Heart attack, stroke or cancer. Take your pick. That was the choice I was being offered, or so it seemed. I'm one of hundreds of patients who were participating in clinical trials to investigate whether COX-2 inhibitors such as Celebrex and Vioxx, commonly used as anti-inflammatory drugs, are also effective in fighting or preventing cancer. But the trials were halted last year after reports that the risk of heart attack or stroke doubled among a group of Vioxx users. Vioxx was summarily yanked from the market and the tort lawyers immediately canceled lunch. Celebrex was also implicated because it's in the same drug class. It's still available, but the FDA has called for a black-box warning about the added danger.
The Vioxx news was disappointing and upsetting, because it sidetracked what scientists believed--and I had come to hope-- was a promising avenue of research. That promise was underscored by several papers presented at the annual meeting of the American Society of Clinical Oncology (ASCO) last week, including one out of UCLA Medical School that showed that Celebrex, used in combination with newer cancer drugs, was successful in treating patients with late-stage lung cancer. In 9 out of 15 patients whose prior treatments had failed, the Celebrex cocktail either stopped the disease from progressing or shrank their tumors. In cancer circles, that is an impressive result.
Although most of the COX-2 cancer trials eventually resumed, some of the original subjects dropped out, and you can't blame them. There's something screwy about the way the whole COX-2 debacle unfolded. Drugs linked to a relatively small risk of heart attack got pulled off the shelves without apparent concern for the cancer patients whose lives the same drugs might save.
Ironically, the trial that exposed the heart risks of COX-2 inhibitors was a cancer experiment, designed to test whether Vioxx or Celebrex could prevent the recurrence of colon cancer. It was halted before any conclusion could be reached. The situation was even more frustrating for patients in a second trial. There, scientists did indeed find a lower recurrence of colon tumors in patients taking Vioxx. "There was a reduction in adenoma recurrence," notes the study's lead author, Dr. Robert Bresalier of MD Anderson Cancer Center. "How that balances with the potential risk remains to be seen."
How indeed. The news from last week's ASCO meeting reassured me that I made the right decision when I rejoined the Celebrex study. Joining the trial in the first place seemed utterly logical--I had cancer of the esophagus, and I was going to go after every advantage I could. My surgeon, Dr. Nasser Altorki, chief of thoracic surgery at Weill Cornell Medical Center in New York City, is both a top esophageal specialist and a researcher. He has been investigating--along with my oncologist, Dr. Roger Keresztes, also at Weill--whether COX-2 inhibitors have a role in making treatment more effective and in keeping the disease at bay. Celebrex would be taken during the chemotherapy phase of treatment--in my case, Taxol and Carboplatin. After chemo, I was to take 800 mg of Celebrex (that's two to four times the normal dose) for two years. Oh, yes, there would be nine hours of surgery to remove the offending esophagus. With this cancer, you get the full sushi.