Departments of Genitourinary Medical Oncology, Biostatistics and Applied Mathematics, and Nuclear Medicine, The University of Texas M. D. Anderson Cancer Center, Houston, TX.

Samarium-153 ((153)Sm) lexidronam is a bone-targeting radiopharmaceutical with a short physical half-life and a favorable toxicity profile. We evaluated the safety and feasibility of a concurrent combination of weekly docetaxel with repeated (153)Sm-lexidronam in patients with castration-resistant prostate cancer (CRPC).

A conventional 3 + 3 dose-escalation design was used for this study. Patients were treated in three cohorts comprising two cycles of weekly docetaxel at 25, 30, and 35 mg/m(2), respectively, on days 1, 8, and 15 of a 28-day cycle in combination with (153)Sm (1 mCi/kg) on day 1. Unacceptable hematologic toxicity (UHT) was defined as more than 7 days delay in therapy for inadequate counts: an absolute neutrophil count (ANC) more than 1,000/microL and platelets more than 70,000/microL were required at days 8 and 15 and ANC more than 1,500/microL and platelets more than 100,000/microL were required at cycle 2, day 1. If counts had not recovered by day 56 of either combination cycle, UHT was declared.

Eighteen patients were treated in three cohorts. Two patients in separate cohorts experienced UHT; the maximum-tolerated dose for this regimen was not reached. The median interval between (153)Sm doses was 35 days (range, 27 to 57 days). The only significant toxicity was mild, transient myelosuppression. Five patients (28%) experienced grade 3 hematologic toxicity. There were no grade >/= 4 hematologic or nonhematologic toxicities.

Two dosing cycles consisting of weekly docetaxel and monthly (153)Sm-lexidronam were well tolerated and feasible in this CRPC population.

Written by:
Tu SM, Mathew P, Wong FC, Jones D, Johnson MM, Logothetis CJ.   Are you the author?

Reference:
J Clin Oncol. 2009 May 4. Epub ahead of print.
doi:10.1200/JCO.2008.20.5393

PubMed Abstract
PMID:19414670

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