Five-year outcomes for frontline brentuximab vedotin with CHP for CD30-expressing peripheral T-cell lymphomas

• Published in: Blood Vol. 131; no. 19; pp. 2120 - 2124
• Main Authors: Fanale, Michelle A., Horwitz, Steven M., Forero-Torres, Andres, Bartlett, Nancy L., Advani, Ranjana H., Pro, Barbara, Chen, Robert W., Davies, Andrew, Illidge, Tim, Uttarwar, Mayur, Lee, Shih-Yuan, Ren, Hong, Kennedy, Dana A., Shustov, Andrei R.
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 10.05.2018; American Society of Hematology
• Subjects: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Brentuximab Vedotin; Brief Report; Clinical Trials and Observations; Cyclophosphamide - adverse effects; Cyclophosphamide - therapeutic use; Doxorubicin - adverse effects; Doxorubicin - therapeutic use; Female; Gene Expression; Humans; Immunoconjugates - administration & dosage; Kaplan-Meier Estimate; Ki-1 Antigen - genetics; Ki-1 Antigen - metabolism; Lymphoma, T-Cell, Peripheral - drug therapy; Lymphoma, T-Cell, Peripheral - genetics; Lymphoma, T-Cell, Peripheral - mortality; Lymphoma, T-Cell, Peripheral - pathology; Male; Middle Aged; Neoplasm Staging; Prednisone - adverse effects; Prednisone - therapeutic use; Treatment Outcome; Vincristine - adverse effects; Vincristine - therapeutic use; Young Adult
• ISSN: 0006-4971; 1528-0020
• DOI: 10.1182/blood-2017-12-821009

This phase 1 study evaluated frontline brentuximab vedotin in combination with cyclophosphamide, doxorubicin, and prednisone (BV+CHP; 6 cycles, then up to 10 cycles of brentuximab vedotin monotherapy) in 26 patients with CD30+ peripheral T-cell lymphoma, including 19 with systemic anaplastic large cell lymphoma. All patients (100%) achieved an objective response, with a complete remission (CR) rate of 92%; none received a consolidative stem cell transplant. After a median observation period of 59.6 months (range, 4.6-66.0) from first dose, neither the median progression-free survival (PFS) nor the median overall survival (OS) was reached. No progression or death was observed beyond 35 months. The estimated 5-year PFS and OS rates were 52% and 80%, respectively. Eighteen of 19 patients (95%) with treatment-emergent peripheral neuropathy (PN) reported resolution or improvement of symptoms. Thirteen patients (50%) remained in remission at the end of the study, with PFS ranging from 37.8+ to 66.0+ months. Eight of these 13 patients received the maximum 16 cycles of study treatment. These final results demonstrate durable remissions in 50% of patients treated with frontline BV+CHP, suggesting a potentially curative treatment option for some patients. This trial was registered at www.clinicaltrials.gov as #NCT01309789. •100% response rate (92% CR) in 26 patients treated with frontline BV+CHP. After ∼5 years, 50% remained in CR (PFS 37.8+ to 66.0+ months).•18 of 19 patients (95%) with treatment-emergent PN reported resolution or improvement in symptoms; 9 had resolution of all PN events. [Display omitted]