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JNCI Journal of the National Cancer Institute 2007 99(2):98-99; doi:10.1093/jnci/djk024
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© The Author 2007. Published by Oxford University Press.

EDITORIAL

Response Rate as an Endpoint in Clinical Trials

Stephen L. George

Correspondence to: Stephen L. George, PhD, Cancer Center/Biostatistics, Duke University Medical Center, 2424 Erwin Rd., Ste. 802, Rm. 8037, Durham, NC 27705-3833 (e-mail: stephen.george@duke.edu).

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In this issue of the Journal, Lewis et al. (1) report the results of a randomized clinical trial in operable osteosarcoma of an extremity designed to compare "standard" two-drug therapy, utilizing cisplatin and doxorubicin given in 3-week cycles, with a "dose-intensive" or "dose-dense" version of the same therapy given in 2-week cycles with granulocyte colony-stimulating factor support. The primary endpoint was overall survival with a secondary endpoint of progression-free survival. More than 500 patients were entered in a 9-year period from 1993 to 2002, the second largest clinical trial ever completed in osteosarcoma, according to the authors. The results of the primary and secondary analyses showed little difference between the treatment groups. The estimated . . . [Full Text of this Article]


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