Value-Based Cancer Care Issues


February 2013, Vol 4, No 2

Infection Poses Lethal Risk Early in Patients with Multiple Myeloma

Charles Bankhead

ASH Annual Meeting

Atlanta, GA—Many patients with multiple myeloma succumb to infection before they have a chance to benefit from cancer therapy, according to a new study from Sweden.

More than 20% of patients died of infection within a year of myeloma diagnosis. Patients had heightened susceptibility to bacterial and viral pathogens, reported Cecilie Blimark, MD, a consultant hematologist at Sahlgrenska University Hospital, Gothenburg, Sweden, at the 2012 American Society of Hematology meeting.

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Nab-Paclitaxel Added to Gemcitabine Extends Survival in Patients with Metastatic Pancreatic Cancer

Mark Knight

GI Cancers Symposium

San Francisco, CA—A new “backbone” of therapy for metastatic pancreatic cancer could be the combination of nab-paclitaxel (Abraxane) and gemcitabine (Gemzar). When added to gemcitabine, weekly nab-paclitaxel improved survival in patients with advanced pancreatic cancer by nearly 2 months compared with gemcita­bine alone, said Daniel D. Von Hoff, MD, FACP, Physician in Chief and Director of Translational Research, Translational Genomics Research Institute, Phoenix, regarding the results of a large international phase 3 clinical trial.

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FDA Expedites Approval of Generic Version of Doxil

FDA Approvals, News & Updates

Drug shortages have hit the oncology community hard. Determined to alleviate the much-publicized drug shortage associated with doxorubicin hydrochloride liposome injection (Doxil; Janssen), the FDA expedited the approval of the first generic version of this agent, which is produced by Sun Pharma Global FZE (Sun). The FDA’s Office of Generic Drugs is using a priority review process to expedite the review of generic applications for drugs on its shortage list.

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New Medicare Rules Will Save Providers $676 Million Annually

Value Propositions

Removing Medicare regulations that are deemed unnecessary or unjustifiably burdensome on providers and hospitals would save nearly $676 million annually, and $3.4 billion over 5 years, through a rule proposed by the Centers for Medicare & Medicaid Services (CMS) in support of President Obama’s call on federal agencies to modify and streamline regulations on business.

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AACR Is Launching Cancer Immunology Research Journal

Value Propositions

The American Association for Cancer Research (AACR) has announced the launch of its newest online journal, Cancer Immunology Research, in the spring at the AACR 2013 annual meeting. The announcement was made in conjunction with the establishment of a new annual AACR–Cancer Research Institute (CRI) award of $10,000—the AACR-CRI Lloyd J. Old Award in Cancer Immunology. The goal is “to take tumor immunology from animal research into clinical research and develop promising new cancer therapies.” AACR press release; January 22, 2013

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HHS Allocates $1.9 Million to Establish Telehealth Programs for Underserved Populations

Value Propositions

The HHS has allocated $1.9 million for new telehealth regional resource centers to serve rural and medically underserved populations. Qualified regional centers will each receive a $325,000 grant through the Telehealth Resource Center Grant Program. These funds are targeted for healthcare organizations and healthcare networks that are establishing medical services programs via telemedicine to reach patients at rural and medically underserved areas of the country.

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New Approach to Treatment Resistance in Head and Neck Cancers

Value Propositions

The majority of head and neck tumors are associated with a deregulation of the PI3K/AKT/mTOR pathway, which has until now been seen as the culprit in treatment resistance in these cancers. However, new data recently published in Cancer Research show that this pathway is not necessarily the reason for tumor progression in this type of cancers. Because head and neck cancers are very heterogeneous, new research has focused on identifying the various drivers of tumor survival to understand why mTOR inhibitors only work in a few patients. [ Read More ]

New Antibody Targeting VEGF Receptor-2 Extends Survival in Advanced Gastric Cancer

Mark Knight

GI Cancers Symposium

San Francisco, CA—Ramucirumab as a second-line therapy extended overall and progression-free survival in a phase 3 clinical trial of patients with metastatic gastric cancer, said Charles S. Fuchs, MD, MPH, Director of the Center for Gastrointestinal Cancer at Dana-Farber Cancer Institute, Boston, and Professor of Medicine at Harvard Medical School, at the 2013 Gastrointestinal Cancers Symposium.

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Mayo Clinic Researchers Propose Screening Algorithm for HER2 in Patients with Esophageal Cancer

Caroline Helwick

GI Cancers Symposium

San Francisco, CA—The preferred screening test for human epidermal growth factor receptor (HER)2 stat­us in surgical esophageal adenocarcinoma specimens is immunohistochemistry (IHC), with fluorescence in situ hybridization (FISH) restricted to cases with an indeterminate (2+) IHC score, according to investigators from the Mayo Clinic, Rochester, MN, who proposed a testing algorithm at the 2013 Gastrointestinal Cancers Symposium.

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Costs of Second-Line Metastatic Colorectal Cancer Treatments Compared

Caroline Helwick

Health Economics

San Francisco, CA—For the second- line treatment of patients with metastatic colorectal cancer (CRC), the total costs were 14% lower with bevacizu­mab (Avastin) than with cetuximab (Erbitux), according to an analysis presented at the 2013 Gastrointestinal Cancers Symposium.

The study was presented by Elaine Yu, PharmD, of Genentech. The analysis was conducted using the UnitedHealthcare claims database and Medicare Advantage plan of patients who had 2 claims for CRC at least 30 days apart between 2007 and 2011, and evidence of 2 lines of therapy.

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Most Women Not Willing to Pay for Genetic Breast Cancer Testing

Caroline Helwick

Health Economics

San Antonio, TX—Direct-to-consumer (DTC) genetic testing using single nucleotide polymorphisms (SNPs) is of interest to women who are concerned about breast cancer; however, these women are unwilling to pay the current costs, researchers from the Department of Surgery and Institute for Health Policy Studies, University of California, San Francisco (UCSF), Medical Center, reported at the 2012 CTRC-AACR San Antonio

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The Importance of Prioritizing Palliative Care in Oncology: How Payers Can Assist Providers

Ellen Licking; John Whang, MD, FACC; Rhonda Greenapple, MSPH, Reimbursement Intelligence

VBCC Perspectives

Too often, palliative care, which was officially recognized as a medical specialty in 2006, is mistakenly thought to be synonymous with hospice care. Although palliative care includes the coordination of care for patients at the end of their lives, it more broadly aims to reduce patient suffering and is available to all patients with serious disease. It is designed to be given alongside active care, and certain chemotherapies have important palliative properties, including reduction in pain and nausea and improved quality of life (QOL) by the use of more tolerable dosing mechanisms.

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A New Multigene Score Identifies Women with ER-Positive Breast Cancer at Risk for Late Metastases

Phoebe Starr

Personalized Medicine

San Antonio, TX—A multigene score called EndoPredict can help to identify women with estrogen receptor (ER)-positive/HER2-negative breast cancer who are likely to develop metastatic disease in the long-term. EndoPredict is different from other multigene assays in its ability to predict late, rather than earlier, metastases, noted lead investigator Peter C. Dubsky, MD, Associate Professor, Department of Surgery, Medical University of Vienna, Austria, who presented results of a recent study at the 2012 CTRC-AACR San Antonio Breast Cancer Symposium.

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Women with Triple-Negative Breast Cancer Very Likely to Carry BRCA1 Gene

Phoebe Starr

Personalized Medicine

San Antonio, TX—Triple-negative breast cancer (TNBC) was strongly associated with BRCA1 status, but not with BRCA2 status, in a large study of medically insured women. The study showed that the number of patients with BRCA mutations with a TNBC profile is statistically significant.

Findings from a poster presented at the 2012 Annual CTRC-AACR San Antonio Breast Cancer Symposium suggest that patients with TNBC should be referred to a genetics counselor for further evaluation and possible genetic testing.

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Preventive Therapy Preserves Sexual Function after Radiotherapy for Patients with Prostate Cancer

Charles Bankhead

Prostate Cancer

Boston, MA—Patients with prostate cancer reported significantly better sexual function for up to 2 years after radiation therapy when they took sildenafil (Viagra) on a daily basis during and after treatment, according to results of a placebo-controlled clinical trial.

Scores on the erectile function domain of the International Index of Erectile Function (IIEF) remained significantly better with sildenafil compared with placebo throughout the follow-up.

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Time to Review Practice Policies: HIPAA Privacy and Security Regulations Released

Ross D. Margulies, JD, MPH; Jayson Slotnik, JD, MPH

Health Policy

On January 17, 2013, nearly 3 years after its initial proposed rule, the US Department of Health and Human Services (HHS) issued the long-awaited and much- anticipated HIPAA “omnibus” rule, extending the scope of the privacy law beyond providers to their business associates and subcontractors and adding increased penalties.1 Regulated entities must be in compliance with the new rules by September 22, 2013, although covered entities and business associates will have up to 1 year after the 180-day compliance date to modify existing contracts to comply with these revised [ Read More ]

Ruxolitinib Treatment Reduces Myelofibrosis Symptoms, Spleen Size

Wayne Kuznar

ASH Annual Meeting

Atlanta, GA—Ruxolitinib (Jakafi) alleviates symptoms such as fever, headache, weight loss, and fatigue, and reduces spleen size in patients with myelofibrosis. This finding, by the French Intergroup of Myeloproliferative Neoplasms (FIM), confirms those from the COMFORT-I and COMFORT-II trials, in which significant reductions in spleen volume were observed with ruxolitinib at weeks 24 and 48.

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Drugs to Reduce Breast Cancer Risk Are Rarely Used Show Data from Geisinger Health System

Caroline Helwick

Breast Cancer

San Antonio, TX—The uptake of US Food and Drug Administration (FDA)-approved drugs for risk reduction of breast cancer is still poor, as was confirmed by a study using the electronic health records (EHRs) from Geisinger Health System in Danville, PA. The researchers described the process of identifying women who are at increased risk for breast cancer and the use of risk-reducing drugs at the 2012 CTRC-AACR San Antonio Breast Cancer Symposium.

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Real-World Evidence Shows Impact of Musculoskeletal Toxicity of Aromatase Inhibitors on Women with Breast Cancer

Phoebe Starr

Breast Cancer

San Antonio, TX—Studies have suggested that musculoskeletal toxicity associated with aromatase inhibitor therapy can lead to noncompliance in up to 33% of women with breast cancer. A new, large cohort study at a single regional cancer center showed that the rate of musculoskeletal toxicity in women with early breast cancer who were treated with endocrine therapy was 64%.

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Ponatinib: New Option for the Treatment of Adults with CML or Ph+ ALL that Is Resistant or Intolerant to Previous Therapy with Tyrosine Kinase Inhibitors

Lynne Lederman, PhD, Medical Writer

Drug Updates

Leukemias are cancers involving the bone marrow and blood, and they account for approximately 4% of cancer deaths.1 The majority of leukemias occur in adults aged >20 years, and the incidence is higher in men than in women. Leukemias are classified by the type of cell involved (ie, lymphocytic or myeloid) and the rate of progression (ie, acute or chronic). Chronic myeloid leukemia (CML) and acute lymphocytic leukemia (ALL) account for approximately 2.5% and 6%, respectively, of deaths resulting from leukemia.1

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Gene-Expression Profiling May Help Select Best Drugs for Pancreatic Cancer

Caroline Helwick

GI Cancers Symposium

San Francisco, CA—Gene-expression profiling (GEP) of circulating tumor cells (CTCs) may help to personalize chemotherapy for patients with pancreatic cancer by predicting how patients will respond to certain treatments, according to a study reported at the 2013 Gastrointestinal Cancers Symposium.

The approach described combines an assay for CTCs with a pharmaco­genomic model that examines a patient’s genetic response to chemotherapy regimens.

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