Burden of advanced breast cancer for patients and caregivers in Europe: comparison of two treatment forms of vinorelbine, oral and intravenous.

AIM: To assess the burden of disease associated with advanced breast cancer (ABC) treated with oral (VinO) or intravenous vinorelbine (VinIV) from the perspective of patients and caregivers in five European countries. METHODS: This was an observational, prospective, international, multicenter study. Patients were included in the study at the beginning of their second cycle of chemotherapy with vinorelbine and categorized into two groups depending on whether they received VinO or VinIV. At baseline (V0) and at the end of the second cycle of chemotherapy (V1), patients and caregivers were asked to complete self-administered questionnaires: SF-12 and burden of disease. RESULTS: At baseline, the two groups were well balanced in demographic and clinical characteristics. However, while HER2+ (human epidermal growth factor receptor 2) disease was significantly more frequent in patients receiving VinIV, patients receiving VinO were predominantly treated with single-agent therapy and were older than those treated with VinIV (67.1 years versus 57.7 years [p = 0.05]). As measured with SF-12, patients with VinO had, at end of cycle 1 and end of cycle 2, significantly more favorable outcomes in physical summary score, role physical, role emotional and mental health (all p < 0.05) than those treated with VinIV. Trends for a better caregiver mental score and social functioning were also observed with VinO (cycle 1 and 2; p < 0.10). From a patient perspective, no major difference was reported on the burden of disease between the two groups, however, a trend for a better" overall impact on daily life" was observed in VinO patients. Major significant differences, showing a lower burden of disease with VinO, were also reported from caregivers. In addition, in patients treated with VinO, mental score was almost similar to the one of the general population. CONCLUSION: VinO showed benefits over VinIV for both patients and caregivers, particularly in health related quality of life and burden of disease. Because of its observational design, results are only informative.

Hemoglobin levels and quality of life in patients with symptomatic chemotherapy-induced anemia: the eAQUA study.

PURPOSE: To assess hemoglobin (Hb) outcomes and fatigue-related quality-of-life (QoL) (electronic assessment) in patients with solid tumors and symptomatic chemotherapy-induced anemia receiving cytotoxic chemotherapy and darbepoetin alfa (DA) or another erythropoiesis-stimulating agent according to European indication. METHODS: eAQUA was a Phase IV prospective observational study. The primary outcome (assessed in the primary analysis set [PAS]: patients receiving one or more DA dose who had baseline and week 9 assessments for Hb and QoL) was the proportion of patients receiving DA having both Hb increases ≥1 g/dL and improved QoL between baseline and week 9. Functional Assessment of Cancer Therapy-Fatigue (FACT-F) subscale scores were anchored to fatigue visual analog scale scores to determine the minimally important difference for improved QoL. Overall data/data over time are reported for the full analysis set (patients receiving one or more erythropoiesis-stimulating agent dose, n=1,158); week 9 data (ie, data relating to the primary and secondary outcomes) are reported for the PAS (n=510). Baseline and safety data are included for both the full analysis set and PAS. RESULTS: In the PAS, 69% of patients had stage IV disease and 96% were fatigued. The minimally important difference in FACT-F change score for QoL improvement was 3.5. From baseline to week 9, 32% (95% confidence interval: 28%-36%) of patients had both improved QoL and an Hb increase ≥1 g/dL; proportions were similar across the most common tumor types. At week 9, 49% and 58% of patients had improved QoL or Hb increases ≥1 g/dL, respectively; 70% and 76% had QoL or Hb improvements between baseline and study end, respectively. In the PAS, 16% of patients required transfusions and 32% required iron supplementation. Few patients (<1%) reported adverse drug reactions. CONCLUSION: In this study, patients with solid tumors receiving DA per European indication for symptomatic chemotherapy-induced anemia had clinically meaningful improvements in Hb and QoL.