1499PEFFECTIVENESS OF DARBEPOETIN ALFA (DA) FOR CHEMOTHERAPY-INDUCED ANAEMIA (CIA) WHEN INITIATED AT HAEMOGLOBIN (HB) ≤10 G/DL

Abstract Aim: In 2008, the label for DA was updated, decreasing Hb treatment initiation and discontinuation thresholds to ≤10 and >12 g/dL, respectively. Few published placebo-controlled data are available on the effectiveness of DA initiated at Hb ≤10 g/dL. Pooled and meta-analyses were conducted to assess DA effectiveness when initiated as per current labelling. Methods: Data for patients with cancer and CIA who initiated DA at Hb ≤10 g/dL were extracted from a database of Amgen-sponsored trials. A comparative analysis was limited to randomised, controlled trials in patients treated with DA or control (placebo/best supportive care). Data for the DA arm(s) of randomised, multiple-arm or prospective, single-arm trials were also extracted (DA-only analysis; non-front loaded studies only). Outcomes included Hb increase ≥1g/dL or ≥2g/dL during the first 12 weeks of treatment. Crude and Kaplan–Meier (KM) proportions of subjects who experienced each outcome, and time (days) to each outcome were summarised by treatment arm. Meta-analysis (fixed effect inverse-variance method) was performed to compare outcomes for DA versus control. Results: The comparative analysis included four studies (two in lung cancer, one in lymphoproliferative disease and one in non-myeloid malignancy): DA, n = 261; control, n = 273. DA-only analysis included 15 studies (n = 3768). Results of the crude and KM analyses are shown in the Table; data are presented as percentages of patients (95% confidence interval [CI]). Hazard ratios (95% CI) for patients with an Hb increase of ≥1 g/dL and ≥2 g/dL for DA vs. control were 2.07 (1.62–2.63) and 2.91 (2.09–4.06), respectively. Median (95% CI) time to a ≥1 g/dL increase was 43 (37,50) days for DA and was not achieved for placebo. First quartile time to a ≥2 g/dL increase was 43 (40–50) days and 83 (76–not evaluable) days, respectively. Hb change % (95% CI)DA (n = 261)Placebo (n = 273)DA only (n = 3768)ΔHb ≥1 g/dLCrude66 (60–71)40 (35–46)67 (65–68)KM76 (69–83)48 (40–57)82 (80–85)ΔHb ≥2 g/dLCrude45 (39–51)19 (15–24)43 (42–45)KM58 (49–68)27 (18–37)60 (57–63) Conclusions: Our study suggests that DA effectively increases Hb levels and reduces time to Hb increase in patients for whom treatment was initiated at Hb ≤10 g/dL, as per current product labelling. Disclosure: M. Hedenus: Minor honoraria for temporary advisory boards for Takeda, Pharmacosmos,and Vifor; L. Belton: Contractor funded by Amgen; J. Terwey: Employee of Amgen (Europe) GmbH. All other