R/R Ph- B-cell ALL: study identifies the 3 components of "cure"

  • Bassan R & al.
  • Adv Ther
  • 7 Mar 2019

  • curated by David Reilly
  • Univadis Clinical Summaries
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Takeaway

  • Findings of a Delphi study suggest there are 3 perceived criteria for what constitutes "cure" in patients with relapsed/refractory Philadelphia-negative (Ph) B-cell precursor acute lymphoblastic leukemia (ALL).

Why this matters

  • Prognosis is poor in this setting, and the concept of "cure" is commonly contested.

Study design

  • Delphi study among 9 hematologists and 1 hemato-oncologist regarding what constitutes cure in patients with R/R ALL.
  • Funding: Amgen Inc.

Key results

  • The clinicians reached consensus on 3 cure components, which function in a stepwise manner:
    • Complete remission: most important in the first 1-3 months as the best early indicator of treatment response.
    • Minimal residual disease negativity: most important at 3-6 months of treatment in confirming eradication of malignant cells.
    • Prolongation of survival: most important beyond 6 months, assuming the prior 2 outcomes have been realized.
  • 80% of the clinicians felt a patient could be considered "cured" at 2 years off therapy; there was high-level consensus that a patient could be considered cured at 3 years off therapy, based on natural history of the disease.

Limitations

  • Limited sample size.
  • Some controversy remains surrounding minimal residual disease testing methods and cutoff values for negativity.

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