Gefitinib versus placebo in completely resected non-small-cell lung cancer: results of the NCIC CTG BR19 study

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). Patients with completely r...

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Vydáno v:Journal of clinical oncology Ročník 31; číslo 27; s. 3320
Hlavní autoři: Goss, Glenwood D, O'Callaghan, Chris, Lorimer, Ian, Tsao, Ming-Sound, Masters, Gregory A, Jett, James, Edelman, Martin J, Lilenbaum, Rogerio, Choy, Hak, Khuri, Fadlo, Pisters, Katherine, Gandara, David, Kernstine, Kemp, Butts, Charles, Noble, Jonathan, Hensing, Thomas A, Rowland, Kendrith, Schiller, Joan, Ding, Keyue, Shepherd, Frances A
Médium: Journal Article
Jazyk:angličtina
Vydáno: United States 20.09.2013
Témata:
Aged
Antineoplastic Agents - adverse effects
Antineoplastic Agents - therapeutic use
Carcinoma, Non-Small-Cell Lung - drug therapy
Carcinoma, Non-Small-Cell Lung - pathology
Carcinoma, Non-Small-Cell Lung - surgery
Chemotherapy, Adjuvant
Disease-Free Survival
Double-Blind Method
Female
Humans
Lung Neoplasms - drug therapy
Lung Neoplasms - pathology
Lung Neoplasms - surgery
Male
Neoplasm Staging
Placebos
Prospective Studies
Quinazolines - adverse effects
Quinazolines - therapeutic use
Survival Rate
Treatment Outcome
ISSN:1527-7755, 1527-7755
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Shrnutí: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). 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. 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. 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.
Bibliografie:ObjectType-Article-1
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ISSN:1527-7755
1527-7755
DOI:10.1200/JCO.2013.51.1816