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- Title
Evaluating the Utility of a 'N-of-1' Precision Cancer Medicine Strategy: The Case for 'Time-to-Subsequent-Disease Progression'.
- Authors
Markman, Maurie; Kramer, Kim; alvarez, Ricardo H.; Weiss, Glen J.; ahn, Eugene; Daneker, George William
- Abstract
It is increasingly recognized that cancer is a highly heterogeneous group of illnesses even within a particular organ site (e.g., breast, lung, colon, etc.). This observation presents a serious challenge to the traditional concept of phase 3 randomized trials designed to define therapeutic efficacy of a novel treatment strategy. For while 10% of the patients with a common malignancy (e.g., non-small-cell lung cancer) may be sufficient to consider such an effort, enrolling a sufficient number of patients into a clinical trial in a timely manner to define clinical utility would be extremely difficult if the population in question represented only 1% of this population, and essentially impossible if one wished to explore the benefits of treatment in a rarer neoplasm (e.g. ovarian cancer). Therefore, in the new era of precision cancer medicine, alternative research designs are imperative. One option would be to compare the time-to-disease progression of an individual cancer patient following treatment with a novel therapeutic to the time-to-disease progression for that specific patient on her/his immediately preceding treatment. The rationale for this strategy and early experience with this innovative approach to evaluating the efficacy of anticancer therapy is highlighted in this report.
- Subjects
ANTINEOPLASTIC agents; TREATMENT effectiveness; CANCER patients; TIME; TUMORS; DISEASE progression; INDIVIDUALIZED medicine
- Publication
Oncology, 2016, Vol 91, Issue 6, p299
- ISSN
0030-2414
- Publication type
Article
- DOI
10.1159/000450682