Letters
Hematologic diseases Cancer
Volume 190 - Issue 8

What changes are needed to the current direction and interpretation of clinical cancer research to meet the needs of the 21st century?

Author:  Maher K Gandhi

Med J Aust 2009; 190 (8): 461. || doi: 10.5694/j.1326-5377.2009.tb02508.x
Published online: 20 April 2009
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To the Editor: The timely article by Olver and Haines on industry-led versus investigator-led studies in cancer clearly outlines the importance of appropriate trial design.1

However, perhaps one aspect of this critical issue was underemphasised. In cancer trials, overall survival is typically seen as the primary endpoint. In fact, at time of relapse or disease progression, patients are generally treated in a non-uniform manner. In this scenario, treatment is frequently tailored depending on whether the aim of therapy is curative or palliative. Ad-hoc or experimental approaches are used for some patients with relapsed or refractory cancer. Thus, although survival is undoubtedly the most clinically relevant endpoint, the lack of standardisation of treatment at relapse inevitably confounds assessment of the impact of the study drug on survival.

Furthermore, for many tumour types, full evaluation of time-to-event outcomes, such as event-free and overall survival, requires prolonged follow-up, resulting in studies taking many years to be completed.

For these reasons, biomarkers that accurately serve as early surrogate endpoints to predict for clinical outcome are urgently needed. Yet a striking feature of much industry-led trial design is the paucity of correlative laboratory studies and tissue banking to identify and validate new biomolecular endpoints. Such studies are frequently seen as unnecessary and burdensome. By contrast, although investigator-led laboratory studies of novel biomarkers generate much interest from the clinical and scientific community, their resource and cost implications (chiefly data manager support) prevent many centres from participating. Lucrative company-sponsored trials will always take precedence unless state and/or federal initiatives to support investigator-led studies are enacted. Funding research nurses and data managers to help oncology units conduct non-industry trials that are well designed and incorporate laboratory-based biomolecular research would be an important beginning.

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