December 2015, Vol. 4, No. 6

Personalized Medicine in Oncology: Disseminating Essential Information

Dear Colleague,On behalf of all of us at Personalized Medicine in Oncology (PMO), I’d like to offer our warmest wishes to you this holiday season and our thanks for your loyal readership throughout 2015. Over this past year, we have witnessed advances in our knowledge of tumor biology, biomarkers, and [ Read More ]

Letter to Our Readers

The Current Landscape in Melanoma Treatment

An Interview with Jeffrey Infante, MD, of Sarah Cannon Research InstituteThe COMBI-d and COMBI-v trials showed that treating BRAF V600 mutation–positive metastatic melanoma with the combination of da­brafenib plus trametinib resulted in a significant increase in overall survival and a 33% reduction in the risk of progression or death compared [ Read More ]

Interview with the Innovators

Commentary: Treatment for Children Receiving Emetogenic Chemotherapy

Chemotherapy-induced nausea and vomiting is a frequent and potentially treatment-limiting complication of cancer therapy in both adults and children. However, pediatric oncologists have been keenly aware that while effective regimens have been developed for adults, effective regimens for children receiving emetogenic chemotherapy have been lacking.1-3 On September 2, 2015, the [ Read More ]

Pediatric Oncology

Inherited Colorectal Cancer: POLE and POLD1

The association of POLE and POLD1 with colorectal cancer risk was demonstrated in 2013. Palles and colleagues studied families with a dominant pattern of inherited colorectal cancer and multiple adenomas through whole genome sequencing.1 Through these efforts, they identified germline mutations in POLE and POLD1 as high-penetrance genes predisposing to [ Read More ]

Cristi Radford, MS, CGC; Tuya Pal, MD, FACMG

Genetic Counseling

FDA Approves Opdivo to Treat Advanced Form of Kidney Cancer

On November 23, 2015, the FDA approved Opdivo (nivolumab) to treat patients with advanced (metastatic) renal cell carcinoma, a form of kidney cancer, who have received a certain type of prior therapy. “Opdivo provides an important therapy option for patients with renal cell carcinoma,” said Richard Pazdur, MD, Director of [ Read More ]

FDA Update

FDA Approves Portrazza to Treat Advanced Squamous Non–Small Cell Lung Cancer

On November 24, 2015, the FDA approved Portrazza (necitumumab) in combination with 2 forms of chemotherapy to treat patients with advanced (metastatic) squamous non–small cell lung cancer (NSCLC) who have not previously received medication specifically for treating their advanced lung cancer. Lung cancer is the leading cause of cancer death [ Read More ]

FDA Update

FDA Drug Approvals: Earlier Availability for Promising Drugs

It’s no secret that developing cancer drugs is a time-consuming and costly endeavor. Although the FDA review represents only a fraction of the entire time line, accelerated evaluation can still shave years off this process. According to data presented at the 2015 Breast Cancer Symposium, expedited programs allow for intensive [ Read More ]

2015 Breast Cancer Symposium

The Affordable Care Act: Extending Coverage to Millions of Americans

A closer look at the $2.7 trillion spent on healthcare in the United States in 2011 reveals a system of extreme imbalances, characterized by excessive consumption of care on the one hand and lack of access to necessary care on the other. The Affordable Care Act (ACA), outlined by Otis [ Read More ]

2015 Breast Cancer Symposium

Poliovirus Shows Complete Response in Several Glioblastoma Patients

In a role reversal, poliovirus is fast becoming a viable therapy for one of cancer’s deadliest diseases. Researchers at The Preston Robert Tisch Brain Tumor Center at Duke University Medical Center are using engineered poliovirus to treat recurrent glioblastoma—making tumors disappear and extending survival beyond 3 years in some patients. [ Read More ]

American Society of Gene and Cell Therapy

Encouraging New Options for Neuroendocrine Tumors

Patients with advanced neuroendocrine tumors (NETs) have 2 promising new treatment options, according to separate phase 3 studies presented as late-breakers at the 2015 European Cancer Congress. The NETTER-1 trial evaluated the radiopharmaceutical agent 177Lu-DOTATATE in NETs confined to the midgut, while RADIANT-4 evaluated the mTOR inhibitor everolimus in patients [ Read More ]

European Cancer Congress

Oncotype DX Breast Cancer Assay Spares Low-Risk Patients from Chemotherapy

Patients with early breast cancer and a low Oncotype DX Recurrence Score (RS) can be safely treated with hormone therapy alone and avoid chemotherapy, according to results from the National Cancer Institute–sponsored TAILORx trial.1,2 Patients who had an RS of <11 treated with hormone therapy alone had less than a [ Read More ]

European Cancer Congress

Case: PIK3CA-Mutant Triple-Negative Breast Cancer Inhibited by Cetuximab

A woman with PIK3CA-mutant triple-negative breast cancer (TNBC), who is an exceptional responder to cetuximab, illustrates how PIK3CA mutations can induce tumor growth by activating the epidermal growth factor receptor (EGFR), and how these cancers may be successfully inhibited by EGFR inhibitors. Joyce O’Shaughnessy, MD, Chair in Breast Cancer Research, [ Read More ]

Breast Cancer

The Annual Report of the Personalized Medicine Coalition

(PMO) is a proud partner of the Personalized Medicine Coalition (PMC). PMO and PMC share the common goal of promoting the understanding and adoption of personalized medicine concepts to ultimately benefit patients and the health system. PMC provides opinion leadership on policy issues that affect personalized medicine; helps to educate [ Read More ]

Edward Abrahams, PhD; William S. Dalton, PhD, MD

The Last Word

Sample Size Calculation for Single-Arm Phase 2 Prostate Cancer Trials

Prostate cancer remains one of the major health issues for men worldwide and is the second leading cause of cancer-related death in males in the United States…

Prostate Cancer