Five-year study by OHSU Cancer Institute shows Gleevec's excellent survival rate

Study published in the New England Journal of Medicine

PORTLAND, Ore. In five years Gleevec, the little yellow pill, has proved itself to be a miracle drug for most patients who take it.

When the drug first was developed by Brian J. Druker, M.D., the leukemia program leader of the Oregon Health & Science University Cancer Institute, the overall survival rate for patients with chronic myelogenous leukemia (CML) taking this new experimental drug was unknown.

"We've completely changed the outlook for patients with this disease. Before Gleevec, patients were fortunate if they lived five years. Now, we've given patients a hopeful future," said Druker, the principal investigator for the study.

Today, after five years, the overall survival of 553 subjects randomized to receive Gleevec as their initial therapy is nearly 90 percent, 95 percent if only deaths related to CML are considered. Just 5 percent of subjects discontinued Gleevec because of side effects. The results are published in the Dec. 7 issue of the New England Journal of Medicine.

This study also shows that the risk of relapse has trended downward during the past three years. In the study's fifth year, less than 1 percent of patients progressed from the chronic phase to more advanced phases of the disease.

"This trend, coupled with the low risk of relapse, means that the possibility of long-term survival with CML is increasingly likely," Druker said.

The five-year study was conducted at 117 centers in 16 countries.

Gleevec also has a larger story to tell. Its targeted therapy approach broke new ground in how to treat cancer. By specifically targeting the cancerous cells, the healthy cells are left unharmed. Gleevec is changing cancer research and the drug is a harbinger of new agents for curing or controlling all cancers. "We are at an important juncture," Druker said, "not unlike the early 1900s where scientists turned infectious diseases from routinely fatal into manageable, curable or preventable diseases. We are on the cusp of turning cancer into a manageable disease."

Gleevec is a signal transduction inhibitor that interferes with the enzymes that trigger the growth of cancerous cells. Gleevec acts on CML cells by inhibiting the disease-causing enzyme BCR-ABL that tells cells to grow and divide.

Gleevec has also been approved for people with advanced gastrointestinal stromal tumors, dermatofibrosarcoma protuberans, Philadelphia chromosome-positive acute lymphoblastic leukemia, certain forms of myeloproliferative disorders, hypereosinophilic syndrome, and aggressive systemic mastocytosis.

Gleevec was co-developed and marketed by the pharmaceutical company Novartis.

Brian Druker, M.D., is the JELD-WEN Chair of Leukemia Research at the Oregon Health & Science University Cancer Institute and an Investigator of the Howard Hughes Medical Institute.

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The OHSU Cancer Institute is the only cancer center designated by the National Cancer Institute between Sacramento and Seattle. It comprises some 120 clinical researchers, basic scientists and population scientists who work together to translate scientific discoveries into longer and better lives for Oregon's cancer patients. In the lab, basic scientists examine cancer cells and normal cells to uncover molecular abnormalities that cause the disease. This basic science informs more than 200 clinical trials conducted at the OHSU Cancer Institute.


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