Multicenter phase II study of bortezomib in patients with relapsed or refractory mantle cell lymphoma

Richard I. Fisher, Steven H. Bernstein, Brad S. Kahl, Benjamin Djulbegovic, Michael Robertson, Sven De Vos, Elliot Epner, Amrita Krishnan, John P. Leonard, Sagar Lonial, Edward A. Stadtmauer, Owen A. O'Connor, Hongliang Shi, Anthony L. Boral, André Goy

Research output: Contribution to journalArticle

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Abstract

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.

Original languageEnglish (US)
Pages (from-to)4867-4874
Number of pages8
JournalJournal of Clinical Oncology
Volume24
Issue number30
DOIs
StatePublished - Oct 20 2006
Externally publishedYes

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Mantle-Cell Lymphoma
Radiology
Research Personnel
Safety
Survival
Peripheral Nervous System Diseases
Therapeutics
Multiple Myeloma
Thrombocytopenia
Reaction Time
Fatigue
Bortezomib
Cause of Death
Education
Population

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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Multicenter phase II study of bortezomib in patients with relapsed or refractory mantle cell lymphoma. / Fisher, Richard I.; Bernstein, Steven H.; Kahl, Brad S.; Djulbegovic, Benjamin; Robertson, Michael; De Vos, Sven; Epner, Elliot; Krishnan, Amrita; Leonard, John P.; Lonial, Sagar; Stadtmauer, Edward A.; O'Connor, Owen A.; Shi, Hongliang; Boral, Anthony L.; Goy, André.

In: Journal of Clinical Oncology, Vol. 24, No. 30, 20.10.2006, p. 4867-4874.

Research output: Contribution to journalArticle

Fisher, RI, Bernstein, SH, Kahl, BS, Djulbegovic, B, Robertson, M, De Vos, S, Epner, E, Krishnan, A, Leonard, JP, Lonial, S, Stadtmauer, EA, O'Connor, OA, Shi, H, Boral, AL & Goy, A 2006, 'Multicenter phase II study of bortezomib in patients with relapsed or refractory mantle cell lymphoma', Journal of Clinical Oncology, vol. 24, no. 30, pp. 4867-4874. https://doi.org/10.1200/JCO.2006.07.9665
Fisher, Richard I. ; Bernstein, Steven H. ; Kahl, Brad S. ; Djulbegovic, Benjamin ; Robertson, Michael ; De Vos, Sven ; Epner, Elliot ; Krishnan, Amrita ; Leonard, John P. ; Lonial, Sagar ; Stadtmauer, Edward A. ; O'Connor, Owen A. ; Shi, Hongliang ; Boral, Anthony L. ; Goy, André. / Multicenter phase II study of bortezomib in patients with relapsed or refractory mantle cell lymphoma. In: Journal of Clinical Oncology. 2006 ; Vol. 24, No. 30. pp. 4867-4874.
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abstract = "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.",
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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

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

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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.

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