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News Notes

BRIEF SUMMARY CONSULT PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use Gemcitabine Injection safely and effectively. See full prescribing information for Gemcitabine Injection.

Gemcitabine Injection For Intravenous Infusion Only. Must Be Diluted Before Use. Initial U.S. Approval: 1996 CONTRAINDICATIONS Patients with a known hypersensitivity to gemcitabine (4) WARNINGS AND PRECAUTIONS • Infusion time and dose frequency: Increased toxicity with infusion time >60 minutes or dosing more frequently than once weekly. (5.1) • Hematology: Monitor for myelosuppression, which can be dose-limiting. (5.2, 5.7) • Pulmonary toxicity: Discontinue Gemcitabine Injection immediately for severe pulmonary toxicity. (5.3) • Renal: Monitor renal function prior to initiation of therapy and periodically thereafter. Use with caution in patients with renal impairment. Cases of hemolytic uremic syndrome (HUS) and/or renal failure, some fatal, have occurred. Discontinue Gemcitabine Injection for HUS or severe renal toxicity. (5.4) • Hepatic: Monitor hepatic function prior to initiation of therapy and periodically thereafter. Use with caution in patients with hepatic impairment. Serious hepatotoxicity, including liver failure and death, have occurred. Discontinue Gemcitabine Injection for severe hepatic toxicity. (5.5) • Pregnancy: Can cause fetal harm. Advise women of potential risk to the fetus. (5.6, 8.1) • Radiation toxicity. May cause severe and life-threatening toxicity. (5.8) ADVERSE REACTIONS The most common adverse reactions for the single-agent (≥20%) are nausea and vomiting, anemia, ALT, AST, neutropenia, leukopenia, alkaline phosphatase, proteinuria, fever, hematuria, rash, thrombocytopenia, dyspnea (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Hospira, Inc. at 1-800-441-4100 or electronically at, or FDA at 1-800-FDA-1088 or

USPSTF Updates Prostate Cancer Screening and Treatment Guidelines Prostate-specific antigen (PSA)-based screening has not been shown to reduce prostate cancer–specific mortality, but is associated with harms related to subsequent evaluation and treatments, some of which may be unnecessary, according to a new analysis of the evidence by the US Preventive Services Task Force (USPSTF) published online in the Annals of Internal Medicine. The new guidelines will downgrade PSA screening from “I—inconclusive” to “D—no benefit” for men younger than 75, basically stating that younger, healthy men should not undergo this testing. The Prostate Cancer Foundation and the American Cancer Society continue to support better communication and processes of informed patient decision-making prior to, and after, PSA screening in healthy men.

Everolimus and Exemestane Combination Prolonged PFS for Advanced Postmenopausal Breast Cancer Patients For women with advanced breast cancer resistant to hormonal therapy, combining everolimus and exemestane improves progression-free survival (PFS) by nearly 7 months compared with exemestane alone, according to phase 3 trial results reported at the European Multidisciplinary Cancer Conference. The Breast Cancer Trials of Oral Everolimus (BOLERO) randomized 724 patients in 24 countries who had been treated previously with letrozole or anastrozole. Previous therapy also included tamoxifen, fulvestrant, and chemotherapy. The trial was stopped early when interim analysis revealed that patients receiving the combination regimen did not experience tumor progression for nearly 11 months, whereas patients receiving exemestane alone progress after approximately 4 months.

Trastuzumab Emtansine Delays Progression of HER2-Positive Metastatic Breast Cancer The antibody-guided drug conjugate trastuzumab emtansine (T-DM1) as initial therapy prolonged progression-free survival (PFS) for patients with HER2-positive metastatic breast cancer compared with docetaxel plus trastuzumab, according to trial results reported at the European Multidisciplinary Cancer Conference. The conjugate delivers trastuzumab directly to tumor cells by attaching the drug to DM1 using a stable linker. This limits the drug’s exposure to normal cells, thus producing fewer side effects than the drug delivers through traditional means. The phase 2 trial randomized 137 patients who were chemotherapy-naïve to either T-DM1 or trastuzumab plus docetaxel chemotherapy. Median PFS was 14.2 months in the T-DM1 group compared with 9.2 months in the trastuzumab/docetaxel group. In the T-DM1 arm, only 7.2% of patients discontinued treatment because of side effects; 28.8% discontinued treatment in the trastuzumab/docetaxel arm.

5-Year Z-FAST Results Show Maintenance of Bone Density with Zoledronic Acid and Letrozole Combination Upfront zoledronic acid significantly and progressively increases bone mineral density (BMD) in postmenopausal women with early breast cancer receiving letrozole for 5 years, according to results of the Zoledronic Acid–Letrozole Adjuvant Synergy Trial (Z-FAST). This finding did not hold true if the zoledronic acid use was delayed (if a postbaseline lumbar spine or total hip T score decreased to less than -2.0, any clinical nontraumatic fracture occurred, or an asymptomatic vertebral fracture was identified at the 36-month follow-up). Patients in the delayed zoledronic acid group who were treated with zoledronic acid after bone loss had occurred did benefit by subsequent increases in BMD. Coadministration of zoledronic acid and letrozole was found to be well tolerated over 5 years, with fracture and disease recurrence rates similar in both groups.

ADT Did Not Increase Cardiovascular Mortality

Manufactured by: Hospira Australia Pty Ltd Mulgrave VIC 3170 Australia Manufactured for: Hospira, Inc. Lake Forest, IL 60045 USA Product of Australia

Adding androgen-deprivation therapy (ADT) to radiation in men with clinically localized prostate cancer was not associated with increased cardiovascular mortality compared with radiation therapy alone, according to results of a multivariate analysis presented at the annual meeting of the American Society for Radiation Oncology. Older age (≥70 years), cardiovascular disease, and diabetes mellitus remained strong risk factors for cardiovascular death. To help quell the controversy surrounding the FDA’s request to add safety labeling of risk of cardiovascular disease to gonadotropin-releasing hormone agonists, the researchers analyzed data from a phase 3 trial that included 1979 men with clinically localized stage T1-2 prostate cancer. The cumulative 10-year incidence of cardiovascular death was 9.8% in the combined ADT and radiation group and 10.7% in the radiation alone arm, which the researchers noted was not statistically significant. Univariate analysis, however, determined that adding ADT improved overall and disease-specific survival but did not worsen cardiovascular mortality. ●

OCTOber 2011 I VOL 4, NO 7


Profile for The Oncology Pharmacist

October 2011 Vol4 No7  

The Oncology Pharmacist® features articles written by and for oncology pharmacists and specifically addresses the issues pharmacists and the...

October 2011 Vol4 No7  

The Oncology Pharmacist® features articles written by and for oncology pharmacists and specifically addresses the issues pharmacists and the...