A phase 2 study of bortezomib in combination with ifosfamide/vinorelbine in paediatric patients and young adults with refractory/recurrent Hodgkin lymphoma: a Children's Oncology Group study

• Published in: British journal of haematology Vol. 170; no. 1; pp. 118 - 122
• Main Authors: Horton, Terzah M., Drachtman, Richard A., Chen, Lu, Cole, Peter D., McCarten, Kathleen, Voss, Stephan, Guillerman, Robert P., Buxton, Allen, Howard, Scott C., Hogan, Shirley M., Sheehan, Andrea M., López‐Terrada, Dolores, Mrazek, Matthew D., Agrawal, Neeraj, Wu, Meng‐Fen, Liu, Hao, De Alarcon, Pedro A., Trippet, Tanya M., Schwartz, Cindy L.
• Format: Journal Article
• Language: English
• Published: England 01-07-2015
• Subjects: Adult; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Boronic Acids - administration & dosage; Bortezomib; Child; Child, Preschool; childhood haematological malignancies; clinical trials; Disease-Free Survival; Hodgkin Disease - drug therapy; Humans; Ifosfamide - administration & dosage; Neoplasm Recurrence, Local - drug therapy; NF‐κB; paediatric oncology; Pyrazines - administration & dosage; Vinblastine - administration & dosage; Vinblastine - analogs & derivatives; Young Adult; NF-κB; clinical trials; paediatric oncology; childhood haematological malignancies
• ISSN: 0007-1048; 1365-2141
• DOI: 10.1111/bjh.13388

Summary
A Children's Oncology Group clinical trial aimed to determine if bortezomib (B) increased the efficacy of ifosfamide and vinorelbine (IV) in paediatric Hodgkin lymphoma (HL). This study enrolled 26 relapsed HL patients (<30 years) treated with two to four cycles of IVB. The primary endpoint was anatomic complete response (CR) after two cycles. Secondary endpoints included overall response (OR: CR + partial response) at study completion compared to historical controls [72%; 95% confidence interval (CI): 59–83%]. Although few patients achieved the primary objective, OR with IVB improved to 83% (95% CI: 61–95%; p = 0·32). Although not statistically different, results suggest IVB may be a promising combination.