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Che cosa è l’Osteoncologia in Italia

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(1)

Toni Ibrahim BSc,MD, PhD

Head of Osteoncology and Rare Tumors Center Cancer Institute of Romagna,IRST-IRCCS Meldola, Italy

Che cosa è

l’Osteoncologia in Italia ?

(2)

Dichiarazione conflitto di interessi

Toni Ibrahim, 19/06/2019

Relationship Company/Organization

Honoraria Consultant EISAI

Grant to Institution Novartis

Partecipation expenses to congress Novartis, Pharmamar, Ipsen

(3)

Outline:

1- Hot topic in Oncology

2- Osteoncology = Evolution and Revolution 3- Conclusions

(4)

Microenvironment

Cancer Cells

Hot topic in Oncology

Cross

talk

(5)

TO DOMINATE CANCER….

Better understand CANCER BIOLOGY and

PATIENT NEEDS

Research Support

Figures Clinical

Researchers

Lab Researchers

We need to join forces and speak the same language…

(6)

NATIONAL PROJECT: MULTIDISCIPLINARY APPROACH TO PATIENTS WITH BONE METASTASES

Prof Dino Amadori

2000 2019

National training courses

2002 Bologna, Rome 2003 Naples, Bologna 2004 Naples, Florence

Course

in Osteoncology

2003 - 2005

II level University Masters in Osteoncology (Modena/Bologna/Forlì)

2009-2019

PhD in Osteoncology (Campus Roma)

Masters/PhD in Osteoncology Publications: 3 books

2003 - 2018

National training and practical courses in Osteoncology (Modena – Forlì- Meldola- Roma- Verona- others)

Establishment of Osteoncology Center

Establishment of Osteoncology field

National Bone

Metastases Data Base

Multidisciplinary Osteoncology School (MOS) 2008

2014 2016

This strategy could be one of the oncology experiences, the recent discipline:

THE OSTEONCOLOGY

(7)

Osteoncology = Evolution and Revolution in Oncology

(8)

Outline:

1- Hot topic in Oncology

2- Osteoncology = Evolution and Revolution 3- Conclusions

(9)

New Bone- Cancer relationship

EVOLUTION

Primitive tumors 1- Bone metastases

2- Cancer Treatment Induced Bone Loss (CTIBL)

REVOLUTION

- Foundation of a new field in Oncology:

OSTEONCOLOGY

- Care

: mono and multidisciplinary approach

- Research:

thanks to new Knowledge in the pathogenesis of bone

metastases, on 2018 the aim of treatments is not only to prevent SREs, but also to have an impact in the natural history of cancer.

Ibrahim T et al. Oncol Lett. 2013

(10)
(11)
(12)
(13)

Danno osseo indotto dai trattamenti antitumorali

0 2 4 6 8 Normal men

Late menop. women Early menop women Aromatase Inhibitor Bone Marrow transpl Androgen deprivation AI + GNrh agonist

Ovarian failure due chemiother

1%

2 % 2.6%

3.3%

4.6%

7.0%

7.6%

Lumbar spine BMD (% /year Bone Loss) 0.5%

Rate of BMD Loss

(14)

Impact of bone metastases

Skeletal Related Events

QoL Outcome Costs

Osteoporosis/

CTIBL

(15)

New Bone- Cancer relationship

EVOLUTION

Primitive tumors 1- Bone metastases

2- Cancer Treatment Induced Bone Loss (CTIBL)

REVOLUTION

- Foundation of a new field in Oncology:

OSTEONCOLOGY

- Care

: mono and multidisciplinary approach

- Research:

thanks to new Knowledge in the pathogenesis of bone

metastases, on 2019 the aim of treatments is not only to prevent SREs, but also to have an impact in the natural history of cancer.

Ibrahim T et al. Oncol Lett. 2013

(16)

Oncologist

Palliative Care Expert

Radiotherapist

Orthopedic Specialist

Radiologist

Physiatrist Clinical

Pathologist Pathologist

Lab Reasearchers Data Manager

Dedicated Nurse

Nuclear Medicine Physician

Patient with bone Cancer disease

Neurological surgeon

Otolaryngologist

General and

Endocrine surgeon Endocrinologist

Psicologist

(17)
(18)
(19)

NATIONAL PROJECT: MULTIDISCIPLINARY APPROACH TO PATIENTS WITH BONE METASTASES

Prof Dino Amadori

2000 2019

National training courses

2002 Bologna, Rome 2003 Naples, Bologna 2004 Naples, Florence

Course

in Osteoncology

2003 - 2005

II level University Masters in Osteoncology (Modena/Bologna/Forlì)

2009-2019

PhD in Osteoncology (Campus Roma)

Masters/PhD in Osteoncology Publications: 3 books

2003 - 2018

National training and practical courses in Osteoncology (Modena – Forlì- Meldola- Roma- Verona- others)

Establishment of Osteoncology Center

Establishment of Osteoncology field

National Bone

Metastases Data Base

Multidisciplinary Osteoncology School (MOS) 2008

2014 2016

(20)

Società Italiana di Osteoncologia Mission

ASSISTENZA

Promuovere la formazione di gruppi multidisciplinari per la cura dei pazienti con patologia oncologica ossea e favorire la nascita di nuovi centri specializzati

RICERCA

Promuovere e sostenere la ricerca di base, traslazionale e clinica, con particolare riferimento agli studi multidisciplinari

DIDATTICA

Favorire la formazione dei professionisti delle discipline connesse all’osteoncologia attraverso l’organizzazione di eventi formativi, convegni e la realizzazione di

pubblicazioni scientifiche dedicate

(21)

Società Italiana di Osteoncologia Governance

Consiglio Direttivo 2017/2020

Presidente: Gaetano Lanzetta Segretario: Stefano Severi Tesoriere: Vittorio Fusco Consiglieri :

- Asssistenza: Alfredo Berruti

- Ricerca preclinica: Francesco Pantano - Ricerca clinica: Toni Ibrahim

- Formazione: Roberto Casadei

Collegio dei Sindaci : Stefania Zoveto (Presidente), Tiziana Falbo, Laura Mercatali Sede legale: Via Pietro Marroncelli, 40 . 47014 Meldola (FC)

C.F. 92068610408 P.I. 04113560405

(22)

Rete Osteoncologia Nazionale

www.osteoncology.it

Centri accreditati di eccellenza:

- Centro di Osteoncologia presso l’istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori IRCCS di Meldola

- Centro di Osteoncologia presso l’istituto Oncologico Veneto IOV - Centro di Osteoncologia presso l’istituto Tumori Regina Elena, Roma - Centro di Osteoncologia presso l’Università Campus Biomedico, Roma Centri che rispettano i requisiti minimi:

- Centro di Osteoncologia presso l’istituto Neurotraumatologico Italiano, Grottaferrata (RM)

- Centro di Osteoncologia presso Ospedale Gradenigo (TO)

(23)

Multidisciplinary Osteoncology School (MOS) IRST,IRCCS, Meldola

Aims:

Promote training in Osteoncology (bone metastases/bone health):

- Mono- and multidisciplinary care

- Basic, translational and clinical research

- Integration between assistance and research

Target :

All professionals interested in Osteoncology from lab to the clinic assistance Methodology: Theorical and practical courses

(24)

National Bone Metastases Data Base

Materials and Methods

BM Data Base is a multicenter prospective observational study, which has as Coordinating Center (CC), IRCCS IRST of Meldola. The database will allow to gather information on the medical history of patients with BM using an online software tailored for these data.

•The platform of the database consists of 4 files containing information regarding patient demographics, characteristics of the primary tumors and BM, as well as their evolution, in particular the onset and the types of SRE.

The data are updated every 6 months by the participating centers and reviewed by CC.

(25)

For information about project, please contact:

Alberto Bongiovanni: alberto.bongiovanni@irst.emr.it Flavia Foca: flavia.foca@irst.emr.it

National Bone Metastases Data Base

(26)

• Italian Bone Metastases Database: Breast Cancer Prospective Data

- Abstract ASCO 2016 e AIOM 2016 - Abstract AIOM 2019 ( submitted)

- In corso Analisi dei dati e stesura Paper per pubblicazione nel 2019

• Italian Bone Metastases Database NSCLC: Cancer Prospective Data

• Bone Metastases NSCLC: ICI + DENOSUMAB vs ICI + Zoledronate

• Prospective Study on BM management in elderly patient’s

• Prospective Study Sarcoma Bone Metastases

National Bone Metastases data Base : Currently Projects …..

(27)

Osteoncology Center

Osteoncology Center: Pathway Indicators

1- Effect on Quality of life and pain 2- Patient Satisfaction

3- Patient adherence

4- Attraction Index

5- Cost of service

(28)

Results: MDOT interventions

(29)

Results: BPI analysis

A significant improvement in the worst (p<0.0001) and current pain (p=0.03) was seen, together with a favorable impact on daily activities (p=0.02).

(30)

Results: Patient’s Satisfaction

(31)

Patient adherence

236 visits (1° semester 2018)

only one patient did not attend

the appointment at the Clinic

(32)

Attraction Index (2014-2018)

6961 patients

(percorso metastasi ossee e CTIBL)

2509 (37 %) Area Vasta Romagna

4452 (63 %) Ext. Area Vasta Romagna

1016 (23 %) Ext. Emilia Romagna

(33)

Il percorso assistenziale in osteoncologia : l’esperienza del

gruppo integrato di cure dell’Azienda Ospedaliera S. Giovanni battista di Torino

The cost analysis of the GIC group confirms this change:

(120 patients GIC vs 35 patients pre-GIC):

A mean cost reduction of 225 euro per patient;

Diagnosis more expensive;

Lower cost of hospital admission (surgery);

Surgery definitive, not palliative kind (preventive fracture);

Fifty percent reduction in waiting time from hospitalisation to surgery

Colangelo I, Mecosan 2006

(34)

New Bone- Cancer relationship

EVOLUTION

Primitive tumors 1- Bone metastases

2- Cancer Treatment Induced Bone Loss (CTIBL)

REVOLUTION

- Foundation of a new field in Oncology:

OSTEONCOLOGY

- Care

: mono and multidisciplinary approach

- Research:

thanks to new Knowledge in the pathogenesis of bone

metastases, on 2019 the aim of treatments is not only to prevent SREs, but also to have an impact in the natural history of cancer.

Ibrahim T et al. Oncol Lett. 2013

(35)

Bone Metastases Are a Mixture of Osteoblastic and Osteoclastic Lesions

Adapted from: Halvorson K et al. Clin J Pain. 2006;22:587.

At

http://www.meddean.luc.edu/lumen/MedEd/Radio/curriculum/Surgery/Met_bone_list1.htm

Osteoblastic Osteolytic

Myeloma Breast

Prostate

Mixed

(36)

OSTEOLYTIC MODEL: a vicious cycle

Buijs, The prostate,2009 RANK

(37)

OSTEOBLASTIC MODEL: a vicious cycle

Ibrahim T, Cancer 2010 (A) Prostate cancer cells secrete osteogenic growth factors, activating osteoblasts to deposit new bone matrix.

(B) Osteoblasts secrete a range of additional factors such as insulin-like growth factor (IGF), fibroblast growth factor (FGF), and transforming growth factor-b (TGFb).

(C) These factors attract prostate cancer cells, further enhancing their proliferation and growth.

(38)

Medical treatment of bone metastases has become

progressively complex and currently includes:

 well known antitumor agents

 bone targeted molecules

Treatment of Bone Metastases

Ibrahim T, Tumori 2013

(39)

The Metastatic Process: hypothesis

Bone (HSC, MSC) Peripheral

tissues

MSC, HSC

physiologica lHSC niche in

tissue

HSC patrolling

1

CTC, DTC

from primary tumor/bone

2

Peripheral tissues (bone, liver,

lung…)

Pre-metastatic niche

3

Metastatic niche

(bone, liver, lung…) Death

Dormancy

Metastatic growth

4

Primitive tumor Bone

(MSC, MF, Neut)

MSC, TAM, TAN STRESSING

FACTORS (cytokines, exosomes…)

HSC, Mac

Ibrahim T, not pubblished

CTIBL

(40)

The metastatic process/pre-metastatic Niche

Tumour cell

Osteoblast HSC

Tumour cell arriving in bone

Osteoblastic Niche

Hematopoietic stem cell niche

Perivascular Niche

Osteoblast cells regulate HSC cells and are closely linked with vascular remodeling and

osteoclast activity

Osteoclast

(41)

Shiozawa Y, Clinical Cancer Research, 2011

Bone Microenvironment

CTIBL

(42)

Summary

-The use of adjuvant BTT has now been demonstrated to reduce the development of bone metastasis, distant

recurrence, and breast cancer mortality among

postmenopausal women and in premenopausal women undergoing ovarian suppression.

- The use of Denosumab has now been demonstrated in

prostate cancer patients at high risk of reccurence, to reduce the development of bone metastasis. No effect on mortality.

Bone Targeted Therapy Advanced setting

Adjuvant setting

(43)

Outline:

1- Hot topic in Oncology

2- Osteoncology = Evolution and Revolution 3- Conclusions

(44)

Osteoncology

Bone Health/Omeostasis

QoL

Outcome

Costs

NATURAL HISTORY OF CANCER

(45)

New Bone- Cancer relationship

EVOLUTION

Primitive tumors 1- Bone metastases

2- Cancer Treatment Induced Bone Loss (CTIBL)

REVOLUTION

- Foundation of a new field in Oncology:

OSTEONCOLOGY

- Care

: mono and multidisciplinary approach

- Research:

thanks to new Knowledge in the pathogenesis of bone

metastases, on 2018 the aim of treatments is not only to prevent SREs, but also to have an impact in the natural history of cancer.

Ibrahim T et al. Oncol Lett. 2013

(46)

Normal bone turnover: bone breackdown and bone formation are in equilibrium

T5

T5

L1 T11

T11 L1

- Progressivo calo del CA 15.3 (10/10: 50, 02/11: 29): Ca duttale inf mammario ER/PgR + in trattamento con Letrozolo - Stabilità pleurica: eupnoica;

- Dicembre 2010: si reca al PS per dolore acuto rachide con crolli e vertebroplastica T11 e L1;

- Persistenza del dolore che ha necessitato un ulteriore lungo ricovero e inserimento catetere epidurale;

- Gennaio 2011: consulenza CDO, inizia bisfosfonato ev con supplementazione di calcio e vitamina D3 - Aprile 2011: TC visceri e osso stabili, markers negativi e pz con analgesici orali (Oxycontin 30 x 2).

(47)

CDO-TR strategies for a new tarsversal discipline as Osteoncology and Rare Tumors

Method: Team (Lab/Clinic)

Specific expertise

National and International Network/Collaborations

Mono/multidisciplinary approach:

assistance and reasearch

Spontaneous Reasearch Pharmaceutical companies

2005

2011

2019

(48)

Princeton Univ. NY

(USA) Y. Kang

Campus Bio- medico Univ

Rome Prof Santini

TMHRI

Texas Univ.

Houston,USA M. Ferrari

Pathology Unit AVR

Leiden Univ Medical Centre (Olanda)

G. Van der Pluijm

Istituti Ortopedici Rizzoli, BO (Prof Donati)

Modena University Prof Catani Duke

University

(USA) X. Wang

National and International Collaborations

Regina Elena Institute

Rome Prof Biagini

Osteoncology National Network

Rare Tumors Network

CDO-TR

CCCN Romagna

(49)

L’Osteoncologia ……

(50)

Osteoncology and Rare Tumors Center CDO-TR

Director: Toni Ibrahim

Oncologists:

Alberto Bongiovanni Sebastiano Calpona Giandomenico Di Menna Lorena Gurrieri

Federica Recine Nada Riva

Valentina Fausti (Tr) Sivia De Bonis (Tr)

Lab Researchers:

Laura Mercatali Chiara Liverani Alessandro De Vita Chiara Spadazzi Giacomo Miserocchi Claudia Cocchi

Data Manager:

Benedetta Rossi Monia Dall’Agata

Alessandra Affatato Statistic:

Flavia Foca Pharmacyst:

Valentina Di Iorio Specialist Nurse:

Venetia Zavoiu

Centro di

Eccellenza

Member and Collaborations:

- CCCN of Romagna

- National Network of Osteoncology - National Network of Rare Tumors

- EURACAN (European Reference Network)

- University of Bologna, Modena, Milan and Ferrara - Alleanza Contro il Cancro

- Istituto Ortopedico Rizzoli - Princeton University, USA

- The Methodist Research Institute, Houston,USA - Leiden University, The Netherlends

50

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