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Annals of Oncology Advance Access published online on December 12, 2008
Annals of Oncology, doi:10.1093/annonc/mdn656
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© The Author 2008. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oxfordjournals.org

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

A. Goy1,*, S. H. Bernstein2, B. S. Kahl3, B. Djulbegovic4, M. J. Robertson5, S. de Vos6, E. Epner7, A. Krishnan8, J. P. Leonard9, S. Lonial10, S. Nasta11, O. A. O'Connor12, H. Shi13, A. L. Boral13 and R. I. Fisher2

1 The Cancer Center at Hackensack University Medical Center, Hackensack
2 University of Rochester, James P. Wilmot Cancer Center, Rochester
3 University of Wisconsin, Madison
4 H. Lee Moffitt Cancer Center, Tampa
5 Indiana University Medical Center, Indianapolis
6 University of California Los Angeles School of Medicine, Los Angeles
7 Oregon Health and Science University, Portland
8 City of Hope National Medical Center, Duarte
9 Weill Medical College of Cornell University/New York Presbyterian Hospital
10 Winship Cancer Institute, Emory University, Atlanta
11 Abramson Cancer Center, University of Pennsylvania, Philadelphia
12 Herbert Irving Comprehensive Cancer Center, New York Presbyterian Hospital, Columbia University
13 Millennium Pharmaceuticals, Inc., Cambridge, USA

* Correspondence to: Dr A. Goy, The Cancer Center at Hackensack University Medical Center, 20 Prospect Avenue, Hackensack, NJ 07601, USA. Tel: +1-201-996-3060; Fax: +1-201-996-3047; E-mail: agoy{at}humed.com

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.

bortezomib, mantle cell lymphoma, refractory, relapsed, response, survival

Received for publication May 1, 2008. Revision received August 27, 2008. Accepted for publication September 3, 2008.


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