Value-Based Cancer Care Issues


January 2013, Vol 4, No 1

Ponatinib Produces High Response Rates in Hard-to-Treat Leukemia

Wayne Kuznar

ASH Annual Meeting

Atlanta, GA—The new oral tyrosine kinase inhibitor (TKI) ponatinib (Iclusig) has significant activity and is well tolerated in patients with highly pretreated chronic myeloid leukemia (CML) or with Philadelphia chromosome–positive acute lymphoblastic leukemia (Ph+ ALL) who otherwise lack therapeutic options. Twelve-month follow-up data from a pivotal phase 2 trial of ponatinib in this population were reported by Jorge E. Cortes, MD, Professor of Medicine and Deputy Chair, Department of Leukemia, at M.D. [ Read More ]

“Dramatic” Responses with Targeted Agent for Patients with CLL

Charles Bankhead

ASH Annual Meeting

Atlanta, GA—Targeting Bruton’s tyrosine kinase (BTK) in patients with chronic lymphocytic leukemia (CLL) resulted in high response rates, without severe toxicity, according to the results of 2 studies that were presented at the 2012 American Society of Hematology meeting.

Data from one trial showed a 70% response rate in 116 patients treated with ibrutinib and a 22-month survival of 96% in previously untreated patients and 76% in the subgroup with relapsed/refractory CLL.

[ Read More ]

Quality Oncology Practice Initiative Shows Strong Improvement in Some Care Measures

Caroline Helwick

ASCO’s 1st Quality Care Symposium

San Diego, CA—Adherence to several quality care standards markedly improved in practices participating in ASCO’s Quality Oncology Practice Initiative (QOPI) over a 4-year period, according to a study presented at ASCO’s inaugural 2012 Quality Care Symposium.

QOPI Participation Enhances Performance

The findings indicate that the oncology practices that participate in the QOPI are able to document significant and rapid improvement in their overall performance. Approximately 15% of US oncology practices are now participating in the QOPI.

[ Read More ]

Ponatinib Approved for CML and Ph+ ALL

FDA Approvals, News & Updates

The US Food and Drug Admin­istration (FDA) approved ponatinib (Iclusig; ARIAD Pharmaceuticals) under its accelerated program for the treatment of patients with chronic- phase (CP), accelerated-phase (AP), or blast-phase (BP) chronic myeloid leukemia (CML) that is resistant to or intolerant to tyrosine kinase inhibitor (TKI) therapy or to Philadelphia chromosome–positive (Ph+) acute lymphoblastic leukemia (ALL) that is resistant to or intolerant to TKI therapy. The recommended dose is 45 mg, taken orally once daily, with no regard to food.

[ Read More ]

Zytiga Receives New Indication for Metastatic Prostate Cancer before Chemotherapy

FDA Approvals, News & Updates

Using its priority review process, the FDA approved a new indication for abiraterone acetate (Zytiga; Janssen Biotech) for the treatment of patients with metastatic, castration-resistant prostate cancer (CRPC) before chemotherapy. The drug is already approved for patients with CRPC whose cancer progressed after receiving chemotherapy with docetaxel.

“Today’s approval demonstrates the benefit of further evaluating a drug in an earlier disease setting,” said Richard Pazdur, MD, Director of the Office of Oncology Drug Products.

[ Read More ]

Cometriq Only Second Drug Approved for Metastatic Medullary Thyroid Cancer

ASCO’s 1st Quality Care Symposium

Cabozantinib (Cometriq; Exelixis) is the second drug ever to be approved by the FDA for the treatment of patients with metastatic medullary thyroid cancer. Cabozantinib is a kinase inhibitor that blocks the abnormal kinase proteins that are involved in the development and growth of medullary cancer cells. Patients should not eat for at least 2 hours before and 1 hour after taking cabozantinib. Cabozantinib re­ceived an orphan drug designation.

[ Read More ]

Genomics Can Reduce Healthcare Disparities

Value Propositions

“Genomics can reduce uncertainty about the translation of population evidence to individual patients in 3 ways. First, the development of genomically targeted therapies ties the treatment decision to the results of a test for a specific genetic alteration in an individual patient, reducing uncertainty about who should be treated. Second, pharmacogenomics enables prediction of drug response from information about variation in metabolizing enzymes….” Katrina Armstrong, MD, MS. JAMA. Published online November 8, 2012

[ Read More ]

First Group to Test Nanoparticles for the Treatment of Lung Cancer

Value Propositions

Cancer Treatment Centers of America (CTCA) in Philadelphia, PA, is the first US center to investigate the use of nanotherapy for the treatment of metastatic lung cancer. The center is launching the first clinical trial using advanced nanotherapy developed by Nanospectra Biosciences, Inc, in Irvine, CA. The trial will allow oncologists to use AuroLase Therapy—a new approach to the treatment of solid tumors using laser energy to heat nanoparticles, which are absorbed by the tumor but not by healthy tissue.

[ Read More ]

Novel Drug Targets Aggressive Form of NHL, Avoiding Chemotherapy a Goal

Value Propositions

Diffuse large B-cell lymphoma (DLBCL) is the most common subtype of non-Hodgkin lymphoma (NHL) and a common type of cancer. Activated B-cell-DLBCL (ABC-DLBCL), the most chemotherapy-resistant form of DLBCL, poses a great therapeutic challenge. An international team has developed a new drug that targets this aggressive form of lymphoma. The drug, MI-2, is a small-molecule agent that irreversibly inactivates MALT1, a key protein that is responsible for driving the growth and survival of ABC-DLBCL cells.

[ Read More ]

Regenerative Medicine the Focus of Presidential Symposium

Mark Knight

ASH Annual Meeting

Atlanta, GA—The promise of regenerative medicine is exemplified by the regeneration of corneal epithelium from human limbal stem-cell culture.

The fields of regenerative medicine and hematology are relevant to one another, said Armand Keating, MD, Chair in Cell Therapy and Transplantation Director, Division of Hematology, University of Toronto, Canada and President of the American Society of Hematology (ASH) during the ASH 2012 Presidential Symposium, which focused on advances in regenerative medicine.

[ Read More ]

Ibrutinib: It’s Not Just for Leukemia

Audrey Andrews

ASH Annual Meeting

Atlanta, GA—The investigational agent ibrutinib, which is making news in the treatment of patients with leukemia, demonstrated “unprecedented” single-agent activity in patients with relapsed or refractory mantle-cell lymphoma (MCL), according to the lead author of an international phase 2 study that was reported at the 2012 American Society of Hematology meeting.

[ Read More ]

Ibrutinib: It’s Not Just for Leukemia

Audrey Andrews

ASH Annual Meeting

Atlanta, GA—The investigational agent ibrutinib, which is making news in the treatment of patients with leukemia, demonstrated “unprecedented” single-agent activity in patients with relapsed or refractory mantle-cell lymphoma (MCL), according to the lead author of an international phase 2 study that was reported at the 2012 American Society of Hematology meeting.

[ Read More ]

Rasburicase Cost-Effective for Tumor Lysis Syndrome

Caroline Helwick

ASH Annual Meeting

A study using real-world data for patients with tumor lysis syndrome (TLS) showed that treatment with rasburicase (Elitek) was associated with significantly greater reductions in uric acid, length of hospital stay, and total hospitalization costs per patient compared with allopurinol (Zyloprim).

TLS, which is a consequence of either tumor treatment or spontaneous tumor death, is an oncologic emergency. TLS can lead to renal failure, seizures, severe muscle weakness, tetany, cardiac arrhythmias, and death. The treatment options for TLS include allopurinol and rasburicase.

[ Read More ]

Oral Proteasome Inhibitor MLN9708 a News Maker at ASH 2012

Caroline Helwick

ASH Annual Meeting

Atlanta, GA—MLN9708, an investigational oral proteasome inhibitor, produced impressive results in a phase 1/2 clinical trial of treatment-naïve patients with multiple myeloma that was featured in a press briefing at the 2012 American Society of Hematology (ASH) meeting.

Used in combination with lenalidomide, MLN9708 achieved an overall response rate exceeding 90%, and complete responses were seen in 25% of patients, reported Shaji K. Kumar, MD, Professor of Medicine at the Mayo Clinic, Rochester, MN.

[ Read More ]

New Data Demonstrate Overall Survival Benefit with Pomalidomide in Advanced Myeloma

Caroline Helwick

ASH Annual Meeting

Atlanta, GA—Support for the oral immunomodulatory agent pomalidomide for the treatment of multiple myeloma took a giant step forward when new data from the phase 3 MM-003 trial showed a survival advantage in patients with advanced disease.

The data were reported at the 2012 American Society of Hematology meeting by Meletios Dimopoulos, MD, Professor and Chairman of the Department of Clinical Therapeutics at Alexandra Hospital in Athens, Greece.

[ Read More ]

Marker Helps Identify Most Aggressive Metastasized Breast Tumors

Rosemary Frei, MSc

ASH Annual Meeting

Boston, MA—Researchers believe they are closing in on a better way to identify breast cancers that are particularly dangerous and therefore require more aggressive therapy.

High levels of the proliferation marker Ki-67 in axillary lymph node metastases from a primary breast tumor are associated with reduced survival, according to a study presented at the American Society for Clinical Pathology’s 2012 meeting.

[ Read More ]

Marker Helps Identify Most Aggressive Metastasized Breast Tumors

Rosemary Frei, MSc

ASH Annual Meeting

Boston, MA—Researchers believe they are closing in on a better way to identify breast cancers that are particularly dangerous and therefore require more aggressive therapy.

High levels of the proliferation marker Ki-67 in axillary lymph node metastases from a primary breast tumor are associated with reduced survival, according to a study presented at the American Society for Clinical Pathology’s 2012 meeting.

[ Read More ]

Low Socioeconomic Status Impedes Access to Early-Phase Clinical Trial for Patients with Cancer

In the Literature

The topic of healthcare disparities has been receiving increased scrutiny lately, yet no studies have investigated the potential impact of the socioeconomic status of patients with cancer on their likelihood to enter an early-phase clinical trial. Ensuring access to clinical trials to all patients is important not only to ensure equal access to care but also to make sure that clinical trial results can be generalized to all patients in the real-world setting. [ Read More ]

Abiraterone versus Placebo before Chemotherapy for Patients with Metastatic Prostate Cancer

In the Literature

Metastatic castration-resistant prostate cancer (mCRPC) is associated with rapid deterioration and leads to mortality in this patient population within 2 to 4 years. The treatment options available for patients with mCRPC who have not received chemotherapy have been proved to produce response in these patients, but new options are needed that could prolong life or lead to tumor regression. A recent study compared the benefit of abiraterone acetate (Zytiga) with prednisone versus placebo plus prednisone for patients with mCRPC before chemotherapy (Ryan CJ, et al. N Engl J Med. [ Read More ]

Azacitidine Reduces Transfusions and Costs for Patients with High-Risk MDS

Caroline Helwick

Health Economics

Atlanta, GA—The use of azacitidine (Vidaza) in patients with high-risk myelodysplastic syndrome (MDS) is associated with the reduced need for red blood cell (RBC) transfusion and transfusion dependence, a report from the 2012 American Society of Hematology meeting showed.

“At 12 and 18 months after azacitidine treatment, there were 26% and 38% reductions in RBC transfusion costs, respectively, per patient compared with the 6 months before therapy,” said Eric Tseng, MD, Department of Hematology, University of Toronto, Ontario, Canada.

[ Read More ]

Genetic Testing with Oncotype DX for Women with DCIS Shown Cost-Effective in Independent Study

Health Economics

San Antonio, TX—In determining the optimal treatment of ductal carcinoma in situ (DCIS), gene expression profiling using the Oncotype DX DCIS Score is more cost-effective than standard clinical assessment, primarily because it avoids radiotherapy for approximately 66% of these patients.

That is the conclusion from an independent (non–industry-funded) study presented at the 2012 CTRC-AACR San Antonio Breast Cancer Symposium by Michael D. Alvarado, MD, Associate Professor, Department of Surgery, University of California School of Medicine, San Francisco.

[ Read More ]

A Call for Transparency in Drug Pricing

VBCC Perspectives

In the December 2012 issue of Value-Based Cancer Care (VBCC), several Editorial Board members addressed the recent events surrounding the cost of cancer drugs and the reduction of the price of ziv-aflibercept (Zaltrap). VBCC continued this discussion with Al B. Benson III, MD, FACP, FASCO.

[ Read More ]

Multidisciplinary Palliative Care Team at Johns Hopkins Achieves Reduction in ICU Utilization, Cost

Caroline Helwick

ASCO’s 1st Quality Care Symposium

San Diego, CA—A multidisciplinary team approach for discussing end-of-life issues with patients reduces the use of the intensive care unit (ICU) without shortening survival time, researchers from the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University said at ASCO’s inaugural 2012 Quality Care Symposium.

Multidisciplinary Support in End-of-Life Decisions

[ Read More ]

Black Women with Invasive Node-Negative Breast Cancer Less Likely to Get Sentinel Lymph Node Biopsy for Axillary Staging, More Likely to Have Lymphedema

Phoebe Starr

Breast Cancer

San Antonio, TX—Black women with clinically node-negative invasive breast cancer were less likely than white women to undergo sentinel lymph node biopsy (SLNB) for axillary staging and also were more likely to develop lymphedema, according to a study presented at the CTRC-AACR San Antonio Breast Cancer Symposium.

This study adds to the growing body of evidence documenting racial disparities in healthcare access.

[ Read More ]

Breast-Conserving Surgery Underutilized

Audrey Andrews

Breast Cancer

Vienna, Austria—Despite a robust response to neoadjuvant chemotherapy, which renders many early breast cancer tumors resectable, breast-conserving surgery is often overlooked in favor of mastectomy, according to an analysis of the Neo-ALLTO clinical trial, which was presented at the 2012 European Society for Medical Oncology Congress.

[ Read More ]

Axillary Ultrasound versus Sentinel Lymph Node Biopsy in Invasive Breast Cancer

Rosemary Frei, MSc

Breast Cancer

Vancouver, BC—In the aftermath of the Z0011 study from the American College of Surgeons Oncology Group, oncology centers across the United States are reexamining their approach to axillary management in breast cancer.

The Z0011 researchers determined that axillary lymph node dissection (ALND) is not beneficial in patients with T1 or T2 invasive breast cancer, 1 or 2 positive sentinel nodes, and breast-conserving therapy followed by whole-breast irradiation (Giuliano AE, et al. JAMA. 2011;305:569-575).

[ Read More ]

Investigational CDK Inhibitor Extends Remission Time

Breast Cancer

San Antonio, TX—The addition of an oral investigational agent to letrozole (Femara) for the treatment of estrogen receptor (ER)-positive metastatic breast cancer more than tripled the time spent in remission compared with endocrine therapy alone, according to a study reported at the CTRC-AACR San Antonio Breast Cancer Symposium.

[ Read More ]