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Related Experiment Videos

Problems in the development of target-based drugs.

N Saijo1, T Tamura, K Nishio

  • 1Medical Oncology Division, National Cancer Center Hospital, Tokyo, Japan. nsaijo@gan2.ncc.go.jp

Cancer Chemotherapy and Pharmacology
|August 19, 2000
PubMed
Summary

New anticancer drugs targeting specific molecules show promise but face evaluation challenges. Demonstrating target inhibition and its link to antitumor effects remains difficult in clinical trials.

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Area of Science:

  • Oncology
  • Molecular Biology
  • Pharmacology

Background:

  • Advances in molecular biology have identified numerous cancer targets, leading to new drug categories like signal transduction inhibitors, cyclin-dependent kinase inhibitors, and anti-angiogenesis agents.
  • These novel drugs, termed target-based, noncytotoxic, or cytostatic, offer unique mechanisms of action and therapeutic potential.
  • Despite their promise, evaluating these drugs presents significant challenges in preclinical and clinical settings.

Purpose of the Study:

  • To review the development and evaluation of novel molecularly targeted anticancer drugs.
  • To discuss the challenges in preclinical and clinical assessment of these agents.
  • To examine the correlation between target inhibition and antitumor efficacy.

Main Methods:

Related Experiment Videos

  • Review of preclinical and clinical trial data for target-based anticancer drugs.
  • Analysis of phase I, II, and III trial designs and endpoints.
  • Examination of studies assessing target inhibition and its clinical relevance.

Main Results:

  • Some target-based drugs exhibit direct antitumor effects, while others do not show direct cytotoxicity.
  • Phase I trials commonly assess maximum tolerated dose, pharmacokinetics, and adverse events, with some target-based drugs showing unexpected toxicities.
  • Few studies have successfully demonstrated target inhibition or established a clear correlation between target inhibition and antitumor effects.

Conclusions:

  • Evaluating target-based anticancer drugs is complex, particularly in designing appropriate phase II studies.
  • Compounds with demonstrated direct antitumor activity, like trastuzumab, are often advanced to phase II trials.
  • The ultimate goal for target-based drugs in phase III trials remains consistent with cytotoxic drugs: improved cure and survival rates.