scholarly journals A Randomized, Double-Blind, Placebo-Controlled, Phase III Noninferiority Study of the Long-Term Safety and Efficacy of Darbepoetin Alfa for Chemotherapy-Induced Anemia in Patients With Advanced NSCLC

2020 ◽  
Vol 15 (2) ◽  
pp. 190-202 ◽  
Author(s):  
Pere Gascón ◽  
Rajnish Nagarkar ◽  
Martin Šmakal ◽  
Konstantinos N. Syrigos ◽  
Carlos H. Barrios ◽  
...  
Keyword(s):  
Darbepoetin Alfa ◽  
Advanced Nsclc ◽  
Phase Iii ◽  
Double Blind ◽  
Safety And Efficacy ◽  
Double Blind Placebo

Darbepoetin Alfa for the Treatment of Chemotherapy-Induced Anemia: Disease Progression and Survival Analysis From Four Randomized, Double-Blind, Placebo-Controlled Trials

2005 ◽  
Vol 23 (28) ◽  
pp. 6941-6948 ◽  
Author(s):  
Michael Hedenus ◽  
Johan Vansteenkiste ◽  
Dusan Kotasek ◽  
Matthew Austin ◽  
Rafael G. Amado
Keyword(s):  
Lung Cancer ◽  
Darbepoetin Alfa ◽  
Randomized Clinical Trials ◽  
Progression Free Survival ◽  
Dose Finding ◽  
Phase Iii ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Multiple Tumor ◽  
Tumor Types

Purpose To determine the effect of darbepoetin alfa (DA) on progression-free survival (PFS) and overall survival (OS) in patients with chemotherapy-induced anemia (CIA). Patients and Methods Two 16-week randomized, double-blind, placebo-controlled phase III studies of weekly DA in anemic patients with lung cancer (n = 314) or lymphoproliferative malignancies (LPMs; n = 344) undergoing chemotherapy were analyzed with prospectively defined long-term PFS and OS end points. Short-term effects of DA on PFS and OS were analyzed by including two additional 16-week dose-finding, double-blind, placebo-controlled studies in anemic patients with multiple tumor types (n = 405) and LPMs (n = 66). Results Median follow-up is 15.8 months (lung cancer) and 32.6 months (LPM). Median duration of PFS was comparable between DA and placebo: 5.1 months (95% CI, 4.1 to 6.9 months) versus 4.4 months (95% CI, 3.7 to 5.3 months) for lung cancer and 14.2 months (95% CI, 12.2 to 17.5 months) versus 15.9 months (95% CI, 13.1 to 19.0 months) for LPMs. The estimated hazard ratio (HR) of death related to DA use for lung cancer was 0.77 (95% CI, 0.59 to 1.01) and 1.26 (95% CI, 0.92 to 1.71) for LPMs. In the pooled analyses of all four studies (n = 1,129), no differences in PFS or OS were observed between DA and placebo (HR = 0.92; 95% CI, 0.78 to 1.07; and HR = 0.95; 95% CI, 0.78 to 1.16, respectively). Conclusion Treatment with DA does not seem to influence PFS or OS in patients with CIA. Prospective, randomized clinical trials will provide additional insights into the effects of DA on PFS and OS in specific tumor types.

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