In the News

In the FDA’s dynamic regulatory environment, the patient voice has been adopted and end points for clinical trials have evolved from overall survival to other efficacy measures. “Having multiple drugs is a good thing. Many are approved on nonsurvival end points, and they have transformed the diseases,” said Richard Pazdur, MD.
The US Food and Drug Administration has granted accelerated approval to pembrolizumab (Keytruda injection) for use in patients with recurrent or metastatic head and neck squamous cell carcinoma whose disease progressed after platinum-containing chemotherapy. The injection is recommended to be administered at 200 mg intravenously for 30 minutes every 3 weeks.
In a recent interview with The Oncology Nurse-APN/PA (TON), Beth Faiman, PhD, APRN-BC, AOCN, Nurse Practitioner, Cleveland Clinic Taussig Cancer Institute, OH, and Editor-in-Chief of TON discussed her recent acceptance of a nomination for the Leukemia & Lymphoma Society (LLS) Woman of the Year award.

According to 2 large breast cancer trials, CYP2D6 genotyping was not predictive of the effectiveness of tamoxifen in postmenopausal women. Thus, the results of these studies are not generalizable to premenopausal women. 

The term “chemo brain” was coined to describe mild cognitive problems in cancer patients attributed to chemotherapy. Although minor chemotherapy-induced memory and cognitive impairments have been described previously, a case-cohort study suggests that these effects can persist more than 20 years posttherapy. 

Primary gastrointestinal stromal tumor (GIST) sited outside the gastrointestinal (GI) tract carries a poorer prognosis than primary GIST within the GI tract, according to a study presented at the recent ASCO GI Symposium in January 2012. 

In patients with chronic kidney disease (CKD), decreasing glomerular filtration rate (GFR) is associated with increased risk of kidney and urothelial cancer in a step-wise fashion, according to a large community-based study. An adjusted multivariate analysis found a 2-fold increase in risk of renal cancer and a substantially increased risk of urothelial cancer at GFR <30 mL/min/1.73 m2. The study was presented at the 2012 ASCO Genitourinary Cancers Symposium, held February 2-4 in San Francisco, California.

According to 2 large breast cancer trials, CYP2D6 genotyping was not predictive of the effectiveness of tamoxifen in postmenopausal women. Thus, the results of these studies are not generalizable to premenopausal women. CYP2D6 genotyping has been a focus of research interest, but studies have been inconclusive as to the value of testing.

The term “chemo brain” was coined to describe mild cognitive problems in cancer patients attributed to chemotherapy. Although minor chemotherapy-induced memory and cognitive impairments have been described previously, a case-cohort study suggests that these effects can persist more than 20 years posttherapy. The authors state that chemo brain effects are subtle compared with women who never had chemotherapy, but it’s possible that these effects place people at greater risk for cognitive decline associated with aging.

A new quantitative imaging bone biomarker has been identified that can assess response and is prognostic for survival in men with metastatic castration-resistant prostate cancer (mCRPC). 

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