Treatment standards in Czech Republic Roman Hjek on

„Treatment standards, in Czech Republic”. Roman Hájek on behalf of CMG March 27, 2010

Initial Treatment Strategy Induction: • VAD or VDD • Thal + Dex • MP or MPT Lenalidomide + Dex Bortezomib + Dex PAD…others Consolidation High dose chemotherapy Novel consolidation Maintenance Interferon / corticoids Thalidomide or Thal + Dexamethasone Lenalidomide + DEX Bortezomib combo’s, others or No Maintenance

Basic Treatment Strategy FOCUS ON LONG PERIOD OF LIFE WITH CANCER 10 YEARS 4 RELAPSES

Reason for the Treatment Discontinuation If we have more than one treatment options than we has change treatment when it is: A: NOT EFFECTIVE B: POORLY TOLERATED /neropathy/

Reason for the Treatment Discontinuation STABLE DISEASE IS NOT SUTISFIED RESPONSE MINIMAL RESPONSE (M-Ig < 50%) IS NOT SUTISFIED RESPONSE

Reason for the Treatment Discontinuation STABLE DISEASE IS NOT SUTISFIED RESPONSE MINIMAL RESPONSE (M-Ig < 50%) IS NOT SUTISFIED RESPONSE WE NEED AT LEAST PARTIAL RESPONSE

Benefit of the new drugs thalidomide and bortezomibe, lenalidomide New drugs have significant benefit for patients with relapse and resistant disease The key rules are: 1. Do not use monotherapy 2. Reserve other new drugs for the future

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

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)

3. THIRD RELAPSE: THALIDOMID VELCADE REVLIMID based regimen + re-transplantation if the regimen is toxic or response after 4 cycle is less than 50% (PR)

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

CTD junior and senior JUNIOR SENIOR Cyclophosphamide 500 mg p. o. day 1, 8, 15 50 mg daily Thalidomid 200 mg 40 mg 100 mg Dexamethazon day 1 -4, 10 -13, 20 -23 20 mg

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)

Treatment of Multiple Myeloma in Czech Republic Effective drugs used in the period 2007 -2009. Total 660 1100 1200 (Total of 1200 from 1600 pts. indicated for the treatment in the year 2010 received effective treatment Česká myelomová skupina a její nadační fond spolupracují při zajišťování informačního servisu pro lékaře a nemocné s mnohočetným myelomem

How can patient organization help? HOW TO INTRODUCE THE BENEFIT OF treatment TO ALL SUITABLE PATIENTS

ACCURATE AND MAXIMAL ENROLMENT TO TRANSPLANTATION PROGRAM KEY FOR EVERYDAY ROUTINE: EFECTIVE AND SHORT TRANSMISSION OF CLINICAL TRIALS RESULTS INTO EVERYDAY USE WITH POSITIVE BENEFIT FOR THE PATIENTS.

Our strategy for routine life in period 2007 -2010 To use thalidomide or Velcade based regiment as first line treatment in all elderly patients up front

Our strategy for routine life in period 2006 -2010 To use VELCADE/THALIDOMIDE/REVLIMIDE based regiment as 2 – 4 lines treatment in all patients

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

Medián Overall Surivval (months) Long-term treatment results 70 60 n = 2981 50 40 30 20 10 0 1971– 1976 1977– 1982 1983– 1988 1989– 1994 1995– 2000– 2006 Period Kumar, et al. , 2008, Blood 111(5): 2516

Our strategy for routine life in period 2006 -2010 SUMMARY We need use new drugs in elderly patients to achive the similar results as in younger patients using autologous transplantation We need less toxic and more safe induction treatment than VAD for younger patients

How can patient organizations help? It is very important, if any of evalauted therapies is considered as new perspective treatment. The more important is, if the most patients can benefit from this treatment in the short time period. Rapid introduction of new effective therapeutic strategy is the place for active patient organizations.

Thank you for you attention