Value-Based Cancer Care Issues


May 2013, Vol 4, No 4

For Florida Congress­woman with a History of Cancer, Genetic Patent Case Is Personal

Caroline Helwick

AVBCC Annual Conference

Hollywood, FL—For the first time, the Annual Conference of the Association for Value-Based Cancer Care (AVBCC) was addressed by a member of Congress. At this year’s conference, Congresswoman Debbie Wasserman Schultz, who represents Florida’s 23rd District (which encompasses Hollywood), shared her personal experience with cancer and took the opportunity to discuss the impact of exclusive licensing of genes and their related laboratory tests on patient outcomes. Ms Schultz is on the side of the consumer patient—because she is one.

[ Read More ]

Charting the Landscape of Driver Mutations in Acute Myeloid Leukemia

In the Literature

The role of acute myeloid leukemia (AML) mutations in the pathogenesis of the disease has not been fully understood, and many genomic mutations in AML remain unknown. A team of researchers has recently analyzed large databases of genetic mutations and has selected 200 adult cases of de novo AML for their new study, using a variety of methods of genomic sequencing (The Cancer Genome Atlas Research Network. N Engl J Med. 2013 May 1. [Epub ahead of print]).

[ Read More ]

Only 57% of Specialty Societies Consider Costs in Clinical Recommendations

In the Literature

Concerns for the cost implications of clinical decision-making by providers and health plans have increased significantly in the recent past, as well as the advice to consider cost in addition to efficacy as a part of the treatment paradigm. However, little research has been conducted to evaluate whether this concern has been reflected in the development of official clinical guidance issued by various medical groups and societies. [ Read More ]

Many Patients Unwilling to Let Costs Influence the Treatment They Receive

In the Literature

The issue of cost in clinical decision-making is increasingly becoming necessary in the face of growing healthcare costs, limited resources, and often limited access to care. Involving patients in the cost discussion has been suggested as a way to begin to curb the rising costs of care. A new study investigated the inclination of Americans with health insurance to discuss their willingness to have cost as part of the decision-making in their care (Sommers R, et al. Health Aff [Millwood]. 2013;32:338-346).

[ Read More ]

Powerful Algorithms Help Decipher the Genetics of Cancer

Value Propositions

Using data-sifting algorithms developed by computer scientists at Brown University, researchers are beginning to untangle the complex genetics of cancer. In a new study published in the New England Journal of Medicine, investigators have outlined the most complete genetic profile of acute myeloid leukemia (AML). This research is expected to lead to new treatments for AML based on the unique genetics of each patient. [ Read More ]

First Recipients of Bridge Grants to Support Hematologic Research Announced

Value Propositions

The American Society of Hematology (ASH) announced the first recipients of its new program, ASH Bridge Grants, that is designed to provide hematologists with research funding to mitigate the reduction in research support from the National Institutes of Health (NIH) as a result of the recent cuts to federal funding, including a $1.6-billion cut in 2013 and additional cuts that will take place during the next several years as a result of sequestration.

[ Read More ]

FDA Approves Lymphoseek for Breast Cancer and Melanoma

FDA Approvals, News & Updates

The US Food and Drug Admini­s­tration (FDA) approved the technetium Tc 99m tilmanocept ([Tc 99m], Lymphoseek Injection; Navidea Biopharmaceuticals)—a novel radioactive receptor-targeted tracer for intraoperative lymphatic mapping—for use in patients with breast cancer or melanoma who are undergoing surgery to remove tumor-draining nodes. Tc 99m is an imaging drug that helps locate lymph nodes; it is not a cancer imaging drug.

[ Read More ]

FDA Approves Lymphoseek for Breast Cancer and Melanoma

FDA Approvals, News & Updates

The US Food and Drug Admini­s­tration (FDA) approved the technetium Tc 99m tilmanocept ([Tc 99m], Lymphoseek Injection; Navidea Biopharmaceuticals)—a novel radioactive receptor-targeted tracer for intraoperative lymphatic mapping—for use in patients with breast cancer or melanoma who are undergoing surgery to remove tumor-draining nodes. Tc 99m is an imaging drug that helps locate lymph nodes; it is not a cancer imaging drug.

[ Read More ]

Ibrutinib Gets 3 Breakthrough Therapy Designations

FDA Approvals, News & Updates

In February 2013, the FDA granted Breakthrough Designation for ibrutinib (Johnson & Johnson) as monotherapy for the treatment of patients with 1 of 2 conditions—refractory or relapsed mantle-cell lymphoma or Waldenström’s macroglobulinemia— both of which are B-cell malignancies. In April 2013, the FDA granted ibrutinib a third Breakthrough Designation for the treatment of patients with chronic lymphocytic leukemia or small lymphocytic lymphoma with chromosome 17p deletion. (April 8, 2013)

[ Read More ]

Palbociclib Receives Breakthrough Therapy Designation

FDA Approvals, News & Updates

The FDA has granted a Break­through Therapy designation for the investigational drug palbociclib (PD-0332991; Pfizer)—an oral, selective inhibitor of cyclin-dependent kinases (CDKs) 4 and 6—for the potential treatment of patients with breast cancer. CDKs 4 and 6 are related kinases that enable tumor-cell progression, which enhances cell division and DNA replication. Inhibition of CDKs 4 and 6 with palbociclib has been shown to inhibit tumor-cell growth and DNA replication.

[ Read More ]

Confusion with Kadcyla’s Generic Name Linked to Medication Errors

FDA Approvals, News & Updates

The FDA warned healthcare professionals about potential medication errors resulting from confusion with the nonproprietary name for the recently approved breast cancer drug ado-trastuzumab emtansine (Kadcyla; also known as T-DM1).

The FDA noted that in various online publications and in different medical electronic systems the drug is sometimes referred to incorrectly as trastuzumab, which is the active ingredient in the older breast cancer drug Herceptin, which had a different dosing and a different treatment schedule.

[ Read More ]

Cancer Support Program Documents Savings

Caroline Helwick

Economics of Cancer Care

Hollywood, FL—A case management program for terminally ill patients with cancer can reduce cancer-related healthcare costs and extend hospice length of stay, according to an analysis of the Cancer Support Program (CSP) of Optum Health, a health services company, which was presented at the 2013 National Comprehensive Cancer Network® annual conference.

[ Read More ]

AACR Issues New Policy on Tobacco Use

Phoebe Starr

AACR Annual Meeting

Washington, DC—Tobacco use among patients with cancer is an important but often overlooked issue that requires intervention by oncology practices. In recognition of the problem and the gap between the need for intervention and the services delivered, the American Association for Cancer Research (AACR) issued a policy on tobacco use at its 2013 annual meeting.

[ Read More ]

Genetically Engineered T Cells for Childhood Leukemia

AACR Annual Meeting

Washington, DC—Although still in very early-phase testing in humans, the results of 2 small studies in children suggest that reinfusing autologous genetically engineered T cells can reverse acute lymphocytic leukemia (ALL) in children. Both studies were presented at the 2013 American Association for Cancer Research meeting.

All the children had run out of treatment options and were close to death; 2 had a remarkable recovery after T-cell therapy and remain in complete remission.

[ Read More ]

CMS’s Proposal to Severely Limit FDG-PET Use for Patients with Cancer Elicits Concern

Rosemary Frei, MSc

Health Policy

US oncologists and radiologists are waiting to see whether the Centers for Medicare & Medicaid Services (CMS) will reconsider its proposal to limit the use of and reimbursement for fluorodeoxy­glucose-positron emission tomography (FDG-PET) scan after initial anti­cancer therapy to 1 scan in patients with solid tumors (with the exception of patients with prostate cancer, who will not be reimbursed for any FDG-PET scans).

[ Read More ]

Novel Immunotherapy Approach Encouraging in Advanced Ovarian Cancer

Phoebe Starr

Ovarian Cancer

Washington, DC—A 2-step immunotherapy approach holds promise for women with advanced recurrent ovarian cancer, a disease that has limited therapeutic options. The 2 steps entail a personalized dendritic-cell vaccine, followed by adoptive T-cell therapy. In an early study reported at the 2013 American Association for Cancer Research (AACR) annual meeting, almost 66% of patients derived clinical benefit from the vaccine alone, and the use of both therapies achieved approximately a 75% benefit.

[ Read More ]

AUA Revises Its Guidelines for Prostate Cancer PSA Screening

Charles Bankhead

Prostate Cancer

San Diego, CA—Prostate cancer screening with prostate-specific antigen (PSA) tests should focus on men aged 55 to 69 years, the group that is the most likely to benefit from screening, according to a new clinical guideline issued by the American Urological Association (AUA) at its 2013 annual meeting. This represents a significant shift from the previous position held by the AUA for strong support of PSA screening for men of all age-groups.

[ Read More ]

Tumor Subtype Fails to Explain Racial Disparity in Breast Cancer Survival

Charles Bankhead

Personalized Medicine

Washington, DC—Black women had worse survival across all breast cancer subtypes, indicating that the survival disparity compared with white women cannot be blamed entirely on more frequent diagnosis of less treatable subtypes, based on data from a breast cancer survivor study.

Consistent with previous data, black women more often had difficult-to-treat triple-negative breast cancer and were less likely than white women to have the more treatable luminal A subtype. Mortality was twice as high in blacks as in whites, as documented in most studies.

[ Read More ]

Gene Expression May Simplify Search for Effective Therapy in Head and Neck Cancer

Charles Bankhead

Personalized Medicine

Washington, DC—Therapeutic development in head and neck cancer could eventually hone in on a handful of gene-expression patterns and signaling pathways that can identify a few discrete subtypes of the disease, data from The Cancer Genome Atlas suggest.

Sequencing of the entire tumor genome of 279 patients revealed 18 frequently mutated genes, of which expression patterns in squamous-cell carcinoma of the head and neck have simplified the search for new, more effective therapies.

[ Read More ]

Higher HER2 Expression Leads to Better Outcomes with T-DM1 in Patients with Metastatic Breast Cancer

Phoebe Starr

Personalized Medicine

Washington, DC—Among women with HER2-positive metastatic breast cancer, patients with the highest expression of HER2 had the best outcomes in treatment with ado-trastuzumab emtansine (T-DM1; Kadcyla), according to a biomarker analysis of the phase 3 EMILIA trial which was presented at the 2013 American As­sociation for Cancer Research annual meeting. Furthermore, the analysis showed that T-DM1 achieved superior outcomes in all patients who were enrolled in the trial versus patients who received capecitabine (Xeloda) plus lapatinib (Tykerb).

[ Read More ]

Liquid Biopsy Improves Detection of Secondary GIST Mutations Causing Drug Resistance

Charles Bankhead

Personalized Medicine

Washington, DC—Analysis of circulating DNA provides information about secondary mutations that cause drug resistance in patients with previously treated gastrointestinal stromal tumors (GISTs), reported George D. Demetri, MD, Director of the Center for Sarcoma and Bone Oncology, Dana-Farber Cancer Institute, Boston, at the 2013 American Association for Cancer Research meeting.

[ Read More ]

No Loss of Efficacy with Anthracycline-Free Induction for Acute Lymphoblastic Leukemia

Charles Bankhead

Hematologic Malignancies

Children with acute lymphoblastic leukemia (ALL) had no drop-off in efficacy with an anthracycline-free regimen that also reduced the long-term risk of cardiotoxicity, reported Andre Baruchel, MD, PhD, Chief of Pediatric Hematology, Robert Debré University Hospital, Paris, France.

Induction therapy without daunorubicin (Cerubidine) led to a 5-year event-free survival (EFS) rate of almost 97%, slightly better than the rate observed in children who received conventional induction that included the anthracycline agent.

[ Read More ]

CHOP Disappearing as Standard of Care for Indolent NHL

Charles Bankhead

Hematologic Malignancies

A long-standing treatment standard for indolent non-Hodgkin lymphoma (NHL) has fallen victim to the chopping block, so to speak, at least in Germany.

The use of the cyclophosphamide (Cytoxan), doxorubicin (Adriamycin), vincristine (Oncovin), and prednisone (Deltasone; CHOP) regimen with or without rituximab (Rituxan; R-CHOP) has declined rapidly with the emergence of bendamustine (Treanda), which is used either alone or with ri­tuximab.

[ Read More ]