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Bortezomib in patients with relapsed or refractory mantle cell lymphoma: updated time-to-event analyses of the multicenter phase 2 PINNACLE study |
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| Authors: | Goy A; Bernstein S H; Kahl B S; Djulbegovic B; Robertson M J; 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 |
| Institution: | 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 |
| Abstract: | Background: We previously reported results of the phase 2, multicenterPINNACLE study, which confirmed the substantial single-agentactivity of bortezomib in patients with relapsed or refractorymantle cell lymphoma (MCL). Materials and methods: We report updated time-to-event data,in all patients and by response to treatment, after extendedfollow-up (median 26.4 months). Results: Median time to progression (TTP) was 6.7 months. Mediantime to next therapy (TTNT) was 7.4 months. Median overall survival(OS) was 23.5 months. In responding patients, median TTP was12.4 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 diseasecharacteristics; among these patients, median TTP and DOR werenot reached, and median OS was 36.0 months. One-year survivalrate was 69% overall and 91% in responding patients. MedianOS from diagnosis was 61.1 months, after median follow-up of63.7 months. Activity was seen in patients with refractory diseaseand patients relapsing following high-intensity treatment. Toxicitywas generally manageable. Conclusions: Single-agent bortezomib is associated with lengthyresponses and notable survival in patients with relapsed orrefractory MCL, with considerable TTP and TTNT in respondingpatients, suggesting substantial clinical benefit. Key words: 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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