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JNCI Journal of the National Cancer Institute 2000 92(19):1552-1553; doi:10.1093/jnci/92.19.1552
© 2000 by Oxford University Press
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Journal of the National Cancer Institute, Vol. 92, No. 19, 1552-1553, October 4, 2000
© 2000 Oxford University Press

EDITORIAL

Response Rates, Survival, and Chemotherapy Trials

Richard Pazdur

Correspondence to: Richard Pazdur, M.D., Division of Oncology Drug Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 5600 Fishers Lane, HFD-150, Rockville, MD 20857 (e-mail: pazdurr@cder.fda.gov).

Early clinical trials of a novel oncology agent or combination regimen usually examine the biologic activity of the therapy using surrogate end points. These end points are believed to predict the clinical benefit of the new treatment, which is then tested in subsequent controlled, randomized clinical trials. The most commonly used surrogate end point, the response rate, has conventionally been examined in phase II trials and allows the early determination of the antitumor activity of the new therapy.

Response rate determinations reflect tumors that exhibit a complete regression or show a defined reduction for a specified time period. Stable tumors are excluded from response rate determinations. Accurate response rate determinations can be confounded by subjective biases introduced in unblinded clinical trials and inaccuracies of radiographic techniques and measurements.

Clinical benefit, a regulatory end point used in . . . [Full Text of this Article]

NOTES

REFERENCES


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