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A Multicenter Randomized Trial Comparing Response-Adapted (RA), Non-Cross-Resistant Induction and Consolidation with Idarubicin/Cytarabine (IDAC) Followed by Mitoxantrone/Etoposide (NOVE) Compared with Consolidation with High Dose Cytarabine (HDAC) in Adult Patients with AML. A Study by the Canadian Leukemia Studies Group (CLSG)
Background: A CLSG pilot rx'd 140 pts.with Response Adapted Rx(RA) with Idarubicin 12 mg/m2 d1-3 & Ara-C 200 mg/m2 d1-7(IDAC);followed by IDAC II, then Mitoxantrone10 mg/m2&VP-16 100 mg/m2d1-5(NOVE), if in CR after IDAC, & NOVE x2 if they had persistent blasts @ d14 or @ recovery. C...
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Published in: | Blood 2005-11, Vol.106 (11), p.4619-4619 |
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Main Authors: | , , , , , , |
Format: | Article |
Language: | English |
Online Access: | Get full text |
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Summary: | Background: A CLSG pilot rx'd 140 pts.with Response Adapted Rx(RA) with Idarubicin 12 mg/m2 d1-3 & Ara-C 200 mg/m2 d1-7(IDAC);followed by IDAC II, then Mitoxantrone10 mg/m2&VP-16 100 mg/m2d1-5(NOVE), if in CR after IDAC, & NOVE x2 if they had persistent blasts @ d14 or @ recovery. CR rate was 74% in pts age15–80.DFS and OS were favourable @ 20 mos & 47 mos in pts ≤ 60. A CALGB study demonstrated the advantage of consolidation with high dose Ara-C(HDAC).We chose to compare HDAC with RA.
Methods: All pts with AML, age15–80, with a performance of 0–2,were included except those with a hx of MDS>3 mos,bili>85 mmol/l, creatinine>220 mmol/l, hx of chemoRx or radiation Rx for another malignancy,CML, ejection fraction60. Dosage adjustments were made to VP-16 according to ↑ AST, to Idarubicin according to↑ bilirubin, and to HDAC according to ↑ ALP and/or ↑ creatinine. Pts with M3 were to be treated at least 45 days with ATRA. Pts were stratified according to age and # of inductions required to achieve CR and were followed until death, relapse, or BMT. Pts were followed for quality of life using both the SF-36 and the FLIC surveys which pts completed at baseline,1,4 and 12 mos post discharge from consolidation. Data went through annual analyses by an independent data monitoring committee comprised of a non-blinded statistician, a hematologist, and a an oncologist not participating in the study who were blinded to treatment allocation. Their analysis was done using group sequential design with early stopping boundaries.
Results: The comparison was made between the RA approach (Arms A+D) vs. consolidation with HDAC (Arms B+C). Analysis was done on an intent-to-treat basis. 503 patients were recruited into the study from 5/96 until 12/01, of whom 461 were assessable. 201 age ≤ 60 and 95 age > 60 were randomized with a median time since randomization of 65.7 mos.Median DFS in RA pts > 60 was 20 mos vs. 13.3 mos in the HDAC arm (p=.15). The overall DFS hazard ratio was 0.72 (0.47, 1.13), p=0.153. For those RA pts > 60 and disease free at 6 mos, the median DFS was 27.3 mos vs. 10.2 mos in the HDAC arm with the hazard ratio of 0.57 (0.33, 1.02), p=0.056. Median DFS in pt |
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ISSN: | 0006-4971 1528-0020 |
DOI: | 10.1182/blood.V106.11.4619.4619 |