Real world patterns of care in HER2-overexpressing breast cancer: Results of a survey of TEACH clinical trial investigators in 2011.

BACKGROUND: HER2-overexpressing breast cancer (BC) is common among young patients and poses a public health burden. Adjuvant anti-HER2/neu therapy with trastuzumab reduces the risk of recurrence and improves survival. METHODS: A web-based survey was sent to 386 physicians of the "TEACH" trial in 2011 to determine access to HER2/neu testing and treatment patterns for HER2-overexpressing BC. RESULTS: There were 151 responders (39%) from 28 countries. Ninety-seven percent reported HER2/neu expression is routinely measured in their institutions by immunohistochemistry (85%), FISH (80%) and other methods (16%). Twenty percent of responders from Asia reported that the test was not routinely available. Forty-eight percent of participants reported instances when adjuvant HER2-directed therapy was recommended to a patient who eventually did not receive it. Reasons for not receiving trastuzumab was cost (73%, p < 0.0001) in low- and middle-income countries and co-morbidities in high-income countries (43%, p = 0.003). CONCLUSIONS: This survey reflects the availability of HER2/neu testing and anti-HER2/neu therapy among physicians who participated in TEACH. A high proportion of women with HER2-overexpressing BC may not receive standard adjuvant therapy due to unavailability of the test and cost of therapy. Despite having some limitations, such as a possible selection bias of participating physicians, variable definitions of access to healthcare among respondents, and changes in trastuzumab availability since 2011, our results demonstrate that access to care and region of practice impact the implementation of cancer treatments.

Factors influencing serum CA125II levels in healthy postmenopausal women.

Our objective was to identify factors that correlate with CA125 concentrations in healthy postmenopausal women and to introduce recommendations for reporting and interpreting individual CA125 assay results. We analyzed repeated serum CA125 levels, as measured by the CA125II assay, in 18,748 postmenopausal women who participated in the ST: Bartholomew's/Royal London Hospital Ovarian Cancer screening trial from 1986 to 1994 and were not diagnosed with ovarian cancer during the 12-year follow-up period. We found that race is a substantial predictor of normal levels of CA125, with average CA125II concentration from African (median, 9.0; 95% range, 4.0-26.0 units/ml) and Asian women (median, 13.0; range, 5.9-33.3 units/ml) lower than that in Caucasian women (median, 14.2; range, 6.0-41.0 units/ml; P < 0.001). Women with a hysterectomy have lower CA125II values (median, 13.6; range 5.5-39.0 units/ml; P < 0.001), and women with a prior cancer diagnosis other than ovarian cancer have higher levels of CA125 II (median, 16.0; range, 6.0-49.0 units/ml; P < 0.003). Regular smoking and caffeine consumption decrease CA125 levels (P < 0.001). A woman's age, age at menarche, age at menopause, and history of a previous ovarian cyst (P < 0.05) are also predictive of baseline CA125 levels. Parity, history of hormone replacement therapy or unilateral oopherectomy, and previous use of oral contraceptives or talcum powder are not significant predictors of CA125 concentrations (P > 0.05). We concluded that clinically significant differences in individual patient characteristics need to be reflected in the screening algorithms that use CA125II so that designed performance characteristics (sensitivity and specificity) are maintained in practice.