Combining Pegylated Liposomal Doxorubicin with Valspodar in Cancer Treatment
Author Information
Author(s): Fracasso P M, Blum K A, Ma M K, Tan B R, Wright L P, Goodner S A, Fears C L, Hou W, Arquette M A, Picus J, Denes A, Mortimer J E, Ratner L, Ivy S P, McLeod H L
Primary Institution: Alvin J Siteman Cancer Center and the Department of Medicine, Washington University School of Medicine
Hypothesis
Does the combination of pegylated liposomal doxorubicin and valspodar affect the pharmacokinetics and toxicity in patients with advanced malignancies?
Conclusion
The combination of pegylated liposomal doxorubicin and valspodar can be administered safely with acceptable toxicity and moderate pharmacokinetic interaction.
Supporting Evidence
- Partial responses were observed in patients with breast and ovarian carcinoma.
- The mean total doxorubicin clearance decreased significantly with the addition of valspodar.
- No dose-limiting toxicities were observed at the highest dose of pegylated liposomal doxorubicin.
Takeaway
This study tested a new cancer treatment that combines two drugs to see if they work better together without making patients too sick.
Methodology
Patients received pegylated liposomal doxorubicin followed by valspodar in a phased treatment design to assess maximum tolerated dose and pharmacokinetics.
Potential Biases
Potential bias due to the small number of patients and the specific eligibility criteria.
Limitations
The study had a small sample size and was limited to specific types of malignancies.
Participant Demographics
14 patients, predominantly female (12 females, 2 males), aged 34-80 years.
Statistical Information
P-Value
0.009
Statistical Significance
p=0.009
Digital Object Identifier (DOI)
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