taxane and Heart-Failure

There is a controversy about late-onset congestive heart failure (CHF) among breast cancer survivors. This study investigated the incidence rate and risk factors of late-onset CHF more than 2 years after the breast cancer diagnosis.. A nationwide, retrospective study was conducted with the National Health Information Database. With 1:3 age- and sex-matched noncancer controls, Cox proportional hazard regression models were used to analyze the incidence and risk factors of late CHF. The cumulative incidence rate of late CHF was evaluated with a Kaplan-Meier analysis and a log-rank test.. A total of 91,227 cases (286,480 person-years) and 273,681 controls (884,349 person-years) were evaluated between January 2007 and December 2013. The risks of late CHF were higher in cases than controls (hazard ratio [HR], 1.396; 95% confidence interval [CI], 1.268-1.538). Younger survivors (age ≤ 50 years) showed a higher risk of late CHF than their younger counterparts (HR, 2.903; 95% CI, 2.425-3.474). Although older age was a risk factor for late CHF, older survivors (age ≥ 66 years) showed no difference in the risk of late CHF in comparison with their counterparts (HR, 0.906; 95% CI, 0.757-1.084). Anthracyclines and taxanes were risk factors for late CHF, although trastuzumab, radiation, and endocrine therapy were not.. Young breast cancer survivors have a greater risk of late CHF than the young population without cancer. More attention should be paid to young breast cancer survivors who receive taxane- or anthracycline-based regimens over the long term.

Topics: Adult; Aged; Anthracyclines; Antineoplastic Agents; Breast; Breast Neoplasms; Bridged-Ring Compounds; Cancer Survivors; Chemotherapy, Adjuvant; Female; Heart Failure; Humans; Kaplan-Meier Estimate; Middle Aged; Proportional Hazards Models; Risk Assessment; Risk Factors; Taxoids; Trastuzumab

Although chemotherapy-induced congestive heart failure (CHF) is a well-known adverse event in cancer survivors, the long-term risk of standard low-dose anthracycline has not yet been reported. This study aimed to investigate the long-term effects of standard anthracycline on late CHF in breast cancer survivors.. A nationwide retrospective cohort study was conducted using the national insurance claims data for nearly 98% of Korean citizens. Between Jan 2010 and Dec 2015, a total of 56,338 newly diagnosed female breast cancer survivors were included.. The total number of person-years was 199,648 and the incidence rate of late CHF was 3.57 per 1000 person-years. In multivariate analysis according to the subject's age at diagnosis, only in the 50-59 age group, anthracycline-based [hazard ratio (HR) 1.765, 95% confidence interval (CI) 1.206-2.583] and taxane plus anthracycline-based regimens (HR 1.816, 95% CI 1.192-2.768) significantly increased the risk of late CHF. In the 50-59 age group, standard low-dose anthracycline significantly increased the risk of late CHF (HR 1.627, 95% CI 1.080-2.451) in Cox proportional hazard regression models. In competing risk model with recurrence and in-hospital death as competing risks, standard low-dose anthracycline was a significant risk factor for late CHF [subdistribution hazard ratio (SHR) 1.553, 95% CI 1.029-2.340].. This nationwide study showed that standard chemotherapy with low-dose anthracycline is a risk factor for late-onset CHF in breast cancer survivors who were in their 50 s at breast cancer diagnosis. Long-term monitoring of late CHF should be considered in these younger breast cancer survivors.

Topics: Age Factors; Anthracyclines; Antineoplastic Agents; Breast Neoplasms; Bridged-Ring Compounds; Cancer Survivors; Female; Heart Failure; Humans; Incidence; Middle Aged; Proportional Hazards Models; Republic of Korea; Retrospective Studies; Risk Factors; Taxoids

Information on deaths occurring during oncological clinical trials has never been systematically assessed. Here, we examine the incidence of death and the profile of patients who died during randomized clinical breast cancer (BC) trials.. Information on fatal events during German Breast Group (GBG) led BC trials was prospectively captured. Data were derived from the trial databases and death narratives. All deaths were evaluated for possible causes, underlying conditions, treatment relatedness, time point and rate of autopsies.. From 12/1996 to 01/2017, 23,387 patients were treated within 32 trials. Of those 88 (0.4%) died on therapy within 17 trials. Median age was 64 [range 35-84] years, 63.2% of patients had a body mass index (BMI) ≥ 25 kg/m. Death during study treatment was mainly related to infections, and patients with advanced disease, high BMI, underlying comorbidities, CRFs and concomitant medications. If considered for study participation these patients need careful monitoring due to their higher risk for death on study.

Topics: Adult; Aged; Aged, 80 and over; Anthracyclines; Antineoplastic Combined Chemotherapy Protocols; Autopsy; Body Mass Index; Breast Neoplasms; Bridged-Ring Compounds; Comorbidity; Female; Germany; Heart Failure; Humans; Middle Aged; Patient Safety; Pneumonia; Prospective Studies; Pulmonary Embolism; Randomized Controlled Trials as Topic; Risk Factors; Sepsis; Taxoids

The purpose of this study was to compare survival and risk of adverse events in women with early stage breast cancer (BC) treated with (1) doxorubicin (A), cyclophosphamide (C) + paclitaxel (P), (2) fluorouracil (F), epirubicin (E), cyclophosphamide (C) + docetaxel (D), or (3) dose-dense AC-P. Retrospective cohort study including 8462 women aged ≥18 years, with resected stage I-III BC, diagnosed between 2003 and 2009 in Ontario, identified through linkage of administrative databases. Primary outcome is overall survival (OS). Secondary outcomes are emergency room (ER) visits/hospitalizations, heart failure (HF), and leukemia. 4710 women were treated with FEC-D, 2065 with AC-P, and 1687 with dd AC-P. Adjusted 5-year OS was 92.1, 87.7, and 90.3 %, for each regimen, respectively (p = 0.0006). There was no difference in OS for FEC-D and dd AC-P in the propensity score-matched analyses (HR 1.24, 95 % CI 0.99-1.55). Five-year risk of HF was also similar (HR 1.09; 0.66-1.791.4 % for dd AC-P and 1.3 % for FEC-D and, p = 0.72). Treatment with FEC-D was significantly associated with ER visits and hospital admissions (p < 0.0001). The risks of leukemia were low and similar among the 3 groups (AC-P: 0.34 %, FEC-D: 0.08 %, dd AC-P: 0.12 %; p = 0.09). Although the efficacy of the three regimens was similar to that observed in randomized trials, we report higher toxicity with the use of these regimens in clinical practice. This was especially concerning for the docetaxel-containing regimen.

Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Breast Neoplasms; Bridged-Ring Compounds; Chemotherapy, Adjuvant; Comorbidity; Databases, Factual; Emergency Medical Services; Female; Heart Failure; Hospitalization; Humans; Middle Aged; Mortality; Neoplasm Staging; Ontario; Population Surveillance; Registries; Risk Factors; Taxoids