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Efficacy and safety of degarelix in Korean patients with prostate cancer requiring androgen deprivation therapy: Open-label multicenter phase III study.

You D, Chung BH, Lee SE, Kim CS - Prostate Int (2015)

Bottom Line: To assess the noninferiority, efficacy, and safety of degarelix in achieving and maintaining testosterone at castrate levels (≤0.5 ng/mL) in Korean patients (CS42) versus non-Asian patients with prostate cancer (PCa).The results were compared with non-Asian patients receiving degarelix 240/80 mg in the CS21 study.Testosterone suppression was noninferior to that in non-Asian patients and safety findings were as would be expected for elderly men with PCa undergoing androgen deprivation therapy.

View Article: PubMed Central - PubMed

Affiliation: Department of Urology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.

ABSTRACT

Purpose: To assess the noninferiority, efficacy, and safety of degarelix in achieving and maintaining testosterone at castrate levels (≤0.5 ng/mL) in Korean patients (CS42) versus non-Asian patients with prostate cancer (PCa).

Methods: A Phase III, open-label, multicenter, single-arm trial was conducted in Korean patients with PCa. Degarelix was administered at a starting dose of 240 mg followed by monthly (28-day intervals) maintenance doses of 80 mg (240/80 mg dose regimen) for 7 months. The results were compared with non-Asian patients receiving degarelix 240/80 mg in the CS21 study.

Results: The estimated difference in the cumulative probabilities of testosterone ≤0.5 ng/mL from Day 28 to Day 196 between the trials was -2.3% (96.7% in CS42 vs. 99.0% in CS21). The lower limit of the 95% confidence interval was -5.5%, i.e., above the predefined noninferiority limit of -10% and thus noninferiority was established. Decreases in serum testosterone, prostate-specific antigen, and luteinizing hormone over time were similar in CS42 and CS21. There were no clinically significant differences in incidence of treatment-emergent adverse events (72% in CS42 vs. 70% in CS21) and changes in clinical chemistry and hematology parameters between the two trials. The most common adverse event was injection-site reaction.

Conclusions: Overall, degarelix was effective and well tolerated in Korean patients. Testosterone suppression was noninferior to that in non-Asian patients and safety findings were as would be expected for elderly men with PCa undergoing androgen deprivation therapy.

No MeSH data available.


Related in: MedlinePlus

Kaplan–Meier plot (95% confidence interval) of the cumulative probability of testosterone ≤0.5 ng/mL from Day 28 to Day 196 in patients receiving degarelix 240/80 mg in studies CS42 and CS21 (240/80 mg, non-Asian patients; full analysis set).
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fig1: Kaplan–Meier plot (95% confidence interval) of the cumulative probability of testosterone ≤0.5 ng/mL from Day 28 to Day 196 in patients receiving degarelix 240/80 mg in studies CS42 and CS21 (240/80 mg, non-Asian patients; full analysis set).

Mentions: Fig. 1 shows KM estimates for cumulative probability of testosterone ≤0.5 ng/mL from Day 28 to Day 196 in CS42 and CS21 (FAS). In CS42, one patient had a testosterone escape (>0.5 ng/mL) at Day 28 and two additional escapes occurred on Day 112 and Day 196. KM estimates of the cumulative probability of testosterone ≤0.5 ng/mL were 96.7% (95% CI: 92.2–98.6%) in Korean patients (CS42) versus 99.0% (95% CI: 95.9–99.7%) in non-Asian men in CS21 (log-rank test, p = 0.138; FAS dataset). Since the lower bound of the 95% CI was above the 90% threshold, degarelix was shown to be effective in achieving and maintaining castrate testosterone levels in Korean patients.


Efficacy and safety of degarelix in Korean patients with prostate cancer requiring androgen deprivation therapy: Open-label multicenter phase III study.

You D, Chung BH, Lee SE, Kim CS - Prostate Int (2015)

Kaplan–Meier plot (95% confidence interval) of the cumulative probability of testosterone ≤0.5 ng/mL from Day 28 to Day 196 in patients receiving degarelix 240/80 mg in studies CS42 and CS21 (240/80 mg, non-Asian patients; full analysis set).
© Copyright Policy - CC BY-NC-ND
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4494635&req=5

fig1: Kaplan–Meier plot (95% confidence interval) of the cumulative probability of testosterone ≤0.5 ng/mL from Day 28 to Day 196 in patients receiving degarelix 240/80 mg in studies CS42 and CS21 (240/80 mg, non-Asian patients; full analysis set).
Mentions: Fig. 1 shows KM estimates for cumulative probability of testosterone ≤0.5 ng/mL from Day 28 to Day 196 in CS42 and CS21 (FAS). In CS42, one patient had a testosterone escape (>0.5 ng/mL) at Day 28 and two additional escapes occurred on Day 112 and Day 196. KM estimates of the cumulative probability of testosterone ≤0.5 ng/mL were 96.7% (95% CI: 92.2–98.6%) in Korean patients (CS42) versus 99.0% (95% CI: 95.9–99.7%) in non-Asian men in CS21 (log-rank test, p = 0.138; FAS dataset). Since the lower bound of the 95% CI was above the 90% threshold, degarelix was shown to be effective in achieving and maintaining castrate testosterone levels in Korean patients.

Bottom Line: To assess the noninferiority, efficacy, and safety of degarelix in achieving and maintaining testosterone at castrate levels (≤0.5 ng/mL) in Korean patients (CS42) versus non-Asian patients with prostate cancer (PCa).The results were compared with non-Asian patients receiving degarelix 240/80 mg in the CS21 study.Testosterone suppression was noninferior to that in non-Asian patients and safety findings were as would be expected for elderly men with PCa undergoing androgen deprivation therapy.

View Article: PubMed Central - PubMed

Affiliation: Department of Urology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.

ABSTRACT

Purpose: To assess the noninferiority, efficacy, and safety of degarelix in achieving and maintaining testosterone at castrate levels (≤0.5 ng/mL) in Korean patients (CS42) versus non-Asian patients with prostate cancer (PCa).

Methods: A Phase III, open-label, multicenter, single-arm trial was conducted in Korean patients with PCa. Degarelix was administered at a starting dose of 240 mg followed by monthly (28-day intervals) maintenance doses of 80 mg (240/80 mg dose regimen) for 7 months. The results were compared with non-Asian patients receiving degarelix 240/80 mg in the CS21 study.

Results: The estimated difference in the cumulative probabilities of testosterone ≤0.5 ng/mL from Day 28 to Day 196 between the trials was -2.3% (96.7% in CS42 vs. 99.0% in CS21). The lower limit of the 95% confidence interval was -5.5%, i.e., above the predefined noninferiority limit of -10% and thus noninferiority was established. Decreases in serum testosterone, prostate-specific antigen, and luteinizing hormone over time were similar in CS42 and CS21. There were no clinically significant differences in incidence of treatment-emergent adverse events (72% in CS42 vs. 70% in CS21) and changes in clinical chemistry and hematology parameters between the two trials. The most common adverse event was injection-site reaction.

Conclusions: Overall, degarelix was effective and well tolerated in Korean patients. Testosterone suppression was noninferior to that in non-Asian patients and safety findings were as would be expected for elderly men with PCa undergoing androgen deprivation therapy.

No MeSH data available.


Related in: MedlinePlus