Differences between a drug regimen employed in early phase 1 trials and the subsequent use of the agent in routine oncologic practice

A note of caution

Authors

  • Maurie Markman MD

    Corresponding author
    1. Clinical Research, The University of Texas M. D. Anderson Cancer Center, Houston, Texas
    • Clinical Research, The University of Texas M. D. Anderson Cancer Center, Mail Box 121, 1515 Holcombe Boulevard, Houston, TX 77030
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Abstract

It is reasonable to assume that a decision to permit wider access to new anticancer agents after the completion of only phase 1 trials will almost certainly result in the administration of such therapy to a substantial population of individuals who would not have been eligible for such “registration-type” testing. However, the optimal use of antineoplastic agents in routine clinical practice may differ substantially from the doses and schedules examined in phase 1 clinical trials.

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