Table 2.
Characteristics of patients studied (i.e., low-volume and high-volume disease) and key outcomes for upfront docetaxel in metastatic prostate cancer in three randomized trials
| CHAARTED n=397 docetaxel patients |
STAMPEDE N=1066 docetaxel patientsa |
GETUG N=189 docetaxel patients |
|
|---|---|---|---|
| Median age (range) | 64 (36–91) | 65–66a (60–70) | 63 (57–68) |
|
| |||
| #/% Low volume | 134 | Unknown | 100 |
| #/% High volume | 263 | 92 | |
|
| |||
| # (%) lung metastases | NR | 6 | 44 (11%) |
| # (%) liver metastases | NR | 13 | 12/395 |
|
| |||
| HR overall survival (95% CI) | 0.61 (0.47–0.8) | 0.76 (0.62–0.93) | 0.9 (0.69–1.81) |
|
| |||
| HR low volume | 1.04 (0.7–1.55) | Unknown | 1.02 (0.67–1.55) |
| HR high volume | 0.63 (0.5–0.79) | 0.78 (0.56–1.09) | |
|
| |||
| Any grade 3–4 toxicity | 29.3% | 52% | NR |
| Grade 3–4 neutropenia | 12% | 10.8% | 41%b |
| Grade 5 toxicity | 1 (0.3%) | 8 (1.2%) | 4 (2.1%) |
CHAARTED, ChemoHormonal Therapy versus Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer; CI, confidence interval; HR, hazard ratio; GETUG, Groupe d’Etude des Tumeurs Urogenitales; NR, not reported.
a
Includes 550 standard of care (SOC) and docetaxel and 516 SOC and zoledronate and docetaxel.
b
The rate of grade 3/4 neutropenia decreased to 15% after an amendment to use prophylactic GCSF.