دورية أكاديمية
Necitumumab plus pemetrexed and cisplatin as first-line therapy in patients with stage IV non-squamous non-small-cell lung cancer (INSPIRE): an open-label, randomised, controlled phase 3 study.
| العنوان: | Necitumumab plus pemetrexed and cisplatin as first-line therapy in patients with stage IV non-squamous non-small-cell lung cancer (INSPIRE): an open-label, randomised, controlled phase 3 study. |
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| المؤلفون: | Paz-Ares, Luis, Mezger, Jorg, Ciuleanu, Tudor E., Fischer, Jurgen R., von Pawel, Joachim, Provencio, Mariano, Kazarnowicz, Andrzej, Losonczy, Gyorgy, de Castro, Gilberto Jr, Szczesna, Aleksandra, Crino, Lucio, Reck, Martin, Ramlau, Rodryg, Ulsperger, Ernst, Schumann, Christian, Miziara, Jose Elias A., Lessa, Alvaro E., Dediu, Mircea, Balint, Beatrix, Depenbrock, Henrik, Soldatenkova, Victoria, Kurek, Raffael, Hirsch, Fred R., Thatcher, Nick, Socinski, Mark A. |
| المساهمون: | LOUIS, Renaud |
| المصدر: | The Lancet Oncology, 16 (3), 328-37 (2015-03) |
| بيانات النشر: | The Lancet Publishing Group |
| سنة النشر: | 2015 |
| المجموعة: | University of Liège: ORBi (Open Repository and Bibliography) |
| مصطلحات موضوعية: | Human health sciences, Cardiovascular & respiratory systems, Sciences de la santé humaine, Systèmes cardiovasculaire & respiratoire |
| الوصف: | peer reviewed ; BACKGROUND: Necitumumab is a second-generation recombinant human immunoglobulin G1 EGFR monoclonal antibody that competitively inhibits ligand binding. We aimed to compare necitumumab plus pemetrexed and cisplatin with pemetrexed and cisplatin alone in patients with previously untreated, stage IV, non-squamous non-small-cell lung cancer (NSCLC). METHODS: We did this randomised, open-label, controlled phase 3 study at 103 sites in 20 countries. Patients aged 18 years or older, with an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 and adequate organ function, were randomly assigned 1:1 to treatment with a block randomisation scheme (block size of four) via a telephone-based interactive voice-response system or interactive web-response system. Patients received either cisplatin 75 mg/m(2) and pemetrexed 500 mg/m(2) on day 1 of a 3-week cycle for a maximum of six cycles alone, or with necitumumab 800 mg on days 1 and 8. Necitumumab was continued after the end of chemotherapy until disease progression or unacceptable toxic effects. Randomisation was stratified by smoking history, ECOG performance status, disease histology, and geographical region. Patients and study investigators were not masked to group assignment. The primary endpoint was overall survival. Efficacy analyses were by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00982111. FINDINGS: Between Nov 11, 2009, and Feb 2, 2011, we randomly assigned 633 patients to receive either necitumumab plus pemetrexed and cisplatin (n=315) or pemetrexed and cisplatin alone (n=318). Enrolment was stopped on Feb 2, 2011, after a recommendation from the independent data monitoring committee. There was no significant difference in overall survival between treatment groups, with a median overall survival of 11.3 months (95% CI 9.5-13.4) in the necitumumab plus pemetrexed and cisplatin group versus 11.5 months (10.1-13.1) in the pemetrexed and cisplatin group (hazard ratio 1.01 [95% CI 0.84-1.21]; ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| تدمد: | 1470-2045 1474-5488 |
| العلاقة: | urn:issn:1470-2045; urn:issn:1474-5488; https://orbi.uliege.be/handle/2268/184977Test; info:hdl:2268/184977; https://orbi.uliege.be/bitstream/2268/184977/1/PAZ-ARES_Necitumumab%20plus%20pemetrexed_OCR.pdfTest; scopus-id:2-s2.0-84924971683; info:pmid:25701171 |
| DOI: | 10.1016/S1470-2045(15)70046-X |
| الإتاحة: | https://doi.org/10.1016/S1470-2045Test(15)70046-X https://orbi.uliege.be/handle/2268/184977Test https://orbi.uliege.be/bitstream/2268/184977/1/PAZ-ARES_Necitumumab%20plus%20pemetrexed_OCR.pdfTest |
| حقوق: | open access ; http://purl.org/coar/access_right/c_abf2Test ; info:eu-repo/semantics/openAccess |
| رقم الانضمام: | edsbas.A37E15F |
| قاعدة البيانات: | BASE |
| تدمد: | 14702045 14745488 |
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| DOI: | 10.1016/S1470-2045(15)70046-X |