Weekly docetaxel in elderly patients with prostate cancer: efficacy and toxicity in patients at least 70 years of age compared with patients younger than 70 years.
(Clinical Trial;Journal Article)
We sought to determine whether age was significantly associated with efficacy and toxicity of weekly docetaxel in patients with metastatic androgen-independent prostate cancer (AIPC). Individual patient data were pooled from 2 phase II clinical trials of weekly docetaxel 36 mg/m(2) for 6 of every 8 weeks in men with metastatic AIPC. Baseline characteristics and outcome measures of men > 70 years of age (n = 52) were compared with patients < 70 of age (n = 34) using Pearson c2 test for categoric variables, Mann-Whitney U test for continuous variables, and log-rank test of Kaplan-Meier estimates for time-dependent variable. Multivariate analysis was used to adjust for any imbalances in baseline characteristics. At baseline, older patients had a lower hemoglobin level (P = 0.05) and a higher serum prostate-specific antigen (PSA; P = 0.04). The PSA response rate was 47% (95% CI, 33%-62%) in older patients and 40% (95% CI, 23%-59%) in younger patients (P = 0.75). Similarly, measurable disease response rate (P = 0.43), time to progression (P = 0.28), and survival (P = 0.52) were not affected by age in both univariate and multivariate analyses. There was also no difference in overall hematologic and nonhematologic toxicity > grade 2. This comparison of pooled individual patient data from 2 phase II studies of weekly docetaxel in AIPC did not reveal significant differences in efficacy or toxicity in men aged > 70 years compared with younger patients. These findings are consistent with the hypothesis that docetaxel chemotherapy in patients with AIPC is equally well tolerated and effective across a wide range of ages.
Beer, TM; Berry, W; Wersinger, EM; Bland, LB
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