dc.contributor.author | Dreyling, M | |
dc.contributor.author | Morschhauser, F | |
dc.contributor.author | Bouabdallah, K | |
dc.contributor.author | Bron, D | |
dc.contributor.author | Cunningham, D | |
dc.contributor.author | Assouline, SE | |
dc.contributor.author | Verhoef, G | |
dc.contributor.author | Linton, K | |
dc.contributor.author | Thieblemont, C | |
dc.contributor.author | Vitolo, U | |
dc.contributor.author | Hiemeyer, F | |
dc.contributor.author | Giurescu, M | |
dc.contributor.author | Garcia-Vargas, J | |
dc.contributor.author | Gorbatchevsky, I | |
dc.contributor.author | Liu, L | |
dc.contributor.author | Koechert, K | |
dc.contributor.author | Peña, C | |
dc.contributor.author | Neves, M | |
dc.contributor.author | Childs, BH | |
dc.contributor.author | Zinzani, PL | |
dc.date.accessioned | 2017-07-13T13:28:42Z | |
dc.date.issued | 2017-09 | |
dc.identifier.citation | Annals of oncology : official journal of the European Society for Medical Oncology, 2017, 28 (9), pp. 2169 - 2178 | |
dc.identifier.issn | 0923-7534 | |
dc.identifier.uri | https://repository.icr.ac.uk/handle/internal/695 | |
dc.identifier.eissn | 1569-8041 | |
dc.identifier.doi | 10.1093/annonc/mdx289 | |
dc.description.abstract | Background Copanlisib is a pan-class I phosphatidylinositol 3-kinase inhibitor with predominant activity against the α- and δ-isoforms.Patients and methods This phase II study evaluated the response rate of copanlisib administered intravenously on days 1, 8, and 15 of a 28-day cycle, in patients with indolent or aggressive malignant lymphoma. Archival tumor tissues were used for immunohistochemistry, gene-expression profiling, and mutation analysis.Results Thirty-three patients with indolent lymphoma and 51 with aggressive lymphoma received copanlisib. Follicular lymphoma (48.5%) and peripheral T-cell lymphoma (33.3%) were the most common histologic subtypes. Most patients (78.6%) had received prior rituximab and 54.8% were rituximab-refractory. Median duration of treatment was 23 and 8 weeks in the indolent and aggressive cohorts, respectively (overall range 2-138). Eighty patients were evaluated for efficacy. The objective response rate was 43.7% (14/32) in the indolent cohort and 27.1% (13/48) in the aggressive cohort; median progression-free survival was 294 days (range 0-874) and 70 days (range 0-897), respectively; median duration of response was 390 days (range 0-825) and 166 days (range 0-786), respectively. Common adverse events included hyperglycemia (57.1%; grade ≥3, 23.8%), hypertension (54.8%; grade ≥3, 40.5%), and diarrhea (40.5%; grade ≥3, 4.8%), all generally manageable. Neutropenia occurred in 28.6% of patients (grade 4, 11.9%). Molecular analyses showed enhanced antitumor activity in tumors with upregulated phosphatidylinositol 3-kinase pathway gene expression.Conclusion Intravenous copanlisib demonstrated promising efficacy and manageable toxicity in heavily pretreated patients with various subtypes of indolent and aggressive malignant lymphoma. Subtype-specific studies of copanlisib in patients with follicular, peripheral T-cell, and mantle cell lymphomas are ongoing. This trial is registered with ClinicalTrials.gov number NCT01660451 (Part A). | |
dc.format | Print | |
dc.format.extent | 2169 - 2178 | |
dc.language | eng | |
dc.language.iso | eng | |
dc.rights.uri | https://creativecommons.org/licenses/by/4.0 | |
dc.subject | Humans | |
dc.subject | Lymphoma | |
dc.subject | Recurrence | |
dc.subject | Pyrimidines | |
dc.subject | Quinazolines | |
dc.subject | Antineoplastic Agents | |
dc.subject | Survival Analysis | |
dc.subject | Aged | |
dc.subject | Aged, 80 and over | |
dc.subject | Middle Aged | |
dc.subject | Female | |
dc.subject | Male | |
dc.subject | PTEN Phosphohydrolase | |
dc.subject | Biomarkers, Tumor | |
dc.subject | Phosphoinositide-3 Kinase Inhibitors | |
dc.title | Phase II study of copanlisib, a PI3K inhibitor, in relapsed or refractory, indolent or aggressive lymphoma. | |
dc.type | Journal Article | |
rioxxterms.versionofrecord | 10.1093/annonc/mdx289 | |
rioxxterms.licenseref.uri | https://creativecommons.org/licenses/by-nc/4.0 | |
rioxxterms.licenseref.startdate | 2017-09 | |
rioxxterms.type | Journal Article/Review | |
dc.relation.isPartOf | Annals of oncology : official journal of the European Society for Medical Oncology | |
pubs.issue | 9 | |
pubs.notes | Not known | |
pubs.organisational-group | /ICR | |
pubs.organisational-group | /ICR/Primary Group | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Clinical Studies | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Clinical Studies/Medicine (RMH Smith Cunningham) | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Clinical Studies/Medicine (RMH Smith Cunningham)/Medicine (RMH Smith Cunningham) (hon.) | |
pubs.organisational-group | /ICR/Primary Group/Royal Marsden Clinical Units | |
pubs.organisational-group | /ICR | |
pubs.organisational-group | /ICR/Primary Group | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Clinical Studies | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Clinical Studies/Medicine (RMH Smith Cunningham) | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Clinical Studies/Medicine (RMH Smith Cunningham)/Medicine (RMH Smith Cunningham) (hon.) | |
pubs.organisational-group | /ICR/Primary Group/Royal Marsden Clinical Units | |
pubs.publication-status | Published | |
pubs.volume | 28 | |
pubs.embargo.terms | Not known | |
icr.researchteam | Medicine (RMH Smith Cunningham) | en_US |
dc.contributor.icrauthor | Cunningham, David | |
dc.contributor.icrauthor | Marsden, | |