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Risk and Benefit for Basket Trials in Oncology: A Systematic Review and Meta-Analysis

Katarzyna Klas1,2, Karolina Strzebonska1, Lucja Zaborowska1,2,3

  • 1Research Ethics in Medicine Study Group (REMEDY), Department of Bioethics, Faculty of Health Sciences, Jagiellonian University Medical College, Michalowskiego 12, 31-126, Kraków, Poland.

Targeted Oncology
|October 25, 2024
PubMed
Abstract

Insights

Basket clinical trials in oncology show an 18% objective response rate. While risks include 30.4% grade 3/4 toxicity, these trials are vital for precision medicine advancements.

Area of Science:

  • Oncology
  • Clinical Trials
  • Precision Medicine

Background:

  • Precision medicine is transforming oncology research with novel clinical trial designs.
  • Basket clinical trials evaluate treatments across multiple tumor types based on molecular characteristics.
  • These trials aim to identify patients likely to benefit from specific experimental therapies.

Purpose of the Study:

  • To systematically evaluate the risks and benefits associated with basket clinical trials in oncology.
  • To provide an evidence-based understanding of treatment-related adverse events and efficacy outcomes.

Main Methods:

  • A systematic literature search was conducted on PubMed, Embase, and ClinicalTrials.gov.
  • Data from basket clinical trials published between 2001 and 2023 were analyzed.
  • Key metrics included objective response rate, progression-free survival, overall survival, and treatment-related adverse events (grades 3-5).

Main Results:

  • The study analyzed 75 basket trials involving 7659 patients.
  • The pooled objective response rate was 18.0%, with a treatment-related death rate of 0.7%.
  • Grade 3/4 drug-related toxicity affected 30.4% of patients; median progression-free survival was 3.1 months and overall survival was 8.9 months.

Conclusions:

  • Basket clinical trials offer a valuable framework for precision medicine in oncology.
  • Results provide an empirical foundation for risk-benefit communication in these novel trial designs.
  • Findings can inform the refinement of future clinical trial models for targeted therapies.

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