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Oncologist. 2019 Oct 4. pii: theoncologist.2019-0395. doi: 10.1634/theoncologist.2019-0395. [Epub ahead of print]

Axicabtagene Ciloleucel, an Anti-CD19 Chimeric Antigen Receptor T-Cell Therapy for Relapsed or Refractory Large B-Cell Lymphoma: Practical Implications for the Community Oncologist.

Author information

1
Dana-Farber Cancer Institute, Boston, Massachusetts, USA caron_jacobson@dfci.harvard.edu.
2
University of Iowa, Iowa City, Iowa, USA.
3
Washington University School of Medicine and Siteman Cancer Center, St. Louis, Missouri, USA.

Abstract

Axicabtagene ciloleucel is the first U.S. Food and Drug Administration-approved autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy for the treatment of patients with relapsed or refractory large B-cell lymphoma after ≥2 prior systemic therapies. Although axicabtagene ciloleucel is administered only at authorized treatment centers, community oncologists play a critical role in the CAR T-cell treatment journey, recognizing potentially eligible patients for referral and then, after treatment, closely collaborating with treatment centers to monitor and manage patients long term. ZUMA-1, the pivotal, multicenter, phase I/II study of 108 patients treated with axicabtagene ciloleucel, resulted in an objective response rate of 83%, including 58% complete responses. With a 27.1-month median follow-up, 39% of patients had ongoing responses. CAR T-cell therapy is associated with the potentially life-threatening adverse events (AEs) of cytokine release syndrome and neurologic events, which generally occur early after treatment. In ZUMA-1, cytokine release syndrome and neurologic events were generally reversible and grade ≥3 cytokine release syndrome and neurologic events occurred in 11% and 32% of patients, respectively. Frequent prolonged AEs included hypogammaglobulinemia, B-cell aplasia, and cytopenias requiring supportive care until recovery of hematopoietic function. Rate of treatment-related mortality was low, at <2%. With appropriate management of common AEs, axicabtagene ciloleucel offers the potential for long-term durable responses in patients who otherwise lack curative treatment options. IMPLICATIONS FOR PRACTICE: Community oncologists should be familiar with key aspects of chimeric antigen receptor (CAR) T-cell indications and eligibility to help recognize and refer potential patients for this paradigm-changing treatment option at the appropriate time during the disease course. To ensure optimal long-term outcomes for patients who have been treated with CAR T-cell therapy, oncologists must also be familiar with common prolonged AEs and their monitoring and management.

KEYWORDS:

Diffuse large B‐cell lymphoma; High‐grade B‐cell lymphoma; Immunotherapy; Primary mediastinal B‐cell lymphoma; Transformed follicular lymphoma

Conflict of interest statement

Disclosures of potential conflicts of interest may be found at the end of this article.

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