Word: bendandi
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Follicular lymphoma cannot currently be cured, but with chemotherapy and other treatments, a patient can usually achieve remission. The cancer almost always returns, however, and each subsequent remission tends to be shorter than the previous one. In 2001, Bendandi began vaccine therapy on 25 patients who had achieved a second remission with chemotherapy. The vaccine did not have any effect on five of the subjects, but the other 20 who did respond received a total of 10 vaccinations over 26 months. "Partway through the study, one of my patients - a hairdresser - came to me and said, 'I know the treatment...
...addition to showing that the vaccine can prolong remission, Bendandi's trial attempted to solve the long-standing problem of quantifying the results of custom-made treatments. Advanced drug trials require a control group, one whose members share key characteristics with those in the experimental arm, but who receive a placebo or another treatment rather than the one under study. According to Bendandi, randomized testing of custom-made vaccines would be meaningless because each patient in the experimental arm receives a different treatment. So he set about proving efficacy in another way. "The course of the study design...
...says, "the gold standard for proof of efficacy." Dr. Kwak, who is conducting his own Phase III trial of a vaccine for the American pharmaceutical company Biovest, believes his former trainee's results support the case for a therapeutic lymphoma vaccine, but is skeptical about his methods. "Dr. Bendandi's study is important because it confirms previously reported results. But taken in isolation, it's a small study with no control group. It's not definitive...
...Bendandi's vaccine also faces challenges common to other customized treatments: it's expensive (an estimated $34,000 per patient), it's difficult to make, and not all pharmaceutical companies (which make profits by mass-producing drugs) are able - or willing - to take on the work of producing a different vaccine for every patient. But with three Phase III clinical trials for idiotype vaccines under way in the U.S., and several other types of custom treatments in development (on March 29, an fda advisory committee found "substantial evidence" that a prostate cancer vaccine is effective, increasing the likelihood...
Especially among the researchers developing them. "My trial was designed to have every chance to fail," says Bendandi. "If just one patient relapsed while receiving the vaccine, it would have been over. I would have needed a new job," he jokes. But the Italian-born physician is still working. In a few weeks he starts his new study, which is designed to test the vaccine's effectiveness in follicular lymphoma patients with an especially poor prognosis. Bendandi plans to administer the vaccine to participants until they relapse or die from a cause other than lymphoma. "This time," he says...