The sub-optimal anti-tumor efficacy of surgery, chemotherapy, and radiotherapy has
prompted the search for additional adjunctive therapies, such as immunotherapy. A
variety of immunologic strategies for eradicating tumor cells have shown promise in
experimental animal models and are being investigated in preclinical studies and clinical
trials. A significant challenge is how to establish most reliably and efficiently
which of these approaches are clinically effective. Pivotal trials require considerable
resources and time—a randomized trial that demonstrated a significant improvement
in disease-free survival for patients with colon cancer receiving an autologous vaccine
required about 10 years to complete.
1
Thus, it is important that intermediate markers of efficacy are explored to help
select which of many agents to test for clinical benefit. The traditional developmental
strategy for a cytotoxic anti-tumor agent relies on tumor regression as an index of
efficacy before initiation of phase III trials, which typically monitor survival as
an endpoint. However, the induction of specific immune responses may be the most reliable
intermediate marker for immunotherapies, especially in trials conducted in patients
with minimal tumor burden.To read this article in full you will need to make a payment
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Article info
Publication history
Accepted:
May 6,
2000
Footnotes
☆Supported by National Institutes of Health (NIH) NRSA CA77894-02 and the Ethicon-Society of University Surgeons fellowship award (P. J. M.); an American Society of Clinical Oncology Career Development Award and an NIH grant M01RR00030 (M. A. M.); and NIH P01 CA 78673 01A1 (A. C. H. T. M. C. and H. K. L.)
☆☆Reprint requests: H. Kim Lyerly, MD, Box 2606, Duke University Medical Center, Durham, NC 27710.
★Surgery 2001;129:248-54
Identification
Copyright
© 2001 Mosby, Inc. Published by Elsevier Inc. All rights reserved.
