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/Toxicities of treatment
Supportive measures
Therapy
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.