1511P - SOMPAS: A prospective, non-interventional study (NIS) of the management of symptomatic chemotherapy (CT)-induced anemia (CIA) in patients (pts) wit...

Date 28 September 2014
Event ESMO 2014
Session Poster Display session
Topics Complications of Treatment
Supportive Care
Presenter Wolfgang Eisterer
Citation Annals of Oncology (2014) 25 (suppl_4): iv517-iv541. 10.1093/annonc/mdu356
Authors W. Eisterer1, A. Trojan2, A. Galid3, F. Haslbauer4, G. Delmore5, R. Kolb6, C. Jaeger7, C. Bast8, I. Pezzani9, M. Schmid10
  • 1Department Of Internal Medicine I, University Hospital Innsbruck, 6020 - Innsbruck/AT
  • 2Internal Medicine, OnkoZentrum Zurich, Zurich/CH
  • 3Gynecology, Gynecology, 1030 - Vienna/AT
  • 4Internal Medicine 1 Oncology, Landeskrankenhaus Vöcklabruck, 4840 - Vöcklabruck/AT
  • 5Oncology Department, Kantonsspital Frauenfeld, 8500 - Frauenfeld/CH
  • 6Pulmonologist, Medical office, 4600 - Wels/AT
  • 7Medical Department, Amgen GmbH, 1040 - Vienna/AT
  • 8Medical Department - Oncology, Amgen Switzerland AG, 6301 - Zug/CH
  • 9Medical Department, Amgen Switzerland AG, 6301 - Zug/CH
  • 10Department Of Medical Oncology & Hematology, Stadtspital Triemli, CH-8063 - Zurich/CH

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 (<12 vs ≥12 g/dL): 83% vs 94% quality of life responders, 17% vs 5% RBCT reduction. The RBCT incidence was 13% in weeks 1-4 (n = 34) and 15% in weeks ≥5 (n = 40). Iron supplementation was administered in 5% (n = 55) of a total of 1226 cycles. ESA treatment patterns: At BL 87% of patients received darbepoetin alfa (DA, n = 236), 13% (n = 34) other ESAs. 78% of pts (n = 603) received 500 µg DA, 16% (n = 122) 300 µg, 6% (n = 46) 150 µg; 79% (n = 606) received DA Q3W, 9% (n = 67) Q2W, 7% (n = 55) QW and 6% (n = 43) at other intervals. Mean number of DA administrations (range): 3.3 (1-6).

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.