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Combined treatment benefits elderly patients with lung cancer

Most elderly patients do not receive combined modality treatment (CMT) with both chemotherapy and radiation for locally advanced, non-small cell lung cancer (NSCLC) despite trial data indicating that CMT enhances survival, decreases comorbidities, and is potentially curative. Data presented by Martin J. Edelman, MD, professor of medicine, University of Maryland Greenebaum Cancer Center, Baltimore, indicate that elderly patients receiving chemotherapy followed by concurrent chemotherapy and radiation derive the most significant survival benefit.

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KRAS gene status predicts response to initial biologic treatment for colorectal cancer

Patients with metastatic colorectal cancer are more likely to respond to initial treatment that includes cetuximab if they have nonmutated, wild-type KRAS gene status, reported Eric Van Cutsem, MD, University Hospital Gasthuisberg, Leuven, Belgium. "For the first time in colorectal cancer, we are able to predict which patients are likely to be helped by the new biologics," he said. "KRAS is the first molecular marker for the selection of a targeted therapy in combination with a standard chemotherapy regimen in first-line metastatic colorectal cancer. KRAS testing should be routinely conducted in all colorectal cancer patients immediately after diagnosis to ensure the best treatment strategies for the individual patient."

Adjuvant Zoledronic Acid Decreases Breast Ca Recurrence in Premenopausal Women

Adding zoledronic acid to anastrozole or tamoxifen therapy decreased recurrence by 35% and increased disease free survival by 36% in premenopausal breast cancer patients, according to results of the Austrian Breast and Colorectal Cancer Study Group Trial 12 (ABCSG-12). The multicenter, Phase III trial is the first large trial to demonstrate the significant antitumor benefit of zoledronic acid, said Michael Gnant, MD, Medical University of Vienna. "Adjuvant treatment with zoledronic acid should be considered in order to improve the standard of care in premenopausal breast cancer patients," he said.

Intervention Program Improves Sleep Quality During Chemotherapy

Adherence to a four-point Individualized Sleep Promotion Plan (ISPP) intervention consisting of stimulus control, sleep restriction, relaxation therapy, and sleep-hygiene practices significantly lowered fatigue and increased sleep quality for patients undergoing adjuvant chemotherapy. Fatigue and sleep disturbances are the most frequently reported symptoms during adjuvant chemotherapy for breast cancer. One-third of breast cancer patients report persistent fatigue and abnormal sleep/wake cycles, said Ann M Berger, PhD, RN, professor, College of Nursing, University of Nebraska Medical Center, Omaha.

Bevacizumab, docetaxel combination is effective first-line treatment for metastatic breast cancer

Phase 3 trial results show that adding bevacizumab to docetaxel as first-line therapy for newly diagnosed HER2-negative, locally recurrent, or metastatic breast cancer resulted in significantly less disease progression. "This shows that the antiangiogenic approach to treating breast cancer is effective, regardless of which taxane drug it is combined with," said lead author David Miles, MD, professor, Mount Vernon Cancer Center, Middlesex, UK. Previous studies have shown that the combination of bevacizumab to paclitaxel doubled progression-free survival among patients with metastatic breast cancer.

Cancer Is Independent Predictor of Increased Vulnerability in Elderly Persons

Cancer is an independent predictor of increased vulnerability, functional limitations, geriatric syndromes, frailty, and fair or poor health status among older Medicare beneficiaries. "Up until now, a lot of this has been more opinion rather than numbers," said Gary R. Morrow, MD, professor of radiation oncology, University of Rochester Cancer Center. "This gives us a method to let us know if we have changed anything.

First-time generic drug approvals, May 2008

Generic drugs approved by FDA (through May 2008) including amifostine for injection, clobetasol foam, granisetron oral solution, calcium acetate capsules, and irinotecan injection.

FDA Pipeline preview, May 2008

Recent FDA action (through May 2008) related to ceftobiprole, sugammadex, romiplostim, Gardasil, and amrubicin.

FDA actions in brief, May 2008

Recent FDA approvals and indications (through May 2008) related to Janumet, PegIntron, Rebetol, Xyzal, Liquadd, and NovoLog.

Physicians urged to return to statins after announcement of ENHANCE results

Experts urged a “return to statins” after hearing the final results of the Ezetimibe and Simvastatin in Hypercholesterolemia Enhances Atherosclerosis Regression (ENHANCE) trial, which demonstrated no slowing of carotid atherosclerosis progression with the addition of ezetimibe to simvastatin therapy.

ONTARGET: ARB noninferior to ACE inhibitor in patients with cardiovascular disease

According to results from the Ongoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial (ONTARGET), the angiotensin receptor blocker (ARB) telmisartan is as effective as the angiotensin-converting enzyme (ACE) inhibitor ramipril in preventing adverse cardiovascular events in high-risk patients with cardiovascular disease but without heart failure.

CDER gains Woodcock as permanent chief

Much to the surprise of most close FDA observers, Janet Woodcock, MD, agreed in March to resume control of the Center for Drug Evaluation and Research (CDER). Dr Woodcock headed CDER for 10 years before becoming deputy commissioner and, more recently, FDA’s chief medical officer. But when CDER director Steven Galson, MD, MPH, left last year, Dr Woodcock served as the temporary CDER chief. Now, after a long search for a replacement, she has decided to accept the position herself.

Research disclosure and drug safety monitoring requirements raise new challenges

The Food and Drug Administration Amendments Act (FDAAA) enacted in September 2007 requires new initiatives to expand information on the risks and benefits of prescription drugs. One goal established in FDAAA is the modernization of FDA’s system for detecting adverse drug events (ADEs); therefore, the current system is being reviewed so limitations and capabilities can be identified.