Phase I/II clinical trial of brentuximab vedotin for pretreated Japanese patients with CD30-positive cutaneous T-cell lymphoma.

Autor: Hirai Y; Department of Dermatology, Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama University, Okayama, Japan., Sakurai J; Center for Innovative Clinical Medicine, Okayama University Hospital, Okayama, Japan., Yoshida S; Center for Innovative Clinical Medicine, Okayama University Hospital, Okayama, Japan., Kikuchi T; Center for Innovative Clinical Medicine, Okayama University Hospital, Okayama, Japan., Mitsuhashi T; Center for Innovative Clinical Medicine, Okayama University Hospital, Okayama, Japan., Miyake T; Department of Dermatology, Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama University, Okayama, Japan., Fujimura T; Department of Dermatology, Tohoku University Graduate School of Medicine, Sendai, Japan., Abe R; Department of Dermatology, Niigata University, Niigata, Japan., Fujikawa H; Department of Dermatology, Niigata University, Niigata, Japan., Boki H; Department of Dermatology, Tokyo University, Tokyo, Japan., Suga H; Department of Dermatology, Tokyo University, Tokyo, Japan., Shibata S; Department of Dermatology, Tokyo University, Tokyo, Japan., Miyagaki T; Department of Dermatology, Tokyo University, Tokyo, Japan., Shimauchi T; Department of Dermatology, Hamamatsu University School of Medicine, Hamamatsu, Japan., Kiyohara E; Department of Dermatology, Osaka University, Osaka, Japan., Kawakami Y; Department of Dermatology, Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama University, Okayama, Japan., Morizane S; Department of Dermatology, Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama University, Okayama, Japan.
Jazyk: angličtina
Zdroj: The Journal of dermatology [J Dermatol] 2024 Aug; Vol. 51 (8), pp. 1037-1049. Date of Electronic Publication: 2024 Jun 14.
DOI: 10.1111/1346-8138.17324
Abstrakt: Brentuximab vedotin (BV), a conjugate of anti-CD30 antibody and monomethyl auristatin E, has emerged as a promising treatment option for refractory CD30+ mycosis fungoides (MF) and primary cutaneous anaplastic large-cell lymphoma (pcALCL). BV has been shown to be safe and effective in treating Hodgkin's lymphoma and peripheral T-cell lymphoma. This multicenter, prospective, single-arm phase I/II study evaluated the efficacy of BV in Japanese patients with CD30+ cutaneous lymphomas, namely CD30+ cutaneous T-cell lymphoma. Participants were divided into two groups: those with CD30+ MF or pcALCL (cohort 1, n = 13) and those with CD30+ lymphoproliferative disorders other than those in cohort 1 (cohort 2, n = 3). The studied population included the full analysis set (FAS), modified FAS (mFAS), and safety analysis set (SAF). These sets were identified in cohorts 1 and 1 + 2 and labeled FAS1 and FAS2, mFAS1 and mFAS2, and SAF1 and SAF2, respectively. Each treatment cycle lasted 3 weeks, and BV was continued for up to 16 cycles after the third cycle based on treatment response. The primary endpoint was the 4-month objective response rate (ORR4) determined by the Independent Review Forum (IRF). ORR4 was 69.2% for FAS1 and 62.5% for FAS2 (P < 0.0001). Secondary endpoints of ORR, assessed using the global response score (53.8% in FAS1) and modified severity-weighted assessment tool (62.5% in FAS1), using the IRF, provided results comparable to the primary findings. The incidence of ≥grade 3 adverse events (≥15%) in SAF1 was peripheral neuropathy in three patients (23%) and fever and eosinophilia in two patients (15%). In conclusion, BV showed favorable efficacy, tolerability, and safety profile in Japanese patients with relapsed or refractory CD30+ primary cutaneous T-cell lymphoma. The trial was registered with University Hospital Medical Information Network Clinical Trials Registry, Japan (protocol ID: UMIN000034205).
(© 2024 The Author(s). The Journal of Dermatology published by John Wiley & Sons Australia, Ltd on behalf of Japanese Dermatological Association.)
Databáze: MEDLINE
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