Bortezomib in patients with relapsed or refractory mantle cell lymphoma: updated time-to-event analyses of the multicenter phase 2 PINNACLE study
Top Cited Papers
- 12 December 2008
- journal article
- research article
- Published by Elsevier BV in Annals Of Oncology
- Vol. 20 (3), 520-525
- https://doi.org/10.1093/annonc/mdn656
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
Funding Information
- Millennium Pharmaceuticals, Inc.;
- Johnson & Johnson Pharmaceutical Research & Development L.L.C
This publication has 31 references indexed in Scilit:
- Bortezomib plus Melphalan and Prednisone for Initial Treatment of Multiple MyelomaNew England Journal of Medicine, 2008
- A new prognostic index (MIPI) for patients with advanced-stage mantle cell lymphomaBlood, 2008
- Preparing Ourselves, Our Trainees, and Our Patients: A Commentary on TruthtellingJournal of Clinical Oncology, 2007
- A phase II study of bortezomib in mantle cell lymphoma: the National Cancer Institute of Canada Clinical Trials Group trial IND.150Annals Of Oncology, 2006
- Frequency, Characteristics, and Reversibility of Peripheral Neuropathy During Treatment of Advanced Multiple Myeloma With BortezomibJournal of Clinical Oncology, 2006
- Bortezomib Therapy in Patients With Relapsed or Refractory Lymphoma: Potential Correlation of In Vitro Sensitivity and Tumor Necrosis Factor Alpha Response With Clinical ActivityJournal of Clinical Oncology, 2006
- Update on the molecular biology of mantle cell lymphomaHematological Oncology, 2006
- ESMO Minimum Clinical Recommendations for diagnosis, treatment and follow-up of cutaneous malignant melanomaAnnals Of Oncology, 2005
- Early consolidation by myeloablative radiochemotherapy followed by autologous stem cell transplantation in first remission significantly prolongs progression-free survival in mantle-cell lymphoma: results of a prospective randomized trial of the European MCL NetworkPublished by American Society of Hematology ,2005
- Sequential chemotherapy by CHOP and DHAP regimens followed by high-dose therapy with stem cell transplantation induces a high rate of complete response and improves event-free survival in mantle cell lymphoma: a prospective studyLeukemia, 2002