Improved Event-Free Survival With Addition of Rituximab to Chemotherapy in B-Lineage Adult ALL


Key Points

  • The addition of rituximab was associated with a significantly improved event-free survival in adults with B-lineage acute lymphoblastic leukemia.
  • There was evidence of an increased benefit in patients with higher CD20 expression on leukemic blasts.

In the phase III GRAALL-2005 trial reported in The New England Journal of Medicine, Maury et al found that the addition of rituximab (Rituxan) to standard chemotherapy resulted in improved event-free survival in adult patients with B-lineage acute lymphoblastic leukemia (ALL).

Study Details

In the trial, 209 patients aged 18 to 59 years with CD20-positive, Philadelphia chromosome (Ph)-negative ALL from 56 French and 8 Swiss sites were randomized between May 2006 and April 2014 to receive standard chemotherapy with (n = 105) or without (n = 104) rituximab. Rituximab was given at 375 mg/m2 during all treatment phases, for a total of 16 to 18 infusions. The primary endpoint was event-free survival.

Event-Free Survival

After a median follow-up of 30 months, rituximab treatment was associated with prolonged event-free survival (hazard ratio [HR] = 0.66, P = 0.04). Estimated event-free survival rates were 65% in the rituximab group vs 52% in the control group at 2 years and 55% vs 43% at 4 years. There appeared to be a greater event-free survival benefit with rituximab among patients with CD20 expression ≥ the median percentage (HR = 0.52) compared with < the median percentage (HR = 0.82). Rituximab was associated with a nonsignificant increase in overall survival (HR = 0.70, P = .10); estimated overall survival was 71% vs 64% at 2 years and 61% vs 50% at 4 years.

Adverse Events

There was no significant difference between the groups in the overall incidence of severe adverse events. Infection was more common in the rituximab group (71 vs 55 events). Allergic reactions to asparaginase were more common in the control group (2% vs 11%).

The investigators concluded: “Adding rituximab to the ALL chemotherapy protocol improved the outcome for younger adults with CD20-positive, Ph-negative ALL.”

The study was funded by the Regional Clinical Research Office, Paris, Programme Hospitalier de Recherche Clinique, the French Ministry of Health, the Institut National du Cancer, and the Swiss State Secretariat for Education, Research, and Innovation.

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