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Lung Cancer Vaccine Shows Promise

Medscape Medical News 2004. © 2004 Medscape

Nov. 2, 2004 (Vienna) — A novel vaccine that attacks cancer cells is showing promise in the treatment of patients with advanced non-small cell lung cancer (NSCLC). It may emerge as a new treatment approach for a disease that has historically low survival rates, according to the trial's lead investigator Charles Butts, MD, from the Cross Cancer Institute in Edmonton, Alberta.

Dr. Butts presented the findings here at the 29th European Society of Medical Oncology Congress.

In a multicenter, phase 2b randomized trial of L-BLP25 Liposome vaccine (Merck) in 171 patients, those who received the vaccine (n = 88) experienced a 4.4-month median survival increase compared with patients who received only supportive care.

Approximately 60% of patients who received the vaccine are still alive two years after the start of the study, Dr. Butts noted, an outcome that the researchers would not have expected given the generally poor survival rates for this type of cancer.

"This is a notable survival increase for a disease as aggressive as [NSCLC], and the vaccine appears to have a good safety profile and does not [adversely] affect quality of life for these patients," Dr. Butts told attendees.

He added that the vaccine's most dramatic results were seen in patients whose disease was stage IIIb and localized, as opposed to those with stage IV cancer. In those patients, two-year survival was 60% compared with 36.7% in patients who received only supportive care.

For the purposes of the trial, survival was calculated from the time of randomization.

"The most exciting results were seen in those earlier-stage patients with localized disease. It is exciting to see a vaccine have this big a benefit, even if it was not statistically significant," Dr. Butts said.

Despite the small patient population, the results are promising considering that treatment options for patients with advanced NSCLC have been limited and not particularly effective. The U.S. Food and Drug Administration has granted the vaccine "fast-track" approval status.

For the 88 patients who received the vaccine, median survival was 17.4 months compared with 13 months in the control group. Two-year overall survival was 43.2% in the treatment group and 28.9% in the control group. Quality of life was also maintained in the treatment group, Dr. Butts said, which is an important consideration for patients afflicted with end-stage cancer from which recovery is unlikely.

All patients included in the trial were required to have stage IIIb or IV disease that was either stable or had shown response to chemotherapy or combined chemotherapy and radiation therapy. The vaccine, which targets a sugar-protein molecule, MUC-1, present on the surface of cancer cells in NSCLC and other cancers, was administered subcutaneously once weekly for eight weeks, followed by a booster dose every six weeks.

Adverse effects were negligible, Dr. Butts said, and included primarily flu-like symptoms and site reactions normally associated with vaccine administration.

29th ESMO Congress: Abstract 31N. Presented Nov. 1, 2004.

Reviewed by Gary D. Vogin, MD

Bonnie Darves is a freelance writer for Medscape.


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