March 2016, Vol. 5, No. 2

Regulation and Reimbursement Policies Will Determine the PMI’s Legacy

On February 25, the Obama administration laid out the next steps for the Precision Medicine Initiative (PMI) before an eager crowd of stakeholders at the White House. The initiative is promising.Zeroing in on President Obama’s vision of building a research cohort that includes 1 million Americans, the National Institutes of [ Read More ]

Edward Abrahams, PhD

The Last Word

First-in-Human CAR T-Cell Trial Shows Activity in Multiple Myeloma

CAR T-cell therapy has been striking in various hematologic malignancies, and, for the first time, the approach is being evaluated in multiple myeloma.At the meeting, James Kochenderfer, MD, of the Experimental Transplantation and Immunology Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD, presented preliminary results from a phase [ Read More ]

James Kochenderfer, MD

ASH 2015, ASH Highlights

Benefit for T-DM1 Confirmed

The antibody-drug conjugate trastuzumab emtansine (T-DM1) improved overall survival (OS) compared with physician’s choice of therapy for patients with pretreated HER2-positive metastatic breast cancer, according to final results from the phase 3 TH3RESA trial. The study was supported by Roche.Treatment with T-DM1 led to a clinically meaningful and statistically significant [ Read More ]

San Antonio Breast Cancer Symposium

Tamoxifen or Anastrozole for DCIS? Age and Symptom Profiles Matter

Tamoxifen and anastrozole are similarly effective in preventing breast cancer recurrence in postmenopausal women with ductal carcinoma in situ (DCIS). The choice depends on patient preferences, side effect profiles, age, and other patient factors, according to separate studies presented at the 2015 San Antonio Breast Cancer Symposium.In the large, placebo-controlled [ Read More ]

Jack Cuzick, PhD

San Antonio Breast Cancer Symposium

Adjuvant Chemoradiotherapy May Provide Benefit in Locally Advanced Bladder Cancer

In the United States, the standard of care for locally advanced bladder cancer after radical cystectomy is to “consider” adjuvant chemotherapy and adjuvant radiation. In a 3-arm randomized trial, adjuvant radiation therapy alone or combined with chemotherapy (ie, chemoradiotherapy) did not significantly improve disease-free survival (DFS) compared with adjuvant chemotherapy [ Read More ]

Genitourinary Cancers Symposium

Regular Aspirin Use Reduces the Risk for Prostate Cancer Death

The regular use of aspirin reduces the incidence of and risk for death from lethal prostate cancer according to the results from a large observational study reported at the Genitourinary Cancers Symposium. For the purposes of this study, lethal prostate cancer was defined as metastatic disease or prostate cancer–specific death.Aspirin [ Read More ]

Genitourinary Cancers Symposium

Cabozantinib Improves Standard of Care for Second-Line Treatment of Advanced Kidney Cancer

Cabozantinib achieved superior progression-free survival (PFS) versus standard treatment with everolimus in patients with previously treated advanced kidney cancer in an updated analysis of the phase 3 METEOR trial reported at the Genitourinary Cancers Symposium. In addition, a strong trend toward overall survival (OS) favored cabozantinib at an interim analysis, [ Read More ]

Bernard Escudier, MD

Genitourinary Cancers Symposium

Reirradiation of Pelvic Area Is Safe and Improves Quality of Life

Experience at a high-volume center suggests that reirradiation of the pelvis for cancer recurrence or second genitourinary (GU) malignancy is safe in patients with advanced cancer and can achieve excellent and durable palliation of symptoms without causing severe radiation-induced morbidity. These patients are typically near the end of life, and [ Read More ]

Genitourinary Cancers Symposium

No Benefit from Nephrectomy in High-Risk RCC with Thrombus

High-risk patients with metastatic renal cell carcinoma (RCC) and venous tumor thrombus derived no benefit from cytoreductive nephrectomy and should be evaluated for clinical trials of systemic therapy, a retrospective multicenter review suggested.Patients with thrombus above the diaphragm had a median overall survival of 6.8 months after surgery, about a [ Read More ]

E. Jason Abel, MD

Genitourinary Cancers Symposium

PD-L1 Inhibitor Has Strong Showing in Metastatic Urothelial Cancer

Patients with previously treated metastatic urothelial cancer had response rates that exceeded historical standards when treated with an investigational immunotherapeutic agent, updated results from a large phase 2 study showed.Treatment with the programmed death-1 ligand 1 (PD-L1) inhibitor atezolizumab led to an overall response rate of 15% in 311 patients, [ Read More ]

Genitourinary Cancers Symposium

Biomarker Panel Warrants More Study as Aid to Early CRC Detection

A panel of 4 blood-derived biomarkers showed promise as an aid to early detection of colorectal cancer (CRC), as reported at the 2016 Gastrointestinal Cancers Symposium.The panel yielded a negative predictive value (NPV) exceeding 90% for CRC, the combination of CRC and high-risk adenomas, and CRC plus other cancers. The [ Read More ]

Gastrointestinal Cancers Symposium

Checkpoint Inhibitors Active in Gastric and Esophageal Cancers

Immune checkpoint inhibitors demonstrated varying degrees of activity in advanced gastric and esophageal cancers, according to preliminary clinical studies reported at the 2016 Gastrointestinal Cancers Symposium.Objective response rates ranged from 9% to 30% with 3 different programmed death-1 (PD-1)/ligand 1 (PD-L1) inhibitors. Safety profiles were consistent with prior clinical studies [ Read More ]

Gastrointestinal Cancers Symposium

Immunotherapies in Development for Pancreatic Cancer

According to the American Cancer Society, an estimated 48,960 new cases of pancreatic cancer and 40,560 deaths due to the disease were expected to occur in the United States in 2015.1 Survival statistics for pancreatic cancer are bleak: for all stages combined, the 1- and 5-year relative survival rates are [ Read More ]

Pancreatic Cancer

Case: Biomarkers in Multiple Myeloma

A protein biomarker predicts response to immunomodulatory drug (IMiD) therapy for multiple myeloma (MM). At PMO Live 2015, A. Keith Stewart, MB, ChB, Consultant, Division of Hematology and Oncology, Mayo Clinic, Scottsdale, AZ, presented a case study illustrating the relative merits of an MM-specific gene panel to test for targetable [ Read More ]

A. Keith Stewart, MB, ChB

PMO Live

The Evolving Phenotype of Li-Fraumeni Syndrome

In the past few years, some of the classic phenotypes and associated cancer risk estimates of inherited cancer syndromes have been questioned. This is due partly to increased access to genetic testing as well as to the availability of next-generation sequencing (NGS) panels for inherited cancer. Such panels allow researchers [ Read More ]

Cristi Radford, MS, CGC

Genetic Counseling

A Century of Medical Product Regulation:
The Historic Framework for Personalized Medicine in Oncology

Progress in personalized medicine is currently taking place within a system of governmental regulation that was largely created before the term was even coined. Today’s regulatory framework, directed primarily by the Food and Drug Administration (FDA) and a handful of other federal and state agencies, was created incrementally over the [ Read More ]

Michael Shea; Jeff Allen, PhD; Ellen Sigal, PhD

Value-Based Cancer Care

Personalizing Oncology Care and the Quest for Companion Diagnostics: A Researcher’s Perspective

An Interview with Suso J. Platero, PhD, of Janssen Pharmaceuticals

Today we interview Dr Suso J. Platero, whose research is probing the frontiers of next-generation sequencing, transcriptional profiling, and proteomics in the validation of biomarkers for lung cancers. In his 2009 book, Molecular Pathology in Drug Discovery and Development, Dr Platero makes the case for clinicians and researchers working together [ Read More ]

Suso J. Platero, PhD

Interview with the Innovators

The Wide Range of Topics Under the Personalized Care Umbrella

Dear Colleague, One important lesson we have learned from our work in personalizing care for oncology patients is that there are many more considerations in implementing care aside from the obvious premises of targeted therapies, companion diagnostics, and next-generation sequencing. There is an ever-broadening array of considerations that goes into [ Read More ]

Al B. Benson III, MD, FACP, FASCO

Letter to Our Readers