Pharmacy & Therapeutics - February 2009 - (Page 103)

MEETING HIGHLIGHTS: San Antonio Breast Cancer Symposium time to distant recurrence, 0.81, respectively). Women in BIG-98 were randomly assigned to one of four arms, each with five years of treatment. In the analysis of 4,634 patients, with the authors testing whether a sequence of agents was superior to letrozole monotherapy, rates of five-year disease-free survival were similar for letrozole (87.9%), for letrozole followed by tamoxifen (87.6%), and for tamoxifen followed by letrozole (86.2%). However, in pairwise comparisons of tamoxifen first, followed by letrozole compared with letrozole alone, a trend favored letrozole alone for overall survival and time to disease progression. Comparing letrozole first, followed by tamoxifen versus letrozole alone, showed no significant differences for these parameters. In a comparison of letrozole alone versus tamoxifen followed by letrozole at five years, letrozole alone was more favorable in terms of overall events (9.1% with tamoxifen, followed by letrozole, and 7.3% with letrozole alone). Similar trends were found in an analysis according to nodal status: node-negative/positive for tamoxifen followed by letrozole was 14.7%/4.9% compared with letrozole (4.9%/3.5% for letrozole). Results for letrozole followed by tamoxifen and for letrozole alone, were “strikingly similar,” Dr. Mouridsen said (overall 7.3% for both and by nodal status 12.5%/12.4% for letrozole followed by tamoxifen/letrozole in node-positive women and 3.9%/3.5%, respectively, in node-negative women). Dr. Mouridsen concluded that BIG-1-98 suggests superior overall survival with letrozole compared with tamoxifen in these patients. Adjuvant endocrine therapy should start with letrozole, especially in women at higher risk for early recurrence. Data on the sequential therapy also showed that women who did not tolerate aromatase inhibitor therapy after two years could be switched to tamoxifen. acid when either their post-baseline T-score decreased to below –2 or a nontraumatic fracture occurred. Zoledronic acid was given at 4 mg intravenously every six months. The primary endpoint was the percentage of change in lumbar spine BMD at 12 months. A secondary endpoint was the time to disease recurrence or relapse. At 36 months, the mean percentage of change in lumbar spine was +4.39 for the IMZA group and –4.9 in the DZA group (Δ9.29, P < 0.0001). Changes at the hip were +1.89 for the IMZA group and –3.52 for the DZA group (Δ5.41, P < 0.0001). Increases in the percentage of change were noted for both sites at 12, 24, and 36 months, but fracture rates at 36 months (5% for the IMZA arm and 6% for the DZA arm) were similar between groups. The disease-free survival event risk was significantly lowered (41%) in the IMZA group (HR = 0.588, P = 0.0314). Adverse effects were similar in the groups except for one case of osteonecrosis of the jaw, which was reported in the IMZA patients. Of 532 patients (4.2%) in the IMZA arm, 22 experienced a local or distant recurrence, compared with 40 of 532 patients (7.5%) in the DZA arm. Even though differences in fracture rates between early and delayed administration were not significant, disease-free survival was significantly improved with initial zoledronic acid therapy. Dr. Eidtmann concluded: “Immediate use of zoledronic acid prevents bone loss in women with early-stage breast cancer receiving adjuvant letrozole. The finding adds to the growing body of evidence that zoledronic acid can provide antitumor effects and may prolong disease-free survival in patients with early breast cancer.” I Zoledronic Acid (Zometa) and Aromatase Inhibitor–Associated Bone Loss in Postmenopausal Women with Early Breast Cancer Receiving Adjuvant Letrozole (Femara) • Holger Eidtmann, MD, University Frauenklinik, Kiel, Germany Beyond confirming the prevention of bone loss with zoledronic acid, 36-month results of ZO–FAST (Zometa–Femara Adjuvant Synergy Trial) add to the accumulating evidence of the bisphosphonate’s antitumor effects. Although the aromatase inhibitor letrozole (Femara) reduces recurrence risk in postmenopausal women with HR+ early breast cancer, it suppresses estrogen and is associated with accelerated bone loss and increased fracture risk. A 12-month analysis of ZO-FAST showed that the immediate use of zoledronic acid prevented bone mineral density (BMD) loss, and trial data from ABSCG-12 (the Austrian Breast and Colorectal Cancer Study Group) demonstrated bone loss prevention and improved disease-free survival. Women in ZO-FAST (N = 1,064, median age, 57.5 years) were postmenopausal with HR+ early breast cancer. They received letrozole at a dose of 2.5 mg once daily for five years. Those with BMD T-scores of –2 or greater were randomly assigned to the immediate-zoledronic acid arm (IMZA). The remainder, in the delayed-zoledronic acid (DZA) arm, received zoledronic COMING SOON TO P&T EDITORIAL: Evidence-Informed Case Rates David B. Nash, MD, MBA DRUG FORECAST: Rilonacept (Arcalyst), an Interleukin-1 Trap For the Treatment of Cr yopyrin-Associated Periodic Syndromes Saloni Kapur, PharmD, MPA, and Mary Ellen Bonk, PharmD FEATURE ARTICLE: Administration of Proton Pump Inhibitors In Patients Requiring Enteral Nutrition Terri M. Wensel, PharmD Vol. 34 No. 2 • February 2009 • P&T® 103

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Pharmacy & Therapeutics - February 2009 Contents Editorial Medication Errors Prescription: Washington New Drugs/Drug News/New Medical Devices Drug Forecast Pushing an Expanded Role for Pharmacists Better Asthma Management with Advanced Technology Pharmaceutical Approval Update 58th Annual Meeting, American Society of Human Genetics, 2008 American Society of Hematology, 50th Annual Meeting and Exposition 2008 San Antonio Breast Cancer Symposium Stahl’s Essential Psychopharmacology, 3rd Edition Author Guidelines

Pharmacy & Therapeutics - February 2009

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