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6 juni 2012: toegevoegd een link naar het gratis in te zien volledige studie rapport van onderstaand abstract: Gefitinib or Chemotherapy for Non–Small-Cell Lung Cancer with Mutated EGFR. Referentielijst staat onderaan abstract

26 jun 2010: Bron ASCO en N Engl J Med. 2010 Jun 24;362(25):2380-8.

Iressa verdubbelt ziektevrije tijd en geeft hoog significant meer completere remissies dan een standaard aanpak met chemo bij longkankerpatienten met de juiste EGRF receptoren. Dit blijkt uit een langjarige gerandomiseerde fase III studie bij 230 longkankerpatienten geselecteerd vooraf op EGRF mutatie. De verschillen waren significant in het voordeel van de Iressagroep: in ziektevrije tijd, 5,4 versus 10,8 maanden, complete remissies 30,7% versus 73,7% en de overall mediane overleving ging van 23,6 in de chemogroep naar 30,5 maanden in de Iressagroep. Voor longkankerpatienten met de juiste receptoren zal nu Iressa iof Tarceva worden voorgesteld als behandeling voor gevorderde longkanker. De studie werd gepubliceerd in the New England Journal of Medicine. Hier het abstract en lees op Medscape een uitgebreidere toelichting op deze studie.

N Engl J Med. 2010 Jun 24;362(25):2380-8.

Gefitinib or chemotherapy for non-small-cell lung cancer with mutated EGFR.

Maemondo M, Inoue A, Kobayashi K, Sugawara S, Oizumi S, Isobe H, Gemma A, Harada M, Yoshizawa H, Kinoshita I, Fujita Y, Okinaga S, Hirano H, Yoshimori K, Harada T, Ogura T, Ando M, Miyazawa H, Tanaka T, Saijo Y, Hagiwara K, Morita S, Nukiwa T; North-East Japan Study Group.

Collaborators (48)

Miyagi Cancer Center, Miyagi, Japan.

Abstract

BACKGROUND: Non-small-cell lung cancer with sensitive mutations of the epidermal growth factor receptor (EGFR) is highly responsive to EGFR tyrosine kinase inhibitors such as gefitinib, but little is known about how its efficacy and safety profile compares with that of standard chemotherapy.

METHODS: We randomly assigned 230 patients with metastatic, non-small-cell lung cancer and EGFR mutations who had not previously received chemotherapy to receive gefitinib or carboplatin-paclitaxel. The primary end point was progression-free survival; secondary end points included overall survival, response rate, and toxic effects. RESULTS: In the planned interim analysis of data for the first 200 patients, progression-free survival was significantly longer in the gefitinib group than in the standard-chemotherapy group (hazard ratio for death or disease progression with gefitinib, 0.36; P<0.001), resulting in early termination of the study. The gefitinib group had a significantly longer median progression-free survival (10.8 months, vs. 5.4 months in the chemotherapy group; hazard ratio, 0.30; 95% confidence interval, 0.22 to 0.41; P<0.001), as well as a higher response rate (73.7% vs. 30.7%, P<0.001). The median overall survival was 30.5 months in the gefitinib group and 23.6 months in the chemotherapy group (P=0.31). The most common adverse events in the gefitinib group were rash (71.1%) and elevated aminotransferase levels (55.3%), and in the chemotherapy group, neutropenia (77.0%), anemia (64.6%), appetite loss (56.6%), and sensory neuropathy (54.9%). One patient receiving gefitinib died from interstitial lung disease.

CONCLUSIONS: First-line gefitinib for patients with advanced non-small-cell lung cancer who were selected on the basis of EGFR mutations improved progression-free survival, with acceptable toxicity, as compared with standard chemotherapy. (UMIN-CTR number, C000000376.) 2010 Massachusetts Medical Society

PMID: 20573926 [PubMed - in process]

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