geoscience.net logo
+ Resolve Article
+ Follow Us
Follow on FacebookFollow on Facebook
Follow on TwitterFollow on Twitter

+ Translate
+ Subscribe to Site Feed
GeoScience Most Shared ContentMost Shared Content

Mito-FLAG with Ara-C as bolus versus continuous infusion in recurrent or refractory AML--long-term results of a prospective randomized intergroup study of the East German Study Group Hematology/Oncology (OSHO) and the Study Alliance Leukemia (SAL)


, : Mito-FLAG with Ara-C as bolus versus continuous infusion in recurrent or refractory AML--long-term results of a prospective randomized intergroup study of the East German Study Group Hematology/Oncology (OSHO) and the Study Alliance Leukemia (SAL). Annals of Oncology 26(7): 1434-1440

For patients with primary refractory or relapsed acute myeloid leukemia (AML), no treatment of choice has until now been defined to date. Cytarabine (Ara-C) is a key drug in the treatment of AML patients, there is still uncertainly regarding its optimal dose and infusion schedule. The aim of this study is to examine the impact of the Ara-C infusion schedule used as part of an intensive salvage regimen, in patients with relapsed or refractory AML. A total of 252 adult patients (median age 59 years) with relapsed or refractory AML were randomly allocated to receive either Mito-FLAG with Ara-C as bolus (B) (1000 mg/m(2) over 1 h, every 12 h, days 1-5), or continuous infusion (CI) (150 mg/m(2) over 24 h, days 1-5) in combination with mitoxantrone, fludarabine, and granulocyte colony-stimulating factor (G-CSF). Autologous or allogeneic hematopoietic stem-cell transplantation was offered as consolidation therapy. Primary end point was the rate of complete remissions (CRs) after the first cycle of Mito-FLAG. The CR rates after Mito-FLAG (B) and Mito-FLAG (CI) were 54% and 43%, respectively (P = 0.1). There was no statistical difference between rates of grade 3/4 neutropenia, thrombocytopenia, mucositis, renal, and liver toxicity. More infections occurred, however, after Mito-FLAG (B) compared with Mito-FLAG (CI) (80% versus 69%, P = 0.01). The early death rate by day 42 was 13% in both arms. Median disease-free survival was comparable in the two arms (7.8 versus 7.1 months, P = 0.53) as was overall survival (7.1 versus 6.6 months, P = 0.53). A 5-day course of Ara-C 2 × 1000 mg/m(2) administered as bolus versus Ara-C 150 mg/m(2) administered by CI (in combination with mitoxantrone, fludarabine, and G-CSF), resulted in a nonsignificant trend in response rates in favor of Mito-FLAG (B) at the selected dose levels, but no differences in the survival outcome in relapsed or refractory AML. LN_NN_2004_39/EudraCT number 2014-000083-18.

US$19.90

PMID: 25922062

DOI: 10.1093/annonc/mdv205


Other references

Jacobs R.E.; White S.H., 1985: The interaction of small hydrophobic peptides with lipid bilayers. Biophysical Journal 47(2 PART 2): 174A

Silvela, Eugenio S., 1995: New impulse for conservation of the white headed duck Nuevo impulso a la conservacion de la malvasia cabeciblanca. Quercus. Mayo; 111: 48

Howaldt, S.; Raedler, A.; Schreiber, S., 1994: Recombinant erythropoietin for the treatment of anaemia in active inflammatory bowel disease Final results from a double-blind cross-over prospective trial. Gastroenterology. 106(4 Suppl.): A702

Zhao, C.M.; Yang, X.J.; Yang, J.H.; Cheng, X.J.; Zhao, X.; Zhou, B.Y.; Xu, S.D.; Wang, H.F., 2013: Effect of ischaemic postconditioning on recovery of left ventricular contractile function after acute myocardial infarction. This study investigated whether ischaemic postconditioning can improve recovery of myocardial contractile function in acute myocardial infarction patients 1 week and 6 months after angioplasty. A total of 62 patients undergoing direct percutaneous...

Choi, H.; Park, S-Hye.; Kim, D.Gyu.; Paek, S.Ha., 2011: Atypical extraventricular neurocytoma. The authors report a case of atypical extraventricular neurocytoma (EVN) transformed from EVN which had been initially diagnosed as an oligodendroglioma 15 years ago. An 8-year-old boy underwent a surgical resection for a right frontal mass which...

Tamura, T., 1991: A simple technique for cervical myelography. A new method has been devised for obtaining high-quality cervical myelograms safely and easily through lumbar injection. This method uses simple radiographic equipment, and does not require a tiltable table or fluoroscopy. Fifty-seven patients wit...

Moser, H., 1981: Breeding aim for German Simmental-Fleckvieh with special regard to the relation milk:beef. This discussion comprises consideration of breeding for milk and beef production, and for reproductive efficiency. National data on progeny and performance testing of bulls and cows are tabulated.

Doria-Lamba, L.; Montaldi, L.; Grosso, P.; Veneselli, E.; Giribaldi, G., 2009: Short latency evoked somatosensory potentials after stimulation of the median nerve in children: normative data. Purpose of the present study was to investigate the early cortical somatosensory evoked potentials after median nerve stimulation and to determine normative data as a function of age. Two hundred forty subjects aged 1 day to 18 years were studied...

Chatelain, R.E.; Manniello, M.J.; Dardik, B.N.; Rizzo, M.; Brosnihan, K.B., 1990: Antihypertensive effects of CGS 19281A, an inhibitor of phenylethanolamine-N-methyltransferase. In experimental hypertension, phenylethanolamine-N-methyltransferase (PNMT) activity and adrenaline levels are elevated in brainstem centers involved in cardiovascular regulation. Known PNMT inhibitors used to lower blood pressure have invariably...

El-Gohary, M.; Yassin, A-Elaziz.; Shalaby, M.A., 2003: The effect of chronic lead exposure on the course of schistosomiasis in hamsters and the protective effect of the antioxidant preparation 'Antox'. Eighty adult male hamsters were used in this study, 20 of them were divided equally into a noninfected, nontreated control group and chronic lead exposed groups, which were given lead acetate intraperitoneally, dissolved in distilled water, 2 mg/k...