title: Bortezomib in patients with relapsed or refractory mantle cell lymphoma: updated time-to-event analyses of the multicenter phase 2 PINNACLE study.
abstract: BACKGROUND
  We previously reported results of the phase 2, multicenter PINNACLE study, which confirmed the substantial single-agent activity of bortezomib in patients with relapsed or refractory mantle cell lymphoma (MCL).
  
  
  METHODS
  We report updated time-to-event data, in all patients and by response to treatment, after extended follow-up (median 26.4 months).
  
  
  RESULTS
  Median time to progression (TTP) was 6.7 months. Median time to next therapy (TTNT) was 7.4 months. Median overall survival (OS) was 23.5 months. In responding patients, median TTP was 12.4 months, median duration of response (DOR) was 9.2 months, median TTNT was 14.3 months, and median OS was 35.4 months. Patients achieving complete response had heterogeneous disease characteristics; among these patients, median TTP and DOR were not reached, and median OS was 36.0 months. One-year survival rate was 69% overall and 91% in responding patients. Median OS from diagnosis was 61.1 months, after median follow-up of 63.7 months. Activity was seen in patients with refractory disease and patients relapsing following high-intensity treatment. Toxicity was generally manageable.
  
  
  CONCLUSIONS
  Single-agent bortezomib is associated with lengthy responses and notable survival in patients with relapsed or refractory MCL, with considerable TTP and TTNT in responding patients, suggesting substantial clinical benefit.
authors.affiliation: The Cancer Center at Hackensack University Medical Center, Hackensack, NJ 07601, USA. agoy@humed.com
authors.forename: A
authors.initials: A
authors.lastname: Goy
authors.forename: S H
authors.initials: SH
authors.lastname: Bernstein
authors.forename: B S
authors.initials: BS
authors.lastname: Kahl
authors.forename: B
authors.initials: B
authors.lastname: Djulbegovic
authors.forename: M J
authors.initials: MJ
authors.lastname: Robertson
authors.forename: S
authors.initials: S
authors.lastname: de Vos
authors.forename: E
authors.initials: E
authors.lastname: Epner
authors.forename: A
authors.initials: A
authors.lastname: Krishnan
authors.forename: J P
authors.initials: JP
authors.lastname: Leonard
authors.forename: S
authors.initials: S
authors.lastname: Lonial
authors.forename: S
authors.initials: S
authors.lastname: Nasta
authors.forename: O A
authors.initials: OA
authors.lastname: O'Connor
authors.forename: H
authors.initials: H
authors.lastname: Shi
authors.forename: A L
authors.initials: AL
authors.lastname: Boral
authors.forename: R I
authors.initials: RI
authors.lastname: Fisher
mesh_terms: D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001897:Boronic Acids / Q000009:adverse effects / Q000627:therapeutic use*; D000069286:Bortezomib; D005260:Female; D006801:Humans; D020522:Lymphoma, Mantle-Cell / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D011719:Pyrazines / Q000009:adverse effects / Q000627:therapeutic use*; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D001897:Boronic Acids; D011719:Pyrazines; D000069286:Bortezomib