Lewis DJ, et al. – This paper substantiated the efficacy and safety of brentuximab vedotin for the treatment of lymphomatoid papulosis (LyP). The findings established its efficacy in treating LyP (overall response rate, 100%; complete response rate, 58%). The recommendation put forth was that its utility ought to be reserved for patients with truly severe and refractory LyP. In order to optimize its dosing to minimize adverse events, such as peripheral neuropathy, advanced research was warranted.
- The setting for this trial was The University of Texas MD Anderson Cancer Center from May 10, 2011, to March 31, 2017.
- 12 patients with LyP received brentuximab vedotin.
- The enrollees were 18 years or older with a diagnosis of LyP and were required to present with scarring, more than 10 lesions, or active lesions on the face, hands, or feet.
- The physician-initiated, open-label, single-center, phase 2 clinical trial of brentuximab vedotin for CD30+ cutaneous T-cell lymphomas and LyP recruited 9 patients, from 2011 to 2013.
- Three patients received later treatment outside of the trial from 2013 to 2017.
- Five patients were on contimous follow-up as of March 2017.
- Intravenous brentuximab vedotin 1.8 mg/kg infused over 30 minutes every 21 days served as the intervention.
- The primary end point comprised of the overall response rate.
- Complete response was defined as zero lesions, and partial response was defined as a 50% or greater reduction in lesion count from baseline.
- A relapse was defined as loss of partial response.
- 12 patients (8 men and 4 women; median age, 46 years) responded to brentuximab vedotin, and 7 exhibited a complete response.
- 3 weeks was determined as the time to response in all patients.
- The median duration of response was 20 weeks (range, 6-103 weeks).
- The median time to relapse was 12 weeks (range, 6-41 weeks) for 5 patients who relapsed.
- One patient who relapsed was retreated and remained in partial response for more than 23 months.
- 10 patients reported the occurrence of grade 1 to 2 neuropathy occurred, it resolved in 5 patients.
- Neutropenia (n = 2) and dizziness/vertigo (n = 1) were exhibited as adverse events of grade 3 or higher.
- 3 patients withdrew as a result of the adverse events.