Healthy Skepticism Library item: 19039

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Publication type: Journal Article

Woloshin S, Schwartz LM
What's the rush? The dissemination and adoption of preliminary research results.
J Natl Cancer Inst 2006 15; 98:(6):372-3
http://jnci.oxfordjournals.org/content/98/6/372.long

Abstract:

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 financial 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 benefit 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 benefit 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 final 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 benefit might not have held up in the longer term, and more harm might have emerged over time. The investigators and the patients were lucky.

Keywords:
Antineoplastic Agents/administration & dosage* Antineoplastic Agents/adverse effects* Breast Neoplasms/drug therapy Breast Neoplasms/mortality Carcinoma, Non-Small-Cell Lung/drug therapy Chemotherapy, Adjuvant Congresses as Topic Diffusion of Innovation Evidence-Based Medicine Female Humans Information Dissemination Lung Neoplasms/drug therapy Multicenter Studies as Topic Neoplasms/drug therapy* Physician's Practice Patterns/standards* Quinazolines/administration & dosage Quinazolines/adverse effects* Randomized Controlled Trials as Topic Survival Analysis Taxoids/administration & dosage* Taxoids/adverse effects Treatment Outcome United States