Randomized Phase II Study of Erlotinib Plus Tivantinib Versus Erlotinib Plus Placebo in Previously Treated Non–Small-Cell Lung Cancer

DOI Web Site 被引用文献13件
  • Lecia V. Sequist
    Lecia V. Sequist, Massachusetts General Hospital Cancer Center and Harvard Medical School; Daniel B. Costa, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston; Edward G. Garmey, Dora Ferrari, Yinpu Chen, Brian Schwartz, ArQule, Woburn, MA; Joachim von Pawel, Asklepios Fachkliniken, München-Gauting; Wolfram Brugger, Schwarzwald-Baar Clinic, Academic Teaching Hospital, University of Freiburg, Villingen-Schwenningen, Germany; Wallace L. Akerley, Huntsman Cancer Institute, Salt Lake City...
  • Joachim von Pawel
    Lecia V. Sequist, Massachusetts General Hospital Cancer Center and Harvard Medical School; Daniel B. Costa, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston; Edward G. Garmey, Dora Ferrari, Yinpu Chen, Brian Schwartz, ArQule, Woburn, MA; Joachim von Pawel, Asklepios Fachkliniken, München-Gauting; Wolfram Brugger, Schwarzwald-Baar Clinic, Academic Teaching Hospital, University of Freiburg, Villingen-Schwenningen, Germany; Wallace L. Akerley, Huntsman Cancer Institute, Salt Lake City...
  • Edward G. Garmey
    Lecia V. Sequist, Massachusetts General Hospital Cancer Center and Harvard Medical School; Daniel B. Costa, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston; Edward G. Garmey, Dora Ferrari, Yinpu Chen, Brian Schwartz, ArQule, Woburn, MA; Joachim von Pawel, Asklepios Fachkliniken, München-Gauting; Wolfram Brugger, Schwarzwald-Baar Clinic, Academic Teaching Hospital, University of Freiburg, Villingen-Schwenningen, Germany; Wallace L. Akerley, Huntsman Cancer Institute, Salt Lake City...
  • Wallace L. Akerley
    Lecia V. Sequist, Massachusetts General Hospital Cancer Center and Harvard Medical School; Daniel B. Costa, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston; Edward G. Garmey, Dora Ferrari, Yinpu Chen, Brian Schwartz, ArQule, Woburn, MA; Joachim von Pawel, Asklepios Fachkliniken, München-Gauting; Wolfram Brugger, Schwarzwald-Baar Clinic, Academic Teaching Hospital, University of Freiburg, Villingen-Schwenningen, Germany; Wallace L. Akerley, Huntsman Cancer Institute, Salt Lake City...
  • Wolfram Brugger
    Lecia V. Sequist, Massachusetts General Hospital Cancer Center and Harvard Medical School; Daniel B. Costa, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston; Edward G. Garmey, Dora Ferrari, Yinpu Chen, Brian Schwartz, ArQule, Woburn, MA; Joachim von Pawel, Asklepios Fachkliniken, München-Gauting; Wolfram Brugger, Schwarzwald-Baar Clinic, Academic Teaching Hospital, University of Freiburg, Villingen-Schwenningen, Germany; Wallace L. Akerley, Huntsman Cancer Institute, Salt Lake City...
  • Dora Ferrari
    Lecia V. Sequist, Massachusetts General Hospital Cancer Center and Harvard Medical School; Daniel B. Costa, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston; Edward G. Garmey, Dora Ferrari, Yinpu Chen, Brian Schwartz, ArQule, Woburn, MA; Joachim von Pawel, Asklepios Fachkliniken, München-Gauting; Wolfram Brugger, Schwarzwald-Baar Clinic, Academic Teaching Hospital, University of Freiburg, Villingen-Schwenningen, Germany; Wallace L. Akerley, Huntsman Cancer Institute, Salt Lake City...
  • Yinpu Chen
    Lecia V. Sequist, Massachusetts General Hospital Cancer Center and Harvard Medical School; Daniel B. Costa, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston; Edward G. Garmey, Dora Ferrari, Yinpu Chen, Brian Schwartz, ArQule, Woburn, MA; Joachim von Pawel, Asklepios Fachkliniken, München-Gauting; Wolfram Brugger, Schwarzwald-Baar Clinic, Academic Teaching Hospital, University of Freiburg, Villingen-Schwenningen, Germany; Wallace L. Akerley, Huntsman Cancer Institute, Salt Lake City...
  • Daniel B. Costa
    Lecia V. Sequist, Massachusetts General Hospital Cancer Center and Harvard Medical School; Daniel B. Costa, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston; Edward G. Garmey, Dora Ferrari, Yinpu Chen, Brian Schwartz, ArQule, Woburn, MA; Joachim von Pawel, Asklepios Fachkliniken, München-Gauting; Wolfram Brugger, Schwarzwald-Baar Clinic, Academic Teaching Hospital, University of Freiburg, Villingen-Schwenningen, Germany; Wallace L. Akerley, Huntsman Cancer Institute, Salt Lake City...
  • David E. Gerber
    Lecia V. Sequist, Massachusetts General Hospital Cancer Center and Harvard Medical School; Daniel B. Costa, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston; Edward G. Garmey, Dora Ferrari, Yinpu Chen, Brian Schwartz, ArQule, Woburn, MA; Joachim von Pawel, Asklepios Fachkliniken, München-Gauting; Wolfram Brugger, Schwarzwald-Baar Clinic, Academic Teaching Hospital, University of Freiburg, Villingen-Schwenningen, Germany; Wallace L. Akerley, Huntsman Cancer Institute, Salt Lake City...
  • Sergey Orlov
    Lecia V. Sequist, Massachusetts General Hospital Cancer Center and Harvard Medical School; Daniel B. Costa, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston; Edward G. Garmey, Dora Ferrari, Yinpu Chen, Brian Schwartz, ArQule, Woburn, MA; Joachim von Pawel, Asklepios Fachkliniken, München-Gauting; Wolfram Brugger, Schwarzwald-Baar Clinic, Academic Teaching Hospital, University of Freiburg, Villingen-Schwenningen, Germany; Wallace L. Akerley, Huntsman Cancer Institute, Salt Lake City...
  • Rodryg Ramlau
    Lecia V. Sequist, Massachusetts General Hospital Cancer Center and Harvard Medical School; Daniel B. Costa, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston; Edward G. Garmey, Dora Ferrari, Yinpu Chen, Brian Schwartz, ArQule, Woburn, MA; Joachim von Pawel, Asklepios Fachkliniken, München-Gauting; Wolfram Brugger, Schwarzwald-Baar Clinic, Academic Teaching Hospital, University of Freiburg, Villingen-Schwenningen, Germany; Wallace L. Akerley, Huntsman Cancer Institute, Salt Lake City...
  • Susan Arthur
    Lecia V. Sequist, Massachusetts General Hospital Cancer Center and Harvard Medical School; Daniel B. Costa, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston; Edward G. Garmey, Dora Ferrari, Yinpu Chen, Brian Schwartz, ArQule, Woburn, MA; Joachim von Pawel, Asklepios Fachkliniken, München-Gauting; Wolfram Brugger, Schwarzwald-Baar Clinic, Academic Teaching Hospital, University of Freiburg, Villingen-Schwenningen, Germany; Wallace L. Akerley, Huntsman Cancer Institute, Salt Lake City...
  • Igor Gorbachevsky
    Lecia V. Sequist, Massachusetts General Hospital Cancer Center and Harvard Medical School; Daniel B. Costa, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston; Edward G. Garmey, Dora Ferrari, Yinpu Chen, Brian Schwartz, ArQule, Woburn, MA; Joachim von Pawel, Asklepios Fachkliniken, München-Gauting; Wolfram Brugger, Schwarzwald-Baar Clinic, Academic Teaching Hospital, University of Freiburg, Villingen-Schwenningen, Germany; Wallace L. Akerley, Huntsman Cancer Institute, Salt Lake City...
  • Brian Schwartz
    Lecia V. Sequist, Massachusetts General Hospital Cancer Center and Harvard Medical School; Daniel B. Costa, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston; Edward G. Garmey, Dora Ferrari, Yinpu Chen, Brian Schwartz, ArQule, Woburn, MA; Joachim von Pawel, Asklepios Fachkliniken, München-Gauting; Wolfram Brugger, Schwarzwald-Baar Clinic, Academic Teaching Hospital, University of Freiburg, Villingen-Schwenningen, Germany; Wallace L. Akerley, Huntsman Cancer Institute, Salt Lake City...
  • Joan H. Schiller
    Lecia V. Sequist, Massachusetts General Hospital Cancer Center and Harvard Medical School; Daniel B. Costa, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston; Edward G. Garmey, Dora Ferrari, Yinpu Chen, Brian Schwartz, ArQule, Woburn, MA; Joachim von Pawel, Asklepios Fachkliniken, München-Gauting; Wolfram Brugger, Schwarzwald-Baar Clinic, Academic Teaching Hospital, University of Freiburg, Villingen-Schwenningen, Germany; Wallace L. Akerley, Huntsman Cancer Institute, Salt Lake City...

説明

<jats:sec><jats:title>Purpose</jats:title><jats:p> c-MET (MET) receptor activation is associated with poor prognosis and epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) resistance in non–small-cell lung cancer (NSCLC). This global, randomized phase II trial examined erlotinib plus tivantinib (ARQ 197; ArQule, Woburn, MA), a novel MET inhibitor. </jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p> Previously treated patients with EGFR TKI–naive advanced NSCLC were randomly assigned to receive oral erlotinib (150 mg daily) plus oral tivantinib (360 mg twice daily) or erlotinib plus placebo (EP). The primary end point was progression-free survival (PFS). At the time of progression, cross-over from EP to erlotinib plus tivantinib (ET) was permitted. Archival tumor tissue specimens were required. </jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p> One hundred sixty-seven patients were randomly assigned to ET (n = 84) and to EP (n = 83). Median PFS was 3.8 months for ET and 2.3 months for EP (hazard ratio [HR], 0.81; 95% CI, 0.57 to 1.16; P = .24). Exploratory analysis revealed that the small cohort with KRAS mutations achieved a PFS HR of 0.18 (95% CI, 0.05 to 0.70; interaction P = .006). Objective responses were seen in 10% of patients on ET, 7% of patients on EP, and in two patients who crossed over from EP to ET, including one with EGFR mutation and MET gene copy number greater than 5. There were no significant differences in adverse events between study arms. </jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p> The combination of the MET inhibitor tivantinib and erlotinib is well-tolerated. Although the study did not meet its primary end point, evidence of activity was demonstrated, especially among patients with KRAS mutations. Additional study of tivantinib and erlotinib in patients with NSCLC is planned. </jats:p></jats:sec>

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