Effectiveness of gefitinib (Iressa) as first-line therapy for inoperable non-small-cell lung cancer with mutated EGFR gene (phase II study)

Tumor regression was reported in 20-30% of patients with inoperable non-small-cell lung cancer (NSLC) following standard first-line chemotherapy. Clinical trials with second-line gefitinib (Iressa) showed a strikingly high response in patients with mutated EGFR. However, clinical experience with gef...

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Bibliographic Details
Published inVoprosy onkologij Vol. 56; no. 1; p. 20
Main Authors Moiseenko, V M, Protsenko, S A, Semenov, I I, Moiseenko, F V, Levchenko, E V, Barchuk, A S, Matsko, D E, Ivantsov, A O, Ievleva, A G, Mitiushkina, N V, Togo, A V, Imianitov, E N
Format Journal Article
LanguageRussian
Published Russia (Federation) 2010
Subjects
Adenocarcinoma - drug therapy
Adenocarcinoma - genetics
Adenocarcinoma - pathology
Adult
Aged
Aged, 80 and over
Antineoplastic Agents - administration & dosage
Antineoplastic Agents - adverse effects
Antineoplastic Agents - therapeutic use
Carcinoma, Non-Small-Cell Lung - drug therapy
Diarrhea - chemically induced
Disease-Free Survival
Drug Eruptions - etiology
Female
Humans
Lung Neoplasms - drug therapy
Lung Neoplasms - genetics
Lung Neoplasms - pathology
Male
Middle Aged
Mutation
Neoplasm Staging
Protein Kinase Inhibitors - therapeutic use
Quinazolines - administration & dosage
Quinazolines - adverse effects
Quinazolines - therapeutic use
Receptor, Epidermal Growth Factor - genetics
Treatment Outcome
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Summary:Tumor regression was reported in 20-30% of patients with inoperable non-small-cell lung cancer (NSLC) following standard first-line chemotherapy. Clinical trials with second-line gefitinib (Iressa) showed a strikingly high response in patients with mutated EGFR. However, clinical experience with gefitinib as first-line therapy had been limited to small-scale trials mostly among subjects of Asian origin. Our study was not associated with the drug manufacturer and included 25 chemotherapy-naive patients with mutated EGFR inoperable lung adenocarcinoma. Standard dose was 250 mg/day. Complete response was observed in 1 patient (4%), partial--11 (44%), sustained stabilization--13 (52%); median time until tumor progression--186 days. Median overall survival failed to be registered within the duration of the study. Among most frequent side-effects were skin rash (19; 76%) and diarrhea (14; 56%): marked side-effect -toxicity grade III (4; 16%). Gefitinib appeared highly efficient and tolerable and may be recommended as first-line treatment of mutated EGFR inoperable NSLC.
ISSN:0507-3758