Oncology NEWS International Vol 15 No 12

Best Rx Most Cost-Effective: RTOG

December 01, 2006

In RTOG 9111, a randomized phase III trial in locally advanced laryngeal cancer, there was no difference in overall survival between the three arms, but disease-free survival, locoregional control, and preservation of the larynx were better in patients receiving induction chemotherapy plus radiation or concurrent chemoradiation, compared with radiation therapy alone.

Grape Seed Found to Be a Natural Aromatase Inhibitor

December 01, 2006

Grape seed extract was effective in inhibiting the enzyme aromatase in both cell culture and animal studies, according to researchers from the City of Hope, Duarte, California. A phase I prevention trial is now underway to test whether this extract lowers estrogen levels in healthy postmenopausal women, and, if so, which dose is the most effective

Drug Combination Prevents ER-Negative Tumors in Mice

December 01, 2006

Two experimental drugs used together were shown to be far more effective than either alone in preventing the development of estrogen-receptor-negative (ER-) breast tumors in mice, Karen Liby, PhD, a postdoctoral fellow at Dartmouth Medical School, said at the AACR's Frontiers in Cancer Prevention Research meeting (abstract PR-08). One of the drugs, LG100268, developed by Ligand Pharmaceuticals, Inc., San Diego, California, is a rexinoid, which binds to retinoid X receptors. Known as 268, the agent has previously been reported to be effective in preventing and treating mammary tumors in animal models of ER+ breast cancer.

Democrats' Agenda May Stifle Efforts for More Ca Funding

December 01, 2006

With the Democrats taking control of the House and Senate in January, expectations have escalated for budget increases for biomedical research, especially at the National Cancer Institute (NCI), and a change in the restrictive policies governing embryonic stem cell research. But whether and to what extent the next Congress can turn these expectations into reality remains an open and contentious question.

No Loss of Efficacy With Synchronous Chemotherapy/ESP

December 01, 2006

Synchronized every-3-week delivery of myelosuppressive chemotherapy and an erythropoiesis-stimulating protein (ESP) to prevent chemotherapy-induced anemia is convenient for patients and feasible using darbepoetin alfa (Aranesp), but researchers have worried that it could affect efficacy and safety, since myelosuppressive chemotherapy is known to be associated with a rapid and transient increase in circulating erythropoietin levels.

'Share Care' Difficult for Ca Survivors and Their Oncologists

December 01, 2006

Just how are new plans to share care of cancer survivors being greeted by oncologists, primary care physicians, and patients? Some speakers on a cancer survivorship panel at the Second Annual Oncology Congress said it would be a big adjustment.

Biomarkers Panel Promising for Detecting Pancreatic Ca

December 01, 2006

A panel of 10 biomarkers found in the blood may prove to be useful in detecting asymptomatic pancreatic cancer, according to researchers at the University of Pittsburgh School of Medicine. "With median survival rates of 6 to 12 months, early detection of pancreatic cancer is crucial to patient survival, but there has been no way to diagnose it early before symptoms occur," Anna E. Lokshin, PhD, associate professor of medicine and pathology, said at the American Association of Cancer Research's Frontiers in Cancer Prevention Research meeting

Preop Avastin/Tarceva in RCC

December 01, 2006

Treating metastatic renal cell carcinoma (RCC) prior to surgery with Avastin (bevacizumab) and Tarceva (erlotinib) appears safe, effective, and may prolong patient survival, researchers reported at the EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics (abstract 250). Although the two agents have been tested previously as postoperative treatment for the disease, the new data provide the first evidence that presurgical treatment with the drugs may improve patient outcomes.

Reovirus Agent Shows Activity in Phase I Trial

December 01, 2006

Results from Oncolytics Biotech's phase I trial of Reolysin, its oncolytic reovirus, show stable disease in 7 of 32 patients with advanced or metastatic solid tumors refractory to standard therapy or for which no curative standard therapy exists. Dr. Timothy Yap of The Institute of Cancer Research, Sutton, UK, presented the study at the 18th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics

Eisai Acquires Four Oncology- Related Products From Ligand

December 01, 2006

Eisai Inc., the US subsidiary of Tokyo-based Eisai Co. Ltd., has completed acquisition of four oncology-related products from Ligand Pharmaceuticals: Ontak (denileukin diftitox), Targretin (bexarotene) capsules, Targretin (bexarotene) gel 1%, and Panretin (alitretinoin gel 0.1%. In other news, the company said it has begun work on a new oncology facility in Research Triangle Park, North Carolina.

Genetic Brain Tumor Study Gets $11 Million NCI Grant

December 01, 2006

The National Cancer Institute (NCI) recently awarded The University of Texas M.D. Anderson Cancer Center $11 million to lead the largest genetic study ever conducted on the causes and risk factors of adult and pediatric gliomas. Melissa Bondy, PhD, professor of epidemiology and director of the Childhood Cancer Epidemiology and Prevention Center, is principal investigators of the "Gliogene" study.

Postoperative RT Boosts Survival in N2 Lung Ca Patients

December 01, 2006

Postoperative radiotherapy, added to adjuvant cisplatin-based chemotherapy, resulted in a near-doubling of median survival in patients with completely resected non-small-cell lung cancer (NSCLC), compared with chemotherapy alone—but only in the presence of mediastinal lymph node involvement (N2 disease).

ACCC Weighs in on Critical Cancer Care Issues:

December 01, 2006

Since 1974, the Association of Community Cancer Centers (ACCC) has been a leading education and advocacy organization in US oncology. Its membership includes more than 650 cancer programs, 250 physician-group practices, and thousands of nurses, pharmacists, and administrators. Cancer Care & Economics (CC&E) recently spoke with Christian Downs, JD, MHA, executive director of ACCC, about some of today's more challenging cancer care issues.

Treatment Strategies Needed for Subpopulations of Colorectal Cancer Patients

December 01, 2006

Clinicians need to develop treatment strategies for subpopulations of patients with colorectal cancer, according to Richard Goldberg, MD, professor of medicine and division chief of hematology-oncology, University of North Carolina School of Medicine, Chapel Hill. He spoke at the 2006 Gastrointestinal Oncology Conference, sponsored by the International Society of Gastrointestinal Oncology.

Oblimersen Added to DTIC Ups Survival in Melanoma

December 01, 2006

At follow-up of more than 2 years, the largest study ever conducted in patients with advanced melanoma has continued to show a trend toward improved survival and a near-doubling of both progression-free survival (PFS) and durable response rates when the targeted antisense drug oblimersen sodium (G3139, Genasense) was added to standard therapy with the alkylating agent dacarbazine (DTIC).

Study Raises Questions About 'Wait & Watch' for Medium-Size Polyps

December 01, 2006

A study published in the December issue of Gastroenterology has shown that medium-sized polyps found in the colon with flexible sigmoidoscopy and subsequently evaluated by full colonoscopy are associated with a significant number of advanced adenomas and cancers.

Still No Risk Group Found That Can Avoid RT After Lumpectomy

December 01, 2006

After 8 years' follow-up, tamoxifen plus breast radiation resulted in a lower rate of ipsilateral breast relapse than tamoxifen alone in women over 50 with early-stage, node-negative breast cancer treated initially with lumpectomy

Panitumumab Responses in Refractory Colorectal Cancer

December 01, 2006

In clinical trials of panitumumab (Vectibix), 8% to 13% of patients with refractory colorectal cancer achieved a partial tumor response with the drug, according to data from five studies reviewed at the 2006 Gastrointestinal Oncology Conference. The meeting was sponsored by the International Society of Gastrointestinal Oncology.

Epirubicin/CMF Better Than CMF Alone in Early Breast Ca

December 01, 2006

At 48 months' follow-up, adjuvant treatment of early breast cancer with epirubicin (Ellence) plus CMF showed significantly improved relapse-free and overall survival, compared with CMF alone, according to combined results of two large randomized studies. Christopher J. Poole, MD, of the University of Birmingham, and his colleagues reported the results in the New England Journal of Medicine

Industry/Government Alliance Needed for Clinical Trials

December 01, 2006

Industry and government need to form a new alliance to more efficiently conduct clinical trials, Howard Hochster, MD, professor of medicine, New York University Medical Center, said at the 2006 Gastrointestinal Oncology Conference, sponsored by the International Society of Gastrointestinal Oncology.

Pharmion Purchases Cabrellis, US Developer of Amrubicin

December 01, 2006

Pharmion Corporation has acquired Cabrellis Pharmaceuticals and gained US and European rights to amrubicin, a third-generation synthetic anthracycline currently in phase II trials for small-cell lung cancer in North America and Europe.

Three-Fourths of Breast Cancer Survivors Report CAM Use

December 01, 2006

Use of complementary and alternative medicine (CAM) is typically higher among cancer patients than the general population. Researchers from the Dana-Farber Cancer Institute further refined this observation by studying the use of CAM among women with varying degrees of breast cancer risk. Reporting at the Third International Conference of the Society for Integrative Oncology (abstract F075), they found that breast cancer survivors with a family history of cancer used significantly more CAM than the other groups.

Herceptin Approved for Adjuvant Use

December 01, 2006

Following a priority review, the US Food and Drug Administration (FDA) has approved Herceptin (trastuzumab for infusion, Genentech) in combination with three other agents for the adjuvant treatment of HER2-positive, node-positive breast cancer following lumpectomy or mastectomy.

Nursing Intervention Improves VTE Prophylaxis in GYN Onc Unit

December 01, 2006

Hospitalized oncology patients are at particular risk for acute venous thromboembolism (VTE); however, more often than not, a standard for VTE prophylaxis does not exist, according to Jerelyn Osoria, RN, OCN, of Memorial Sloan-Kettering Cancer Center. Ms. Osoria reported at the Oncology Nursing Society 31st Annual Congress (abstract 113) that an electronic medical orders system and better nursing documentation have helped improve this situation at her institution's Gynecology (GYN) oncology inpatient nursing unit.

Nodal Ratio Predicts Breast Cancer Recurrence, Survival

December 01, 2006

At the 48th Annual Meeting of the American Society for Therapeutic Radiology and Oncology (ASTRO), researchers presented two analyses showing that in node-positive breast cancer, the nodal ratio—the number of positive nodes divided by the number of nodes resected—is superior to the absolute nodal count as a clinical predictor of treatment outcomes.

Who Will Care for the Growing Number of Ca Survivors?

December 01, 2006

Who will watch over the burgeoning numbers of cancer survivors and provide the surveillance, general medical care, education, and psycho-social support that the upwards of 10 million survivors in America need and demand? Pilot programs and survivorship care guidelines may be shifting some responsibilities away from oncologists

Radiotherapy Shows Long-Term Benefit in Early Breast Ca

December 01, 2006

Most groups of women with early breast cancer who received radiotherapy after mastectomy in clinical trials conducted in the 1960s to 1980s continued to show fewer local recurrences and somewhat reduced breast cancer mortality after 15 years of follow-up, compared with controls who did not receive radiation, according to the latest analysis of the Early Breast Cancer Trialists Collaborative Group (EBCTCG).

AVEO Initiates Phase I Trial of AV-412 in Solid Tumors

December 01, 2006

AVEO Pharmaceuticals, Inc., has begun enrolling patients with advanced solid tumors in a phase I clinical study of AV-412, a next-generation oral tyrosine kinase inhibitor of EGFR and HER2. In preclinical studies, AV-412 has shown activity in various tumor models, has a toxicity profile similar to other molecules in its class, and has shown preclinical activity against tumor cells that are resistant to first-generation tyrosine kinase inhibitors, the company said in a press release.

Tykerb Gets Priority FDA Review

December 01, 2006

GlaxoSmithKline's New Drug Application for Tykerb (lapatinib), an oral small molecule dual inhibitor of EGFR and HER2, has been granted priority review by the FDA. The designation requires that the agency decide on a drug application no longer than 6 months after submission, which was September 18, 2006, for Tykerb. The Tykerb application is for treatment of advanced or metastatic HER2-positive breast cancer in combination with capecitabine (Xeloda) for patients who have received prior treatment.

FDA Approves the First Generic Versions of Ondansetron

December 01, 2006

The US Food and Drug Administration (FDA) has approved the first generic versions of Zofran (ondansetron, GlaxoSmithKline). Marketing approval has been granted to Teva Pharmaceuticals USA for ondansetron for injection and to SICOR Pharmaceuticals for ondansetron injection premixed.

Two 'Hot' New Targets in Colorectal Cancer

December 01, 2006

Two of the hottest targets in colorectal cancer are spurring "lots of enthusiasm," Lee M. Ellis, MD, professor of surgical oncology and cancer biology, The University of Texas M.D. Anderson Cancer Center, said at the 2006 Gastrointestinal Oncology Conference, sponsored by the International Society of Gastrointestinal Oncology. The two targets, c-Src and urokinase plasminogen activator receptor (uPAR), both play key roles in tumor metastases and migration.

Voters Approve Six of Eight State Anti-tobacco Initiatives

December 01, 2006

Big Tobacco found itself a big loser in the November elections as voters in five states approved six statewide ballot initiatives aimed at reducing the health threats of cigarettes and other tobacco products. Voters in two other states, however, turned down anti-tobacco proposals.

3D Volumetric Imaging Enhances RT Treatment Planning

December 01, 2006

A device that displays a holograph-like 3-dimensional (3D) image, created from a CT, MRI, or PET dataset, holds promise for more accurate radiotherapy treatment planning (see image on page 1). James C. H. Chu, PhD, professor of radiation oncology, Rush University Medical Center, presented results of a pilot study of the Perspecta Spatial 3D System, developed by Actuality Systems, Inc. (Bedford, Massachusetts), at the 48th Annual Meeting of the American Society for Therapeutic Radiology and Oncology

FDA Approves Two Silicone Gel-Filled Breast Implants

December 01, 2006

The FDA has approved the marketing of two silicone gel-filled breast implants, Inamed (Allergan) and MemoryGel (Mentor), for use in breast reconstruction in women of all ages and for breast augmentation in women ages 22 and older. The decision supporting the safety and efficacy of the devices came 14 years after FDA placed a moratorium on the use of silicone gel implants except in clinical trials because of concerns they might cause pain, deformity, connective tissue disease, and cancer if they ruptured. Saltwater-filled breast implants remained available.

M.D. Anderson Opens First-Ever IBC Clinic

December 01, 2006

The University of Texas M.D. Anderson Cancer Center has opened the first clinic in the world dedicated to the research and treatment of inflammatory breast cancer (IBC). The clinic, under the co-direction of Massimo Cristofanilli, MD, associate professor of breast medical oncology, and Thomas Buchholz, MD, professor of radiation oncology, is housed in the Nellie B. Connally Breast Center.

Aurora B Protein Is a New Target for Cancer Therapeutics

December 01, 2006

An innovative cancer agent called PHA-739358, which inhibits one of the aurora proteins, has shown indications of potential benefit in 7 of 36 patients (19.4%) with advanced or metastatic solid tumors who participated in a phase I dosing and toxicity study, Dutch researchers reported at the EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics

Taxane Regimens Equally Effective for Advanced Breast Ca

December 01, 2006

For women with advanced breast cancer, three taxane-based chemotherapy regimens that avoid the potentially cardiotoxic anthracyclines were all equally beneficial as first-line therapy in terms of survival and disease progression

Amgen VP Discusses 'Responsible Pricing' of New Cancer Drugs and Pharm-Sponsored Patient Assistance Programs

December 01, 2006

In today's cost-conscious health care environment, the pricing of cancer drugs has come under scrutiny from payers, providers, policy makers, and the public. Large pharmaceutical companies are often cast as the villain in this debate. In order to shed light on this issue, Cancer Care & Economics (CC&E) recently spoke with Joshua J. Ofman, MD, MSHS, vice president of reimbursement and payment policy at Amgen, one of the world's leading biotechnology companies.

Sorafenib Melanoma Trial Misses Primary Endpoint

December 01, 2006

Bayer Pharmaceuticals Corporation and Onyx Pharmaceuticals, Inc. (Emeryville, California) have announced that a phase III trial administering sorafenib (Nexavar) or placebo tablets in combination with carboplatin and paclitaxel in patients with advanced melanoma did not meet its primary endpoint of improving progression-free survival. The treatment effect was comparable in each arm.

FDA Gets New Analysis of Oblimersen CLL Study

December 01, 2006

Back in September, the FDA's Oncologic Drugs Advisory Committee (ODAC) failed to recommend that the agency grant accelerated approval to Genta's oblimersen (Genasense) plus chemotherapy (fludarabine/cyclophosphamide) for treatment of relapsed/refractory chronic lymphocytic leukemia (CLL).

Soy Consumption in Childhood May Decrease Breast Cancer Risk, Epidemiologic Study Suggests

December 01, 2006

Consuming soy during childhood, adolescence, and adult life is associated with a decreased risk of breast cancer, but the strongest and most consistent effect is childhood consumption, according to a recent collaborative study led by researchers from the National Cancer Institute (NCI)

Longer Androgen Deprivation Isn't Better, Study Suggests

December 01, 2006

In a study of high-risk prostate cancer treated with radical prostatectomy or radiation therapy, more than 6 months of androgen deprivation therapy was associated with higher mortality than shorter durations, Cliff Robinson, MD, reported at the 48th Annual Meeting of the American Society for Therapeutic Radiology and Oncology

RAV12 Monoclonal Antibody Promising in GI Cancers

December 01, 2006

In a phase I study, the chimeric monoclonal antibody, RAV12 (Raven biotechnologies inc) has shown preliminary evidence of efficacy in gastrointestinal (GI) tumors. Howard A Burris III, MD, director of drug development at the Sarah Cannon Cancer Center, Nashville, one of three centers where the trial is underway, spoke about the research at the Chemotherapy Foundation Symposium XXIV

Microspheres Studied as First-Line Therapy of Liver Mets

December 01, 2006

Sirtex is supporting a phase I trial of its SIR-Sphere microspheres as first-line therapy of liver metastases in patients with colorectal cancer in combination with chemotherapy (the FOLFOX-6 and FOLFIRI regimens). The principal investigator is Seza Gulec, MD, director of the Goshen Cancer Institute's Hepatic Oncology Program in Goshen, Indiana, where the trial is being conducted.

Trial Using CTCs to Make Therapy Decisions

December 01, 2006

Immunicon Corporation has announced that a major clinical trial using the CellSearch Assay has opened to enrollment. The randomized phase III trial (S0500), conducted by the Southwest Oncology Group (SWOG), is testing the strategy of changing therapy vs maintaining therapy for metastatic breast cancer patients who have elevated circulating tumors cells (CTCs) at first follow-up assessment. Immunicon will perform CTC testing for participating sites.