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Blood, 15 November 2001, Vol. 98, No. 10, pp. 3074-3081
NEOPLASIA
Chronic myeloid leukemia and interferon- : a study of
complete cytogenetic responders
Francesca Bonifazi,
Antonio de Vivo,
Gianantonio Rosti,
François Guilhot,
Joëlle Guilhot,
Elena Trabacchi,
Rüdiger Hehlmann,
Andreas Hochhaus,
Patricia C. A. Shepherd,
Juan Luis Steegmann,
Hanneke C. Kluin-Nelemans,
Josef Thaler,
Bengt Simonsson,
Andries Louwagie,
Josy Reiffers,
François
Xavier Mahon,
Enrico Montefusco,
Giuliana Alimena,
Joerg Hasford,
Sue Richards,
Giuseppe Saglio,
Nicoletta Testoni,
Giovanni Martinelli,
Sante Tura, and
Michele Baccarani for the European Study Group on
Interferon in Chronic Myeloid Leukemia
From the Study and Report Committee of the European Study Group
on Interferon in Chronic Myeloid Leukemia, on behalf of the Italian
Cooperative Study Group on CML, the France Intergroup of CML, the
German CML Study Group, the UK Medical Research Council Working Party
on CML, the Spanish CML Study Group, the Benelux CML Study Group, the
Austrian CML Study Group, and the Swedish CML Study Group.
Achieving a complete cytogenetic response (CCgR) is a major target
in the treatment of chronic myeloid leukemia (CML) with interferon-
(IFN- ), but CCgRs are rare. The mean CCgR rate is 13%, in a range
of 5% to 33%. A collaborative study of 9 European Union countries has
led to the collection of data on 317 patients who were first seen
between 1983 and 1997 and achieved CCgRs with IFN- alone or in
combination with hydroxyurea. The median time to first CCgR was 19 months (95% CI, 17-21; range, 3-84 months). At last contact, 212 patients were still alive and in continuous CCgR; 105 patients had lost
CCgR, but 53% of them were still alive and in chronic phase. IFN-
treatment was discontinued permanently in 23 cases for response loss,
in 36 cases for chronic toxicity (15 are still in unmaintained
continuous CCgR), and in 8 cases because it was believed that treatment
was no longer necessary (7 of these 8 patients are still in
unmaintained continuous CCgR). The 10-year survival rate from first
CCgR is 72% (95% CI, 62%-82%) and is related to the risk profile.
High-risk patients lost CCgR more frequently and more rapidly and none
survived more than 10 years. Low-risk patients survived much longer
(10-year survival probability 89% for Sokal low risk and 81% for Euro
low risk). These data point out that a substantial long-term survival
in CCgRs is restricted mainly to low-risk and possibly
intermediate-risk patients and occurs significantly less often in
high-risk patients.

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