Abstract | PURPOSE: PATIENTS AND METHODS: In this phase III study, eligible patients with stage IIIB/IV lung adenocarcinoma were screened for EGFR mutations. Mutation-positive patients were stratified by mutation type (exon 19 deletion, L858R, or other) and race (Asian or non-Asian) before two-to-one random assignment to 40 mg afatinib per day or up to six cycles of cisplatin plus pemetrexed chemotherapy at standard doses every 21 days. The primary end point was PFS by independent review. Secondary end points included tumor response, overall survival, adverse events, and patient-reported outcomes (PROs). RESULTS: A total of 1,269 patients were screened, and 345 were randomly assigned to treatment. Median PFS was 11.1 months for afatinib and 6.9 months for chemotherapy (hazard ratio [HR], 0.58; 95% CI, 0.43 to 0.78; P = .001). Median PFS among those with exon 19 deletions and L858R EGFR mutations (n = 308) was 13.6 months for afatinib and 6.9 months for chemotherapy (HR, 0.47; 95% CI, 0.34 to 0.65; P = .001). The most common treatment-related adverse events were diarrhea, rash/ acne, and stomatitis for afatinib and nausea, fatigue, and decreased appetite for chemotherapy. PROs favored afatinib, with better control of cough, dyspnea, and pain. CONCLUSION:
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Authors | Lecia V Sequist, James Chih-Hsin Yang, Nobuyuki Yamamoto, Kenneth O'Byrne, Vera Hirsh, Tony Mok, Sarayut Lucien Geater, Sergey Orlov, Chun-Ming Tsai, Michael Boyer, Wu-Chou Su, Jaafar Bennouna, Terufumi Kato, Vera Gorbunova, Ki Hyeong Lee, Riyaz Shah, Dan Massey, Victoria Zazulina, Mehdi Shahidi, Martin Schuler |
Journal | Journal of clinical oncology : official journal of the American Society of Clinical Oncology
(J Clin Oncol)
Vol. 31
Issue 27
Pg. 3327-34
(Sep 20 2013)
ISSN: 1527-7755 [Electronic] United States |
PMID | 23816960
(Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial)
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Chemical References |
- Glutamates
- Quinazolines
- Pemetrexed
- Afatinib
- Guanine
- ErbB Receptors
- Cisplatin
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Topics |
- Adenocarcinoma
(drug therapy, enzymology, genetics, pathology)
- Adenocarcinoma of Lung
- Adult
- Afatinib
- Aged
- Aged, 80 and over
- Antineoplastic Combined Chemotherapy Protocols
(adverse effects, pharmacokinetics, therapeutic use)
- Cisplatin
(administration & dosage, adverse effects, pharmacokinetics)
- ErbB Receptors
(genetics)
- Female
- Glutamates
(administration & dosage, adverse effects, pharmacokinetics)
- Guanine
(administration & dosage, adverse effects, analogs & derivatives, pharmacokinetics)
- Humans
- Lung Neoplasms
(drug therapy, enzymology, genetics, pathology)
- Male
- Middle Aged
- Mutation
- Neoplasm Metastasis
- Pemetrexed
- Quinazolines
(adverse effects, pharmacokinetics, therapeutic use)
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