Roman Hájek on behalf of CMG March 27, 2010 Roman Hájek on behalf of CMG March 27, 2010...

Roman Hájek on behalf of CMG Roman Hájek on behalf of CMG March 27, 2010 March 27, 2010

Roman Hájek on behalf of CMG Roman Hájek on behalf of CMG March 27, 2010 March 27, 2010

„Treatment standards, in Czech Republic”.

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M Y E L O M AM Y E L O M A

ČESKÁ MYELOMOVÁ SKUPINA

Initial Treatment StrategyInitial Treatment Strategy

Induction:• VAD or VDD•Thal + Dex• MP or MPT

High dose chemotherapy

Interferon / corticoidsThalidomide or Thal + Dexamethasone

Induction Consolidation Maintenance

Lenalidomide + DexBortezomib + DexPAD…others

Novel consolidation

Lenalidomide + DEXBortezomib combo’s, others

orNo Maintenance

Basic Treatment StrategyBasic Basic Treatment StrategyTreatment Strategy

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Č E SK Á M YE LOM OVÁ SK U PINA

FOCUS ON LONG PERIOD OF LIFE WITH CANCER FOCUS ON LONG PERIOD OF LIFE WITH CANCER

10 YEARS10 YEARS

4 RELAPSES4 RELAPSES

FOCUS ON LONG PERIOD OF LIFE WITH CANCER FOCUS ON LONG PERIOD OF LIFE WITH CANCER

10 YEARS10 YEARS

4 RELAPSES4 RELAPSES

Basic Treatment StrategyBasic Treatment Strategy

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Rulesfor the treatment of MM

according guidelinesof

Czech Myeloma Group

RulesRulesforfor thethe ttreatmentreatment ofof MMMM

accordingaccording guidelinesguidelinesofof

CzechCzech MyelomaMyeloma GroupGroup

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If we have more than one treatment options than we If we have more than one treatment options than we has change treatment when it is: has change treatment when it is:

A: NOT EFFECTIVE A: NOT EFFECTIVE

B: POORLY TOLERATED B: POORLY TOLERATED

/neropathy//neropathy/

If we have more than one treatment options than we If we have more than one treatment options than we has change treatment when it is: has change treatment when it is:

A: NOT EFFECTIVE A: NOT EFFECTIVE

B: POORLY TOLERATED B: POORLY TOLERATED

/neropathy//neropathy/

Reason for the Treatment DiscontinuationReason for the Treatment Discontinuation

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STABLE DISEASE STABLE DISEASE IS NOT SUTISFIED RESPONSEIS NOT SUTISFIED RESPONSE

MINIMAL RESPONSE (M-Ig MINIMAL RESPONSE (M-Ig < 50< 50%) %) IS NOT SUTISFIED RESPONSEIS NOT SUTISFIED RESPONSE




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WE NEED AT LEAST PARTIAL RESPONSE

New drugs have significant benefit for patients New drugs have significant benefit for patients with relapse and resistant diseasewith relapse and resistant disease

The key rules are: The key rules are:

1. Do not use monotherapy1. Do not use monotherapy

2. Reserve other new drugs for the 2. Reserve other new drugs for the futurefuture

Benefit of the new drugs - Benefit of the new drugs - thalidomide and bortezomibe, lenalidomidethalidomide and bortezomibe, lenalidomide

Benefit of the new drugs - Benefit of the new drugs - thalidomide and bortezomibe, lenalidomidethalidomide and bortezomibe, lenalidomide

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Treatment Strategyfor

JUNIORS (< 65 years)

TreatmentTreatment StrategyStrategyforfor

JUNIORS JUNIORS ((< 65 years< 65 years))

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1. NEW DIAGNOSIS: THALIDOMID + TRANSPLANTATION (gold standard)

1. NEW DIAGNOSIS: THALIDOMID + TRANSPLANTATION (gold standard)

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2. FIRST RELAPSE

NEUROPATHY: NO VELCADE based regimen

NEUROPATHY: YES REVLIMIDE based regimen

+ re-transplantation if the regimen is toxic or response after 4 cycle is less than 50% (PR)

2. FIRST RELAPSE

NEUROPATHY: NO VELCADE based regimen

NEUROPATHY: YES REVLIMIDE based regimen


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33. THIRD RELAPSE: THALIDOMID VELCADE REVLIMID based regimen


33. THIRD RELAPSE: THALIDOMID VELCADE REVLIMID based regimen


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Treatment Strategyfor

SENIORS (> 65 years)

TreatmentTreatment StrategyStrategyforfor

SENIORS SENIORS ((> 65 years> 65 years) )

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1. NEW DIAGNOSIS: 80% THALIDOMID 20% VELCADE based regimen 1-3. FIRST RELAPSE: THALIDOMID VELCADE REVLIMIDE based regimen

1. NEW DIAGNOSIS: 80% THALIDOMID 20% VELCADE based regimen 1-3. FIRST RELAPSE: THALIDOMID VELCADE REVLIMIDE based regimen

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CTD junior and senior

JUNIOR SENIOR Cyclophosphamide 500mg p.o. day 1, 8, 15 50mg daily Thalidomid 200 mg 100 mg Dexamethazon

40 mg day 1-4, 10-13, 20-23 20 mg

CTD junior and senior

JUNIOR SENIOR Cyclophosphamide 500mg p.o. day 1, 8, 15 50mg daily Thalidomid 200 mg 100 mg Dexamethazon

40 mg day 1-4, 10-13, 20-23 20 mg

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VELCADE based regimens CVD junior and senior VMP junior and senior VD junior and senior

THALIDOMIDE based regimens CTD junior and senior

MPT junior and senior TD junior and senior (Cyclophosphamide or melphalan; corticoids; new drug)

VELCADE based regimens CVD junior and senior VMP junior and senior VD junior and senior

THALIDOMIDE based regimens CTD junior and senior

MPT junior and senior TD junior and senior (Cyclophosphamide or melphalan; corticoids; new drug)

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Effective drugs usedin Czech Rep.

in numbers

EffectiveEffective drugsdrugs usedusedin in CzechCzech RepRep..

in in numbersnumbers

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NADAČNÍ FONDCMGCMGC

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ČESKÁ MYELOMOVÁ SKUPINAČeská myelomová skupina a její nadační fond spolupracují při zajišťování informačního servisu pro lékaře a nemocné s mnohočetným myelomem

DRUG/No. of Pts. 2008 2009 2010 MYRIN

(thalidomid) 453 600 560 VELCADE

(bortezomib) 187 380 480 REVLIMID (lenalidomid) 20 120 160

Celkem 660 1100 1200 Total 660 1100 1200

(Total of 1200 from 1600 pts. indicated for the treatment in the year 2010 received effective treatment

Treatment of Multiple Myeloma in Czech Republic Effective drugs used in the period 2007-2009.

How can we improve results&

How patient organisation canhelp ?

HowHow cancan wewe improveimprove resultsresults&&

HHowow patientpatient organisationorganisation cancanhelp ?help ?

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HOW TO INTRODUCE THE

BENEFIT OF treatment TO ALL

SUITABLE PATIENTS

How can patient organization help?How can patient organization help?

KEY FOR EVERYDAY ROUTINE:

EFECTIVE AND SHORT TRANSMISSION OF CLINICAL TRIALS RESULTS INTO EVERYDAY USE WITH POSITIVE BENEFIT FOR THE PATIENTS..

KEY FOR EVERYDAY ROUTINE:

EFECTIVE AND SHORT TRANSMISSION OF CLINICAL TRIALS RESULTS INTO EVERYDAY USE WITH POSITIVE BENEFIT FOR THE PATIENTS..

ACCURATE AND MAXIMAL ENROLMENT ACCURATE AND MAXIMAL ENROLMENT TO TRANSPLANTATION PROGRAMTO TRANSPLANTATION PROGRAM

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ConlusionsConlusionsConlusions

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Autologous transplantationis

gold standardfor newly diagnosed patients with MM at age under 65

Autologous transplantationAutologous transplantationisis

goldgold standard standardfor for newly diagnosed patientsnewly diagnosed patients with with MM MM at ageat age underunder 65 65

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To use thalidomide or VelcadeTo use thalidomide or Velcade based regiment based regiment as first line treatmentas first line treatment in all elderly patients in all elderly patients up front up front

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Our strategy for routine life in period 2007-2010 Our strategy for routine life in period 2007-2010


To use To use VELCADE/THALIDOMIDE/REVLIMIDEVELCADE/THALIDOMIDE/REVLIMIDE based regiment based regiment as 2 – 4 lines treatmentas 2 – 4 lines treatment in all patients in all patients



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There is evidence that new drugs There is evidence that new drugs can can significantly change prognosis of significantly change prognosis of more more than 50% of patients who can t than 50% of patients who can t benefit benefit from autologous transplantation from autologous transplantation as as primary treatment primary treatment

Where we are going ? Where we are going ?

Where we are going ? Where we are going ?

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Long-term treatment results Long-term treatment results Long-term treatment results Long-term treatment results

Period

Med

ián

Overa

ll S

uri

vval (m

on

ths)

10

60

70

20

30

40

50

1971–1976 1977–1982 1983–1988 1989–1994 1995–2000 2000–2006

0

n = 2981

Kumar, et al., 2008, Blood 111(5): 2516

We need use new drugs in elderly We need use new drugs in elderly patients patients to achive the similar results as in to achive the similar results as in younger younger patients using autologous patients using autologous transplantationtransplantation

We need less toxic and more safe We need less toxic and more safe induction treatment than VAD for induction treatment than VAD for younger patientsyounger patients

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Our strategy for routine life in period 2006-2010 Our strategy for routine life in period 2006-2010 SUMMARY SUMMARY

Our strategy for routine life in period 2006-2010 Our strategy for routine life in period 2006-2010 SUMMARY SUMMARY

How can patient organizations help? How can patient organizations help?

It is very important, if any of evalauted therapies It is very important, if any of evalauted therapies is considered as new perspective treatment. is considered as new perspective treatment.

The more important is, if the most patients can The more important is, if the most patients can benefit from this treatment in the short time period.benefit from this treatment in the short time period.

Rapid introduction of new effective therapeutic Rapid introduction of new effective therapeutic strategy strategy is the place for active patient organizations. is the place for active patient organizations.

It is very important, if any of evalauted therapies It is very important, if any of evalauted therapies is considered as new perspective treatment. is considered as new perspective treatment.

The more important is, if the most patients can The more important is, if the most patients can benefit from this treatment in the short time period.benefit from this treatment in the short time period.

Rapid introduction of new effective therapeutic Rapid introduction of new effective therapeutic strategy strategy is the place for active patient organizations. is the place for active patient organizations.

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Thank you for you attention Thank you for you attention Thank you for you attention Thank you for you attention

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Roman Hájek on behalf of CMG March 27, 2010 Roman Hájek on behalf of CMG March 27, 2010...

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