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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

Secondary endpoints. (a) Median (interquartile range) serum testosterone (ng/mL) and (b) median (interquartile range) percentage change in serum prostate-specific antigen (PSA; ng/mL), over time in patients receiving degarelix 240/80 mg in CS42 and CS21 (240/80 mg, non-Asian patients; full analysis set).
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fig2: Secondary endpoints. (a) Median (interquartile range) serum testosterone (ng/mL) and (b) median (interquartile range) percentage change in serum prostate-specific antigen (PSA; ng/mL), over time in patients receiving degarelix 240/80 mg in CS42 and CS21 (240/80 mg, non-Asian patients; full analysis set).

Mentions: Decreases in testosterone over time were similar in CS42 and CS21 (Fig. 2A). At Day 3, median testosterone was 0.26 ng/mL and 0.24 ng/mL in CS42 and CS21, respectively, and median percentage decreases from baseline were 94.0% and 94.2%, respectively. The proportion of patients with testosterone ≤0.5 ng/mL at Day 3 was 97.4% in CS42 and 96.1% in CS21 (p = 0.566, Fisher's exact test; FAS). At Day 196, very similar decreases in testosterone were observed: median serum testosterone had decreased by 98.4% and 98.1% in CS42 and CS21, respectively (median testosterone at Day 196 was 0.070 ng/mL and 0.086 ng/mL in CS42 and CS21, respectively). In addition, in CS42 and CS21, the KM estimates of the cumulative probabilities of testosterone ≤0.5 ng/mL from Day 56 to Day 196 were 96.7% and 99.0%, respectively (log-rank test, p = 0.140; FAS), similar to the results from Day 28 onwards.


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)

Secondary endpoints. (a) Median (interquartile range) serum testosterone (ng/mL) and (b) median (interquartile range) percentage change in serum prostate-specific antigen (PSA; ng/mL), over time in patients receiving degarelix 240/80 mg in 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

fig2: Secondary endpoints. (a) Median (interquartile range) serum testosterone (ng/mL) and (b) median (interquartile range) percentage change in serum prostate-specific antigen (PSA; ng/mL), over time in patients receiving degarelix 240/80 mg in CS42 and CS21 (240/80 mg, non-Asian patients; full analysis set).
Mentions: Decreases in testosterone over time were similar in CS42 and CS21 (Fig. 2A). At Day 3, median testosterone was 0.26 ng/mL and 0.24 ng/mL in CS42 and CS21, respectively, and median percentage decreases from baseline were 94.0% and 94.2%, respectively. The proportion of patients with testosterone ≤0.5 ng/mL at Day 3 was 97.4% in CS42 and 96.1% in CS21 (p = 0.566, Fisher's exact test; FAS). At Day 196, very similar decreases in testosterone were observed: median serum testosterone had decreased by 98.4% and 98.1% in CS42 and CS21, respectively (median testosterone at Day 196 was 0.070 ng/mL and 0.086 ng/mL in CS42 and CS21, respectively). In addition, in CS42 and CS21, the KM estimates of the cumulative probabilities of testosterone ≤0.5 ng/mL from Day 56 to Day 196 were 96.7% and 99.0%, respectively (log-rank test, p = 0.140; FAS), similar to the results from Day 28 onwards.

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