TY - JOUR
T1 - Sequential response-adapted induction and consolidation regimens idarubicin/cytarabine and mitoxantrone/etoposide in adult acute myelogenous leukemia
T2 - 10 year follow-up of a study by the Canadian Leukemia Studies Group
AU - van der Jagt, Richard
AU - Robinson, K. Sue
AU - Belch, Andrew
AU - Yetisir, Elizabeth
AU - Wells, George
AU - Larratt, Loree
AU - Shustik, Chaim
AU - Gluck, Stefan
AU - Stewart, Keith
AU - Sheridan, David
N1 - Funding Information:
Correspondence: Richard van der Jagt, MD, FRCP(C), Chair Canadian Leukemia Studies Group, Associate Professor of Hematology, Ottawa Hospital – General Campus, 501 Smyth Road, Room 7208, Ontario K1H 8L6, Canada. Tel: 613 737 8804. E-mail: rvanderjagt@ohri.ca Supported by: Pharmacia and Upjohn, Mississauga, Ontario and the Canadian Institute of Health Research (CIHR).
PY - 2006/4
Y1 - 2006/4
N2 - Purpose. The Canadian Leukemia Studies Group (CLSG) sought to test the safety and efficacy of response-adapted, non-cross resistant chemotherapy in de novo acute myeloid leukemia (AML). The combinations of idarubicin 12 mg/m2/d on days 1 - 3 and Ara-C (200 mg/ m2/d) on days 1 - 7 (IDAC) followed by mitoxantrone 10 mg/ m2/day, and etoposide 100 mg/m2/day, on days 1 - 5 (NOVE) were used according to patient response to induction and consolidation. Patients and methods. In this multi-centre open-label phase II study, 140 patients up to age 80 were given induction with IDAC. Patients were entered between March 1993 and August 1995. If patients had persistent blasts at day 14 or on recovery, they were given NOVE. As consolidation, patients achieving complete remission (CR) with IDAC were given 1 further cycle of IDAC and 1 cycle of NOVE. Patients achieving CR after NOVE were given 2 further cycles of NOVE. Results. 76% of all patients achieved remission after IDAC +/- NOVE, 81% in patients aged ≤60 years and 67% in patients aged >60. Overall, induction mortality was 11% and toxicity was similar to other cooperative group studies. Median follow-up was 104.0 months with 95% CI: (100.0, 105.2). Median overall survival (OS) in responding patients ≤60 was not reached: Of the 79 responders ≤60, 35 died. The median disease free survival (DFS) in these responding patients was 22.7 (14.9, na) months. Median OS and DFS in responding patients >60 was 10.0 (7.3, 15.2) months and 7.5 (6.2, 15.2) months, respectively. Conclusion. The results of this trial are very encouraging and suggest that there may be long-term benefit to this method. On the basis of these results, a randomized phase III trial has been performed.
AB - Purpose. The Canadian Leukemia Studies Group (CLSG) sought to test the safety and efficacy of response-adapted, non-cross resistant chemotherapy in de novo acute myeloid leukemia (AML). The combinations of idarubicin 12 mg/m2/d on days 1 - 3 and Ara-C (200 mg/ m2/d) on days 1 - 7 (IDAC) followed by mitoxantrone 10 mg/ m2/day, and etoposide 100 mg/m2/day, on days 1 - 5 (NOVE) were used according to patient response to induction and consolidation. Patients and methods. In this multi-centre open-label phase II study, 140 patients up to age 80 were given induction with IDAC. Patients were entered between March 1993 and August 1995. If patients had persistent blasts at day 14 or on recovery, they were given NOVE. As consolidation, patients achieving complete remission (CR) with IDAC were given 1 further cycle of IDAC and 1 cycle of NOVE. Patients achieving CR after NOVE were given 2 further cycles of NOVE. Results. 76% of all patients achieved remission after IDAC +/- NOVE, 81% in patients aged ≤60 years and 67% in patients aged >60. Overall, induction mortality was 11% and toxicity was similar to other cooperative group studies. Median follow-up was 104.0 months with 95% CI: (100.0, 105.2). Median overall survival (OS) in responding patients ≤60 was not reached: Of the 79 responders ≤60, 35 died. The median disease free survival (DFS) in these responding patients was 22.7 (14.9, na) months. Median OS and DFS in responding patients >60 was 10.0 (7.3, 15.2) months and 7.5 (6.2, 15.2) months, respectively. Conclusion. The results of this trial are very encouraging and suggest that there may be long-term benefit to this method. On the basis of these results, a randomized phase III trial has been performed.
KW - Acute myeloid leukemia
KW - Adult leukemia
KW - Long-term follow-up
KW - Non-cross resistant
KW - Response-adapted therapy
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U2 - 10.1080/10428190500467917
DO - 10.1080/10428190500467917
M3 - Article
C2 - 16690529
AN - SCOPUS:33646803000
SN - 1042-8194
VL - 47
SP - 697
EP - 706
JO - Leukemia and Lymphoma
JF - Leukemia and Lymphoma
IS - 4
ER -