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Clinical Trial
. 2017 Mar 9;129(10):1275-1283.
doi: 10.1182/blood-2016-09-736686. Epub 2016 Dec 21.

Long-term outcome of acute promyelocytic leukemia treated with all- trans-retinoic acid, arsenic trioxide, and gemtuzumab

Yasmin Abaza  1 , Hagop Kantarjian  1 , Guillermo Garcia-Manero  1 , Elihu Estey  2 , Gautam Borthakur  1 , Elias Jabbour  1 , Stefan Faderl  3 , Susan O'Brien  4 , William Wierda  1 , Sherry Pierce  1 , Mark Brandt  1 , Deborah McCue  5 , Rajyalakshmi Luthra  6 , Keyur Patel  6 , Steven Kornblau  1 , Tapan Kadia  1 , Naval Daver  1 , Courtney DiNardo  1 , Nitin Jain  1 , Srdan Verstovsek  1 , Alessandra Ferrajoli  1 , Michael Andreeff  1 , Marina Konopleva  1 , Zeev Estrov  1 , Maria Foudray  1 , David McCue  1 , Jorge Cortes  1 , Farhad Ravandi  1
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Clinical Trial

Long-term outcome of acute promyelocytic leukemia treated with all- trans-retinoic acid, arsenic trioxide, and gemtuzumab

Yasmin Abaza et al. Blood. .

Abstract

The combination of all-trans-retinoic acid (ATRA) plus arsenic trioxide (ATO) has been shown to be superior to ATRA plus chemotherapy in the treatment of standard-risk patients with newly diagnosed acute promyelocytic leukemia (APL). A recent study demonstrated the efficacy of this regimen with added gemtuzumab ozogamicin (GO) in high-risk patients. We examined the long-term outcome of patients with newly diagnosed APL treated at our institution on 3 consecutive prospective clinical trials, using the combination of ATRA and ATO, with or without GO. For induction, all patients received ATRA (45 mg/m2 daily) and ATO (0.15 mg/kg daily) with a dose of GO (9 mg/m2 on day 1) added to high-risk patients (white blood cell count, >10 × 109/L), as well as low-risk patients who experienced leukocytosis during induction. Once in complete remission, patients received 4 cycles of ATRA plus ATO consolidation. One hundred eighty-seven patients, including 54 with high-risk and 133 with low-risk disease, have been treated. The complete remission rate was 96% (52 of 54 in high-risk and 127 of 133 in low-risk patients). Induction mortality was 4%, with only 7 relapses. Among low-risk patients, 60 patients (45%) required either GO or idarubicin for leukocytosis. Median duration of follow-up was 47.6 months. The 5-year event-free, disease-free, and overall survival rates are 85%, 96%, and 88%, respectively. Late hematological relapses beyond 1 year occurred in 3 patients. Fourteen deaths occurred beyond 1 year; 12 were related to other causes. This study confirms the durability of responses with this regimen.

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Figures

Figure 1.
Figure 1.
Treatment regimen. (A) Details of induction course, regimen A. (B) Details of induction course, regimen B. *One dose of GO 9 mg/m2 was given on day 1 for high-risk patients (defined by WBC count >10 × 109/L on presentation) and low-risk patients in whom the WBC count increased to more than 10 × 109/L during the first 4 weeks of therapy. D, day; mCR, marrow complete remission; wks, weeks.
Figure 2.
Figure 2.
Patient disposition.
Figure 3.
Figure 3.
Survival outcomes for the whole population. (A) Event-free survival. (B) Disease-free survival. (C) Overall survival for the entire group.
Figure 4.
Figure 4.
Outcomes by risk subsets. (A) Event-free survival by risk group. (B) Disease-free survival by risk group. (C) Overall survival by risk group.
Figure 5.
Figure 5.
Outcomes by age. (A) Event-free survival by age group. (B) Disease-free survival by age group. (C) Overall survival by age group.
Figure 6.
Figure 6.
Survival for specified subsets. (A) Gemtuzumab vs idarubicin among high-risk APL patients. (B) Overall survival by cytogenetics.
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