Anemia chemioindo;a. Paolo Pronzato, Genova

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Adriana Marchi
6 anni fa
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1 Anemia chemioindo;a Paolo Pronzato, Genova

2 Introduc.on

4 Treatment for CIA Observa.on Across Europe H Ludwig, Support Care Cancer 2014

5 Anemia Diagnos.c Tests Observa.on Across Europe H Ludwig, Support Care Cancer 2014

6 Overall Results of ESA 23 RCTs with the EMA licensed star.ng dose L Crathorne, NICE 2014

7 Overall Results of ESA L Crathorne, NICE 2014

8 NICE

9 A Step Backward

10 Physiopathology of Cancer Anemia Decrease in oxygen delivery to the kidneys EPO Increased oxygen delivery to Cssues Peritubular intersccal cells detect low oxygen levels in the blood Peritubular intersccal cells secrete EPO into the blood Proerythroblasts in red bone marrow mature more quickly into recculocytes More recculocytes enter circulacng blood Return to homeostasis when response brings oxygen delivery to kidneys back to normal Larger number of RBCs in circulacon Mulcahy L. Semin Oncol. 2001;28(2 suppl 8):19-23.

Physiopathology of Cancer Anemia Anemia- inducing substance Tumor cells Ac.

TNF Shortened survival IL- 1 a, b TNF IFN- g IL- 1 TNF a 1 - anctrypsin

on Suppressed BFU- E CFU- E Impaired iron u.liza.on Nowrousian M et al.

11 Physiopathology of Cancer Anemia Anemia- inducing substance Tumor cells Ac.vated immune system Macrophages RBCs Erythrophagocytosis Dyserythropoiesis TNF Shortened survival IL- 1 a, b TNF IFN- g IL- 1 TNF a 1 - anctrypsin IFN- g IL- 1 TNF Anemia Reduced EPO produc.on Suppressed BFU- E CFU- E Impaired iron u.liza.on Nowrousian M et al. In: Smyth JF, et al, eds. rherythropoietin in cancer supportive treatment. New York, NY: Marcel Dekker Inc; 1996:13-34.

12 Enthusiasm ESA shown to reduce CIA & RBC Transf Anemia as a nega3ve Prognos3c/Predic3ve Factor Anemia as the cause of Common Symptoms and Impairment of QoL ESA to Improve Prognosis ESA to Improve QoL Also without Chemotherapy

13 ESA 2015

14 ESA and Iron

15 RCT on IV Iron + ESA L Bas.t, JCO 2008

16 ESA and QoL

17 Impact on QoL. EPO- INT- 47 P Pronzato, The Oncologist 2010

18 QoL Meta- Analysis pts in 37 RCTs CIA (mean diff) No CT (mean diff) Fact- F 2.81* 2.41* Fact- An 4.50** 4.09** StaCsCcally Significant but below the threshold (>3) for clinically important difference Sta.s.cally Significant and above the threshold (>4) for clinically important difference J Bohlius, BJC 2014

19 ESA and Prognosis

20 EPO and Survival in a RCT BEST, EPO- INT- 76 B Leyland Jones, JCO 2005

21 EPO and Survival in a RCT BEST, EPO- INT- 76 B Leyland Jones, JCO 2005

22 Milan Breast Cancer Conference, Milan, Italy; June 26-27, 2014 SURVIVAL OUTCOMES FROM RANDOMIZED CONTROLLED TRIALS IN PATIENTS WITH BREAST CANCER RECEIVING ESAS ON STUDY: A META-ANALYSIS PRONZATO, PAOLO 1 ; Aapro, Matti 2 ; Moebus, Volker 3 ; Nitz, Ulrike 4 ; O Shaughnessy, Joyce 5 ; Untch, Michael 6 ; Tomita Dianne 7 ; Bohac, Chet 7 ; Leyland-Jones, Brian 8 1 Department of Medical Oncology, National Cancer Research Institute, Genova, Italy; 2 Multidisciplinary Oncology Institute, Clinique de Genolier, Genolier, Switzerland; 3 Department of Gynecology and Obstetrics, Clinic Frankfurt Hoechst, Academic Hospital of the Goethe University, Frankfurt, Germany; 4 Geriatric Breast Center, Evangelina Bethesda Hospital for Breast Diseases, Nordrhein-Westfalen, Germany; 5 Texas Oncology Baylor Sammons Cancer Center, and US Oncology, Dallas, TX, USA; 6 Department of Obstetrics and Gynecology, Helios Clinic Berlin-Buch, Berlin, Germany; 7 Amgen Inc., Thousand Oaks, CA, USA; 8 Avera Health, Sioux Falls, SD, USA

23 SURVIVAL OUTCOMES FROM RANDOMIZED CONTROLLED TRIALS IN PATIENTS WITH BREAST CANCER RECEIVING ESAS ON STUDY: A META-ANALYSIS Overall Mortality of Patients With Breast Cancer Receiving Chemotherapy, ESAs vs Control The literature search identified 9 eligible randomized controlled trials that reported the use of ESAs versus control (no ESAs) in patients with breast cancer receiving chemotherapy In these 9 studies (N = 4713; ESA n = 2346, control n = 2367), the overall OR (95% confidence interval [CI]) for death was 1.20 ( ) for ESA compared to control. CI, confidence interval

24 EPO- ANE 3010 at SABCS 2014

32 EPO- ANE 310 Key Points Intriguing Results (PFS & OS) Low Risk of Anemia and RBC Incidence

33 Transfusions Risks

34 Transfusion Risks S Hopewell, BMJOpen 2013

35 Transfusion Risks AA Khorana, Arch Int Med 2008

36 Dose- Dense Context

37 AGO- ETC Trial V Moebus, JNCI 2013

38 AGO- ETC Trial V Moebus, JNCI 2013

39 AGO- ETC Trial V Moebus, JNCI 2013

40 Conclusions

41 Conclusions about ESA (and Breast Cancer) Reduc.on of RBCt for pa.ents at risk Improvement of QoL Increase Risk of TVE Concern for Effects on Tumor Evolu.on Cau.on in applying To be seen as an alterna.ve to RBCt Consider the context (cura.ve,early pallia.on, late pallia.on)

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