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Allocation:<br />

suitable for<br />

<strong>transplantation</strong>,<br />

consent?<br />

Hehlmannetal. 121<br />

German CML-Studv III A<br />

Alio BMT<br />

Figure 4. Study scheme of CML Study III A.<br />

High dose chemotherapy<br />

Autografting<br />

related mortality considerably exceeds mortality in IFN-treated patients during the<br />

first years after diagnosis. Only in the long term will BMT patients have a survival<br />

advantage. No studies exist thus far that prospectively quantify risks <strong>and</strong> chances<br />

of treatment by BMT vs. IFN. A simulation of possible outcomes was undertaken<br />

by the IBMTR <strong>and</strong> the German CML Study Group. 30<br />

The results showed that a<br />

survival advantage for most BMT patients became significant after about 4-8<br />

years. Only for low-risk IFN- or HU-treated patients a significant survival<br />

advantage of BMT was not observable by year 8.<br />

A prospective controlled comparison therefore was started in 1995 as part of<br />

CML Studies III <strong>and</strong> III A. About 725 patients have been recruited for this<br />

comparison within the two studies by now, <strong>and</strong> about 150 have been transplanted.<br />

After a follow-up of about 2.5 years, IFN has a survival advantage, but it can be<br />

Table 7. Superiority of early therapy in CML<br />

• Allogeneic BMT, survival advantage after early BMT (Clift et al., 1993 43<br />

; Goldman et<br />

al., 1993 44<br />

; Clift <strong>and</strong> Storb, 1996 45<br />

)<br />

• IFN-a superior in early CML (Alimena et al., 1988 46<br />

; Talpaz et al., 1988 47<br />

; Hasford et<br />

al., 1996 10<br />

)<br />

• Mobilization of Ph-negative progenitor cells in early chronic phase (Carella et al.,<br />

1996 48<br />

)<br />

• Chemotherapy, cytogenetic responses in (early) chronic phase (Cunningham et al.,<br />

1979 27<br />

; Sharp et al., 1979 28<br />

)<br />

• Intensified hydroxyurea treatment, cytogenetic responses in early chronic phase (Kolitz<br />

et al., 1992 29<br />

; Johnson et al., 1996 49<br />

; Coutinho et al., 1996 50<br />

)

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