In a surprise action by a panel of experts, a major international clinical trial conceived and led by PMH’s Dr. Paul Goss involving 5,187 women across nine countries, was recently halted early because the results were so astoundingly positive.

The trial was conducted under the auspices of the National Cancer Institute of Canada’s Clinical Trial Group, the US NCI and the Breast International Group in Europe.

The study, reported as an expedited on-line publication earlier this month, showed that a new drug (letrozole), given after a round of treatment with tamoxifen, cut the risk of breast cancer returning by 44% in post-menopausal women.

Researchers randomly assigned women to receive either the drug or an inactive pill (placebo).

Many post-menopausal breast cancer survivors take tamoxifen to ensure that the cancer does not return. However, tamoxifen is only effective for about five years leaving the survivors with no effective therapies to follow.

“Having ended the trial, we are now able to offer letrozole to women who were receiving placebo, so that they too may benefit from the treatment,” says Dr. Goss. “This is the first time we have proof of an effective treatment after tamoxifen that will keep cancer at bay in women who are at substantial ongoing risk of suffering a relapse.”

The study showed letrozole to be more effective than chemotherapy at preventing the recurrence of breast cancer. “This finding will change the way breast cancer is treated worldwide, and it offers significant new hope to women,” says Dr. Goss.

N Engl J Med. 2003 Oct 9 [Epub ahead of print]
[PubMed abstract]

New Malaria Therapy Defies Conventional Wisdom

Malaria is an infectious disease spread by mosquitoes infected with the Plasmodium parasite. It afflicts between 300 and 500 million people around the globe, destroying red blood cells and causing inflammation. While most drugs try to kill the parasite itself, the parasite eventually learns to ignore the drug, rendering it ineffective.

New research from Dr. Kevin Kain's lab suggests that a new method of treatment—one that challenges conventional therapies—may be more effective. Instead of attacking the parasite, Dr. Kain boosted the immune system. He gave malaria-infected mice a new drug that increased their levels of an immune protein called CD36. Amazingly, their rate of survival doubled.

“New treatment strategies are desperately needed to curb the growing threat of malaria,” says Dr. Kain. “We are very excited about this finding, and we've arranged to start a new clinical trial of our therapy in 140 patients in the spring of 2004.”

The trial is in partnership with the Hospital for Tropical Diseases, Mahidol University, Thailand.

Institute: TGRI/TGH
Division: Genomic Medicine
Priority Platform: Genes, Proteins & People

Vitamin K May Have “Special” Role in Osteoporosis Prevention

Dr. Angela Cheung, Head of the Osteoporosis Program at TGRI/TGH, in collaboration with researchers at Sunnybrook Women’s College and St. Michael’s Hospital, has organized a clinical trial that is testing whether a daily dose of vitamin K will prevent the development of osteoporosis in at-risk post-menopausal women.

One in four women and one in eight men over the age of 50 suffer from osteoporosis, a disease that causes bones to become weak and brittle.

“There is evidence to suggest that vitamin K acts as the biological ‘glue’ that keeps calcium in our bones,” explains Dr. Cheung, “and we’re hoping that by boosting the levels of this nutrient, we’ll be able to decrease bone loss in these patients.”

Four hundred and fifty women will take part in the study, which began in January, 2002.

Institute: TGRI/TGH
Division: Clinical Investigation & Human Physiology
Priority Platform: Health Informatics