Oncology NEWS International Vol 15 No 1

FDA Approves Nexavar for Use in Advanced Kidney Cancer

January 01, 2006

The Food and Drug Administration (FDA) has approved Nexavar (sorafenib tosylate) tablets for the treatment of patients with advanced renal cell carcinoma. Nexavar, a multikinase inhibitor that has been shown to double progression-free survival in these patients, is the first FDA-approved treatment for this type of cancer in more than a decade, Bayer Pharmaceuticals Corporation and Onyx Pharmaceuticals, Inc.

Avastin Benefits Metastatic Breast Cancer

January 01, 2006

Bevacizumab (Avastin), a monoclonal antibody targeting vascular endothelial growth factor (VEGF), conferred additional benefit to paclitaxel when the combination was used as first-line therapy in locally recurrent and metastatic breast cancer patients in the Eastern Cooperative Oncology Group (ECOG) phase III E2100 study.

Amgen to Acquire Abgenix

January 01, 2006

THOUSAND OAKS, California—Amgen and Abgenix, Inc. (Fremont, California) have signed a definitive merger agreement under which Amgen will acquire Abgenix for approximately $2.2 billion in cash plus the assumption of debt. The acquisition of Abgenix provides Amgen with full ownership of one of its most important advanced pipeline products, panitumumab. The agent, which inhibits the epidermal growth factor receptor (EGFR), has shown significant improvement in progression-free survival for metastatic colorectal cancer patients who have failed standard chemotherapy (see ONI December 2005, page 14). Abgenix also brings to the merger its proprietary fully human monoclonal antibody technology, XenoMouse.

Better Prognosis for ‘Elsewhere' Local Breast Ca Recurrences

January 01, 2006

When breast cancer recurs locally after breast-conserving therapy, prognosis is better for patients whose recurrence is "elsewhere" in the breast than for those whose recurrence is in the primary tumor bed, new research shows. However, regardless of the type, control of the local recurrence is the most significant predictor of subsequent distant metastasis and survival.

Herceptin/Taxotere Ups DFS in Early HER2+ Breast Ca

January 01, 2006

The first interim results from the BCIRG 006 phase III trial showed that trastuzumab (Herceptin) combined with docetaxel (Taxotere)-based regimens significantly improved disease-free survival (DFS) in early HER2-positive breast cancer. Genetic studies further delineated a subgroup of patients for whom truly targeted therapy may be applied in the future.

NIH 2006 Budget Is Likely to Be Lower Than in 2005

January 01, 2006

Once again, the National Cancer Institute (NCI) faces the likelihood of an annual operating budget lower in actual dollars than the previous year. In the waning days of December 2005, Congress passed the budget for the Department of Health and Human Services (HHS) for fiscal year (FY) 2006, which began October 1, 2005.

Amooranin, a Plant Compound, Shows Potential as Cancer Treatment

January 01, 2006

Amooranin (AMR), derived from the Amoora rohituka stem bark, shows clinical potential in treating human cancers, Steven Melnick, MD, PhD, said at the Society for Integrative Oncology (SIO) annual meeting (abstract 57). Dr. Melnick, chief, Department of Pathology and Clinical Laboratories, Miami Children's Hospital, said that the Amoora rohituka stem bark is one of the components of a natural preparation used for the treatment of human malignancies in the Ayurvedic system of medicine in India. Derived from stem bark that grows wild in Asia, the preparation contains parts of three medicinal plants: Amoora rohituka stem bark, Glycyrrhiza glabra roots, and Semicarpus anacardium fruits.

Mesenchymal Stem Cell Transplantation Potential Novel Treatment for Patients With Severe Graft-vs-Host-Disease

January 01, 2006

For transplant patients with severe acute graft-versus-host disease (GVHD), a novel treatment option may be in the form of another transplant, this time with mesenchymal stem cells (MSCs), according to research presented at the American Society of Hematology annual meeting

FDA Launches 7 Initiatives With European Drug Regulators

January 01, 2006

Cancer drug regulators at the FDA and the European Medicines Agency (EMEA) have agreed to seven programs aimed at providing each agency with a better understanding of the basis of the scientific advice the other offers, as well as optimizing product development and avoiding unnecessary duplication. The seven initiatives resulted from an agreement finalized on Sept. 16, 2005, between the FDA, EMEA, and the European Commission, the executive body of the European Union.

Taxanes Comparable as Adjuvant Therapy of Breast Cancer; Weekly Paclitaxel More Effective Than q3wk

January 01, 2006

Docetaxel (Taxotere) and paclitaxel (Taxol) produced similar outcomes in the adjuvant treatment of breast cancer in the North American Breast Cancer Intergroup Trial E1199. Joseph Sparano, MD, profesor of medicine, Albert Einstein Cancer Center, Montefiore Medical Center, New York, presented the results as a late-breaking abstract at the 28th Annual San Antonio Breast Cancer Symposium (abstract 48).

Lessons From Ongoing Clinical Experience With MammoSite Breast Brachytherapy

January 01, 2006

Accumulating clinical experience with MammoSite breast brachytherapy is supporting its safety, efficacy, and good cosmetic outcomes, while also providing lessons to improve its use, according to a pair of studies presented at the 47th Annual Meeting of the American Society for Therapeutic Radiology and Oncology

Antibody Detects AML-Associated Stem Cells

January 01, 2006

The malignant stem cells believed to develop into cells associated with acute myeloid leukemia (AML) appear to be distinguishable from normal stem cells with the use of a novel antigen marker, Gerrit Jan Schuurhuis, PhD, said at the 2005 American Society of Hematology annual meeting (abstract 4). Dr. Schuurhuis is associate professor of hematology, VU University Medical Center, Amsterdam, The Netherlands.

Trial of Tykerb for HER2-Positive Breast Cancer Brain Mets Begins

January 01, 2006

SAN ANTONIO—GlaxoSmithKline has announced the initiation of a global multicenter phase II trial (known as EGF 105084) to evaluate Tykerb (lapatinib) for the treatment of ErbB2 (HER2)-overexpressing breast cancer that has metastasized to the brain. Tykerb is an orally bioavailable small molecule that potently inhibits two receptors, ErbB2 and ErbB1. It is currently in development as a first-line treatment for ErbB2-overexpressing breast cancer.

Len/Dex for Relapsed or Refractory Myeloma

January 01, 2006

Combination therapy with lenalidomide (Revlimid) plus dexamethasone (Len/Dex) appears to provide a survival advantage over dexamethasone alone in patients with relapsed or refractory multiple myeloma, according to a study presented at the 2005 annual meeting of the American Society of Hematology (abstract 6).

Encouraging Results With Ixabepilone in Metastatic Breast Ca

January 01, 2006

Recent clinical studies from the National Cancer Institute (NCI) show that the macrolide analog ixabepilone (BMS-247550) is effective in treating metastatic breast cancer, is less susceptible to resistance than paclitaxel, and is associated with much lower rates of peripheral neuropathy than the taxanes.

RT Proves Beneficial Even in Favorable Early Breast Cancer

January 01, 2006

Radiation therapy (RT) reduces the risk of breast cancer recurrence even in women with favorable early disease, researchers reported at the 47th Annual Meeting of the American Society for Therapeutic Radiology and Oncology (abstract 3). Although recurrence was uncommon with combined breast-conserving surgery and hormonal therapy, it was one-half less common when whole-breast radiation therapy was further added to treatment.

Zensana, Ondansetron Oral Spray, Enters Pivotal Trials

January 01, 2006

SOUTH SAN FRANCISCO, California—Hana Biosciences has received FDA clearance for its Investigational New Drug Application for Zensana (ondansetron oral spray) to prevent chemotherapy-induced nausea and vomiting. In a press release, Hana said it is initiating a series of pivotal pharmacokinetic trials, including comparison of Zensana with ondansetron tablets (Zofran). Zensana is the first multidose oral spray 5-HT3 antagonist. Patients experiencing nausea and vomiting have difficulty swallowing and holding down pills. Zensana delivers full doses of ondansetron. In addition, drug delivery via a spray to the oral mucosa avoids degradation in the gastrointestinal tract and metabolism by liver enzymes.

Oncology Nursing: Quo Vadis? A 30-Year Perspective

January 01, 2006

The myriad changes that oncology physicians have experienced in the last 20 years are certainly applicable to oncology nurses, in particular, the technology explosion and its effects on diagnosis, treatment, and survivorship; the emergence of cancer as a disease of the elderly; challenges posed by shortages of health care workers; and the fact that almost all cancer patients today are treated as outpatients. Recent therapeutic innovations and management approaches have been keenly felt by oncology nurses, who typically play a major role in patient education.

Lung Cancer Patient Fights for Social Security Disability Benefits

January 01, 2006

This case study illustrates some of the nonmedical issues your cancer patients often encounter, particularly when they are unable to return to work as a result of their disease or its treatment. Questions about disability benefits are something you may have to face on a regular basis. For patients, pursuing disability benefits is often a rocky road that is difficult to navigate even without the added burden of dealing with a cancer diagnosis. This case study portrays how you can help your patients deal with such issues and what resources are available to them.

Standard Measures, Improved Collection of Data Needed to Increase Quality of Ca Care

January 01, 2006

A 1999 Institute of Medicine (IOM) report, "Ensuring Quality Cancer Care," suggested that many cancer patients in the United States are not receiving the care known to be effective for their disease. The IOM committee recommended a number of remedial steps including the development of a national quality care monitoring system. CC&E spoke with Eric C. Schneider, MD, assistant professor of health policy and management, Harvard School of Public Health, and assistant professor of medicine, Harvard Medical School, about, among other things, the ongoing initiatives to link quality care performance measures to the delivery and reimbursement of oncology services.

Code Gray at LSU's University Hospital in New Orleans

January 01, 2006

On the weekend before Hurricane Katrina struck, Gabriela Ballester, MD, was the hematology/oncology fellow on call for LSU patients at University Hospital (part of the Medical Center of Louisiana at New Orleans, along with Charity Hospital). She shared her story in a telephone interview with ONI.

3D Digital Breast Tomosynthesis Provides Clearer Picture of Breast Anatomy Than Does Standard Mammography

January 01, 2006

Based on their initial experience with 3D digital breast tomosynthesis, radiologists at Dartmouth Hitchcock Medical Center and Dartmouth Medical School believe the investigational technique "is closer to the truth than standard mammography," Steven Poplack, MD, associate professor of diagnostic radiology and obstetrics and gynecology, said at the 2005 meeting of the Radiological Society of North America (abstract SSG01-05).