maintained. During or after complex treatment, more than half of patients with EBC report the occurrence of functional disorders that reduce the QL. Aim: to evaluate the event-free survival rate (EFS) of EBC patients undergoing rehabilitation within the framework of a biopsychosocial approach in the course of complex antitumor treatment. Materials and methods: the study involved 228 patients with EBC who received complex treatment from 2015 to 2019. In the prospective part of the study, 114 patients were subjected to rehabilitation measures in the framework of a biopsychosocial approach that considers both biological features of functional restriction and psychosocial disorders, a multidisciplinary team of specialists worked with all patients. In the control group, 114 patients were selected retrospectively and underwent physical and psychological rehabilitation as prescribed by a doctor. Patients of both groups are divided into subgroups depending on the availability of preoperative chemotherapy. Event-free survival was assessed over a 2-year follow-up period. Events were accepted as censored events: relapse, metastases, the occurrence of another cancer, a new concomitant disease, an exacerbation of concomitant pathology, and death. Results: Rehabilitation measures within the framework of the biopsychosocial model improve the indicators of EFS in patients with EBC. The use of a biopsychosocial approach in rehabilitation increased EFS by 3.8 months. The results of multivariate analysis, reducing the risk of occurrence of the event EBC patients undergoing rehabilitation within the framework of the biopsychosocial approach in the presence of neoadjuvant chemotherapy was 28%, in patients of younger age group (25–44 years) was 29%, in patients in menopause – 25%.

The PERSEPHONE trial: Duration of trastuzumab with chemotherapy in women with HER2-positive early breast cancer.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. TPS660-TPS660
Author(s):  
Helena Margaret Earl ◽  
David A. Cameron ◽  
David Miles ◽  
Andrew M. Wardley ◽  
Emma Ogburn ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cost Effectiveness ◽  
Early Breast Cancer ◽  
Primary Outcome ◽  
Disease Free Survival ◽  
Phase Iii ◽  
Her2 Positive ◽  
Free Survival ◽  
Disease Free

TPS660 Background: Persephone is a phase III randomised controlled trial comparing six months of trastuzumab to the standard 12 month duration in patients with HER2 positive early breast cancer in respect of disease free survival, safety and cost-effectiveness. A Persephone sister study, the PHARE trial run by the National Institute for Cancer, successfully closed to recruitment in 2010. A prospective meta-analysis is planned once each trial has reported individually. Methods: A total of 4000 patients will be randomised into each of the two treatment groups. The power calculations assume that the disease-free survival (DFS) of the standard treatment of 12 months trastuzumab will be 80% at 4 years. On this basis, with 5% 1-sided significance and 85% power, a trial randomising 2000 in each arm will have the ability to prove non-inferiority of the experimental arm defining non-inferiority as ‘no worse than 3%’ below the control arm 4 year DFS. Primary outcome is disease-free survival non-inferiority (equivalence) of 6 months trastuzumab compared with 12 months in women with early breast cancer. Secondary outcomes are overall survival non-inferiority (equivalence); expected incremental cost effectiveness; cardiology function and analysis of predictive factors for development of cardiac damage. Two mandatory sub-studies are: Tumour block collection to discover molecular predictors of survival with respect to duration of trastuzumab treatment and blood sample collection, used to discover single nucleotide polymorphisms (SNPs) as genetic/pharmaco-genetic determinants of prognosis, toxicity and treatment outcome. A third optional sub-study is the quality of life questionnaires. Results: Persephone opened to recruitment in October 2007. To date, 1847 patients (46%) of its total have been randomised from 147 UK sites. Recruitment is due to complete by December 2013 and the first planned interim analysis of the primary outcome will be mid-2016. The IDSMC last reviewed the trial in June 2011 and congratulated the Trial Management Group on the conduct of the trial and the quality of the data. No safety concerns were identified, and the IDSMC proposed that the trial continue to planned recruitment.

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