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A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
Phase I Clinical Trials in Patients ≥80
Himabindu Gaddipati1, Pingfu Fu, Afshin Dowlati
1Division of Hematology/Oncology, Case Western Reserve University and University Hospitals Case Medical Center and the Developmental Therapeutics Program, Case Comprehensive Cancer Center, Cleveland, OH.
Journal of Geriatric Oncology
|May 24, 2011
Summary
Octogenarians (patients aged 80+) on phase I cancer trials face a higher risk of dose-limiting toxicities (DLT) compared to younger patients. This suggests caution is needed when enrolling elderly individuals in early-phase chemotherapy studies.
Area of Science:
- Oncology
- Clinical Pharmacology
- Geriatric Medicine
Background:
- Phase I clinical trials are essential for determining cancer therapeutic safety and dosage.
- Existing data suggests phase I trial participants are typically younger (median age 50-55).
- Limited data exists on octogenarians' safety and tolerability in phase I trials.
Purpose of the Study:
- To evaluate the safety and tolerability of phase I clinical trials in octogenarians.
- To compare the incidence of dose-limiting toxicities (DLT) in octogenarians versus younger controls.
Main Methods:
- Retrospective review of 22 octogenarian patients (median age 83) on phase I trials.
- Comparison with a matched control group of patients under 80 years old.
- Analysis of toxicities, including cardiovascular, gastrointestinal, and infectious complications.
Main Results:
- Octogenarians had a 3-fold higher rate of dose-limiting toxicities (DLT) (p=0.06) compared to controls at the same dose level.
- Over 50% of octogenarians were chemotherapy-naïve, suggesting physician concerns about standard therapy toxicity.
- Observed toxicities included cardiovascular, gastrointestinal, and infectious issues.
Conclusions:
- Enrollment of patients aged 80 and above in phase I chemotherapy trials is associated with an increased risk of DLT.
- Further research is needed to understand the specific risks and benefits for octogenarians in early-phase cancer trials.
- Molecular targeted treatments showed no significant toxicities in the three octogenarian patients studied.
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