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Journal of the National Cancer Institute, Vol. 98, No. 6, March 15, 2006 How fast should the preliminary results of medical research be disseminated and adopted into clinical practice? In this issue of the Journal, Giordano et al. ( 1 ) provide an example of moving fast. They describe the substantial increase in use of taxane chemotherapy for women with node-positive breast cancer in the year following the presentation of the Cancer and Leukemia Group B (CALGB) 9344 study at the 1998 American Society of Clinical Oncology (ASCO) meeting — nearly 5 years before publication of the results in a peer-reviewed journal. Moving fast is appealing. It means being on the cutting edge of medicine. It means bringing new hope to patients. There is a presumption that newer treatments are better than older ones. And all sorts of forces encourage the rapid adoption of new, so-called breakthrough treatments and technologies, including investigators with professional and fi nancial interests, pharmaceutical companies, an uncritical news media, aggressive disease advocacy groups, and desperate patients with progressive disease and no good options. The taxane story supports the idea that moving fast can benefi t patients: Women with early breast cancer did not have to wait 5 years to get access to a useful treatment that has become a standard of care. The results presented at the 1998 ASCO meeting — released at the recommendation of the study’s data safety and monitoring board ( 1 ) — came from a well-done, large (more than 3000 women), multicenter randomized trial. The investigators found a small but real benefi t in a fundamentally important outcome — overall survival ( 2 ) . The meeting presentation also clearly reported the associated harms (e.g., grade 3 or greater toxicities such as transient myelosuppression [21%], neuropathy [5%], and pain [5%]). Fortunately, things worked out well. The interim results in the 1998 meeting report (97% of women in the taxane plus standard chemotherapy group and 95% of those in the standard chemotherapy group were alive at 18 months) closely mirrored the fi nal results published in 2003 (80% versus 77% were alive at 5 years) ( 1 ) . But the story might have had a very different ending: The early benefi t might not have held up in the longer term, and more harm might have emerged over time. The investigators and the patients were lucky. The point is that moving fast is a gamble. When preliminary fi ndings turn out to be true, patients benefi t. When the fi ndings are not true, patients get hurt: They are exposed to ineffective or harmful treatments, or they forgo good alternatives. The story of gefi tinib (Iressa) demonstrates the other side of the coin — a case where the adoption of preliminary results was a mistake. Unlike the taxane results, which were preliminary in time (i.e., the interim results were disseminated before publication of any results in a peer-reviewed journal article), Iressa is a story about results from a study that was preliminary in terms of design (i.e., a small, hypothesis-generating study using a surrogate outcome). Gefi tinib is a drug developed for the treatment of EDITORIAL

What's the Rush? The Dissemination and Adoption of Preliminary Research Results