Research findings published in the International Journal of Clinical Oncology suggest that temsirolimus effectively stabilizes disease progression in patients with metastatic renal cell carcinoma (mRCC) undergoing hemodialysis.
Temsirolimus, a novel specific inhibitor of mammalian target of rapamycin, has previously been shown to exhibit an inhibitory effect on tumor cell growth and demonstrated significant overall and progression-free survival benefits compared with interferon (IFN)-alpha in patients with untreated poor-prognosis mRCC.
The findings from the current retrospective pilot study expand this research to include patients with renal impairment. "Treatment of patients undergoing hemodialysis with temsirolimus could be a promising approach considering both its efficacy and tolerability," say Hideaki Miyake (Kobe University, Japan) and colleagues.
For the study, 10 Japanese patients, aged a median of 61 years, underwent radical nephrectomy, with seven patients diagnosed with clear cell carcinoma and three with papillary carcinoma type 2. The median duration of hemodialysis prior to temsirolimus treatment was approximately 15.5 years.
Weekly intravenous temsirolimus 25 mg and diphenhydramine 25 mg as premedication was administered and resulted in stable disease for at least 6 weeks in nine patients.
Medication was continued until patients experienced disease progression or intolerable adverse events. The median duration of treatment was 13 months. The researchers note that during the observation period of 14 months, nine patients were still alive.
Dose modification due to medication-related adverse events was required in four patients, giving an average relative dose intensity of 89.5% throughout the study.
"This suggests it would be possible to provide temsirolimus therapy for mRCC patients on hemodialysis equivalent to that for those with normal renal function," say Miyake and co-authors.
Adverse events were recorded for all patients, but those of grade 3 or above occurred only in four patients and included thrombocytopenia in two patients, anemia in one patient, and asthenia in one patient.
Patient health-related quality of life was not significantly different before and 3 months after treatment with temsirolimus, as evaluated by the Short Form-36.
"It is warranted to perform a prospective study accumulating a sufficient number of patients to support the outcomes described in this study," conclude the researchers.
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