Phase II Clinical Trial of Chemotherapy-Naïve Patients ≥ 70 Years of Age Treated With Erlotinib for Advanced Non–Small-Cell Lung Cancer

DOI Web Site 被引用文献6件
  • David M. Jackman
    From the Dana-Farber Cancer Institute; Brigham and Women’s Hospital; Massachusetts General Hospital; and Harvard Medical School, Boston, MA
  • Beow Y. Yeap
    From the Dana-Farber Cancer Institute; Brigham and Women’s Hospital; Massachusetts General Hospital; and Harvard Medical School, Boston, MA
  • Neal I. Lindeman
    From the Dana-Farber Cancer Institute; Brigham and Women’s Hospital; Massachusetts General Hospital; and Harvard Medical School, Boston, MA
  • Panos Fidias
    From the Dana-Farber Cancer Institute; Brigham and Women’s Hospital; Massachusetts General Hospital; and Harvard Medical School, Boston, MA
  • Michael S. Rabin
    From the Dana-Farber Cancer Institute; Brigham and Women’s Hospital; Massachusetts General Hospital; and Harvard Medical School, Boston, MA
  • Jennifer Temel
    From the Dana-Farber Cancer Institute; Brigham and Women’s Hospital; Massachusetts General Hospital; and Harvard Medical School, Boston, MA
  • Arthur T. Skarin
    From the Dana-Farber Cancer Institute; Brigham and Women’s Hospital; Massachusetts General Hospital; and Harvard Medical School, Boston, MA
  • Matthew Meyerson
    From the Dana-Farber Cancer Institute; Brigham and Women’s Hospital; Massachusetts General Hospital; and Harvard Medical School, Boston, MA
  • Alison J. Holmes
    From the Dana-Farber Cancer Institute; Brigham and Women’s Hospital; Massachusetts General Hospital; and Harvard Medical School, Boston, MA
  • Ana M. Borras
    From the Dana-Farber Cancer Institute; Brigham and Women’s Hospital; Massachusetts General Hospital; and Harvard Medical School, Boston, MA
  • Boris Freidlin
    From the Dana-Farber Cancer Institute; Brigham and Women’s Hospital; Massachusetts General Hospital; and Harvard Medical School, Boston, MA
  • Patricia A. Ostler
    From the Dana-Farber Cancer Institute; Brigham and Women’s Hospital; Massachusetts General Hospital; and Harvard Medical School, Boston, MA
  • Joan Lucca
    From the Dana-Farber Cancer Institute; Brigham and Women’s Hospital; Massachusetts General Hospital; and Harvard Medical School, Boston, MA
  • Thomas J. Lynch
    From the Dana-Farber Cancer Institute; Brigham and Women’s Hospital; Massachusetts General Hospital; and Harvard Medical School, Boston, MA
  • Bruce E. Johnson
    From the Dana-Farber Cancer Institute; Brigham and Women’s Hospital; Massachusetts General Hospital; and Harvard Medical School, Boston, MA
  • Pasi A. Jänne
    From the Dana-Farber Cancer Institute; Brigham and Women’s Hospital; Massachusetts General Hospital; and Harvard Medical School, Boston, MA

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<jats:sec><jats:title>Purpose</jats:title><jats:p> This is a phase II, multicenter, open-label study of chemotherapy-naïve patients with non–small-cell lung cancer (NSCLC) and age ≥ 70 years who were treated with erlotinib and evaluated to determine the median, 1-year, and 2-year survival. The secondary end points include radiographic response rate, time to progression (TTP), toxicity, and symptom improvement. </jats:p></jats:sec><jats:sec><jats:title>Patients and Methods</jats:title><jats:p> Eligible patients with NSCLC were treated with erlotinib 150 mg/d until disease progression or significant toxicity. Tumor response was assessed every 8 weeks by computed tomography scan using Response Evaluation Criteria in Solid Tumors. Tumor samples were analyzed for the presence of somatic mutations in EGFR and KRAS. </jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p> Eighty eligible patients initiated erlotinib therapy between March 2003 and May 2005. There were eight partial responses (10%), and an additional 33 patients (41%) had stable disease for 2 months or longer. The median TTP was 3.5 months (95% CI, 2.0 to 5.5 months). The median survival time was 10.9 months (95% CI, 7.8 to 14.6 months). The 1- and 2- year survival rates were 46% and 19%, respectively. The most common toxicities were acneiform rash (79%) and diarrhea (69%). Four patients developed interstitial lung disease of grade 3 or higher, with one treatment-related death. EGFR mutations were detected in nine of 43 patients studied. The presence of an EGFR mutation was strongly correlated with disease control, prolonged TTP, and survival. </jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p> Erlotinib monotherapy is active and relatively well tolerated in chemotherapy-naïve elderly patients with advanced NSCLC. Erlotinib merits consideration for further investigation as a first-line therapeutic option in elderly patients. </jats:p></jats:sec>

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