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dc.contributor.authorFennell, Dean A.
dc.contributor.authorMcDowell, Cliona
dc.contributor.authorBusacca, Sara
dc.contributor.authorWebb, Glen
dc.contributor.authorMoulton, Brian
dc.contributor.authorCakana, Andrew
dc.contributor.authorO’Byrne, Kenneth J.
dc.contributor.authorMeerbeeck, Jan V.
dc.contributor.authorDonnellan, Paul
dc.contributor.authorMcCaffrey, John
dc.contributor.authorBaas, Paul
dc.identifier.citationFennell, Dean A. McDowell, Cliona; Busacca, Sara; Webb, Glen; Moulton, Brian; Cakana, Andrew; O’Byrne, Kenneth J.; Meerbeeck, Jan V.; Donnellan, Paul; McCaffrey, John; Baas, Paul (2012). Phase ii clinical trial of first or second-line treatment with bortezomib in patients with malignant pleural mesothelioma. Journal of Thoracic Oncology 7 (9), 1466-1470
dc.description.abstractBased on promising preclinical efficacy of bortezomib in mesothelioma, a single-arm phase II trial (Ireland Cooperative Oncology Research Group 05-10 study), with Simon's two-stage design, was undertaken to assess efficacy of bortezomib monotherapy in the first-line (poor performance status) and second-line settings. The Bcl-2 homology domain 3-only protein Noxa has been implicated as a key inducer of apoptosis by bortezomib. Thus, in a biomarker research substudy, we hypothesized that deficiency in Noxa expression might correlate with resistance. In the second-line setting, 23 patients were enrolled. Partial response was confirmed in one patient (4.8%) who received four cycles of bortezomib. One patient had stable disease; however, progression occurred in the majority of patients within the first two cycles. Median progression-free survival and overall survival were 2.1 and 5.8 months, respectively. In the first-line setting, ten patients were accrued, and there was no evidence of objective response. In the tumor analysis, expression of Noxa was seen in all biopsies. Bortezomib monotherapy exhibits insufficient activity to warrant further investigation in unselected patients with mesothelioma.
dc.publisherElsevier BV
dc.relation.ispartofJournal of Thoracic Oncology
dc.rightsAttribution-NonCommercial-NoDerivs 3.0 Ireland
dc.subjectproteasome inhibitor bortezomib
dc.titlePhase ii clinical trial of first or second-line treatment with bortezomib in patients with malignant pleural mesothelioma

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