Chemotherapy

In a United Kingdom MRC study, adult and pediatric patients were randomly assigned to receive either four or five courses of intensive therapy.[1,12][Level of evidence A1]

In a United Kingdom MRC study, adult and pediatric patients were randomly assigned to receive either four or five courses of intensive therapy.[1,12][Level of evidence A1]

Five courses of therapy did not show an advantage for relapse-free survival and OS.

Based on this MRC data, in the COG AAML1031 (NCT01371981) trial, non–high-risk patients treated without HSCT in first CR (73% of all patients) received four cycles of chemotherapy (two induction cycles and two consolidation cycles) rather than five cycles (two induction cycles and three consolidation cycles). In the previous COG AAML0531 (NCT00372593) and AAML03P1 (NCT00070174) trials, patients who did not undergo HSCT received five cycles of chemotherapy.[63] Additional study of the number of intensification courses and specific agents used will better address this issue. However, these data suggest that four chemotherapy courses should only be administered to the favorable group described above, and that all other patients who do not undergo HSCT should receive five chemotherapy courses.

Based on this MRC data, in the COG AAML1031 (NCT01371981) trial, non–high-risk patients treated without HSCT in first CR (73% of all patients) received four cycles of chemotherapy (two induction cycles and two consolidation cycles) rather than five cycles (two induction cycles and three consolidation cycles). In the previous COG AAML0531 (NCT00372593) and AAML03P1 (NCT00070174) trials, patients who did not undergo HSCT received five cycles of chemotherapy.[63] Additional study of the number of intensification courses and specific agents used will better address this issue. However, these data suggest that four chemotherapy courses should only be administered to the favorable group described above, and that all other patients who do not undergo HSCT should receive five chemotherapy courses.

In a retrospective analysis, non–high-risk patients treated without HSCT on the COG AAML1031 trial (four chemotherapy cycles) had significantly worse outcomes than did those who had received five cycles of chemotherapy on the AAML0531 trial (four- vs. five-cycle outcomes):

Based on this MRC data, in the COG AAML1031 (NCT01371981) trial, non–high-risk patients treated without HSCT in first CR (73% of all patients) received four cycles of chemotherapy (two induction cycles and two consolidation cycles) rather than five cycles (two induction cycles and three consolidation cycles). In the previous COG AAML0531 (NCT00372593) and AAML03P1 (NCT00070174) trials, patients who did not undergo HSCT received five cycles of chemotherapy.[63] Additional study of the number of intensification courses and specific agents used will better address this issue. However, these data suggest that four chemotherapy courses should only be administered to the favorable group described above, and that all other patients who do not undergo HSCT should receive five chemotherapy courses. › In a retrospective analysis, non–high-risk patients treated without HSCT on the COG AAML1031 trial (four chemotherapy cycles) had significantly worse outcomes than did those who had received five cycles of chemotherapy on the AAML0531 trial (four- vs. five-cycle outcomes):

The OS rate was 77.0% for patients who received four chemotherapy cycles, compared with 83.5% for patients who received five chemotherapy cycles (HR, 1.45; 95% CI, 0.97–2.17; P = .068).

Based on this MRC data, in the COG AAML1031 (NCT01371981) trial, non–high-risk patients treated without HSCT in first CR (73% of all patients) received four cycles of chemotherapy (two induction cycles and two consolidation cycles) rather than five cycles (two induction cycles and three consolidation cycles). In the previous COG AAML0531 (NCT00372593) and AAML03P1 (NCT00070174) trials, patients who did not undergo HSCT received five cycles of chemotherapy.[63] Additional study of the number of intensification courses and specific agents used will better address this issue. However, these data suggest that four chemotherapy courses should only be administered to the favorable group described above, and that all other patients who do not undergo HSCT should receive five chemotherapy courses. › In a retrospective analysis, non–high-risk patients treated without HSCT on the COG AAML1031 trial (four chemotherapy cycles) had significantly worse outcomes than did those who had received five cycles of chemotherapy on the AAML0531 trial (four- vs. five-cycle outcomes):

The DFS rate was 56% for patients who received four cycles, compared with 67% for patients who received five cycles (HR, 1.45; 95% CI, 1.10–1.91; P = .009).

Based on this MRC data, in the COG AAML1031 (NCT01371981) trial, non–high-risk patients treated without HSCT in first CR (73% of all patients) received four cycles of chemotherapy (two induction cycles and two consolidation cycles) rather than five cycles (two induction cycles and three consolidation cycles). In the previous COG AAML0531 (NCT00372593) and AAML03P1 (NCT00070174) trials, patients who did not undergo HSCT received five cycles of chemotherapy.[63] Additional study of the number of intensification courses and specific agents used will better address this issue. However, these data suggest that four chemotherapy courses should only be administered to the favorable group described above, and that all other patients who do not undergo HSCT should receive five chemotherapy courses. › In a retrospective analysis, non–high-risk patients treated without HSCT on the COG AAML1031 trial (four chemotherapy cycles) had significantly worse outcomes than did those who had received five cycles of chemotherapy on the AAML0531 trial (four- vs. five-cycle outcomes):

The relapse rate was 40.9% for patients who received four cycles, compared with 31.4% for patients who received five cycles (HR, 1.40; 95% CI, 1.06–1.85; P = .019).

Based on this MRC data, in the COG AAML1031 (NCT01371981) trial, non–high-risk patients treated without HSCT in first CR (73% of all patients) received four cycles of chemotherapy (two induction cycles and two consolidation cycles) rather than five cycles (two induction cycles and three consolidation cycles). In the previous COG AAML0531 (NCT00372593) and AAML03P1 (NCT00070174) trials, patients who did not undergo HSCT received five cycles of chemotherapy.[63] Additional study of the number of intensification courses and specific agents used will better address this issue. However, these data suggest that four chemotherapy courses should only be administered to the favorable group described above, and that all other patients who do not undergo HSCT should receive five chemotherapy courses.

An exception was found in the low-risk subgroup defined by favorable cytogenetics or molecular genetics who were MRD negative at the end of induction cycle 1. This subset of patients had similar outcomes regardless of whether they received four chemotherapy cycles (AAML1031) or five chemotherapy cycles (AAML0531).