Oncology NEWS International Vol 16 No 6

ACS Launches Major Epidemiology Study

June 01, 2007

The American Cancer Society (ACS) is launching a 20-year cancer epidemiology study of 500,000 cancer-free adults across the United States. Cancer Prevention Study 3 (CPS-3) will enroll geographically and ethnically diverse participants at 64 of the 4,800 ACS-sponsored Relay for Life events taking place across the country in 2007, and it will continue the accrual process at select Relay events through 2011.

Pt Selection Key to Radioembolization of Liver Ca's

June 01, 2007

Therapy via radioembolization improves outcomes in some patients with primary or metastatic liver tumors that are unresectable or refractory to chemotherapy, and research is helping to better identify these patients upfront

Million Dollar Gotham Prize Announced

June 01, 2007

A group of leading scientists and hedge fund managers have announced the annual $1 million Gotham Prize for Cancer Research, which is being launched to accelerate progress in the prevention, diagnosis, and treatment of cancer by fostering collaboration among top researchers in the field.

Velcade/Doxil Approved for Relapsed or Refractory Multiple Myeloma Pts

June 01, 2007

The US Food and Drug Administration (FDA) has approved the use of Doxil (doxorubicin liposome injection, Ortho Biotech) in combination with Velcade for Injection (bortezomib, Millennium) to treat patients with multiple myeloma who have not previously received Velcade and have received at least one prior therapy.

Junovan Fails to Win ODAC Nod for Osteosarcoma Treatment

June 01, 2007

The Oncologic Drugs Advisory Committee (ODAC) voted 12-to-2 not to recommend that FDA approve Junovan (mifamurtide, IDM Pharma) for treating newly diagnosed, resectable high-grade osteosarcomas in combination with chemotherapy following surgical resection.

ODAC: orBec Yields No 'Substantial Efficacy' in GI GVHD

June 01, 2007

The FDA's Oncologic Drugs Advisory Committee (ODAC) voted 7-to-2 that the data presented by DOR BioPharma in support of its new drug application for orBec (beclomethasone dipropionate) failed to demonstrate substantial efficacy for orBec for its intended purpose

Gene Expression Profiles of HCC Revealed on CT Scans

June 01, 2007

Researchers at Stanford and the University of California, San Diego (UCSD) have decoded the gene expression profiles of hepatocellular carcinomas (HCCs) noninvasively using the radiographic features of the tumors as seen on three-phase contrast-enhanced CT scans

Best Measure of Lung Cancer Screening: Curability or Mortality?

June 01, 2007

Although any steps taken to prevent cancer require many years before they influence outcomes, clinical investigators typically do not consider the time lag needed for prevention to elicit a measurable effect on life and health, opting instead to assess mortality in the short term

New Labeling Restrictions for ESAs: ODAC

June 01, 2007

The Food and Drug Administration (FDA) should require additional restrictions in product labeling and/or additional clinical trials before approving new erythropoiesis-stimulating agents (ESAs) or new indications for ESAs already on the market, the Oncologic Drugs Advisory Committee (ODAC) told the agency.

Vaccine & New TKI in Early-Stage Lung Cancer Trials

June 01, 2007

While pharmaceutical companies are actively engaged in the development of new drug treatments for cancer, the number of drugs eventually approved by the US Food and Drug Administration for oncology has declined.

New Breast Cancer Vaccine Strategy Effective in Mice

June 01, 2007

Repetitive injections of a synthetic peptide vaccine in combination with a strong adjuvant prevented spontaneous tumors and caused established tumors to regress in a mouse model of HER2/neu breast cancer

Cougar Biotechnology Reports Positive Data on CB7630

June 01, 2007

LOS ANGELES—Cougar Biotechnology, Inc.'s CB7630 (abiraterone acetate) was well tolerated at doses as high as 2,000 mg/d with minimal toxicity in a phase I/II trial of chemotherapy-naive patients with castration-refractory prostate cancer, who had progressive disease despite treatment with LHRH analogs and multiple other hormonal therapies. Of 30 evaluable patients, 18 (60%) had a confirmed decline in PSA of greater than 50%, while 10 (33%) had declines greater than 90%. Of 20 evaluable patients with measurable lesions, 11 (55%) had a partial radiological response, while 7 had ongoing stable disease and 3 had regressing bone disease. The data were presented at the American Urological Association (AUA) annual meeting.

Approvable Letter for Emend for Injection

June 01, 2007

Merck & Co., Inc. announced that it has received an approvable letter from the US Food and Drug Administration (FDA) for the company's New Drug Application (NDA) for Emend (fosaprepitant dimeglumine) for Injection, also known as MK-0517, an investigational intravenous therapy for chemotherapy-induced nausea and vomiting.

Colonoscopy With Polyp Removal Reduces Mortality

June 01, 2007

With up to 23 years of follow-up data on thousands of participants in the National Polyp Study (NPS), it is clear that colonoscopy with removal of polyps produces "a substantial, long-term reduction in colorectal cancer (CRC) mortality,"

Meta-Analysis Shows Rituximab-Chemo Increases Overall Survival in Indolent/Mantle Cell Lymphoma

June 01, 2007

Adding the anti-CD20 monoclonal antibody rituximab (Rituxan) to chemotherapy (R-chemo) achieved better overall survival rates than chemotherapy alone for patients with advanced indolent or mantle cell lymphoma, according to a recent meta-analysis.

Enrollment Begins for Phase I Trial of NPI-0052 in Myeloma

June 01, 2007

NORWALK, Connecticut—The Multiple Myeloma Research Consortium (MMRC) and Nereus Pharmaceuticals, Inc., San Diego, have initiated enrollment in a multicenter phase I clinical trial to study Nereus' novel, second-generation proteasome inhibitor NPI-0052 in patients with relapsed or relapsed/refractory multiple myeloma. Participants in the open-label study will receive escalating, once-weekly intravenous doses of NPI-0052. The compound was discovered during the fermentation of a new marine actinomycete (Salinispora tropica).

Virtual Colonoscopy Gaining New Respect as a Sensitive and Cost-Effective CRC Screening Tool

June 01, 2007

For the past few decades, optical colonoscopy has been the gold standard in colon cancer screening. However, recent studies have shown that virtual colonoscopy may be the safest and most cost-effective colon cancer screening method available. Cancer Care & Economics (CC&E) recently spoke with Abraham H. Dachman, MD, professor of radiology at the University of Chicago Hospitals.

Medicare Reacts to Recent Scrutiny of ESAs

June 01, 2007

The Centers for Medicare & Medicaid Services (CMS) has reacted to an FDA "Black Box Warning" for erythropoiesis-stimulating agents (ESAs), manufactured by Amgen (Ara-nesp and Epogen) and Johnson & Johnson (Procrit) by proposing a national coverage decision (NCD) that would put limits on the dose and duration of therapy in patients with cancer and related neoplastic conditions.

Intrathecal 131I-8H9 for CNS Mets

June 01, 2007

Radioimmunotherapy (RIT) with a radiolabeled monoclonal antibody 131I-8H9, delivered intrathecally, appears to have clinical utility when added to salvage therapy for patients with metastatic cancer to the central nervous system (CNS), according to a phase I study reported at the 2007 American Association of Cancer Research annual meeting (LB-4).

Sorafenib Boosts Overall Survival in Advanced HCC

June 01, 2007

In a randomized phase III trial, patients with advanced, previously untreated hepatocellular carcinoma (HCC) treated with sorafenib (Nexavar) lived 44% longer than those treated with placebo and had a 73% prolongation in time to progression.

PEG-SN38 Shows Anti-Tumor Activity in Resistant Models

June 01, 2007

BRIDGEWATER, New Jersey—Enzon Pharmaceuticals, Inc.'s PEG-SN38, a novel polyethyleneglycol-SN38 conjugate, resulted in significant tumor growth inhibition in mice resistant to irinotecan (Camptosar) (a 25% decrease in tumor volume) and outperformed irinotecan when given as a second-round therapy to mice initially sensitive to irinotecan, the company said in a news release. The data were presented at the American Association for Cancer Research 2007 meeting (abstract 1494). Additionally, PEG-SN38 demonstrated long-lasting anti-tumor activity in mouse models of human breast and pancreatic cancers, the company said.

ASCO Guideline: Bisphosphonates in Myeloma

June 01, 2007

The American Society of Clinical Oncology (ASCO) has developed updated guideline recommendations on the use of bisphosphonates in patients with multiple myeloma. The key recommendations address three areas: therapy duration, dosage, and monitoring; osteonecrosis of the jaw; and several previous recommendations.

Vitamin E-Based Paclitaxel May Be Less Neurotoxic

June 01, 2007

A novel vitamin E-based paclitaxel emulsion may be less neurotoxic than the currently approved taxanes, including cremophor-based paclitaxel (Taxol), nab-paclitaxel (albumin-bound) (Abraxane), and docetaxel (Taxotere)