Table 2 Summary of Efficacy Outcomes With Common SOC Chemotherapy Regimens in Newly Diagnosed Adult Patients With Ph-Negative BCP-ALL*.

From: Frontline Ph-negative B-cell precursor acute lymphoblastic leukemia treatment and the emerging role of blinatumomab

Common Regimen

N

Median Age (Range), y

Outcome Summary

PETHEMA ALL-96 [71]

81

20 (15–30)

• Median follow-up: 4.2 y

• 6-year EFS: 61% (95% CI: 51–72)

• 6-year OS: 69% (95% CI: 59–81)

MRC UKALLXII/ECOG2993 [82]

1229

30 (14–65)

• Median follow-up: 8.9 y

• 5-year OS: 42% (95%CI: 39-44)

DFCI ALL [70]

92

28 (18–50)

• Median follow-up: 4.5 y

• 4-year DFS: 66% (95% CI: 50–78)

• 4-year OS: 68% (95% CI: 53–79)

Linker 4-drug regimen [74]

84

27 (16–59)

• Median follow-up: 5.6 y

• 5-year EFS: 52% for 78 patients who achieved remission

• 5-year DFS: 54% for patients who achieved remission

• 5-year OS: 47% (overall population)

CALGB 10403 [69]

295

24 (17.0–39.0)

• Median follow-up: 64.2 mo (0.4–110)

• 3-year EFS: 59% (95% CI: 54–65)

• 3-year DFS: 81.7% (95% CI: 58.4–NE)

• 3-year OS: 73% (68–78)

USC/MSKCC ALL [73]

51

32 (18–57)

• Median follow-up: NR

• 7-year DFS: 58%

• 7-year OS: 58%

CALGB 8811 Larson [75]

197

32 (16–80)

• Median follow-up: 43 mo (24–64)

• Estimated median survival: 36 mo

GRAALL-2014 [22]

104

36 (18–59)

• Median follow-up: 4.3 y

• 2.5-year DFS (Ph-negative BCP-ALL patients): 54% (95% CI: 43–63)

• 2.5-year OS (Ph-negative BCP-ALL patients): 76% (95% CI: 66–83)

Hyper-CVAD [53]

69†

41 (32–50)

• Median follow-up: 44 mo (26–53)

• 4-year EFS: 59% (95%CI: 48-73)

• 4-year OS: 68% (95% CI: 58–81)

GIMEMA LAL 1913 [60]

139‡

41 (18–65)

• Median follow-up: 38.7 mo (2.2–64.2)

• 3-year EFS: 53.4% (95% CI: 45.5–62.8)

• 3-year DFS: 61.4% (95% CI: 52.9–71.1)

• 3-year OS: 64.9% (95% CI: 57–73.9)

HOVON-100[61]

79§

42 (18–70)

• Median follow-up: not reported

• 5-year EFS (Ph-negative BCP-ALL patients): 48% (95% CI: 36–58)

• 5-year DFS (Ph-negative BCP-ALL patients): 52% (95%CI: 40–63)

• 5-year OS (Ph-negative BCP-ALL patients): 61% (95% CI: 49–71)

JALSG 202-0 [81]

229||

43

• Median follow-up: 7.5–7.8 y

• 5-year DFS (Hd-MTX): 58% (95% CI: 45–68); 56% (43–68) for BCP-ALL subgroup

• 5-year DFS (Id-MTX): 32% (95% CI: 22–43); 35% (23–46) for BCP-ALL subgroup

• 5-year OS (Hd-MTX): 64% (95% CI: 51–74)

• 5-year OS (Id-MTX): 48% (95% CI: 37–59)

UKALL14 [80]

288#

45 (22–65)

• Median follow-up: 53.7 mo (40.3–70.4)

• Median EFS: 23.2 mo (95% CI: 19.2–34.0)

• 3-year EFS: 43.7% (95% CI: 37.8–49.5); 43.1% (95% CI: 35.9–50.0) for Ph-negative BCP-ALL

• Median OS: 40.1 mo (95% CI: 33.2–75.0); 48.8% (95% CI: 41.5–55.7) for Ph-negative BCP-ALL

ECOG1910 Control** [17, 19]

112

50 (30–70)

• Median follow-up: 3.6 y

• 3-year RFS: 64.0%

3-year OS: 68.0%

Modified DFCI-01 [40]

51††

65 (60–79)

• Median follow-up: 21.6 mo (0.7–95)

• 5-year DFS (Ph-negative–negative pts): 57.4% (95% CI: 32.8–75.8)

• 5-year OS (Ph–negative pts): 40.5% (95% CI: 20.0–60.2)

  1. *Most of these studies include a mixed population of patients with ALL; however, most patients had BCP-ALL. Findings for the mixed population reported unless otherwise noted.
  2. †Based on 67 patients with BCP-ALL and 2 patients with B-cell lymphoblastic lymphoma.
  3. ‡Includes 1 patient with lymphoblastic lymphoma.
  4. §Ph-negative BCP-ALL population; HOVON-70 approach was used in patients aged ≤ 40 years.
  5. ||Includes 196 with BCP-ALL.
  6. #Includes 202 with Ph-negative BCP-ALL.
  7. **Time from randomization with patients already receiving induction therapy and MRD-negative.
  8. ††Includes 48 patients with BCP-ALL, of which 32 had Ph-negative BCP-ALL.
  9. ALL acute lymphoblastic leukemia, BCP-ALL B-cell precursor acute lymphoblastic leukemia, DFCI Dana-Farber Cancer Institute, DFS disease-free survival, EFS event-free survival; GIMEMA Gruppo Italiano Malattie Ematologico dell’Adulto, GRAALL Group for Research on Adult Acute Lymphoblastic Leukemia, Hd high dose, HOVON Haemato Oncology Foundation for Adults in the Netherlands, Id intermediate dose, IQR interquartile range, MTX methotrexate, NE not estimable, NR not reported, OS overall survival, Ph Philadelphia chromosome, RFS relapse-free survival.
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