Study Results Presented at Annual Meeting of American Society of Clinical Oncology

Researchers at the annual meeting of the American Society of Clinical Oncology in Chicago this weekend presented several studies that found "encouraging results in new ways of treating cancer," the Wall Street Journal reports. Studies of new and current existing cancer medications, although a "far cry from curing desperately ill patients," may provide credibility for gene-based treatment approaches, according to the Journal (Abboud/Hamilton, Wall Street Journal, 6/2). Summaries of some study results appear below:

• Avastin: In a study conducted by Dr. Herbert Hurwitz of Duke University, 925 patients with colon cancer received either Avastin, manufactured by Genentech, or a placebo, in addition to standard chemotherapy (AP/Richmond Times-Dispatch, 6/2). Study participants who took Avastin lived an average of 20.3 months, compared to 15.6 months for those who took the placebo (Gillis, Washington Post, 6/2). Avastin, which appears to reduce tumor growth, blocks a protein called vascular endothelial growth factor, or VEGF, one substance that tumors require to grow new blood vessels (Peres, Chicago Tribune, 6/2). Genentech has begun discussions with the FDA to seek approval of Avastin; the medication may reach the market next year (Tansey/Torassa, San Francisco Chronicle, 6/2).
  
  
• Eloxatin: New research on Eloxatin, a last-resort chemotherapy medication that received FDA approval last August, found that participants who received the medication lived about five months longer than those who received standard chemotherapy treatments. Richard Goldberg, professor of oncology and gastrointestinal cancer at the Mayo Clinic and colleagues from Vanderbilt University, presented the research from two new studies and one 850-patient follow-up study. French pharmaceutical company Sanofi-Synthelabo manufactures Eloxatin (Loyd, Philadelphia Inquirer, 6/2).
  
  
• Erbitux: In a 329-patient study conducted by German pharmaceutical company Merck KgaA, researchers found that Erbitux in combination with irinotecan reduced tumor size in 22.9% of colorectal cancer patients. About 11% of study participants who received Erbitux alone had reduced tumor size. The results of the study "were almost the same" as those of past studies that the FDA rejected in 2001 because they were "poorly designed and sloppily conducted," the New York Times reports (Pollack, New York Times, 6/2). Erbitux, developed by ImClone Systems, targets epidermal growth factor receptors on the surface of cancer cells to reduce tumor growth. Officials Merck KgaA -- which has the European rights to Erbitux -- said that they will seek European approval of the medication (MacPherson, Newark Star-Ledger, 6/2). In the United States, ImClone and partner Bristol-Meyers Squibb hope to receive FDA approval to market the Erbitux in 2004 (New York Times, 6/2).
  
  
• Irinotecan: Researchers at the University of Chicago found that patients who take Irinotecan and have a specific variant of a gene called UGT1A1 are more likely to experience a decrease in white blood cells as a side effect. Patients with the gene could take lower doses of Irinotecan or take a different medication. A test for the gene is available at the University of Chicago and could become available on the market within two years (Ritter, Chicago Sun-Times, 6/2).
  
  
• TRICOM: Researchers reported that the cancer vaccine, manufactured by Therion Biologics, blocked the progression of cancer in 40% of patients with advanced colorectal, pancreatic, breast and lung cancers. In a 58-patient study, 23 participants experienced stabilization for at least four months. The vaccine appears to stimulate an immune response against a protein found on the surface of cancer tumors, but the treatment does not appear to reduce the size of tumors or increase survival rates (Akoi, Boston Globe, 6/2).
  
  
• Breast cancer: Dr. Lajos Pusztai of the Anderson Cancer Center in Houston found that some genetic indications predicted with 75% accuracy which breast cancer patients would "respond well" to a combination of Taxol and three other chemotherapy medications, the Sun-Times reports.
  
  
• Lung cancer: Researchers from Massachusetts General Hospital analyzed a procedure to select chemotherapy treatment for lung cancer patients based on two genes (Chicago Sun-Times, 6/2).

In related news, FDA Commissioner Mark McClellan and agency Director of Oncology Drug Products Richard Pazdur said that the FDA plans to revise rules for expedited approval of new prescription drugs that "serve an unmet medical need" to help "clear obstacles" for future cancer treatments, the Journal reports. Under the new rules, companies that receive expedited approval would not receive patent protection for the medication drugs until they submit data from follow-up studies required under the expedited approval process. Competitors would have to complete the full FDA approval process to market their medications. The proposed revision to the rules is "one way of tackling the problem of incomplete follow-up studies," according to the Journal (Wall Street Journal, 6/2).

Two broadcast programs reported on the study results presented at the ASCO conference:

• CBS' "Evening News" Friday reported on the study results for Erbitux (Mason, "Evening News," CBS, 5/30). The full segment is available in RealPlayer online.
  
  
• NBC's "Nightly News" Sunday reported on the Avastin and Erbitux studies. The segment includes comments from Hurwitz and Dr. Leonard Saltz from Memorial Sloan-Kettering Cancer Center (Bazell, "Nightly News," NBC, 6/1). The full segment is available in Windows Media online.