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How to Define Treatment Success or Failure if Tumors Do Not Shrink

Consequences for Trial Design

  • Chapter
Molecular Targeting in Oncology

Part of the book series: Cancer Drug Discovery and Development ((CDD&D))

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Summary

The development of targeted anti cancer drugs in recent years puts a challenge on classical trial designs. In this chapter we point out that defining a biological relevant dose might become more important than a MTD and establishing the mechanism of action becomes pivotal early in drug development. Furthermore we present examples of trails that show the importance of defining the patient population likely to benefit from targeted drugs.

Furthermore, the use of surrogate tissues to evaluate the biological activity of the agents under study is described.

Non-invasive techniques like PET, CT or MRI imaging are addressed as well as their present lack of validity in predicting patient outcome.

Alternative endpoint in phase II trail designs in relation to the development of targeted anticancer drugs are described.

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Authors
  1. J.J.E.M. Kitzen MD
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  2. M.J.A. de Jonge MD, PhD
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  3. J. Verweij MD, PhD
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Editor information

Editors and Affiliations

  1. Division of Surgical Oncology, Columbia University, New York, NY

    Howard L. Kaufman

  2. Division of Hematology and Medical Oncology, Department of Medicine, Weill Medical College Cornell University, New York, NY

    Scott Wadler

  3. Boston University Medical Campus Boston University School of Medicine, Boston, MA

    Karen Antman

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© 2008 Humana Press

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Kitzen, J., Jonge, M.d., Verweij, J. (2008). How to Define Treatment Success or Failure if Tumors Do Not Shrink. In: Kaufman, H.L., Wadler, S., Antman, K. (eds) Molecular Targeting in Oncology. Cancer Drug Discovery and Development. Humana Press. https://doi.org/10.1007/978-1-59745-337-0_28

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  • DOI: https://doi.org/10.1007/978-1-59745-337-0_28

  • Publisher Name: Humana Press

  • Print ISBN: 978-1-58829-577-4

  • Online ISBN: 978-1-59745-337-0

  • eBook Packages: MedicineMedicine (R0)

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