Randomised unicenter trial for comparison of three regimens inde novo adult acute nonlymphoblastic leukaemia
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Various regimens have been explored in the treatment of acute nonlymphoblastic leukaemia (AML), but so far none has been shown to be superior. Here we report on a comparison of three widely used protocols defined by Berman (Group 1), MRC AML 10 (Group 2), and Arlin (Group 3). Group 1 includes cytosine arabinoside (Ara-C) (100 mg/m2/d, days 1–7) and idarubicin (Ida) (12 mg/m2/d, days 1–3) for induction, and Ara-C (200 mg/m2/d, days 1–6) and Ida (15 mg/m2/d, day 1) twice for consolidation. Group 2 includes Ara-C (200 mg/m2/d, days 1–10), daunorubicin (Dnc) (50 mg/m2/d, days 1, 3, 5) and etoposide (VP16) (100 mg/m2/d, days 1–5) for induction. The first consolidation therapy consisted of the same schedule except for Ara-C given on days 1–8. The second consolidation regimen consisted of Ara-C (200 mg/m2/d, days 1–8), VP16 (100 mg/m2/d, days 1–5) and amsacrine (100 mg/m2/d, days 1–5). Mitoxantrone (Mitox) (10 mg/m2/d, days 1–5) and Ara-C (200 mg/m2/d, days 1–3) were given as the third consolidation therapy. Group 3 was identical to Group 1 except for Ida being replaced with Mitox. During the study period 99 patients were enrolled and 34 were allocated randomly to Group 1, 36 to Group 2, and 29 to Group 3. Except for age distribution all patients’ characteristics were similar between the groups. As there were more elderly patients in Group 1, time to complete remission (CR) was longer in this group as they needed more second induction. Induction deaths were 9.7%, 12.9% and 14.8% in Groups 1, 2 and 3, respectively. Patients in Group 2 received a higher amount of Ara-C compared with the other groups (P<0.001). After a median follow-up period of 45 months (1–67 for survivors) an advantage in Group 1 was observed. Relapse-free survival (RFS) was better in Group 1 (P=0.014) at 3 years. Fourteen of the patients were transplanted (11 allografts, 3 autografts). When patients with transplants were excluded, overall survival was longer in Group 1 both at 3 years and 5 years (P=0.05). In conclusion, despite patient advanced age and lower dose of Ara-C, the idarubicin-containing treatment was superior to the other regimens.
- Arlin Zet al. Randomized multicenter trial of cytosine arabinoside with mitoxantrone or daunorubicin in previously untreated adult patients with acute nonlymphoblastic leukemia.Leukemia 1990;4: 177–183.
- Vogler WRet al. A phase III trial comparing idarubicin or daunorubicin in combination with cytarabine in acute myelogenous leukemia: A Southeastern Cancer Study Group Experience.J Clin Oncol 1992;10: 1103–1111.
- Wiernik PHet al. Cytarabine plus Idarubicin or Daunorubicin as induction and consolidation therapy for previously untreated adult patients with acute myeloid leukemia.Blood 1992;79: 313–319.
- Berman E, Heller G, Santorsa J. Results of a randomized trial comparing idarubicin and cytosine arabinoside with daunorubicin and cytosine arabinoside in adult patients with newly diagnosed acute myelogenous leukemia.Blood 1991;77: 1666–1674.
- Bishop JFet al. Etoposide in acute nonlymphoblastic leukemia.Blood 1990;75: 27–32.
- Burnett AKet al. The role of BMT in addition to intensive chemotherapy in AML in first CR: Results of the MRC AML-10 trial.Blood 1994;84 (suppl 1): 252a.
- Hann IMet al. Randomized comparison of DAT versus ADE as induction chemotherapy in children and younger adults with acute myeloid leukemia. Results of the Medical Resource Council’s 10th Trial (MRC AML10).Blood 1997;89: 2311–2318.
- Kaplan EL, Meier P. Nonparametric estimation from incomplete observations.J Am Stat Assn 1958;53: 457–481. CrossRef
- Kolbfleisch JD, Prentice RL.The Statistical Analysis of Failure Time Data Wiley: New York, 1980, pp 16–19.
- Berman E. Chemotherapy in acute myelogenous leukemia: high dose, higher expectations.J Clin Oncol 1995;13: 1–4.
- Zittoun Ret al. Autologous or allogeneic bone marrow transplantation compared with intensive chemotherapy in acute myelogenous leukemia.N Engl J Med 1995;322: 217–223. CrossRef
- Stone RM, Mayer RJ. Treatment of the newly diagnosed adult withde novo acute myeloid leukemia.Hematol Oncol Clin N Am 1993;7: 47–64.
- Berman E. New drugs in acute myelogenous leukemia: a review.J Clin Pharmacol 1992;32: 296–309.
- Berman E, McBride M. Comparative cellular pharmacology of daunorubicin and idarubicin in human multidrug-resistant leukemia cells.Blood 1992;79: 3267–3273.
- Bishop JF. The treatment of adult acute myeloid leukemia.Semin Oncol 1997;24: 57–69.
- Wheatley K. (on behalf of the AML Collaborative Group MRC/CRF Cancer Studies Unit). Meta-analysis of randomized trials of idarabucin (idar) or mitoxantrone (mito) versus daunorubicin (dnr) as induction therapy for acute myeloid leukemia (AML).Blood 1995;86 (Suppl 1): 1724.
- Bishop JFet al. A randomized study of high-dose cytarabine in induction in acute myeloid leukemia.Blood 1996;87: 1710–1717.
- Randomised unicenter trial for comparison of three regimens inde novo adult acute nonlymphoblastic leukaemia
Volume 15, Issue 3 , pp 183-190
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- acute nonlymphoblastic leukemia
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- 1. Ibni Sina Hospital, Department of Hematology-Oncology, Ankara University, School of Medicine, 06100 Sihhiye, Ankara, Turkey