November 2016, Vol. 5, No. 9

Providing Practical Information to Promote Targeted, Effective, and Personalized Treatments

Dear Colleague, With every issue, all of us on the editorial staff of Personalized Medicine in Oncology (PMO) strive to provide members of multidisciplinary oncology teams practical information about research advances and improvements within the personalized medicine spectrum that allow for more targeted and effective treatments. We are pleased to [ Read More ]

Al B. Benson III, MD, FACP, FASCO

Letter to Our Readers

Understanding the Current Classification Criterion and Prognostic Models for the Myelodysplastic Syndromes and Dysplastic Cytopenias of Undetermined Significance as a Paradigm for Personalized Medicine

Myelodysplastic syndromes (MDS) define a group of hematologic disorders whose pathologic findings have been well defined.1 Controversy exists, however, in the reproducibility of the various subtypes. The 4th edition of the World Health Organization’s WHO Classification of Tumours of the Haematopoietic and Lymphoid Tissues was last published in 2008.2,3 The [ Read More ]

Steven Sandler, MD

Myelodysplastic Syndromes

A One Pathway “Two-Different Hit” Hypothesis: Symbiosis in Transformation

The Knudson Two-Hit Hypothesis is the accepted common mechanism for transformation in patients with most familial cancer syndromes. A germline deleterious mutation in a tumor suppressor gene (TSG) increases the risk of developing specific malignancies. The gatekeeper event is loss of heterozygosity (LOH) or loss of expression of normal protein [ Read More ]

Steven Sorscher, MD; Boris Pasche, MD, PhD, FACP; Shakti Ramkissoon, MD, PhD;

Genetics

Published Studies Underreport Toxicities Associated with Targeted Therapy and Immunotherapy

Most oncologists’ knowledge about toxicities associated with newer therapies comes mainly from clinical trials, but publications of clinical trial safety results may be misleading, according to a study presented at the European Society for Medical Oncology 2016 Congress. The study investigators found suboptimal reporting of adverse events in studies of [ Read More ]

ESMO 2016

Quality of Life Improved with Nivolumab versus Chemotherapy

In recent years, the cancer patient’s experience has been recognized as an important factor in determining the value of a treatment. According to patient reports, their quality of life (QOL) remained stable on the immunotherapy nivolumab, whereas it significantly deteriorated on chemotherapy, as shown in an analysis of a phase [ Read More ]

ESMO 2016

Potentially Practice-Changing: Ribociclib/Letrozole Combo in Advanced Breast Cancer

The addition of the selective CDK4/6 inhibitor ribociclib to letrozole significantly improved progression-free survival (PFS) in hormone receptor–positive (HR+) advanced breast cancer. Compared with letrozole alone, the combination of ribociclib/letrozole improved PFS by 44%. These results from the phase 3 MONALEESA-2 trial were presented at the European Society for Medical [ Read More ]

ESMO 2016

Encouraging Outcome with Adjuvant Sunitinib in Renal Cell Carcinoma

For the first time, a randomized study showed that adjuvant therapy improved outcomes in renal cell carcinoma (RCC). Adjuvant sunitinib improved disease-free survival (DFS) by more than 1 year in high-risk locoregional RCC following nephrectomy. Although this is encouraging news, some experts are not ready to adopt this as a [ Read More ]

ESMO 2016

Practice-Changing Study Shows Niraparib Extends Progression-Free Survival in Platinum-Sensitive Ovarian Cancer

Maintenance therapy with niraparib, an investigational oral PARP inhibitor, significantly prolonged progression-free survival (PFS) in patients with recurrent platinum-sensitive ovarian cancer regardless of BRCA status and homologous recombination deficiency (HRD) status. “This is a breakthrough for patients with ovarian cancer. We have never seen such large benefits in progression-free survival [ Read More ]

ESMO 2016

Pembrolizumab plus Chemotherapy Doubled Response Rate Over Chemotherapy Alone in NSCLC

With the success of programmed death-1 (PD-1) and PD-1 ligand 1 (PD-L1) inhibitors in non–small cell lung cancer (NSCLC), attention has focused on how best to combine these immunotherapies, and one question has been whether they can be safely and effectively combined with standard chemotherapy. Combining pembrolizumab with a standard [ Read More ]

ESMO 2016

Managing Immune-Related Toxicities

For many patients with advanced melanoma and lung cancer, checkpoint inhibitors have been a godsend, helping to extend survival to previously unthinkable lengths. While the impression is that checkpoint inhibitors are free of adverse effects, in reality, clinicians strive daily to balance the efficacy and toxicity of these treatments. At [ Read More ]

Palliative Care

Where We Agree When It Comes to Regulating Laboratory-Developed Diagnostics

Federal agencies have a long history of finalizing regulatory documents at the end of an administration. If that history repeats itself in 2016, it may mean a new regulatory environment for an industry that includes more than 60,000 genetic testing products and services. The FDA published a detailed proposal for [ Read More ]

Amy M. Miller, PhD; Executive Vice President; Personalized Medicine Coalition

The Last Word