SCORE DI KHORANA: APPLICABILITA NELLA PRATICA CLINICA

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1 SCORE DI KHORANA: APPLICABILITA NELLA PRATICA CLINICA Mario Mandalà U.O. Oncologia Ospedali Riuniti Bergamo, Roma, 14 Giugno 2012

2 Relazioni con soggetti portatori di interessi commerciali in campo sanitario Ai sensi dell art. 3.3 sul Conflitto di Interessi del Regolamento Applicativo dell Accordo Stato-Regione del 5 novembre 2009, dichiaro che negli ultimi due anni non ho avuto rapporti anche di finanziamento con soggetti portatori di interessi commerciali in campo sanitario.

3 Hematological Lung Gastrointestinal Breast Distant metastases 0 to 3 months 3 to 12 months 1 to 3 years 5 to 10 years > 15 years Adjusted odds ratio Effect of Malignancy on Risk of Venous Thromboembolism (VTE) Population-based case-control (MEGA) study N=3220 consecutive patients with 1st VTE vs. n=2131 control subjects CA patients = OR 7x VTE risk vs. non-ca patients Type of cancer Silver In: The Hematologist - modified from Blom et. al. JAMA 2005;293:715 Time since cancer diagnosis

4 IN QUALI PAZIENTI E PIU FREQUENTE?

5 PER RICORDARSI DOVE: dove vediamo il paziente COME: Come è estesa la malattia QUANDO: storia naturale, CT o No

6 DUE GRUPPI DI PAZIENTI Ospedalizzati Chemioterapia Allettamento Evento acuto Trasfusione G-CSF Polipatologie Malattia avanzata Ambulatoriali Chemioterapia Polipatologie

7 VTE rate (%) Risk in hospitalised patients Khorana AA, et al. J Clin Oncol. 2006;24:

8 Risk of VTE persists also after hospital discharge OR 4 1 Hospitalization Diagnosis Chemotherapy Metastasis Remission Time End of life Risk in cancer population Risk in general population Rao MV, et al. Who s at risk for thrombosis? In: Francis CW, Khorana AA, editors. Cancer-associated thrombosis: new findings in translational science, prevention, and treatment. 8 New York: Informa Healthcare; p

9 SCORE KHORANA

10 SCORE KHORANA

11 CLINICAL SCORE PER TEV Khorana, A. A. et al. Blood 2008;111:

12 CLINICAL SCORE PER TEV Khorana, A. A. et al. Blood 2008;111:

13 RATE OF VTE: CLINICAL SCORE Khorana, A. A. et al. Blood 2008;111:

14 TIMING

15 LIMITI Popolazioni non rappresentate PS Follow-up Aggiudicazione eventi Registro per Neutropenia NPV: 98%, PPV: 7%. Alto Rischio 13%, Basso Rischio 27%, Medio 60% Tipo di CT

16 Chemiotherapia e rischio di VTE Rischio di VTE durante chemioterapia Fattori Confondenti Eterogeneità dei pazienti con cancro (sede e stadio) Eterogeneità dei trattamenti chemioterapici Comorbidità Chirurgia, CVC, procedure invasive

17 KHORANA E CDDP 932 PTS 18% TEE MSKCC Khorana Derivative score 0: 13% 0.3% score of 1-2: 17.1%, 2% score of 3 : 28.2% 6.7%

18 Kaplan-Meier estimates of the risk of VTE in patients with risk scores 0, 1, 2, and 3 according to the risk scoring model developed by Khorana et al.16 The cumulative probability of VTE showed statistically significant association with the risk scores (lo... Ay C et al. Blood 2010;116:

19 VT E inc idenc e during c hemotherapy % VTE incidence according to scores from the risk model in the Khorana cohorts versus SENDO phase I cohort. Mandala et al. Ann Oncol L ow (0) Intermediate (1-2) High ( 3) R isk c a teg ory (sc ore) K horana development cohort K horana validation cohort S E NDO P has e I cohort

20 VTE COMPLICATIONS IN PAHSE 1 SENDO EXPERIENCE Mandala et al. Ann Oncol % con VTE stop terapia. Implicazioni sullo sviluppo di nuovi farmaci

21 STUDIO IN CORSO NCT

22 Chemotherapy: guideline recommendations for VTE prophylaxis in ambulatory cancer patients ASCO ACCP ESMO NCCN Ambulatory cancer patients receiving outpatient chemotherapy Routine thromboprophylaxis during systemic chemotherapy is not recommended Prophylaxis is recommended in myeloma patients receiving thalidomide or lenalidomide Routine thromboprophylaxis is not recommended Routine thromboprophylaxis is not recommended, But may be considered in high risk patients Routine thromboprophylaxis is recommended for: multiple myeloma patients receiving thalidomide or lenalidomide in combination with high dose dexamethasone or doxirubicin or multiagent chemotherapy myeloma patients with 2 or more risk factors Consider prophylaxis in other outpatients at risk 1. Lyman GH, et al. J Clin Oncol. 2007;25: Geerts WH, et al. Chest. 2008;133:381S-453S. 3. Mandala M, et al. Ann Oncol. 2012;21: NCCN guidelines 2011: available from Accessed August 2011.

23 COME UTILIZZARLO Discutere con paziente Profilassi in tutti gli alti rischio? Utilizzo di coorti di validazione

24 SOLO KHORANA?

25 PROTECHT SCORE: Khorana + cddp/cbdca/gem

26 MICROPARTICLES NCT The purpose of this research study is to see if enoxaparin is effective in preventing blood clots in the veins in participants who have cancer of the pancreas, colorectal, non-small cell lung, ovary, or gastric and also have high levels of tissue factor bearing microparticles in their blood (TFMP).

27 CONCLUSIONI Selezione dei pazienti ad alto rischio Studi di intervento per score Score clinico o biologico