title: Multicenter phase II study of bortezomib in patients with relapsed or refractory mantle cell lymphoma.
abstract: OBJECTIVE
  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).
  
  
  METHODS
  Bortezomib 1.3 mg/m(2) 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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: University of Rochester, James P. Wilmot Cancer Center, Rochester, USA. Richard_Fisher@urmc.rochester.edu
authors.forename: Richard I
authors.initials: RI
authors.lastname: Fisher
authors.forename: Steven H
authors.initials: SH
authors.lastname: Bernstein
authors.forename: Brad S
authors.initials: BS
authors.lastname: Kahl
authors.forename: Benjamin
authors.initials: B
authors.lastname: Djulbegovic
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Robertson
authors.forename: Sven
authors.initials: S
authors.lastname: de Vos
authors.forename: Elliot
authors.initials: E
authors.lastname: Epner
authors.forename: Amrita
authors.initials: A
authors.lastname: Krishnan
authors.forename: John P
authors.initials: JP
authors.lastname: Leonard
authors.forename: Sagar
authors.initials: S
authors.lastname: Lonial
authors.forename: Edward A
authors.initials: EA
authors.lastname: Stadtmauer
authors.forename: Owen A
authors.initials: OA
authors.lastname: O'Connor
authors.forename: Hongliang
authors.initials: H
authors.lastname: Shi
authors.forename: Anthony L
authors.initials: AL
authors.lastname: Boral
authors.forename: André
authors.initials: A
authors.lastname: Goy
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001897:Boronic Acids / Q000009:adverse effects / Q000627:therapeutic use*; D000069286:Bortezomib; D019008:Drug Resistance, Neoplasm; D005260:Female; D006801:Humans; D020522:Lymphoma, Mantle-Cell / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy; D011719:Pyrazines / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D001897:Boronic Acids; D011719:Pyrazines; D000069286:Bortezomib