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Sökning: id:"swepub:oai:DiVA.org:uu-350496" > Ibrutinib, lenalido...

LIBRIS Formathandbok  (Information om MARC21)
FältnamnIndikatorerMetadata
00006834naa a2200541 4500
001oai:DiVA.org:uu-350496
003SwePub
008180509s2018 | |||||||||||000 ||eng|
009oai:lup.lub.lu.se:c801db77-dcf8-4689-9cc8-e694011abd10
024a https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-3504962 URI
024a https://doi.org/10.1016/S2352-3026(18)30018-82 DOI
024a 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 7a ref2 swepub-contenttype
072 7a art2 swepub-publicationtype
100a 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
2451 0a Ibrutinib, lenalidomide, and rituximab in relapsed or refractory mantle cell lymphoma (PHILEMON) :b a multicentre, open-label, single-arm, phase 2 trial
264 1b 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 7a MEDICIN OCH HÄLSOVETENSKAPx Klinisk medicinx Hematologi0 (SwePub)302022 hsv//swe
650 7a MEDICAL AND HEALTH SCIENCESx Clinical Medicinex Hematology0 (SwePub)302022 hsv//eng
650 7a MEDICIN OCH HÄLSOVETENSKAPx Klinisk medicinx Cancer och onkologi0 (SwePub)302032 hsv//swe
650 7a MEDICAL AND HEALTH SCIENCESx Clinical Medicinex Cancer and Oncology0 (SwePub)302032 hsv//eng
650 7a MEDICIN OCH HÄLSOVETENSKAPx Klinisk medicinx Kirurgi0 (SwePub)302122 hsv//swe
650 7a MEDICAL AND HEALTH SCIENCESx Clinical Medicinex Surgery0 (SwePub)302122 hsv//eng
700a Eskelund, Christian Wintheru Rigshosp, Dept Haematol, Copenhagen, Denmark.;Univ Copenhagen, Fac Hlth Sci, Biotech Res & Innovat Ctr, Copenhagen, Denmark.,University of Copenhagen4 aut
700a Hutchings, Martinu Rigshosp, Dept Haematol, Copenhagen, Denmark.;Univ Copenhagen, Fac Hlth Sci, Biotech Res & Innovat Ctr, Copenhagen, Denmark.,University of Copenhagen4 aut
700a Raty, Riikkau Helsinki Univ Hosp, Dept Haematol, Helsinki, Finland.,Helsinki University Central Hospital4 aut
700a Wader, Karin Fahlu St Olavs Univ Hosp, Dept Oncol, Trondheim, Norway.,St. Olav’s University Hospital4 aut
700a Laurell, Annau Uppsala universitet,Experimentell och klinisk onkologi,Uppsala University Hospital4 aut0 (Swepub:lu)onk-ala
700a Toldbod, Helleu Aarhus Univ Hosp, Clin Trial Off, Dept Haematol, Aarhus, Denmark.,Aarhus University Hospital4 aut
700a Pedersen, Lone Bredou Rigshosp, Dept Haematol, Copenhagen, Denmark.;Univ Copenhagen, Fac Hlth Sci, Biotech Res & Innovat Ctr, Copenhagen, Denmark.,University of Copenhagen4 aut
700a Niemann, Carsten Utoftu Rigshosp, Dept Haematol, Copenhagen, Denmark.;Univ Copenhagen, Fac Hlth Sci, Biotech Res & Innovat Ctr, Copenhagen, Denmark.,University of Copenhagen4 aut
700a Dahl, Christinau Danish Canc Soc, Res Ctr, Copenhagen, Denmark.,Danish Cancer Society4 aut
700a Kuitunen, Hanneu Oulu Univ Hosp, Dept Oncol, Oulu, Finland.,Oulu University Hospital4 aut
700a Geisler, Christian H.u Rigshosp, Dept Haematol, Copenhagen, Denmark.;Univ Copenhagen, Fac Hlth Sci, Biotech Res & Innovat Ctr, Copenhagen, Denmark.,University of Copenhagen4 aut
700a Gronbaek, Kirstenu Rigshosp, Dept Haematol, Copenhagen, Denmark.;Univ Copenhagen, Fac Hlth Sci, Biotech Res & Innovat Ctr, Copenhagen, Denmark.4 aut
700a Kolstad, Arneu Oslo Univ Hosp, Dept Oncol, Oslo, Norway.,Oslo university hospital4 aut
700a Grønbæk, Kirstenu University of Copenhagen4 aut
710a Lymfom - Klinisk forskningb Forskargrupper vid Lunds universitet4 org
773t Tha Lancet Haematologyd : ELSEVIER SCI LTDg 5:3, s. E109-E116q 5:3<E109-E116x 2352-3026
856u http://dx.doi.org/10.1016/S2352-3026(18)30018-8y FULLTEXT
8564 8u https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-350496
8564 8u https://doi.org/10.1016/S2352-3026(18)30018-8
8564 8u https://lup.lub.lu.se/record/c801db77-dcf8-4689-9cc8-e694011abd10

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