Gefitinib Versus Placebo in Completely Resected Non–Small-Cell Lung Cancer: Results of the NCIC CTG BR19 Study

  • Glenwood D. Goss
    Glenwood D. Goss and Ian Lorimer, Ottawa Hospital Cancer Center, University of Ottawa, Ottawa; Chris O'Callaghan and Keyue Ding, NCIC CTG, Queens University, Kingston; Ming-Sound Tsao and Frances A. Shepherd, University Health Network, Princess Margaret Hospital, University of Toronto, Toronto; Jonathan Noble, Northeast Cancer Center, Sudbury, Ontario; Charles Butts, Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada; Gregory A. Masters, Christiana Care's Helen F. Graham Cancer...
  • Chris O'Callaghan
    Glenwood D. Goss and Ian Lorimer, Ottawa Hospital Cancer Center, University of Ottawa, Ottawa; Chris O'Callaghan and Keyue Ding, NCIC CTG, Queens University, Kingston; Ming-Sound Tsao and Frances A. Shepherd, University Health Network, Princess Margaret Hospital, University of Toronto, Toronto; Jonathan Noble, Northeast Cancer Center, Sudbury, Ontario; Charles Butts, Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada; Gregory A. Masters, Christiana Care's Helen F. Graham Cancer...
  • Ian Lorimer
    Glenwood D. Goss and Ian Lorimer, Ottawa Hospital Cancer Center, University of Ottawa, Ottawa; Chris O'Callaghan and Keyue Ding, NCIC CTG, Queens University, Kingston; Ming-Sound Tsao and Frances A. Shepherd, University Health Network, Princess Margaret Hospital, University of Toronto, Toronto; Jonathan Noble, Northeast Cancer Center, Sudbury, Ontario; Charles Butts, Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada; Gregory A. Masters, Christiana Care's Helen F. Graham Cancer...
  • Ming-Sound Tsao
    Glenwood D. Goss and Ian Lorimer, Ottawa Hospital Cancer Center, University of Ottawa, Ottawa; Chris O'Callaghan and Keyue Ding, NCIC CTG, Queens University, Kingston; Ming-Sound Tsao and Frances A. Shepherd, University Health Network, Princess Margaret Hospital, University of Toronto, Toronto; Jonathan Noble, Northeast Cancer Center, Sudbury, Ontario; Charles Butts, Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada; Gregory A. Masters, Christiana Care's Helen F. Graham Cancer...
  • Gregory A. Masters
    Glenwood D. Goss and Ian Lorimer, Ottawa Hospital Cancer Center, University of Ottawa, Ottawa; Chris O'Callaghan and Keyue Ding, NCIC CTG, Queens University, Kingston; Ming-Sound Tsao and Frances A. Shepherd, University Health Network, Princess Margaret Hospital, University of Toronto, Toronto; Jonathan Noble, Northeast Cancer Center, Sudbury, Ontario; Charles Butts, Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada; Gregory A. Masters, Christiana Care's Helen F. Graham Cancer...
  • James Jett
    Glenwood D. Goss and Ian Lorimer, Ottawa Hospital Cancer Center, University of Ottawa, Ottawa; Chris O'Callaghan and Keyue Ding, NCIC CTG, Queens University, Kingston; Ming-Sound Tsao and Frances A. Shepherd, University Health Network, Princess Margaret Hospital, University of Toronto, Toronto; Jonathan Noble, Northeast Cancer Center, Sudbury, Ontario; Charles Butts, Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada; Gregory A. Masters, Christiana Care's Helen F. Graham Cancer...
  • Martin J. Edelman
    Glenwood D. Goss and Ian Lorimer, Ottawa Hospital Cancer Center, University of Ottawa, Ottawa; Chris O'Callaghan and Keyue Ding, NCIC CTG, Queens University, Kingston; Ming-Sound Tsao and Frances A. Shepherd, University Health Network, Princess Margaret Hospital, University of Toronto, Toronto; Jonathan Noble, Northeast Cancer Center, Sudbury, Ontario; Charles Butts, Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada; Gregory A. Masters, Christiana Care's Helen F. Graham Cancer...
  • Rogerio Lilenbaum
    Glenwood D. Goss and Ian Lorimer, Ottawa Hospital Cancer Center, University of Ottawa, Ottawa; Chris O'Callaghan and Keyue Ding, NCIC CTG, Queens University, Kingston; Ming-Sound Tsao and Frances A. Shepherd, University Health Network, Princess Margaret Hospital, University of Toronto, Toronto; Jonathan Noble, Northeast Cancer Center, Sudbury, Ontario; Charles Butts, Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada; Gregory A. Masters, Christiana Care's Helen F. Graham Cancer...
  • Hak Choy
    Glenwood D. Goss and Ian Lorimer, Ottawa Hospital Cancer Center, University of Ottawa, Ottawa; Chris O'Callaghan and Keyue Ding, NCIC CTG, Queens University, Kingston; Ming-Sound Tsao and Frances A. Shepherd, University Health Network, Princess Margaret Hospital, University of Toronto, Toronto; Jonathan Noble, Northeast Cancer Center, Sudbury, Ontario; Charles Butts, Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada; Gregory A. Masters, Christiana Care's Helen F. Graham Cancer...
  • Fadlo Khuri
    Glenwood D. Goss and Ian Lorimer, Ottawa Hospital Cancer Center, University of Ottawa, Ottawa; Chris O'Callaghan and Keyue Ding, NCIC CTG, Queens University, Kingston; Ming-Sound Tsao and Frances A. Shepherd, University Health Network, Princess Margaret Hospital, University of Toronto, Toronto; Jonathan Noble, Northeast Cancer Center, Sudbury, Ontario; Charles Butts, Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada; Gregory A. Masters, Christiana Care's Helen F. Graham Cancer...
  • Katherine Pisters
    Glenwood D. Goss and Ian Lorimer, Ottawa Hospital Cancer Center, University of Ottawa, Ottawa; Chris O'Callaghan and Keyue Ding, NCIC CTG, Queens University, Kingston; Ming-Sound Tsao and Frances A. Shepherd, University Health Network, Princess Margaret Hospital, University of Toronto, Toronto; Jonathan Noble, Northeast Cancer Center, Sudbury, Ontario; Charles Butts, Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada; Gregory A. Masters, Christiana Care's Helen F. Graham Cancer...
  • David Gandara
    Glenwood D. Goss and Ian Lorimer, Ottawa Hospital Cancer Center, University of Ottawa, Ottawa; Chris O'Callaghan and Keyue Ding, NCIC CTG, Queens University, Kingston; Ming-Sound Tsao and Frances A. Shepherd, University Health Network, Princess Margaret Hospital, University of Toronto, Toronto; Jonathan Noble, Northeast Cancer Center, Sudbury, Ontario; Charles Butts, Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada; Gregory A. Masters, Christiana Care's Helen F. Graham Cancer...
  • Kemp Kernstine
    Glenwood D. Goss and Ian Lorimer, Ottawa Hospital Cancer Center, University of Ottawa, Ottawa; Chris O'Callaghan and Keyue Ding, NCIC CTG, Queens University, Kingston; Ming-Sound Tsao and Frances A. Shepherd, University Health Network, Princess Margaret Hospital, University of Toronto, Toronto; Jonathan Noble, Northeast Cancer Center, Sudbury, Ontario; Charles Butts, Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada; Gregory A. Masters, Christiana Care's Helen F. Graham Cancer...
  • Charles Butts
    Glenwood D. Goss and Ian Lorimer, Ottawa Hospital Cancer Center, University of Ottawa, Ottawa; Chris O'Callaghan and Keyue Ding, NCIC CTG, Queens University, Kingston; Ming-Sound Tsao and Frances A. Shepherd, University Health Network, Princess Margaret Hospital, University of Toronto, Toronto; Jonathan Noble, Northeast Cancer Center, Sudbury, Ontario; Charles Butts, Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada; Gregory A. Masters, Christiana Care's Helen F. Graham Cancer...
  • Jonathan Noble
    Glenwood D. Goss and Ian Lorimer, Ottawa Hospital Cancer Center, University of Ottawa, Ottawa; Chris O'Callaghan and Keyue Ding, NCIC CTG, Queens University, Kingston; Ming-Sound Tsao and Frances A. Shepherd, University Health Network, Princess Margaret Hospital, University of Toronto, Toronto; Jonathan Noble, Northeast Cancer Center, Sudbury, Ontario; Charles Butts, Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada; Gregory A. Masters, Christiana Care's Helen F. Graham Cancer...
  • Thomas A. Hensing
    Glenwood D. Goss and Ian Lorimer, Ottawa Hospital Cancer Center, University of Ottawa, Ottawa; Chris O'Callaghan and Keyue Ding, NCIC CTG, Queens University, Kingston; Ming-Sound Tsao and Frances A. Shepherd, University Health Network, Princess Margaret Hospital, University of Toronto, Toronto; Jonathan Noble, Northeast Cancer Center, Sudbury, Ontario; Charles Butts, Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada; Gregory A. Masters, Christiana Care's Helen F. Graham Cancer...
  • Kendrith Rowland
    Glenwood D. Goss and Ian Lorimer, Ottawa Hospital Cancer Center, University of Ottawa, Ottawa; Chris O'Callaghan and Keyue Ding, NCIC CTG, Queens University, Kingston; Ming-Sound Tsao and Frances A. Shepherd, University Health Network, Princess Margaret Hospital, University of Toronto, Toronto; Jonathan Noble, Northeast Cancer Center, Sudbury, Ontario; Charles Butts, Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada; Gregory A. Masters, Christiana Care's Helen F. Graham Cancer...
  • Joan Schiller
    Glenwood D. Goss and Ian Lorimer, Ottawa Hospital Cancer Center, University of Ottawa, Ottawa; Chris O'Callaghan and Keyue Ding, NCIC CTG, Queens University, Kingston; Ming-Sound Tsao and Frances A. Shepherd, University Health Network, Princess Margaret Hospital, University of Toronto, Toronto; Jonathan Noble, Northeast Cancer Center, Sudbury, Ontario; Charles Butts, Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada; Gregory A. Masters, Christiana Care's Helen F. Graham Cancer...
  • Keyue Ding
    Glenwood D. Goss and Ian Lorimer, Ottawa Hospital Cancer Center, University of Ottawa, Ottawa; Chris O'Callaghan and Keyue Ding, NCIC CTG, Queens University, Kingston; Ming-Sound Tsao and Frances A. Shepherd, University Health Network, Princess Margaret Hospital, University of Toronto, Toronto; Jonathan Noble, Northeast Cancer Center, Sudbury, Ontario; Charles Butts, Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada; Gregory A. Masters, Christiana Care's Helen F. Graham Cancer...
  • Frances A. Shepherd
    Glenwood D. Goss and Ian Lorimer, Ottawa Hospital Cancer Center, University of Ottawa, Ottawa; Chris O'Callaghan and Keyue Ding, NCIC CTG, Queens University, Kingston; Ming-Sound Tsao and Frances A. Shepherd, University Health Network, Princess Margaret Hospital, University of Toronto, Toronto; Jonathan Noble, Northeast Cancer Center, Sudbury, Ontario; Charles Butts, Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada; Gregory A. Masters, Christiana Care's Helen F. Graham Cancer...

説明

<jats:sec><jats:title>Purpose</jats:title><jats:p> Survival of patients with completely resected non–small-cell lung cancer (NSCLC) is unsatisfactory, and in 2002, the benefit of adjuvant chemotherapy was not established. This phase III study assessed the impact of postoperative adjuvant gefitinib on overall survival (OS). </jats:p></jats:sec><jats:sec><jats:title>Patients and Methods</jats:title><jats:p> Patients with completely resected (stage IB, II, or IIIA) NSCLC stratified by stage, histology, sex, postoperative radiotherapy, and chemotherapy were randomly assigned (1:1) to receive gefitinib 250 mg per day or placebo for 2 years. Study end points were OS, disease-free survival (DFS), and toxicity. </jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p> As a result of early closure, 503 of 1,242 planned patients were randomly assigned (251 to gefitinib and 252 to placebo). Baseline factors were balanced between the arms. With a median of 4.7 years of follow-up (range, 0.1 to 6.3 years), there was no difference in OS (hazard ratio [HR], 1.24; 95% CI, 0.94 to 1.64; P = .14) or DFS (HR, 1.22; 95% CI, 0.93 to 1.61; P = .15) between the arms. Exploratory analyses demonstrated no DFS (HR, 1.28; 95% CI, 0.92 to 1.76; P = .14) or OS benefit (HR, 1.24; 95% CI, 0.90 to 1.71; P = .18) from gefitinib for 344 patients with epidermal growth factor receptor (EGFR) wild-type tumors. Similarly, there was no DFS (HR, 1.84; 95% CI, 0.44 to 7.73; P = .395) or OS benefit (HR, 3.16; 95% CI, 0.61 to 16.45; P = .15) from gefitinib for the 15 patients with EGFR mutation-positive tumors. Adverse events were those expected with an EGFR inhibitor. Serious adverse events occurred in ≤ 5% of patients, except infection, fatigue, and pain. One patient in each arm had fatal pneumonitis. </jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p> Although the trial closed prematurely and definitive statements regarding the efficacy of adjuvant gefitinib cannot be made, these results indicate that it is unlikely to be of benefit. </jats:p></jats:sec>

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