Clinical Abstracts From Overseas

By Stanton R. Mehr
Published: Monday, Jun 07, 2010
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Clinical Abstracts From Overseas

Spain


Paclitaxel Improves Survival in Early Breast Cancer Though Hormone-Receptor Status not a Factor

Taxane drugs, when added to adjuvant chemotherapy, have been shown to increase survival in patients with metastatic breast cancer, but toxicity limits their utility. Spanish researchers from multiple centers tested whether paclitaxel added to standard adjuvant chemotherapy would improve outcomes in patients with early breast cancer and to determine whether a subset of patients could be identified in whom paclitaxel might be optimally effective.

A total of 1,246 women (median age, 50 yr) with early breast cancer who underwent surgical excision were randomized to receive either six 21-day cycles of fluorouracil, epirubicin, and cyclophosphamide (FEC) (632 pts) or FEC followed by weekly doses of paclitaxel (FEC-P), consisting of four 21-day cycles of FEC, three weeks of no treatment, and eight 1-week courses of paclitaxel (614 pts). All patients had at least one positive axillary lymph node of the minimum six removed during their primary curative surgery. Approximately 70% of both patient groups underwent radiation treatment. All patients with tumors positive for estrogen receptor, progesterone receptor, or both received tamoxifen therapy for five years after completion of their assigned regimens.

The investigators calculated the median relative dose intensities in the control and study groups to be at least 99%. Seventy-three women in the FEC-P group died compared with 95 in the FEC group. Their analysis revealed that patients administered paclitaxel had a 5-year disease-free survival of 78.5% compared with those receiving FEC who had a disease-free survival of 72.1% (P = .006). With multiple adjustments for such factors as lymph node involve, tumor size, age, histology, and others, they calculated a 23% reduced risk of relapse associated with paclitaxel use.

Although the researchers found that HER2 and hormone-receptor status was significantly associated with survival overall (HER2-positive patients had lower survival, hormone-receptor negatives had lower survival), they also found that the use of paclitaxel in patients with HER-2 amplification or hormone-receptor positivity did not predict greater survival. Therefore, a subset of patients in whom paclitaxel worked optimally could not be isolated based on these factors.


Martin M, Rodriguez-Lescure A, Ruiz A, et al: Randomized phase 3 trial of fluorouracil, epirubicin, and cyclophosphamide alone or followed by paclitaxel for early breast cancer. J Natl Cancer Inst 2008;100:805-814.

Canada

Daily Multivitamin Use Associated With Greater Breast Density

A vitamin a day may be deemed beneficial by consumers, but a group of Canadian researchers fear that it may have a negative effect in terms of breast cancer risk. Breast density is considered to be a biomarker for increased breast cancer risk, and a link between vitamin use and greater breast tissue density may set off a few alarms, in light of the prevalence of multivitamin use.

The investigators recruited more than 1,600 pre- and post-menopausal women (split evenly) at the time of routine screening mammography to take part in the study, in which demographic characteristics were obtained, and lifestyle and behavioral habits were recorded during a telephone interview. Twenty-two percent of women reported multivitamin use (21% of premenopausal and 23% of postmenopausal women). When analyzing the data against the mammography results, the investigators found a trend for higher adjusted mean breast density among premenopausal women who were current multivitamin users (P = .009) compared with those who used them in the past or never used them. Duration of use did not seem to affect the findings.

The absolute difference in breast densities were relatively small (approximately 5 percentage points), but the evaluation revealed this to be a statistically significant difference. There is no information whether this degree of increased density is clinically significant, however. Furthermore, the researchers pointed out that no link between multivitamin use and breast tissue density could be found in post-menopausal women.

The authors recommend further study of this association before pre-menopausal women should be advised to stop taking multivitamins or that they should receive more frequent mammograms.


Berube S, Diorio C, Brisson J: Multivitamin- multimineral supplement use and mammographic breast density. Am J Clin Nutr 2008;87: 1400-1404.

Austria

What an Effective Public Health Program Can Do

Regular prostate-specific antigen (PSA) screening for men in their 40s is recommended to enhance the early detection of prostate cancer. However, it is often not performed because of cost considerations, the worry that high PSA levels may result in false-positive tests and lead to unnecessary work-ups and biopsies, and simply because of patient noncompliance.


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