Articles

A study comparing patient-reported outcomes (PROs) labeling claims in Europe and in the United States showed that the European Medicines Agency (EMA) is more proactive in considering patient-generated feedback in their drug labeling decisions—this despite the US Food and Drug Administration (FDA)’s 2009 guidance that emphasized the importance of gathering and disseminating such data.

Getting technical information about companion diagnostic tests required to make formulary decisions about oncology drugs may not be easy, according to a small telephone survey conducted by Aashish Surti, PharmD can­didate, and Iris Tam, PharmD, Di­rector, Managed Care Med­i­­cal Com­mu­n­i­­cations, Genentech. They reported their survey results in a poster presented at the 2013 Academy of Man­aged Care Pharmacy (AMCP) meeting.

An analysis comparing the prescribing habits of urology practices shows that, despite treatment guideline recommendations to the contrary, gonadotropin-releasing hormone (GnRH) agonists, which are only indicated for the palliative treatment of advanced prostate cancer, are routinely prescribed for patients with localized, low- or intermediate-grade prostate cancer, particularly by urologists who have no practice affiliation with a medical school.

;Researchers looking at whether guideline-directed adjuvant treatments for breast cancer were actually being administered in rural areas of the United States found that only 41% of the patients in this study received all of the suggested treatment modalities for breast cancer.

The use of costly diagnostic imaging of uncertain value is increasing rapidly for patients with localized non–small-cell lung cancer (NSCLC), according to data from the Surveillance, Epidemiology and End Results (SEER)-Medicare database.

Mr Margulies is an Associate, Foley Hoag, LLP, and Mr Slotnik is a Partner, Health Policy Strategies, LLC, Washington, DC

Chicago, IL—Data continue to build for the application of immunotherapy for patients with metastatic melanoma. At the 2013 Annual Meeting of the American Society of Clinical Oncology (ASCO), several sessions were devoted to recent advances in melanoma, focusing on new ways to boost the activity of current therapies, introducing a new class of immunotherapy in development, and a new form of immunotherapy—an oncolytic vaccine.

Lynch syndrome (LS) is an inherited syndrome of predisposition to cancer with an increased risk for colorectal cancer ranging from 30% to 80%. Prostate cancer has been described as a component tumor of LS, but the lifetime risk of prostate cancer in patients with LS has not been quantified because of inherent difficulties. In a new analysis, researchers have used genetic data to define the risk of prostate cancer in men with LS (Raymond VM, et al. J Clin Oncol. 2013;31:1713-1718).