Intensive postremission chemotherapy in adults with acute myeloid leukemia (Cancer and Leukemia Group B): trial

Intensive postremission chemotherapy in adults with acute myeloid leukemia (Cancer and Leukemia Group B)

Phase 3N = 1,088

Population

Adults with newly diagnosed AML (1088 treated; 596 in complete remission randomised to postremission cytarabine).

Design

Adults with newly diagnosed AML received daunorubicin for 3 days and cytarabine for 7 days. Of 693 patients who achieved complete remission, 596 were randomly assigned to four courses of cytarabine at 100 mg/m2 per day for 5 days by continuous infusion, 400 mg/m2 per day for 5 days by continuous infusion, or 3 g/m2 in a 3-hour infusion every 12 hours on days 1, 3 and 5; all then received four monthly maintenance courses. Median follow-up 52 months. The 1994 abstract prints no study number; the label CALGB 8525 in the trial id comes from a later CALGB report with the same three-dose randomisation and is an unconfirmed inference.

Arms

Cytarabine 100 mg/m2 (control): Cytarabine 100 mg/m2 per day for 5 days by continuous infusion, four courses
Cytarabine 400 mg/m2 (experimental): Cytarabine 400 mg/m2 per day for 5 days by continuous infusion, four courses
Cytarabine 3 g/m2 (experimental): Cytarabine 3 g/m2 in a 3-hour infusion every 12 hours on days 1, 3 and 5, four courses

People

Mayer RJ, Cancer and Leukemia Group B

DFSHR 0.67 (95% CI 0.53–0.86)DFSHR 0.75 (95% CI 0.60–0.94)Δ 48-month Continuous complete remission+5 points

Show the numbers

Results reported for Intensive postremission chemotherapy in adults with acute myeloid leukemia (Cancer and Leukemia Group B)
Endpoint	Analysis	Cytarabine 400 mg/m2 / Cytarabine 3 g/m2	Cytarabine 100 mg/m2	Effect
DFSPatients in complete remission randomised to postremission cytarabine (596)	primarymedian follow-up 52 monthsMayer 1994	—	—	HR 0.67 (95% CI 0.53–0.86)P=0.003Hazard ratio for 3 g/m2 versus 100 mg/m2. The P value is for the difference among the three dose groups, as published.
DFSPatients in complete remission randomised to postremission cytarabine (596)	primarymedian follow-up 52 monthsMayer 1994	—	—	HR 0.75 (95% CI 0.60–0.94)P=0.003Hazard ratio for 400 mg/m2 versus 100 mg/m2. The P value is for the difference among the three dose groups, as published.
Continuous complete remissionPatients aged 60 years or younger	primaryMayer 1994	29% at 4 y	24% at 4 y	P=0.002For patients older than 60 the abstract gives the probability of remaining disease-free at four years as 16 percent or less in each of the three groups.

Results reported for Intensive postremission chemotherapy in adults with acute myeloid leukemia (Cancer and Leukemia Group B)
Endpoint	Analysis	Cytarabine 400 mg/m2 / Cytarabine 3 g/m2	Cytarabine 100 mg/m2	Effect
DFSPatients in complete remission randomised to postremission cytarabine (596)	primarymedian follow-up 52 monthsMayer 1994	—	—	HR 0.67 (95% CI 0.53–0.86)P=0.003Hazard ratio for 3 g/m2 versus 100 mg/m2. The P value is for the difference among the three dose groups, as published.
DFSPatients in complete remission randomised to postremission cytarabine (596)	primarymedian follow-up 52 monthsMayer 1994	—	—	HR 0.75 (95% CI 0.60–0.94)P=0.003Hazard ratio for 400 mg/m2 versus 100 mg/m2. The P value is for the difference among the three dose groups, as published.
Continuous complete remissionPatients aged 60 years or younger	primaryMayer 1994	29% at 4 y	24% at 4 y	P=0.002For patients older than 60 the abstract gives the probability of remaining disease-free at four years as 16 percent or less in each of the three groups.

Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.

Data table

Endpoint	HR	95% CI
DFS	0.67	0.53–0.86
DFS	0.75	0.6–0.94

Appears in

1994 High-dose cytarabine consolidation: CALGB randomised trial, 1994

Sources

Mayer RJ, Davis RB, Schiffer CA, Berg DT, Powell BL, Schulman P, et al. Intensive postremission chemotherapy in adults with acute myeloid leukemia. Cancer and Leukemia Group B. N Engl J Med. 1994;331(14):896-903.
PubMed DOI