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A phase 2, multicenter, open-label study of sepantronium bromide (YM155) plus docetaxel in patients with stage III (unresectable) or stage IV melanoma.

Kudchadkar R, Ernst S, Chmielowski B, Redman BG, Steinberg J, Keating A, Jie F, Chen C, Gonzalez R, Weber J - Cancer Med (2014)

Bottom Line: Secondary endpoints were objective response rate (ORR), 1-year overall survival (OS) rate, time from first response to progression, clinical benefit rate (CBR), and safety.The best ORR (complete response [CR] + partial response [PR]) per IRC was 12.5% (8/64).YM155 was generally well tolerated, but the predetermined primary efficacy endpoint (i.e., 6-month PFS rate ≥20%) was not achieved.

View Article: PubMed Central - PubMed

Affiliation: Winship Cancer Institute, Emory University, Atlanta, Georgia.

No MeSH data available.


Related in: MedlinePlus

Kaplan–Meier plot with two-sided 95% confidence intervals for overall survival, full analysis set.
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fig03: Kaplan–Meier plot with two-sided 95% confidence intervals for overall survival, full analysis set.

Mentions: All efficacy analyses include all 64 enrolled patients. Data presented are from Independent Review Committee (IRC) assessment, unless otherwise specified. The median PFS was 4.2 (95% CI, 2.7–5.6) months (Figure2). Six-month PFS rate per independent assessment was 34.8% (95% CI, 21.3–48.6%); per Investigator's assessment, 6-month PFS was 31.3% (95% CI, 19.5–43.9%). The median OS was 14.9 (95% CI, 8.8–24.3) months, and the estimated probability of 1-year survival was 56.3% (Figure3).


A phase 2, multicenter, open-label study of sepantronium bromide (YM155) plus docetaxel in patients with stage III (unresectable) or stage IV melanoma.

Kudchadkar R, Ernst S, Chmielowski B, Redman BG, Steinberg J, Keating A, Jie F, Chen C, Gonzalez R, Weber J - Cancer Med (2014)

Kaplan–Meier plot with two-sided 95% confidence intervals for overall survival, full analysis set.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4430257&req=5

fig03: Kaplan–Meier plot with two-sided 95% confidence intervals for overall survival, full analysis set.
Mentions: All efficacy analyses include all 64 enrolled patients. Data presented are from Independent Review Committee (IRC) assessment, unless otherwise specified. The median PFS was 4.2 (95% CI, 2.7–5.6) months (Figure2). Six-month PFS rate per independent assessment was 34.8% (95% CI, 21.3–48.6%); per Investigator's assessment, 6-month PFS was 31.3% (95% CI, 19.5–43.9%). The median OS was 14.9 (95% CI, 8.8–24.3) months, and the estimated probability of 1-year survival was 56.3% (Figure3).

Bottom Line: Secondary endpoints were objective response rate (ORR), 1-year overall survival (OS) rate, time from first response to progression, clinical benefit rate (CBR), and safety.The best ORR (complete response [CR] + partial response [PR]) per IRC was 12.5% (8/64).YM155 was generally well tolerated, but the predetermined primary efficacy endpoint (i.e., 6-month PFS rate ≥20%) was not achieved.

View Article: PubMed Central - PubMed

Affiliation: Winship Cancer Institute, Emory University, Atlanta, Georgia.

No MeSH data available.


Related in: MedlinePlus