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Relationship between phase I study duration and symptom burden.

Michelle Treasure1, Barbara Daly2, Pingfu Fu3

  • 1Department of Medicine, Division of Hematology and Oncology, MetroHealth Medical Center, Case Western Reserve University, 2500 MetroHealth Drive, Cleveland, OH, 44109, USA. mxt269@case.edu.

Supportive Care in Cancer : Official Journal of the Multinational Association of Supportive Care in Cancer
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PubMed
Summary
This summary is machine-generated.

Adverse events (AEs) and symptom burden often cause early withdrawal from cancer clinical trials. Reducing these burdens may improve participant quality of life and trial outcomes.

Keywords:
Clinical trialPalliative carePhase I; drug-related side effects and adverse eventsQuality of lifeRetrospective studies

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Area of Science:

  • Oncology
  • Clinical Trials
  • Cancer Therapeutics

Background:

  • Phase I clinical trials are essential for developing new cancer treatments.
  • Early treatment withdrawal due to adverse events (AEs) or symptom burden can hinder the evaluation of treatment effectiveness.
  • Distinguishing between disease-related and treatment-related AEs is often challenging.

Purpose of the Study:

  • To characterize the reasons for early treatment termination in phase I cancer clinical trials.
  • To identify potentially modifiable events contributing to treatment discontinuation.

Main Methods:

  • Retrospective chart review of solid tumor patients in phase I clinical trials.
  • Data collected from the Case Comprehensive Cancer Center between 2003 and 2013.

Main Results:

  • 255 patients were analyzed; mean study duration was 78.4 days, with 23% discontinuing within 30 days.
  • Disease progression (57.6%) was the primary reason for discontinuation, followed by adverse events (16.5%).
  • Symptom burden accounted for 41.7% of 'other' reasons for discontinuation, and increased AEs correlated with shorter study duration (r = -0.331, p < 0.01).

Conclusions:

  • Adverse events and symptom burden can lead to early trial termination, complicating the assessment of investigational cancer therapies.
  • Interventions to mitigate AEs may prolong trial participation, influence recommended phase II doses, and enhance patient quality of life.