EBMT Slide template Barcelona 7 February2008

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					                                EBMT Slide template
                        Standard versus research or
                                          Barcelona
                           experimental HCT in 2008
                                    7 February 2008
                                     Per Ljungman




The European Group for Blood and Marrow Transplantation
The European Group for Blood and Marrow Transplantation
          Some questions for this
          symposium

• What is a standard / optional/ research /
  experimental HSCT?

• Are the patient’s, donor’s, and transplant
  physicians perspectives the same?

• Should there be different indications for:
  – Family donors?
  – Unrelated donors?
  – Cord blood donors?


       The European Group for Blood and Marrow Transplantation
      The European Group for Blood and Marrow Transplantation
      The European Group for Blood and Marrow Transplantation
                     Perspectives
• Patient’s perspective?
   – We all evaluate the indication of transplant in our decision
     process.
   – Do we have facts to support our reasoning?

• Physicians’ perspective
   –   Experience
   –   Environment
   –   Research / development
   –   Other

• Donor’s perspective?
   – Should the perspective of the donor influence the
     decision??

         The European Group for Blood and Marrow Transplantation
        The European Group for Blood and Marrow Transplantation
        The European Group for Blood and Marrow Transplantation
• Indication for SCT?
• Donor selection

• Patient status

• Stem cell source?
• Conditioning regimen?
• Other??


     The European Group for Blood and Marrow Transplantation
    The European Group for Blood and Marrow Transplantation
    The European Group for Blood and Marrow Transplantation
• Indication for SCT?
• Donor selection

• Patient status

• Stem cell source?
• Conditioning regimen?
• Other??


     The European Group for Blood and Marrow Transplantation
    The European Group for Blood and Marrow Transplantation
    The European Group for Blood and Marrow Transplantation
            Indications for SCT –
                EBMT history

• The Accreditation Sub-Committee of the EBMT
  regularly publishes special reports on current
  HSCT practice in Europe.

• Four reports have been published (1996, 1998,
  2002, 2006)

• A fifth report is in preparation


       The European Group for Blood and Marrow Transplantation
      The European Group for Blood and Marrow Transplantation
      The European Group for Blood and Marrow Transplantation
                Document preparation

• Based in the EBMT working parties

• Consulatations with outside experts

• Consultations with National Societies

• Consulations with ELN Work Packages




       The European Group for Blood and Marrow Transplantation
      The European Group for Blood and Marrow Transplantation
      The European Group for Blood and Marrow Transplantation
 The European Group for Blood and Marrow Transplantation
The European Group for Blood and Marrow Transplantation
The European Group for Blood and Marrow Transplantation
                   Standard of care

• Transplants categorised as ‘standard of care’
  can be carried out in many centres in Europe.

• The results of such transplants are, in general,
  reasonably well defined and compare
  favourably (or are superior to) results of non-
  transplant treatment approaches




      The European Group for Blood and Marrow Transplantation
     The European Group for Blood and Marrow Transplantation
     The European Group for Blood and Marrow Transplantation
                   Standard of care

• Transplants categorised as ‘standard of care’
  can be carried out in many centres in Europe.

• The results of such transplants are, in general,
  reasonably well defined and compare
  favourably (or are superior to) results of non-
  transplant treatment approaches

• My interpretation: No major problem regarding
  the donor perspective

      The European Group for Blood and Marrow Transplantation
     The European Group for Blood and Marrow Transplantation
     The European Group for Blood and Marrow Transplantation
                Clinical option
Transplants categorized as clinical option are done in
situations when HSCT is a valuable option for the
individual patient after careful discussions of risks and
benefits with the patient.

For groups of patients, the value of HSCT for patients
included in this category needs further evaluation.

It is necessary to carefully weigh the available donor,
the stem cell source, and the conditioning regimens
used since outcome is likely to vary depending on
these choices.


       The European Group for Blood and Marrow Transplantation
      The European Group for Blood and Marrow Transplantation
      The European Group for Blood and Marrow Transplantation
          Clinical option - continued

HSCT for these indications should be performed
in a specialist centre with major experience with
HSCT procedures, with an appropriate
infrastructure as defined by EBMT guidelines and,
optimally, shall meet JACIE standards

My interpretation: No major problem regarding
the donor perspective


       The European Group for Blood and Marrow Transplantation
      The European Group for Blood and Marrow Transplantation
      The European Group for Blood and Marrow Transplantation
          Clinical option - continued

HSCT for these indications should be performed
in a specialist centre with major experience with
HSCT procedures, with an appropriate
infrastructure as defined by EBMT guidelines and,
optimally, shall meet JACIE standards




       The European Group for Blood and Marrow Transplantation
      The European Group for Blood and Marrow Transplantation
      The European Group for Blood and Marrow Transplantation
                      Developmental

Transplants have been classified as
developmental if there is little experience with this
particular type of transplant and when additional
research is needed to define the role of HSCT.

These transplants should be done within the
framework of a clinical protocol.

My interpretation: How do we ascertain that the
donor perspective is taken into account?

        The European Group for Blood and Marrow Transplantation
       The European Group for Blood and Marrow Transplantation
       The European Group for Blood and Marrow Transplantation
                      Developmental

Transplants have been classified as
developmental if there is little experience with this
particular type of transplant and when additional
research is needed to define the role of HSCT.

These transplants should be done within the
framework of a clinical protocol.




        The European Group for Blood and Marrow Transplantation
       The European Group for Blood and Marrow Transplantation
       The European Group for Blood and Marrow Transplantation
         Generally not recommended

• This category includes early disease stages when
  results of conventional treatment do not normally
  justify the additional risk of transplantation-related
  mortality,

• or when the disease is so advanced that the
  chance of success is so small that the risk of the
  harvest procedure for the normal donor is difficult
  to justify.

• ‘GNR’ may not apply to specific situations where
  a syngeneic donor exists.

       The European Group for Blood and Marrow Transplantation
      The European Group for Blood and Marrow Transplantation
      The European Group for Blood and Marrow Transplantation
                   EBMT Activity survey on HSCT in 2006:
                             main indications
                                    Allogeneic   Autologous
Indication                            1st Tx.      1st Tx.     Total

Leukaemias                            6784          1179        7963
Lymphoproliferative                   1597         12572       14169
disorders
Bone marrow failures                   506             0         506
Solid tumours                           85          1479        1564
Non-malignant disorders                609           125         734
Others                                  80            34         114

Total                                 9661         15389       25050
        605 teams in 43 countries
             The European Group for Blood and Marrow Transplantation
            The European Group for Blood and Marrow Transplantation
            The European Group for Blood and Marrow Transplantation
         Variations between countries

• There are major differences in indications
  between countries.

• New trends are taken up quicker in some
  countries and most likely at some centers.




      The European Group for Blood and Marrow Transplantation
     The European Group for Blood and Marrow Transplantation
     The European Group for Blood and Marrow Transplantation
                        HSCT - rates in Europe 2006


Total allogeneic (1st.)
transplants per 10 million
2006
       0 or no report
       1 - 50
       51 - 100
       101 - 150
       > 150


  Algeria
  Iran
  Israel
  Saudi Arabia
  Tunisia


                   The European Group for Blood and Marrow Transplantation
                  The European Group for Blood and Marrow Transplantation
                  The European Group for Blood and Marrow Transplantation
 The European Group for Blood and Marrow Transplantation
The European Group for Blood and Marrow Transplantation
The European Group for Blood and Marrow Transplantation
                  Variations between countries
             transplant rates / 10 million inhabitants

                        AML                      ALL                      ST
Country       Related     Unrelated   Related       Unrelated

Sweden          1.4           1.6       0.9             1.2              0.7

Finland         1.8           1.3       1.1             1.4               0

Denmark         1.0           1.0       0.5             1.0               0

Norway          1.3           0.6       0.9             0.4               0



                                              Brinch et al abstract no p 1072.

           The European Group for Blood and Marrow Transplantation
          The European Group for Blood and Marrow Transplantation
          The European Group for Blood and Marrow Transplantation
          2008 version of the EBMT
           indications document

• The 2008 version is under development

• There is an intention this time to produce a
  more evidence based document

• Classification according to donor type




      The European Group for Blood and Marrow Transplantation
     The European Group for Blood and Marrow Transplantation
     The European Group for Blood and Marrow Transplantation
                          Chronic leukemia WP
                              suggestions

                                Sib    well match    mm unrel
                                       unrelated/    > 1 ag rel
                                       1 ag mm rel
CML 1:st chronic phase (CP),
“resistant” to imatinib         S         S            GNR
Accelerated phase or >1:st CP   S         S            CO
Blast crisis                    GNR       GNR          GNR

Myeloproliferative disorders    CO        CO           D

Myelodysplastic syndrome
RA, RAEB                        S         S            CO
RAEBt, sAML in CR1 or CR2       S         S            CO
More advanced stages            S         CO           D



          The European Group for Blood and Marrow Transplantation
         The European Group for Blood and Marrow Transplantation
         The European Group for Blood and Marrow Transplantation
              Acute leukemia WP suggestions
                               Sibling   well matched   mm unrealted
Disease                                  unrelated      mm related
AML
CR1 (low risk*)                CO          D             GNR
CR1 (intermediate* )           S           CO            D
CR1 (high risk*)               S           S             CO
CR2                            S           S             CO
CR3, incipient relapse         S           CO            D
M3 Molecular persistence       S           CO           GNR
M3 Molecular CR2               S           CO            GNR
Relapse or refractory          CO          D             D

ALL
CR1 (standard/intermediate*)   D           GNR           GNR
CR1 (high risk*)               S           S             CO
CR2, incipient relapse         S           S             CO
Relapse or refractory          CO          D             D
        The European Group for Blood and Marrow Transplantation
       The European Group for Blood and Marrow Transplantation
       The European Group for Blood and Marrow Transplantation
• Indication for SCT?
• Donor selection

• Patient status

• Stem cell source?
• Conditioning regimen?
• Other??


     The European Group for Blood and Marrow Transplantation
    The European Group for Blood and Marrow Transplantation
    The European Group for Blood and Marrow Transplantation
               How do we handle
            individual risk assessments

• We know that the risk for transplant related
  mortality varies between different patients


• How should we include this knowledge in our
  assessments?




      The European Group for Blood and Marrow Transplantation
     The European Group for Blood and Marrow Transplantation
     The European Group for Blood and Marrow Transplantation
                    Quantification of risk of
                 transplant related mortality
Disease stage
   early (e.g. AML CR1)                               0
   intermediate (e.g. AML CR2)                        1
   advanced (e.g. refractory disease)                 2
Age of patient
  < 20 y                                              0
  20-40 y                                             1
  > 40 y
Time interval - diagnosis to transplant
   > 12 months                                        0
   > 12 months (does not apply for patients in 1CR)   1
Histocompatibility
   HLA-identical sibling                              0
   Other donor                                        1
Gender combination
  Other                                               0
  Female donor for male recipient                     1
         The European Group for Blood and Marrow Transplantation
        The European Group for Blood and Marrow Transplantation
        The European Group for Blood and Marrow Transplantation
            AML

    TRM                              Overall survival




 The European Group for Blood and Marrow Transplantation
The European Group for Blood and Marrow Transplantation
The European Group for Blood and Marrow Transplantation
         Possible additional elements

Comorbidity/Karnovsky >80               +1

Donor > 50 years                        +1

CMV not -/-                             +1

Syngeneic                               -1

Unrelated donor 10/10 high              -1
resolution matched


      The European Group for Blood and Marrow Transplantation
     The European Group for Blood and Marrow Transplantation
     The European Group for Blood and Marrow Transplantation
                                   Extension by including other risk
                                               factors


                                                                           CMV +


                                                                           CMV -




* Available in 19‘612 donor/recipient pairs
                          The European Group for Blood and Marrow Transplantation
                         The European Group for Blood and Marrow Transplantation
                         The European Group for Blood and Marrow Transplantation
              Basis for risk adapted
              treatment strategies

Low risk disease   – low risk HSCT (score 0-1)

   Intermediate risk      – Intermediate risk HSCT
   (score 0-3)

   High risk disease      – High risk HSCT (score 0-5)

   Too high risk   – No HSCT



     The European Group for Blood and Marrow Transplantation
    The European Group for Blood and Marrow Transplantation
    The European Group for Blood and Marrow Transplantation
• Indication for SCT?
• Donor selection

• Patient status

• Stem cell source?
• Conditioning regimen?
• Other??


     The European Group for Blood and Marrow Transplantation
    The European Group for Blood and Marrow Transplantation
    The European Group for Blood and Marrow Transplantation
               Donor perspective

• How should we assess the rights of the donors to be
  certain that the indication for transplant is
  reasonable?

• How should ”new” indications be introduced?

• How should new procedures be introduced?




        The European Group for Blood and Marrow Transplantation
       The European Group for Blood and Marrow Transplantation
       The European Group for Blood and Marrow Transplantation
                     • I have posed many
                       questions; it is up to the
                       other speakers to give
                       you the answers!




 The European Group for Blood and Marrow Transplantation
The European Group for Blood and Marrow Transplantation
The European Group for Blood and Marrow Transplantation
                      Thank you to

• WP chairs and members participating in this
  activity

• Alois Gratwohl and Helen Baldomero




      The European Group for Blood and Marrow Transplantation
     The European Group for Blood and Marrow Transplantation
     The European Group for Blood and Marrow Transplantation

				
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