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Evolving or Immutable - Phase I Solid Tumor Trials in the Era of Precision Oncology
Shannon S Stockton1, G Dan Ayers1, Cody Lee1
1Vanderbilt University Medical Center.
Research Square
|May 15, 2024
Summary
Precision oncology trials increasingly use targeted therapy and immunotherapy. However, traditional chemotherapy dose escalation schemes are still prevalent in early-phase solid tumor studies.
Area of Science:
- Oncology
- Clinical Trials
- Precision Medicine
Background:
- The landscape of systemic therapy for solid tumors has evolved with the advent of precision oncology (PO).
- Chemotherapy (CT) is being supplanted by targeted therapy (TT) and immunotherapy (IO) in patient treatment strategies.
- Phase I clinical trials are crucial for evaluating novel cancer therapeutics.
Approach:
- A systematic literature review identified 437 phase I studies in adult solid tumors published between 2010-2020.
- Data on inclusion criteria, dose escalation schemes (DES), and expansion cohorts (ECs) were extracted and analyzed.
- Two independent reviewers abstracted data, with a third reviewer establishing concordance.
Key Points:
- Targeted therapy (47.6%) and immunotherapy (22%) dominated drug classes in phase I trials, surpassing chemotherapy (6.9%).
- Significant heterogeneity exists in the reporting and specification of study inclusion criteria.
- Expansion cohorts were utilized in 40.1% of studies, with genomic selection defining 46.6% of these.
- Rule-based DES, particularly the 3+3 design (80.5%), remain the predominant method for dose escalation (89%).
Conclusions:
- Targeted therapy and immunotherapy are the primary focus of current phase I solid tumor trials.
- Despite the shift towards PO, traditional rule-based dose escalation schemes, more suited for chemotherapy, continue to be widely employed.
