Abstract
ABSTRACT Aim: SOMPAS investigated the clinical practice of symptomatic CIA management in AT and CH. Methods: Design: multi-center, prospective NIS. Eligibility: adults with CRC, BC or LC and ≥3 cycles of planned CT in combination with an erythropoiesis-stimulating agent (ESA). 1° objective: adherence to EORTC guidelines and ESA label. 1° outcome: Hb threshold at ESA initiation; 2° outcomes: Hb trajectory, ESA treatment patterns, red blood cell transfusions (RBCTs), iron supplementation. Hb values within 28 days after RBCTs were excluded. Results: 270/273 enrolled pts were analyzed (3 received no ESA). Median age at baseline (BL) was 64.0 yrs (range 33-86) and 67% of pts were female and 12% had ECOG ≥2. Tumors: 47% BC, 37% LC, 21% CRC; 81% stage III-IV disease. CT use: 36% platinum, 22% taxane, 15% anthracycline, 58% other; 77% palliative intent. Most frequent anemia symptoms at BL: 72% fatigue, 19% pallor, 16% respiratory distress, 15% depression, 29% other. Indications for ESA use by Hb target ( Hb outcomes: Hb range at ESA initiation 9-11 g/dL (EORTC)a ≤10 g/dL (label) 71% (n = 191) 49% (n = 132) Mean Hb (95% CI) ESA initiation (n = 270) ESA end of treatmentb (n = 241) 10.2 g/dL (10.1-10.3)c 10.9 g/dL (10.7-11.1)c Hb >10 g/dLd 90% (n = 243) aexcludes pts with Hb >11-11.9 g/dL and declining Hb trend; blast available Hb value; cdifference statistically significant [non-overlapping CIs]; din ≥1 cycle Conclusions: ESAs were used as per EORTC guidelines in 71% of pts, 51% of pts were initiated at Hb >10g/dL. Pts achieved a significant increase in Hb during ESA treatment; 90% had a Hb >10 g/dL. A large proportion of pts avoided RBCTs while treated with an ESA. Disclosure: G. Delmore: declares to be a member of the Amgen advisory board; C. Jaeger, C. Bast and I. Pezzani: declares to be an Amgen employee and to hold Amgen stock; M. Schmid: declares to be a member of the Amgen advisory board. All other authors have declared no conflicts of interest.
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