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- Title
No benefit from adding GM-CSF to induction chemotherapy in transforming myelodysplastic syndromes: better outcome in patients with less proliferative disease.
- Authors
Hast, R.; Hellström-Lindberg, E.; Ohm, L.; Björkholm, M.; Celsing, F.; Dahl, I.-M.; Dybedal, I.; Gahrton, G.; Lindberg, G.; Lerner, R.; Linder, O.; Löfvenberg, E.; Nilsson-Ehle, H.; Paul, C.; Samuelsson, J.; Tangen, J.-M.; Tidefelt, U.; Turresson, I.; Wahlin, A.; Wallvik, J.
- Abstract
In this prospective randomized multicenter trial 93 patients, median age 72 years, with RAEB-t (n=25) and myelodysplastic syndrome (MDS)-AML (n=68) were allocated to a standard induction chemotherapy regimen (TAD 2+7) with or without addition of granulocyte-macrophage-CSF (GM-CSF). The overall complete remission (CR) rate was 43% with no difference between the arms. Median survival times for all patients, CR patients, and non-CR patients were 280, 550, and 100 days, respectively, with no difference between the arms. Response rates were significantly better in patients with serum lactate dehydrogenase (S-LDH) levels ?9.5?µkat/l, bone marrow cellularity ?70%, and WBC counts <4.0 × 109/l, but S-LDH was the only variable independently associated with response by logistic regression analysis. Cox's regression analysis identified four significant prognostic factors for survival: bone marrow cellularity, S-LDH, cytogenetic risk group (International Prognostic Scoring System), and age. Only bone marrow cellularity (P=0.01) and S-LDH (P=0.0003) retained statistical significance in the log-rank test. Severe adverse events were significantly more common in the GM-TAD arm (P=0.01). Thus, addition of GM-CSF to chemotherapy showed no clinical benefit in terms of response but carried an increased risk for side effects. We present a clinically useful tool to predict response to chemotherapy and survival in elderly patients with transforming MDS, favoring patients with features of less proliferative disease.Leukemia (2003) 17, 1827-1833. doi:10.1038/sj.leu.2403035
- Subjects
MYELODYSPLASTIC syndromes; DRUG therapy; LACTATE dehydrogenase; REGRESSION analysis; MACROPHAGES; BLOOD plasma
- Publication
Leukemia (08876924), 2003, Vol 17, Issue 9, p1827
- ISSN
0887-6924
- Publication type
Article
- DOI
10.1038/sj.leu.2403035