TITLE: A retrospective multicenter analysis of the safety and efficacy of Brentuximab Vedotin (BV) as monotherapy or in combination with Bendamustine (BV-B) in relapsed refractory Classic Hodgkin Lymphoma (cHL) in Argentina.

PURPOSE: We performed a retrospective multicenter study in Argentina to collect information on patients (pts) with relapsed refractory cHL treated with BV as monotherapy or with its combination with BV-B. All patients that received either therapy were included with no exclusion criteria. The primary endpoint was response rate and EFS. Toxicity and OS were secondary end points. PATIENTS AND METHODS: Between 8/2011 and 2/2017, 112 pts met inclusion criteria, 93 had complete data and were evaluable for response, among these 71 pts received BV as monotherapy and 22 with BV-B. Median age for all pts was 29 (range 16-73).

RESULTS: All 112 pts were evaluable for toxicity. In the group of 78 pts treated with BV 46 (59%) presented at least one adverse events (AE). With 13 (17%) of AE grade III-IV (4 grade IV peripheral neuropathy, 7 grade III-IV infections and 3 grade III neutropenia). In the group of 34 pts treated with BV-B, 17 (50%) had some AE, 11 pts (32%) presented grade III-IV AE: 2 peripheral neuropathy, 1 grade IV infection and 4 (12%) pts with SNC AE (1 seizures, 2 aseptic meningitis and 1 encephalopathy).

With a median follow up of 13 months, pts treated with BV had a PFS of 41% and an OS of 75% at 1 yr. The outcome was better for those pts who achieved a CR, with a PFS of 80% and an OS 95%.

In a multivariate analysis for obtaining CR after BV, considering: Bulky disease, 2 vs > 2 lines of prior treatment and primary refractory/early relapse vs late relapse, the only significant unfavorable prognostic factors was being primary refractory/first relapse within the first year (P=0.019).

For the group of pts with BV-B the PFS was 42% with an OS of 95%, and 62% and 100% for those in CR.

CONCLUSIONS: This is the first and only retrospective multicenter trial showing the Argentine experience with Brentuximab. Our findings add to the growing body of evidence supporting the efficacy of Bv as monotherapy and the high ORR and CR of the combination of Bv-B, and warrant a confirmatory randomized trial to re-examine the efficacy and toxicity of this drug combination over BV as monotherapy.

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Disclosures

Shanley: Gador: Speakers Bureau. Pavlovsky: Janssen: Honoraria, Speakers Bureau. Riveros: Janssen: Consultancy, Speakers Bureau; Raffo: Consultancy, Speakers Bureau; BMS: Speakers Bureau. Pavlovsky: TAKEDA: Speakers Bureau.

Topics:
argentina, bendamustine, brentuximab vedotin, chile, chlorambucil, hodgkin's disease, brachial plexus neuritis, toxic effect, infections, peripheral neuropathy

Author notes

*

Asterisk with author names denotes non-ASH members.

© 2017 by The American Society of Hematology
2017
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