TY - JOUR
T1 - Multicenter phase II study of bortezomib in patients with relapsed or refractory mantle cell lymphoma
AU - Fisher, Richard I.
AU - Bernstein, Steven H.
AU - Kahl, Brad S.
AU - Djulbegovic, Benjamin
AU - Robertson, Michael J.
AU - De Vos, Sven
AU - Epner, Elliot
AU - Krishnan, Amrita
AU - Leonard, John P.
AU - Lonial, Sagar
AU - Stadtmauer, Edward A.
AU - O'Connor, Owen A.
AU - Shi, Hongliang
AU - Boral, Anthony L.
AU - Goy, André
PY - 2006/10/20
Y1 - 2006/10/20
N2 - Purpose: Evaluate response rate, duration of response (DOR), time-to-progression (TTP), overall survival (OS), and safety of bortezomib treatment in patients with relapsed or refractory mantle cell lymphoma (MCL). Patients and Methods: Bortezomib 1.3 mg/m2 was administered on days 1, 4, 8, and 11 of a 21-day cycle, for up to 17 cycles. Response and progression were determined using International Workshop Response Criteria, both using data from independent radiology review and by the investigators. Primary efficacy analyses were based on data from independent radiology review. Results: In total, 155 patients were treated. Median number of prior therapies was one (range, one to three). Response rate in 141 assessable patients was 33% including 8% complete response (CR)/unconfirmed CR. Median DOR was 9.2 months. Median TTP was 6.2 months. Results by investigator assessments were similar. Median OS has not been reached after a median follow-up of 13.4 months. The safety profile of bortezomib was similar to previous experience in relapsed multiple myeloma. The most common adverse events grade 3 or higher were peripheral neuropathy (13%), fatigue (12%), and thrombocytopenia (11%). Death from causes that were considered to be treatment related was reported for 3% of patients. Conclusion: These results confirm the activity of bortezomib in relapsed or refractory MCL, with predictable and manageable toxicities. Bortezomib provides significant clinical activity in terms of durable and complete responses, and may therefore represent a new treatment option for this population with usually very poor outcome. Studies of bortezomib-based combinations in MCL are ongoing.
AB - Purpose: Evaluate response rate, duration of response (DOR), time-to-progression (TTP), overall survival (OS), and safety of bortezomib treatment in patients with relapsed or refractory mantle cell lymphoma (MCL). Patients and Methods: Bortezomib 1.3 mg/m2 was administered on days 1, 4, 8, and 11 of a 21-day cycle, for up to 17 cycles. Response and progression were determined using International Workshop Response Criteria, both using data from independent radiology review and by the investigators. Primary efficacy analyses were based on data from independent radiology review. Results: In total, 155 patients were treated. Median number of prior therapies was one (range, one to three). Response rate in 141 assessable patients was 33% including 8% complete response (CR)/unconfirmed CR. Median DOR was 9.2 months. Median TTP was 6.2 months. Results by investigator assessments were similar. Median OS has not been reached after a median follow-up of 13.4 months. The safety profile of bortezomib was similar to previous experience in relapsed multiple myeloma. The most common adverse events grade 3 or higher were peripheral neuropathy (13%), fatigue (12%), and thrombocytopenia (11%). Death from causes that were considered to be treatment related was reported for 3% of patients. Conclusion: These results confirm the activity of bortezomib in relapsed or refractory MCL, with predictable and manageable toxicities. Bortezomib provides significant clinical activity in terms of durable and complete responses, and may therefore represent a new treatment option for this population with usually very poor outcome. Studies of bortezomib-based combinations in MCL are ongoing.
UR - http://www.scopus.com/inward/record.url?scp=33750625445&partnerID=8YFLogxK
U2 - 10.1200/JCO.2006.07.9665
DO - 10.1200/JCO.2006.07.9665
M3 - Article
C2 - 17001068
AN - SCOPUS:33750625445
SN - 0732-183X
VL - 24
SP - 4867
EP - 4874
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 30
ER -