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Efficacy and safety of once-weekly and twice-weekly bortezomib in patients with relapsed systemic AL amyloidosis: results of a phase 1/2 study

This first prospective phase 2 study of single-agent bortezomib in relapsed primary systemic AL amyloidosis evaluated the recommended (maximum planned) doses identified in phase 1 testing (1.6 mg/m2 once weekly [days 1, 8, 15, and 22; 35-day cycles]; 1.3 mg/m2 twice weekly [days 1, 4, 8, and 11; 21-...

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Main Authors: Reece, Donna E. (Author) , Hegenbart, Ute (Author) , Sanchorawala, Vaishali (Author) , Merlini, Giampaolo (Author) , Palladini, Giovanni (Author) , Bladé, Joan (Author) , Fermand, Jean-Paul (Author) , Hassoun, Hani (Author) , Heffner, Leonard (Author) , Vescio, Robert A. (Author) , Liu, Kevin (Author) , Enny, Christopher (Author) , Esseltine, Dixie-Lee (Author) , van de Velde, Helgi (Author) , Cakana, Andrew (Author) , Comenzo, Raymond L. (Author)
Format: Article (Journal)
Language:English
Published: July 28, 2011
In: Blood
Year: 2011, Volume: 118, Issue: 4, Pages: 865-873
ISSN:1528-0020
DOI:10.1182/blood-2011-02-334227
Online Access:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1182/blood-2011-02-334227
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Author Notes:Donna E. Reece, Ute Hegenbart, Vaishali Sanchorawala, Giampaolo Merlini, Giovanni Palladini, Joan Bladé, Jean-Paul Fermand, Hani Hassoun, Leonard Heffner, Robert A. Vescio, Kevin Liu, Christopher Enny, Dixie-Lee Esseltine, Helgi van de Velde, Andrew Cakana, and Raymond L. Comenzo
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Summary:This first prospective phase 2 study of single-agent bortezomib in relapsed primary systemic AL amyloidosis evaluated the recommended (maximum planned) doses identified in phase 1 testing (1.6 mg/m2 once weekly [days 1, 8, 15, and 22; 35-day cycles]; 1.3 mg/m2 twice weekly [days 1, 4, 8, and 11; 21-day cycles]). Among all 70 patients enrolled in the study, 44% had ≥ 3 organs involved, including 73% and 56% with renal and cardiac involvement. In the 1.6 mg/m2 once-weekly and 1.3 mg/m2 twice-weekly groups, the hematologic response rate was 68.8% and 66.7% (37.5% and 24.2% complete responses, respectively); median time to first/best response was 2.1/3.2 and 0.7/1.2 months, and 78.8% and 75.5% had response durations of ≥ 1 year, respectively. One-year hematologic progression-free rates were 72.2% and 74.6%, and 1-year survival rates were 93.8% and 84.0%, respectively. Outcomes appeared similar in patients with cardiac involvement. Among all 70 patients, organ responses included 29% renal and 13% cardiac responses. Rates of grade ≥ 3 toxicities (79% vs 50%) and discontinuations/dose reductions (38%/53% vs 28%/22%) resulting from toxicities appeared higher with 1.3 mg/m2 twice-weekly versus 1.6 mg/m2 once-weekly dosing. Both bortezomib dose schedules represent active, well-tolerated regimens in relapsed AL amyloidosis. This study was registered at www.clinicaltrials.gov as #NCT00298766.
Item Description:Gesehen am 14.09.2022
Physical Description:Online Resource
ISSN:1528-0020
DOI:10.1182/blood-2011-02-334227

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