Search

The randomized phase III trial EGF100151 demonstrated that the combination of lapatinib plus capecitabine (L + C) significantly improved time to progression (TTP) compared with capecitabine alone (C) in heavily pretreated patients with HER2+ (ErbB2+) advanced or metastatic breast cancer. This analysis assessed the effects of study treatments on quality of life (QOL) among patients in EGF100151. Quality of life was assessed using the Functional Assessment of Cancer Therapy-Breast (FACT-B) and EuroQoL (EQ-5D) questionnaires. Patients completed questionnaires during efficacy and safety assessment visits (i.e., at screening visit, every 6 weeks for the first 24 weeks, every 12 weeks thereafter, and at discontinuation of study treatment). Primary analyses compared the treatment groups based on change from baseline QOL. Exploratory analyses compared proportion of patients achieving minimum important differences (MID) in QOL scores and the relationship between QOL and tumor status. Quality of life for patients in both treatment groups was maintained during 24 weeks of follow-up. Adjusted mean changes from baseline in all QOL scores for the L + C arm were comparable to those for the C arm. The between-group differences ranged from 0.7 to 2.2 (FACT-B total) and 0.3 to 1.8 (EQ-5D visual analog scale) and were consistently in favor of the L + C arm, although not statistically significant. Patients with an objective tumor response or stable disease showed clinically meaningful differences in QOL scores compared to patients with progressive disease. A greater proportion of patients receiving L + C versus C achieved the MID for all five QOL scores, although differences were not statistically significant. The addition of lapatinib to capecitabine significantly increases TTP without any evidence of a deleterious effect on patients’ QOL, confirming its clinical benefit in this heavily pretreated patient population with advanced HER2+ breast cancer that has progressed on trastuzumab therapy.

Breast cancer is the most commonly diagnosed non-skin cancer and second leading cause of cancer deaths among women in the US. This study compared healthcare resource utilization and costs in women with breast cancer to a control group in a managed care population. Women ≥ 18 years with breast cancer were identified using ICD-9 codes from claims databases of five US health plans during 2004. A randomly matched control group of women without cancer served as a comparator group. Healthcare costs included all medical and pharmacy costs during the year. Comparisons were made using per patient per month (PPPM) costs (total costs per patient within 2004 calendar year/months of eligibility). 10,697 women (mean age 55 years) with breast cancer were identified (prevalence of 250 per 100,000) in 2004, with prevalence increasing with age. Mean attributable PPPM costs associated with breast cancer were $2,896 (median = $1,940) with hospitalization contributing most of the costs ($1,340), followed by pharmacotherapy ($537), and surgical intervention ($470). Mean unadjusted all-cause PPPM total costs were $4,421 (median = $2,964) compared to $3,352 (median = $665) p < 0.0001) for cases and controls respectively. Multivariate analyses controlling for differences in comorbidities showed mean adjusted PPPM costs to be 2.28 times (p

To estimate the incidence, prevalence, and economic burden of secondary breast cancer brain metastases (BCBM) among a US-based population of patients with primary breast cancer. Female patients diagnosed with secondary BCBM between 1/2002 and 12/2004 and with a brain or head diagnostic test within 30 days of the BCBM diagnosis were identified in a US commercial insurance claims database. A 12-month look-back period was used to identify patients with a breast cancer diagnosis and those with and without a history of BCBM. Patients were required to be continuously enrolled in their health plan for the duration of the study. Incident BCBM patients were matched to a control group of breast cancer patients with no evidence of BCBM. Patient characteristics at baseline, incidence and prevalence rates, and resource utilization and health care costs were determined. From 2002 to 2004, 779 incident and 995 prevalent BCBM patients and 8,518 primary breast cancer patients were identified. The incidence of BCBM during this time period was 9.1% (95% CI = 8.5%, 9.8%); the prevalence of BCBM was 11.7% (95% CI = 11.0%, 12.4%), with rates increasing from 2002 to 2004. About 22% of incident patients died (based on a proxy measure) during the follow-up period, an average of 158 days (95% CI = 131.1, 183.9) from the index BCBM diagnosis. A 1:1 match of incident BCBM patients to controls resulted in 775 patients in each group. At 6 months follow-up (N = 398), incident BCBM patients had significantly more hospital stays (mean 1.1 vs. 0.5, P