OFFICIAL TRIAL NAME
"An Open-Label, Randomized, Phase 3 Trial of Intravenous Temsirolimus (CCI-779) at Two Dose Levels Compared to Investigator's Choice Therapy in Relapsed, Refractory Subjects With Mantle Cell Lymphoma (MCL)."
PUBLICATION
The Journal of Clinical Oncology, official journal of the American Society of Clinical Oncology.
LEAD STUDY AUTHOR
Georg Hess, MD, Department of Hematology/Oncology, Johannes Gutenberg-University, Langenbeckstr 1, Mainz, DE 55101.
PATIENTS
Aged 18 and older with relapsed or refractory mantle cell lymphoma (MCL).
DRUG AND REGIMEN
Drug: Temsirolimus. Currently it is only FDA-approved for the treatment of renal cell carcinoma, a type of kidney cancer.
Target regimen: Temsirolimus 175 mg weekly for three weeks followed by 75 mg weekly. This is substantially higher than the recommended dosage (25 mg weekly) of temsirolimus.
RESULTS
Median PFS (progression free survival) in:
The temsirolimus 175 mg/75 mg group: 4.8 months
The investigator’s choice group: 1.9 months
Median OS (overall survival) rate with:
Temsirolimus 175 mg/75 mg group: 12.8 months
Investigator’s choice group: 9.7 months
Objective response rate
In the temsirolimus 175 mg/75 mg group: 22%
In the investigator’s choice therapy group: 2%
ADVERSE EVENTS (SIDE EFFECTS)
Eighty-nine percent of the patients receiving the target regimen of temsirolimus 175 mg/75 mg experienced grade-3 or grade-4 adverse events including thrombocytopenia, anemia, neutropenia and asthenia.
CONCLUSION
"Temsirolimus 175 mg weekly for 3 weeks followed by 75 mg weekly significantly improved PFS and objective response rate compared with investigator's choice therapy in patients with relapsed or refractory MCL."
Source: Hess G. J Clin Oncol. 2009;27:3822-3829
by Ross Bonander
