Bud Romine’s life was turned upside-down in September 1995 when a routine blood test revealed he had cancer. He was one of nearly 6,000 Americans diagnosed each year with chronic myelogenous leukemia, or CML, a deadly cancer of bone marrow cells that caused his white blood cells to soar to more than 12 times the normal limit.
Romine (above, left), who was looking forward to a quiet retirement with his wife and family, suddenly found himself faced with only four years to live, the average life expectancy for patients in the early stages of CML.
Romine’s doctors put him on the anticancer agent interferon in hopes that it would lead to a remission of his cancer and prolong his life. But despite 18 months of grueling treatments, his white blood cells continued to increase and his condition worsened. Unfortunately, he was considered too old and sick to undergo bone marrow transplantation, an alternative treatment for CML, which remains the only curative therapy for the disease.
"The cancer just creeps up on you and leaves you feeling weak and powerless," he explains. Romine was so weak that he couldn’t leave his home and would often faint when he tried to exert himself.
In April 1996, Romine read an article in his local newspaper about an experimental cancer pill being researched by an area doctor, Brian Druker, an oncologist and researcher at the Oregon Health Sciences University in Portland. Romine called the doctor, hoping Druker's pill could be the miracle he needed.
Because of that call, Romine became the first person to take the experimental pill, tentatively named STI 571. Today, the now 70-year-old retired railroad conductor is in remission.
"My patients have also had good results," says Carol Miller, M.D., an oncologist and clinical researcher at Johns Hopkins Oncology Center, who became involved in testing the safety and efficacy of STI 571. "However, there are still many things we don’t know about STI 571, such as the long-term effects of the drug or whether patients will develop resistance to it. Much research is still needed."
What Makes This Pill So Promising?
Ninety-five percent of patients with CML, who typically have a four-year survival rate from the time of diagnosis, have an abnormal chromosome called the Philadelphia chromosome, which contains a faulty gene that produces an enzyme believed to cause the deadly cancer. Unlike standard treatments for CML, STI 571 targets only this enzyme and inhibits it without harming healthy cells.
"That may be why early clinical trials have produced such dramatic results with only minimal side effects," says Druker. All of the initial 31 patients in Druker's study are now in remission.
"For the past four years, leukemia had been the first thing on Bud’s mind when he woke up in the morning and the last on his mind when he went to bed,” says Romine's wife Yvonne. "Now he's running around the golf course. I can't keep up with him."
In addition to Hopkins and Druker's clinic, many medical institutions throughout the United States are studying STI 571. If all goes well, the drug may be approved by the Food and Drug Administration by 2002. If approved, it will represent the first of a new class of drugs designed to target specific molecular defects in the leukemia cells without harming normal cells.
"The success of STI 571 may have far-reaching implications, beyond the treatment of leukemia, to affect research on treatment for other cancers," says Druker.
As for Romine, he never imagined five years ago that he’d be around today to tell his story. Now he’s enjoying the retirement he always dreamed of – spending his winters playing golf in Southern California and his summers with his family on the Oregon shore. "I expect to live at least another 20 years thanks to Dr. Druker and his breakthrough cancer pill."
To learn more about STI 571 clinical trials, call the Novartis Oncology Clinical Trials Hotline at (800) 340-6843 or visit the company’s Web site at www.novartisoncology.com.