1561P - Predictive Diagnostics for Response to Therapy of Chemotherapy Associated Anemia with Darbepoetin Alfa +/- Intravenous Iron in Cancer Patients: PFAD-3 a Multicentre Cohort Study in Outpatients

Abstract

ABSTRACT Introduction Seven randomized studies have demonstrated a benefit of combining erythropoiesis stimulating agents (ESA) with intravenous iron (iv Fe) in the treatment of chemotherapy-associated anemia in cancer patients (pts). Because, so far there is no proven recommendation for the best pretherapeutic diagnostics to select optimal therapy (ESA, iron or both), we conducted a multicenter cohort study. Methods Cancer pts were included and eligible for response if they had a symptomatic anemia (hemoglobin (Hb) Results Between 03/07 - 08/10 in 9 outpatient clinics 331 pts received DA on day 0. Mean age was 66.3 years, 58% were women. 202 pts (61%) received at least one dose iv Fe additionally to DA on day 0. Baseline Hb was 9.53g/dl (SD 0.78) and increased in average 1.23g/dl (SD 1.34) and 1.53 g/dl (SD 1.49) til weeks 6 and 9, respectively. Transfusion rate in weeks 3-9 was 15.1%. Associations of relevant criteria with response are shown in the table. Table: 1561P . Predictive factor for response* to DA to DA with additional iv-iron to DA without iv-iron OR (95% CI) (N)*** OR (95% CI) (N)*** OR (95% CI) (N)*** Ferritin (F) 1.80 (0.85-3.81) (200) 4.60 (1.62-13.09) (135) 0.13 (0.02-1.07) (65) TSAT 1.28 (0.72-2.27) (200) 1.10 (0.80-3.59) (136) 0.65 (0.24-1.76) (64) sTFR ≥ 1.76 mg/dl 1.51 (0.87-2.60) (216) 1.70 (0.87-3.30) (146) 1.13 (0.43-2.99) (70) FI, sTFR/logF ≤ 3.2** 3.92 (0.43-35.70) (197) 7.29 (0.38-140.76) (134) 0.57 (0.02-17.60) (63) eEPO 1.96 (0.80-4.80) (200) 2.26 (0.65-7.89) (142) 1.29 (0.34-4.90)(58) Δ sTFR d14-1 ≥25% 1.75 (0.78-3.91) (153) 1.85 (0.73-4.68) (103) 1.98 (0.35-11.35) (50) Δ Hb d21-1 ≥0,6 g/dl 6.09 (3.23-11.49) (189) 8.20 (3.71-18.10) (130) 3.11 (1.05-9.23) (59) * Hb d42 ≥ 11 g/dl or Δ Hb d42-d1 ≥ 1.5 g/dl,no transfusion d21-d42 ** If CRP > 5 mg/l : FI ≤ 2 *** Odds ratio, confidence intervall,and number of pts with … … DA therapy conform with protocol,treatment response and predictivefactors evaluable Conclusion The results confirm the increase of Hb within the first 3 weeks as strong predictor for response to DA in week 6. Pts with Hb-increase ≥ 0.6 g/dl have a 6-fold higher chance of being responders than those without. Ferritin is a stronger predictor for response to iv Fe than TSAT. Supported by Amgen, Munich, Germany. Disclosure H..T. Steinmetz: Member of advisory boards for Amgen, Janssen, Medice, Novartis, Roche, Vifor. Investigator in studies for Amgen, Janssen, Novartis, Roche, Vifor., M. Neise: Investigator in studies with Amgen, J. Mittermuller: Investigator in studies with Amgen, H.W. Tessen: Investigator in studies with Amgen, M. Reiser: Investigator in studies with Amgen, K. Severin: Ivestigator in studies with Amgen, Roche, Vifor, S. Schmitz: Investigator in studies with Amgen, Novartis, Roche, Vifor. All other authors have declared no conflicts of interest.