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Optimizing biomarkers and endpoints in oral cancer chemoprevention trials

William N William1, Vassiliki A Papadimitrakopoulou

  • 1Department of Thoracic/Head and Neck Medical Oncology, University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Unit 432, Houston, TX 77030, USA.

Cancer Prevention Research (Philadelphia, Pa.)
|May 4, 2013
PubMed

Insights

Bowman Birk Inhibitor (BBI) showed less promising results in a phase IIb trial for oral premalignant lesions. Further research is needed on biomarkers and endpoints for dietary chemoprevention agents.

Area of Science:

  • Oncology
  • Preventive Medicine
  • Biochemistry

Background:

  • Chemoprevention aims to halt cancer development but faces slow progress, especially for oral cancer.
  • Dietary phytochemicals are explored for oral cancer prevention due to pharmaceutical safety concerns, yet clinical success remains limited.
  • Bowman Birk Inhibitor (BBI), a soybean-derived protease inhibitor, previously showed promise in a Phase IIa trial for oral leukoplakia.

Purpose of the Study:

  • To present the results of a randomized, placebo-controlled phase IIb trial of BBI complex in patients with oral premalignant lesions.
  • To discuss the challenges in developing dietary chemoprevention agents for oral cancer.
  • To highlight the complexities in defining biomarkers and endpoints for oral cancer prevention trials.

Main Methods:

  • A randomized, placebo-controlled phase IIb clinical trial was conducted.
  • Patients with oral premalignant lesions received either BBI complex or a placebo.
  • Clinical responses and biomarker changes were assessed.

Main Results:

  • The phase IIb trial yielded less promising results compared to the earlier phase IIa trial.
  • Measurable clinical responses and favorable biomarker changes observed in the Phase IIa trial were not replicated.
  • The study underscores the need for refined methodologies in oral cancer chemoprevention research.

Conclusions:

  • The development of effective dietary chemoprevention agents for oral cancer requires further investigation.
  • Optimal biomarkers and trial endpoints are critical for advancing oral cancer prevention strategies.
  • Translating promising preclinical or early-phase trial findings into clinical success remains a significant challenge.

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