Abstract | PURPOSE: PATIENTS AND METHODS: RESULTS: PFS was similar (5.0 v 6.6 months; P = .1988) in patients randomly assigned to erlotinib alone (arm A; n = 81) or to ECP (arm B; n = 100). EGFR mutation analysis was possible in 91% (164 of 181) of patients, and EGFR mutations were detected in 40% (51 of 128) of never smokers and in 42% (15 of 36) of light former smokers. In arm A, response rate (70% v 9%), PFS (14.1 v 2.6 months), and overall survival (OS; 31.3 v 18.1 month) favored EGFR-mutant patients. In arm B, response rate (73% v 30%), PFS (17.2 v 4.8 months), and OS (38.1 v 14.4 months) favored EGFR-mutant patients. Incidence of grades 3 to 4 hematologic (2% v 49%; P < .001) and nonhematologic (24% v 52%; P < .001) toxicity was greater in patients treated with ECP. CONCLUSION:
Erlotinib and erlotinib plus chemotherapy have similar efficacy in clinically selected populations of patients with advanced NSCLC. EGFR mutations identify patients most likely to benefit.
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Authors | Pasi A Jänne, Xiaofei Wang, Mark A Socinski, Jeffrey Crawford, Thomas E Stinchcombe, Lin Gu, Marzia Capelletti, Martin J Edelman, Miguel A Villalona-Calero, Robert Kratzke, Everett E Vokes, Vincent A Miller |
Journal | Journal of clinical oncology : official journal of the American Society of Clinical Oncology
(J Clin Oncol)
Vol. 30
Issue 17
Pg. 2063-9
(Jun 10 2012)
ISSN: 1527-7755 [Electronic] United States |
PMID | 22547605
(Publication Type: Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial)
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Chemical References |
- Placebos
- Quinazolines
- Carboplatin
- Erlotinib Hydrochloride
- ErbB Receptors
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Topics |
- Adenocarcinoma
(drug therapy)
- Adenocarcinoma of Lung
- Adult
- Aged
- Aged, 80 and over
- Antineoplastic Combined Chemotherapy Protocols
(therapeutic use)
- Carboplatin
(administration & dosage)
- Disease-Free Survival
- ErbB Receptors
(genetics)
- Erlotinib Hydrochloride
- Female
- Humans
- Lung Neoplasms
(drug therapy)
- Male
- Middle Aged
- Placebos
- Quinazolines
(administration & dosage)
- Smoking
(adverse effects)
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