An open-label, multicenter, randomized, phase II study of Cisplatin and Pemetrexed with or without Cixutumumab (IMC-A12) as a first-line therapy in patients with advanced nonsquamous non-small cell lung cancer.

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  • dc.contributor.author Novello, Silviaca
  • dc.contributor.author Scagliotti, Giorgioca
  • dc.contributor.author De Castro, Gilbertoca
  • dc.contributor.author Kiyik, Muratca
  • dc.contributor.author Kowalyszyn, Rubénca
  • dc.contributor.author Deppermann, Karl-Matthiasca
  • dc.contributor.author Arriola Aperribay, Edurneca
  • dc.contributor.author Bosquee, Lionelca
  • dc.contributor.author Novosiadly, Ruslan D.ca
  • dc.contributor.author Nguyen, Tuan S.ca
  • dc.contributor.author Forest, Amelieca
  • dc.contributor.author Tang, Shandeca
  • dc.contributor.author Kambhampati, Siva Rama Prasadca
  • dc.contributor.author Cosaert, Janca
  • dc.contributor.author Reck, Martinca
  • dc.date.accessioned 2017-02-09T12:34:33Z
  • dc.date.available 2017-02-09T12:34:33Z
  • dc.date.issued 2017
  • dc.description.abstract INTRODUCTION: Type 1 insulin-like growth factor receptor is deregulated in solid tumors. Cixutumumab, a monoclonal antibody that inhibits the activity of type 1 insulin-like growth factor receptor, was investigated in combination with pemetrexed/cisplatin in the frontline setting. METHODS: In this open-label, phase II study, patients with stage IV nonsquamous NSCLC and a performance status of 0 to 1 were randomized (1:1) to receive 20 mg/kg cixutumumab, 500 mg/m2 pemetrexed, and 75 mg/m2 cisplatin (cixutumumab [n = 87]) or pemetrexed and cisplatin (control [n = 85]). Eligible patients received pemetrexed-based maintenance therapy with cixutumumab (cixutumumab arm) or without it (control arm). The primary end point was progression-free survival. Secondary end points assessed overall survival, objective response rate, and safety. Survival was analyzed by the Kaplan-Meier method and Cox proportional hazard model. Exploratory correlative analyses were also performed. RESULTS: The mean age of the intent-to-treat population (n = 172) was 59 years (range 32-83). Median progression-free survival was 5.45 months with cixutumumab versus 5.22 months in the control (hazard ratio = 1.15, 95% confidence interval: 0.81-1.61; p = 0.44). Median overall survival was 11.33 months with cixutumumab versus 10.38 months in the control (hazard ratio = 0.93, 95% confidence interval: 0.64-1.36). Objective response rate did not differ between treatments (p = 0.338). Grade 3 or 4 hyperglycemia occurred at a higher rate with cixutumumab than in the control (9.4% versus 1.2%). One death possibly related to cixutumumab occurred. CONCLUSIONS: Efficacy was not improved in patients with nonsquamous NSCLC when cixutumumab was added to pemetrexed/cisplatin. Combination therapy was well tolerated and no new safety concerns were reported.ca
  • dc.description.sponsorship This work was supported by Eli Lilly and Company.
  • dc.format.mimetype application/pdfca
  • dc.identifier.citation Novello S, Scagliotti G, de Castro G Jr, Kiyik M, Kowalyszyn R, Deppermann KM, etal. An open-label, multicenter, randomized, phase II study of Cisplatin and Pemetrexed with or without Cixutumumab (IMC-A12) as a first-line therapy in patients with advanced nonsquamous non-small cell lung cancer. J Thorac Oncol. 2017 Feb;12(2):383-389. doi: 10.1016/j.jtho.2016.07.013ca
  • dc.identifier.doi http://dx.doi.org/10.1016/j.jtho.2016.07.013
  • dc.identifier.issn 1556-0864
  • dc.identifier.uri http://hdl.handle.net/10230/28098
  • dc.language.iso engca
  • dc.publisher Elsevierca
  • dc.relation.ispartof Journal of Thoracic Oncology. 2017 Feb;12(2):383-9
  • dc.rights ª 2016 International Association for the Study of Lung Cancer. Published by Elsevier Inc. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).ca
  • dc.rights.accessRights info:eu-repo/semantics/openAccessca
  • dc.rights.uri https://creativecommons.org/licenses/by-nc-nd/4.0/ca
  • dc.subject.other Pulmons -- Càncer -- Tractamentca
  • dc.title An open-label, multicenter, randomized, phase II study of Cisplatin and Pemetrexed with or without Cixutumumab (IMC-A12) as a first-line therapy in patients with advanced nonsquamous non-small cell lung cancer.ca
  • dc.type info:eu-repo/semantics/articleca
  • dc.type.version info:eu-repo/semantics/publishedVersionca

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