July 15, 2001Journal of Clinical Oncology
Developing Drugs to Decrease the Toxicity of Chemotherapy
Why the study?
Does TLC D-99 liposomal formulation reduce cardiotoxicity compared to conventional doxorubicin in patients with metastatic breast cancer?
Population
Patients with metastatic breast cancer
Comparison
TLC D-99 liposomal formulation doxorubicin vs Conventional doxorubicin
Design
Editorial
Authors
Discussion
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Implication
The authors acknowledge design flaws in an underpowered single-agent study of liposomal doxorubicin, while defending the safety and efficacy endpoints of their published combination trial.
Structured PICO
Does TLC D-99 liposomal formulation reduce cardiotoxicity compared to conventional doxorubicin in patients with metastatic breast cancer?
P
Population
Patients with metastatic breast cancer
I
Intervention
TLC D-99 liposomal formulation (Myocet) doxorubicin
C
Comparator
Conventional doxorubicin
O
Outcome
Cardiotoxicity and antitumor efficacysafety
The authors acknowledge design flaws in an underpowered single-agent study of liposomal doxorubicin, while defending the safety and efficacy endpoints of their published combination trial.
Limitations
- Underpowered due to erroneous assumptions regarding anticipated response rates in both the control and experimental arms
Cite This Study
Williams et al. (2001) studied this question.