Gemcitabine combined with the monoclonal antibody nimotuzumab is an active first-line regimen in KRAS wildtype patients with locally advanced or metastatic pancreatic cancer: a multicenter, randomized phase IIb study

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dc.contributor.authorSchultheis, B.
dc.contributor.authorReuter, D.
dc.contributor.authorEbert, M. P.
dc.contributor.authorSiveke, J.
dc.contributor.authorKerkhoff, A.
dc.contributor.authorBerdel, W. E.
dc.contributor.authorHofheinz, R.
dc.contributor.authorBehringer, D. M.
dc.contributor.authorSchmidt, W. E.
dc.contributor.authorGoker, E.
dc.contributor.authorDe Dosso, S.
dc.contributor.authorKneba, M.
dc.contributor.authorYalcin, S.
dc.contributor.authorOverkamp, F.
dc.contributor.authorSchlegel, F.
dc.contributor.authorDommach, M.
dc.contributor.authorRohrberg, R.
dc.contributor.authorSteinmetz, T.
dc.contributor.authorBulitta, M.
dc.contributor.authorStrumberg, D.
dc.date.accessioned2019-10-27T11:05:20Z
dc.date.available2019-10-27T11:05:20Z
dc.date.issued2017
dc.departmentEge Üniversitesien_US
dc.description.abstractBackground: This randomized study was designed to investigate the superiority of gemcitabine (gem) plus nimotuzumab (nimo), an anti-epidermal growth factor receptor monoclonal antibody, compared with gem plus placebo as first-line therapy in patients with advanced pancreatic cancer. Patients and methods: Patients with previously untreated, unresectable, locally advanced or metastatic pancreatic cancer were randomly assigned to receive gem: 1000 mg/m(2), 30-min i.v. once weekly (d1, 8, 15; q29) and nimo: fixed dose of 400 mg once weekly as a 30-min infusion, or gem plus placebo, until progression or unacceptable toxicity. The primary end point was overall survival (OS), secondary end points included time to progression, overall response rate, safety and quality of life. Results: A total of 192 patients were randomized, with 186 of them being assessable for efficacy and safety (average age 63.6 years). One-year OS/progression-free survival (PFS) was 34%/22% for gem plus nimo compared with 19%/10% for gem plus placebo (HR = 0.69; P = 0.03/HR = 0.68; P = 0.02). Median OS/PFS was 8.6/5.1 months for gem plus nimo versus 6.0/3.4 mo in the gem plus placebo group (HR = 0.69; P = 0.0341/HR = 0.68; P = 0.0163), with very few grade 3/4 toxicities. KRAS wildtype patients experienced a significantly better OS than those with KRAS mutations (11.6 versus 5.6 months, P = 0.03). Conclusion: This randomized study showed that nimo in combination with gem is safe and well tolerated. The 1-year OS and PFS rates for the entire population were significantly improved. Especially, those patients with KRAS wildtype seem to benefit. The study was registered as protocol ID OSAG101-PCS07, NCT00561990 and EudraCT 2007-000338-38.en_US
dc.description.sponsorshipOncoscience AG, Schenefeld, Germanyen_US
dc.description.sponsorshipThis multi-institutional, randomized phase IIb trial was sponsored by Oncoscience AG, Wedel (recently Schenefeld), Germany. There is no grant number applicable.en_US
dc.identifier.doi10.1093/annonc/mdx343en_US
dc.identifier.endpage2435en_US
dc.identifier.issn0923-7534
dc.identifier.issn1569-8041
dc.identifier.issue10en_US
dc.identifier.pmid28961832en_US
dc.identifier.scopusqualityQ1en_US
dc.identifier.startpage2429en_US
dc.identifier.urihttps://doi.org/10.1093/annonc/mdx343
dc.identifier.urihttps://hdl.handle.net/11454/31659
dc.identifier.volume28en_US
dc.identifier.wosWOS:000411827200016en_US
dc.identifier.wosqualityQ1en_US
dc.indekslendigikaynakWeb of Scienceen_US
dc.indekslendigikaynakScopusen_US
dc.indekslendigikaynakPubMeden_US
dc.language.isoenen_US
dc.publisherOxford Univ Pressen_US
dc.relation.ispartofAnnals of Oncologyen_US
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/openAccessen_US
dc.subjectgemcitabineen_US
dc.subjectnimotuzumaben_US
dc.subjectKRAS wildtypeen_US
dc.subjectpancreatic canceren_US
dc.subjectEGFR inhibitoren_US
dc.titleGemcitabine combined with the monoclonal antibody nimotuzumab is an active first-line regimen in KRAS wildtype patients with locally advanced or metastatic pancreatic cancer: a multicenter, randomized phase IIb studyen_US
dc.typeArticleen_US

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