A three-arm randomized phase II study of oral vinorelbine plus capecitabine versus oral vinorelbine and capecitabine in sequence versus docetaxel plus capecitabine in patients with metastatic breast cancer previously treated with anthracyclines.

Owing to the increased number of patients treated with anthracycline-based adjuvant chemotherapy, there is a need for new effective and tolerable nonanthracycline regimens in metastatic breast cancer. Patients with HER2-negative metastatic breast cancer previously treated with anthracyclines in (neo)adjuvant setting were randomized to fully oral 3 weekly cycles of the combination of oral vinorelbine with capecitabine (V + C), to the same drugs alternating every three cycles (V↔C), or to the combination of docetaxel and capecitabine (D + C). V was given at 80 mg/m(2) (after the first cycle at 60 mg/m(2)) on days 1 and 8 in the V + C arm and weekly in the V↔C arm, C at 1,000 mg/m(2) bid from days 1 to 14, and D on day 1 at 75 mg/m(2). The primary end point was disease control rate (CR + PR + NC ≥ 3 months). A total of 139 patients were randomly assigned to V + C (44 patients), V↔C (47 patients), and D + C (48 patients). After an independent review, the disease control rate in the intent-to-treat population in the V + C, V↔C, and D + C arms [95% CI] was 70.5% [54.8-83.2], 37.0% [23.2-52.5], and 70.8% [55.9-83.1], and the median overall survival 22.2, 19.4, and 24.2 months, respectively. When taken into account the disease control rate, the alternating V↔C regimen seems to be less effective compared with V + C or D + C combinations. Combinations of V + C or D + C showed similar efficacy and a different toxicity profile; V + C induced less neutropenia, infection, hand-foot syndrome, fatigue/asthenia, and alopecia, whereas D + C - less gastrointestinal toxicity. V + C combination constitutes a valuable fully oral alternative option to D + C in patients with metastatic breast cancer previously treated with anthracyclines in (neo)adjuvant setting, while offering the advantages of an all-oral treatment.

Evolution of breast cancer screening in countries with intermediate and increasing incidence of breast cancer.

BACKGROUND: Few studies have been published regarding the practice of breast cancer screening in Asian countries. AIMS: The present study illustrates how the health policy for breast cancer screening has evolved in Taiwan from selective mammographic screening within a high-risk group, firstly to a programme of physical examination by public health nurses, and finally to a two-stage breast cancer screening programme, with a risk assessment followed by mammography for those at moderate to high risk. DATA SOURCES: Breast cancer screening has evolved from 1995 to 2004 in Taiwan in three stages: (1) selective screening for breast cancer with mammography, ultrasound and physical examination only in first-degree relatives of breast cancer cases (1995-1998); (2) a programme of mass screening (1999-2001) with physical examination by public health nurses; and (3) two-stage breast cancer screening with a risk factor questionnaire and mammography for those deemed at moderate-to-high risk (2002-2004). The questionnaire was based on significant risk factors in a previous epidemiological study, in conjunction with the physical examination programme, a risk score was constructed from the logistic regression coefficients from the previous study, and women with a score above the median in the previous epidemiological study were assigned to mammography. RESULTS: Two-stage mammography screening had the most favourable results compared with the two previous screening regimes. It had a positive predictive value of recall after mammography of 14%, compared with 8% for selective screening and 2% for physical examination. Of screen-detected cancers in the two-stage programme, 71% were either ductal carcinoma in situ or stage T1, compared with 61% for selective screening and 60% for physical examination. The area under the receiver operating characteristic curve was 71% for the two-stage programme. CONCLUSIONS: For a low- to medium-risk country such as Taiwan, two-stage screening has acceptable parameters of recall and cancer detection, and compares well with other screening strategies.