Bortezomib in patients with relapsed or refractory mantle cell lymphoma: Updated time-to-event analyses of the multicenter phase 2 PINNACLE study

A. Goy, S. H. Bernstein, B. S. Kahl, B. Djulbegovic, Michael Robertson, S. de Vos, E. Epner, A. Krishnan, J. P. Leonard, S. Lonial, S. Nasta, O. A. O'Connor, H. Shi, A. L. Boral, R. I. Fisher

Research output: Contribution to journalArticle

243 Citations (Scopus)

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). Materials and 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.

Original languageEnglish
Pages (from-to)520-525
Number of pages6
JournalAnnals of Oncology
Volume20
Issue number3
DOIs
StatePublished - 2009

Fingerprint

Mantle-Cell Lymphoma
Survival
Bortezomib
Therapeutics
Multicenter Studies
Survival Rate

Keywords

  • Bortezomib
  • Mantle cell lymphoma
  • Refractory
  • Relapsed
  • Response
  • Survival

ASJC Scopus subject areas

  • Oncology
  • Hematology

Cite this

Bortezomib in patients with relapsed or refractory mantle cell lymphoma : Updated time-to-event analyses of the multicenter phase 2 PINNACLE study. / Goy, A.; Bernstein, S. H.; Kahl, B. S.; Djulbegovic, B.; Robertson, Michael; de Vos, S.; Epner, E.; Krishnan, A.; Leonard, J. P.; Lonial, S.; Nasta, S.; O'Connor, O. A.; Shi, H.; Boral, A. L.; Fisher, R. I.

In: Annals of Oncology, Vol. 20, No. 3, 2009, p. 520-525.

Research output: Contribution to journalArticle

Goy, A, Bernstein, SH, Kahl, BS, Djulbegovic, B, Robertson, M, de Vos, S, Epner, E, Krishnan, A, Leonard, JP, Lonial, S, Nasta, S, O'Connor, OA, Shi, H, Boral, AL & Fisher, RI 2009, 'Bortezomib in patients with relapsed or refractory mantle cell lymphoma: Updated time-to-event analyses of the multicenter phase 2 PINNACLE study', Annals of Oncology, vol. 20, no. 3, pp. 520-525. https://doi.org/10.1093/annonc/mdn656
Goy, A. ; Bernstein, S. H. ; Kahl, B. S. ; Djulbegovic, B. ; Robertson, Michael ; de Vos, S. ; Epner, E. ; Krishnan, A. ; Leonard, J. P. ; Lonial, S. ; Nasta, S. ; O'Connor, O. A. ; Shi, H. ; Boral, A. L. ; Fisher, R. I. / Bortezomib in patients with relapsed or refractory mantle cell lymphoma : Updated time-to-event analyses of the multicenter phase 2 PINNACLE study. In: Annals of Oncology. 2009 ; Vol. 20, No. 3. pp. 520-525.
@article{054454368a2143a7b5e09448fd9e580e,
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). Materials and 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.",
keywords = "Bortezomib, Mantle cell lymphoma, Refractory, Relapsed, Response, Survival",
author = "A. Goy and Bernstein, {S. H.} and Kahl, {B. S.} and B. Djulbegovic and Michael Robertson and {de Vos}, S. and E. Epner and A. Krishnan and Leonard, {J. P.} and S. Lonial and S. Nasta and O'Connor, {O. A.} and H. Shi and Boral, {A. L.} and Fisher, {R. I.}",
year = "2009",
doi = "10.1093/annonc/mdn656",
language = "English",
volume = "20",
pages = "520--525",
journal = "Annals of Oncology",
issn = "0923-7534",
publisher = "Oxford University Press",
number = "3",

}

TY - JOUR

T1 - Bortezomib in patients with relapsed or refractory mantle cell lymphoma

T2 - Updated time-to-event analyses of the multicenter phase 2 PINNACLE study

AU - Goy, A.

AU - Bernstein, S. H.

AU - Kahl, B. S.

AU - Djulbegovic, B.

AU - Robertson, Michael

AU - de Vos, S.

AU - Epner, E.

AU - Krishnan, A.

AU - Leonard, J. P.

AU - Lonial, S.

AU - Nasta, S.

AU - O'Connor, O. A.

AU - Shi, H.

AU - Boral, A. L.

AU - Fisher, R. I.

PY - 2009

Y1 - 2009

N2 - 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). Materials and 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.

AB - 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). Materials and 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.

KW - Bortezomib

KW - Mantle cell lymphoma

KW - Refractory

KW - Relapsed

KW - Response

KW - Survival

UR - http://www.scopus.com/inward/record.url?scp=61649094981&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=61649094981&partnerID=8YFLogxK

U2 - 10.1093/annonc/mdn656

DO - 10.1093/annonc/mdn656

M3 - Article

C2 - 19074748

AN - SCOPUS:61649094981

VL - 20

SP - 520

EP - 525

JO - Annals of Oncology

JF - Annals of Oncology

SN - 0923-7534

IS - 3

ER -