Word: vaccinees
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Dates: during 2000-2009
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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...
In 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...
Not everyone is convinced by that logic. Dr. Robert Schwartz, an editor at the New England Journal of Medicine, says, "Using patients as their own control is a bit shaky, especially for follicular lymphoma." A Phase III randomized trial, more difficult but still possible to conduct even with customized vaccines...
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...
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...