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Brentuximab vedotin in Relapsed Anaplastic Large Cell Lymphoma
Anaplastic large cell lymphoma (ALCL) is a subtype of T-cell lymphoma which is characterized by strong CD30 expression. Relapsed ALCL has poor survival outcomes when treated with chemotherapy or with stem cell transplant. Barbara Pro of Lurie Cancer Center in Chicago, Illinois, and colleagues, conducted a phase II study to determine safety and efficacy of single agent brentuximab vedotin in relapsed or refractory ALCL (NCT00866047).
Patient Population
- N = 58 patients
- Median age = 52 years
- Age range 14–76 years
- ALK negative disease = 72%
Key Findings
- Five-year overall survival (OS) = 60%
- OS in CR patients = 79% (95% CI, 65%–92%)
- OS in non-CR patients = 25% (95% CI, 6%–44%)
- Best response
- Complete remission (CR) = 66%
- Partial remission (PR) = 21%
- Stable disease (SD) = 7%
- Progressive disease = 3%
- Not evaluable = 3%
- Remained in CR until end of study = 42.1%
- Median PFS = 20 months
- Median duration of response = 25.6 months
- Median duration of response in CR = not reached
- Consolidative stem cell transplant (SCT) after CR
- SCT = 42.1%
- Five-year PFS = 69% (95% CI, 46%–91%)
- Five-year OS = 75% (95% CI, 54%–96%)
- PFS at last follow up = 69%
- Non-SCT after CR
- Non-SCT = 57.9%
- Five-year PFS = 48% (95% CI, 25%–70%)
- Five-year OS = 81% (95% CI, 65%–98%)
- PFS at last follow up = 54%
- Impact of age
- Five-year survival ≥40 years = 59% (95% CI, 39%–86%) vs ≤40 years = 63% (95% CI, 44%–74%)
- Five-year survival PFS ≥40 years = 20 months vs ≤40 years = 14.1 months
- Peripheral neuropathy
- neuropathy = 57%
- complete resolution of neuropathy within 2 years = 67%
- improvement or partial resolution of neuropathy = 24%
The results of this study demonstrated a high rate of disease remission and a reversible toxicity profile. The rates of CR and durability of response shows benefit compared to historical data. This highlights single agent brentuximab vedotin as a potential choice for treatment of relapsed or refractory ALCL.
References