Sökning: onr:"swepub:oai:DiVA.org:uu-350496" > Ibrutinib, lenalido...
Fältnamn | Indikatorer | Metadata |
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000 | 06834naa a2200541 4500 | |
001 | oai:DiVA.org:uu-350496 | |
003 | SwePub | |
008 | 180509s2018 | |||||||||||000 ||eng| | |
009 | oai:lup.lub.lu.se:c801db77-dcf8-4689-9cc8-e694011abd10 | |
024 | 7 | a https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-3504962 URI |
024 | 7 | a https://doi.org/10.1016/S2352-3026(18)30018-82 DOI |
024 | 7 | a https://lup.lub.lu.se/record/c801db77-dcf8-4689-9cc8-e694011abd102 URI |
040 | a (SwePub)uud (SwePub)lu | |
041 | a engb eng | |
042 | 9 SwePub | |
072 | 7 | a ref2 swepub-contenttype |
072 | 7 | a art2 swepub-publicationtype |
100 | 1 | a Jerkeman, Matsu Lund University,Lunds universitet,Lymfom - Klinisk forskning,Forskargrupper vid Lunds universitet,Lymphoma - Clinical Research,Lund University Research Groups,Skåne University Hospital4 aut0 (Swepub:lu)onk-mje |
245 | 1 0 | a Ibrutinib, lenalidomide, and rituximab in relapsed or refractory mantle cell lymphoma (PHILEMON) :b a multicentre, open-label, single-arm, phase 2 trial |
264 | 1 | b ELSEVIER SCI LTD,c 2018 |
338 | a print2 rdacarrier | |
520 | a Background Regimens based on ibrutinib alone and lenalidomide and rituximab in combination show high activity in patients with relapsed or refractory mantle cell lymphoma. We hypothesised that the combination of all three drugs would improve efficacy compared with previously published data on either regimen alone. Methods In this multicentre, open-label, single-arm, phase 2 trial, we enrolled patients aged 18 years or older with relapsed or refractory mantle cell lymphoma who had previously been treated with at least one rituximab-containing regimen, an Eastern Cooperative Oncology Group performance status score of 0-3, and at least one site of measurable disease, and who met criteria for several laboratory-assessed parameters. Treatment was divided into an induction phase of 12 cycles of 28 days with all three drugs and a maintenance phase with ibrutinib and rituximab only (cycle duration 56 days), given until disease progression or unacceptable toxicity. In the induction phase, patients received intravenous (375 mg/m(2)) or subcutaneous (1400 mg) rituximab once a week during cycle 1 and then once every 8 weeks. Oral ibrutinib (560 mg once a day) was given to patients every day in the cycle, whereas oral lenalidomide (15 mg once a day) was given on days 1-21. The primary endpoint was overall response assessed in the intention-totreat population according to Lugano criteria. Safety analysis included all patients who received the treatment, irrespective of eligibility or duration of treatment. The trial is ongoing, but is no longer accruing patients, and is registered with ClinicalTrials. gov, number NCT02460276. Findings Between April 30, 2015, and June 1, 2016, we enrolled 50 patients with relapsed or refractory mantle cell lymphoma at ten centres in Sweden, Finland, Norway, and Denmark. At a median follow-up of 17.8 months (IQR 14.7-20.9), 38 (76%, 95% CI 63-86) patients had an overall response, including 28 (56%, 42-69) patients who had a complete response and ten (20%, 11-33) who had a partial response. The most common grade 3-4 adverse events were neutropenia (in 19 [38%] of 50 patients), infections (in 11 [22%] patients), and cutaneous toxicity (in seven [14%] patients). There were three treatment-related deaths during the study, two due to sepsis and one due to embolic stroke. Interpretation Our results provide preliminary evidence that the triplet combination of ibrutinib, lenalidomide, and rituximab is an active regimen in patients with relapsed or refractory mantle cell lymphoma, and should be evaluated in a prospective randomised controlled trial. | |
650 | 7 | a MEDICIN OCH HÄLSOVETENSKAPx Klinisk medicinx Hematologi0 (SwePub)302022 hsv//swe |
650 | 7 | a MEDICAL AND HEALTH SCIENCESx Clinical Medicinex Hematology0 (SwePub)302022 hsv//eng |
650 | 7 | a MEDICIN OCH HÄLSOVETENSKAPx Klinisk medicinx Cancer och onkologi0 (SwePub)302032 hsv//swe |
650 | 7 | a MEDICAL AND HEALTH SCIENCESx Clinical Medicinex Cancer and Oncology0 (SwePub)302032 hsv//eng |
650 | 7 | a MEDICIN OCH HÄLSOVETENSKAPx Klinisk medicinx Kirurgi0 (SwePub)302122 hsv//swe |
650 | 7 | a MEDICAL AND HEALTH SCIENCESx Clinical Medicinex Surgery0 (SwePub)302122 hsv//eng |
700 | 1 | a Eskelund, Christian Wintheru Rigshosp, Dept Haematol, Copenhagen, Denmark.;Univ Copenhagen, Fac Hlth Sci, Biotech Res & Innovat Ctr, Copenhagen, Denmark.,University of Copenhagen4 aut |
700 | 1 | a Hutchings, Martinu Rigshosp, Dept Haematol, Copenhagen, Denmark.;Univ Copenhagen, Fac Hlth Sci, Biotech Res & Innovat Ctr, Copenhagen, Denmark.,University of Copenhagen4 aut |
700 | 1 | a Raty, Riikkau Helsinki Univ Hosp, Dept Haematol, Helsinki, Finland.,Helsinki University Central Hospital4 aut |
700 | 1 | a Wader, Karin Fahlu St Olavs Univ Hosp, Dept Oncol, Trondheim, Norway.,St. Olav’s University Hospital4 aut |
700 | 1 | a Laurell, Annau Uppsala universitet,Experimentell och klinisk onkologi,Uppsala University Hospital4 aut0 (Swepub:lu)onk-ala |
700 | 1 | a Toldbod, Helleu Aarhus Univ Hosp, Clin Trial Off, Dept Haematol, Aarhus, Denmark.,Aarhus University Hospital4 aut |
700 | 1 | a Pedersen, Lone Bredou Rigshosp, Dept Haematol, Copenhagen, Denmark.;Univ Copenhagen, Fac Hlth Sci, Biotech Res & Innovat Ctr, Copenhagen, Denmark.,University of Copenhagen4 aut |
700 | 1 | a Niemann, Carsten Utoftu Rigshosp, Dept Haematol, Copenhagen, Denmark.;Univ Copenhagen, Fac Hlth Sci, Biotech Res & Innovat Ctr, Copenhagen, Denmark.,University of Copenhagen4 aut |
700 | 1 | a Dahl, Christinau Danish Canc Soc, Res Ctr, Copenhagen, Denmark.,Danish Cancer Society4 aut |
700 | 1 | a Kuitunen, Hanneu Oulu Univ Hosp, Dept Oncol, Oulu, Finland.,Oulu University Hospital4 aut |
700 | 1 | a Geisler, Christian H.u Rigshosp, Dept Haematol, Copenhagen, Denmark.;Univ Copenhagen, Fac Hlth Sci, Biotech Res & Innovat Ctr, Copenhagen, Denmark.,University of Copenhagen4 aut |
700 | 1 | a Gronbaek, Kirstenu Rigshosp, Dept Haematol, Copenhagen, Denmark.;Univ Copenhagen, Fac Hlth Sci, Biotech Res & Innovat Ctr, Copenhagen, Denmark.4 aut |
700 | 1 | a Kolstad, Arneu Oslo Univ Hosp, Dept Oncol, Oslo, Norway.,Oslo university hospital4 aut |
700 | 1 | a Grønbæk, Kirstenu University of Copenhagen4 aut |
710 | 2 | a Lymfom - Klinisk forskningb Forskargrupper vid Lunds universitet4 org |
773 | 0 | t Tha Lancet Haematologyd : ELSEVIER SCI LTDg 5:3, s. E109-E116q 5:3<E109-E116x 2352-3026 |
856 | 4 | u http://dx.doi.org/10.1016/S2352-3026(18)30018-8y FULLTEXT |
856 | 4 8 | u https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-350496 |
856 | 4 8 | u https://doi.org/10.1016/S2352-3026(18)30018-8 |
856 | 4 8 | u https://lup.lub.lu.se/record/c801db77-dcf8-4689-9cc8-e694011abd10 |
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