Overexpression of human epidermal growth factor receptor-2 (HER2) in metastatic breast cancer (MBC) is associated with poor prognosis. This single-arm open-label trial (EGF109491; NCT00508274) was designed to confirm the efficacy and safety of lapatinib in combination with capecitabine in 52 heavily pretreated Chinese patients with HER2-positive MBC. The primary endpoint was clinical benefit rate (CBR). Secondary endpoints included progression-free survival (PFS), time to response (TTR), duration of response (DoR), central nervous system (CNS) as first site of relapse, and safety. The results showed that there were 23 patients with partial responses and 7 patients with stable disease, resulting in a CBR of 57.7%. The median PFS was 6.34 months (95% confidence interval, 4.93-9.82 months). The median TTR and DoR were 4.07 months (range, 0.03-14.78 months) and 6.93 months (range, 1.45-9.72 months), respectively. Thirteen (25.0%) patients had new lesions as disease progression. Among them, 2 (3.8%) patients had CNS disease reported as the first relapse. The most common toxicities were palmar-plantar erythrodysesthesia (59.6%), diarrhea (48.1%), rash (48.1%), hyperbilirubinemia (34.6%), and fatigue (30.8%). Exploratory analyses of oncogenic mutations of PIK3CA suggested that of 38 patients providing a tumor sample, baseline PIK3CA mutation status was not associated with CBR (P = 0.639) or PFS (P = 0.989). These data confirm that the lapatinib plus capecitabine combination is an effective and well-tolerated treatment option for Chinese women with heavily pretreated MBC, irrespective of PIK3CA status.
Adult ; Aged ; Antineoplastic Combined Chemotherapy Protocols ; adverse effects ; therapeutic use ; Asian Continental Ancestry Group ; Breast Neoplasms ; drug therapy ; genetics ; metabolism ; pathology ; Capecitabine ; Class I Phosphatidylinositol 3-Kinases ; Deoxycytidine ; administration & dosage ; adverse effects ; analogs & derivatives ; Diarrhea ; chemically induced ; Disease Progression ; Disease-Free Survival ; Exanthema ; chemically induced ; Female ; Fluorouracil ; administration & dosage ; adverse effects ; analogs & derivatives ; Hand-Foot Syndrome ; etiology ; Humans ; Middle Aged ; Mutation ; Neoplasm Staging ; Phosphatidylinositol 3-Kinases ; genetics ; Quinazolines ; administration & dosage ; adverse effects ; Receptor, ErbB-2 ; metabolism ; Remission Induction

Background: Health literacy is important in the self-management of hypertension. It is, thus, necessary to assess the health literacy of hypertensive patients to identify health literacy gaps and make appropriate interventions. A prerequisite to health literacy assessment is an accurate and efficient measurement of health literacy. Objective: This study examined the psychometric properties of the Filipino version of Health Literacy Short-Form 12 (HLS-SF12) among adult patients with hypertension. Methodology: A cross-sectional study was conducted among 47 hypertensive patients from a selected barangay who were registered in the local health center. Data were analyzed using correlation analysis, Cronbach's alpha test, and Mann-Whitney U test. Results: The acceptability was demonstrated by the absence of missing data, lack of significant floor and ceiling effects, and adequate distribution of scores. Cronbach's alpha was 0.78, and most corrected item-total correlations ranged from .31 to .58, which suggested satisfactory reliability. The pattern of interdomain correlations (r = .38-.69) and domain score-total score correlations (r = .76-.91) supported the construct validity of the instrument. Known-groups validity was also exhibited by the lower health literacy scores among those with primary education than those with secondary or tertiary education (median: 22.22 vs 29.17, p = 0.04). Conclusion Satisfying the set criteria, the Filipino version of HLS-SF12 is an acceptable, reliable, and valid instrument to measure the health literacy of adult hypertensive patients in a selected barangay in Manila.
Health Literacy ; Hypertension