Phase II trial of brentuximab vedotin in relapsed/refractory germ cell tumors Journal Article
| Authors: | Ashkar, R.; Feldman, D. R.; Adra, N.; Zaid, M. A.; Funt, S. A.; Althouse, S. K.; Perkins, S. M.; Snow, C. I.; Lazzara, K. M.; Sego, L. M.; Quinn, D. I.; Hanna, N. H.; Einhorn, L. H.; Albany, C. |
| Article Title: | Phase II trial of brentuximab vedotin in relapsed/refractory germ cell tumors |
| Abstract: | Background CD-30 is highly expressed in some patients with non-seminomatous germ-cell tumors. Brentuximab vedotin is an antibody–drug conjugate directed to CD-30. We report a phase 2 trial of brentuximab vedotin in patients with chemo-refractory GCT. Patients and methods This is a single arm, two cohort phase 2 trial investigating brentuximab vedotin 1.8 mg/kg IV every 3 weeks until disease progression or intolerable toxicities in patients with relapsed GCT who have no curative options. Patients with mGCT who progressed after first line cisplatin-based chemotherapy and after at least 1 salvage regimen (high-dose or standard-dose chemotherapy) were eligible. CD30 expression was assessed and two cohorts defined: CD30 positive and CD30 negative/unknown. Results 18 patients were enrolled. Median age 34.7 (range, 23–56). All patients had non-seminoma. Median AFP 4.9 (range, 1–219,345) and hCG 282 (range, 0.6–172,064). Five patients had late relapse (> 2 years). Median number of previous chemotherapy regimens was 3 (range, 2–7). Ten patients received prior high-dose chemotherapy. Seven patients had positive CD30 staining. There were two grade 3 treatment-related adverse events. No partial or complete responses were observed. 6 patients achieved radiographic stable disease (range, 9–14.9 weeks), 5 had elevated AFP or hCG at trial entry and all 5 had transient > 50% decline in baseline AFP/hCG: 4 had CD30 -ve and 2 had CD30 + ve staining; 10 patients had progression of disease as their best response; 2 were not evaluable for response. Conclusion Brentuximab vedotin does not appear to have clinically meaningful single-agent activity in patients with refractory GCT. © 2021, The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature. |
| Keywords: | testicular cancer; germ cell tumor; brentuximab vedotin; relapsed testicular cancer |
| Journal Title: | Investigational New Drugs |
| Volume: | 39 |
| Issue: | 6 |
| ISSN: | 0167-6997 |
| Publisher: | Springer |
| Date Published: | 2021-12-01 |
| Start Page: | 1656 |
| End Page: | 1663 |
| Language: | English |
| DOI: | 10.1007/s10637-021-01134-1 |
| PROVIDER: | scopus |
| PUBMED: | 34031784 |
| PMCID: | PMC9534326 |
| DOI/URL: | |
| Notes: | Article -- Source: Scopus |
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