Phase I / II study of brentuximab vedotin in Japanese patients with relapsed or refractory CD30-positive Hodgkin's lymphoma or systemic anaplastic large-cell lymphoma.
Bottom Line: Grade 3/4 adverse events in more than two patients were lymphopenia (50%) and neutropenia (15%).The pharmacokinetic profile was similar to that observed in the previous studies in the USA.These results show that brentuximab vedotin has an acceptable safety profile and promising antitumor activity in the Japanese population.
Affiliation: Department of Hematology and Oncology, Nagoya Daini Red Cross Hospital, Nagoya, Japan.Show MeSH
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Mentions: Serum concentration–time profiles and PK parameters of brentuximab vedotin assessed in the phase I part are shown in Figure 2 and Table 5, respectively. The serum concentration gradually declined after the completion of each infusion. The mean terminal-phase half-life ranged from 5 to 7 days. At both dose levels, the mean values of AUC and Cmax were similar between days 1 (first infusion) and 21 (second infusion). Furthermore, the mean AUC and Cmax increased in a dose-related manner. Minor MMAE was determined in plasma samples. Plasma concentrations of MMAE reached Cmax until approximately 4 days after the infusion and then declined with the mean half-life of approximately 4 days at 1.8 mg/kg. The mean Cmax and AUC accounted for 0.0036 μg/mL and 0.023 day/μg/mL on cycle 1 and 0.0019 μg/mL and 0.016 day/μg/mL on cycle 2, respectively.
Affiliation: Department of Hematology and Oncology, Nagoya Daini Red Cross Hospital, Nagoya, Japan.