Gefitinib plus best supportive care in previously treated patients with refractory advanced non-small-cell lung cancer: results from a randomised, placebo-controlled, multicentre study (Iressa Survival Evaluation in Lung Cancer)

Thatcher, Nick; Chang, Alex Y.; Parikh, Purvish M.; Pereira, José Rodrígues; Ciuleanu, Tudor-Eliade; Pawel, Joachim von; Thongprasert, Sumitra; Tan, Eng‐Huat; Pemberton, Kristine; Archer, Venice; Carroll, Kevin

doi:10.1016/s0140-6736(05)67625-8

Cited by 1,935 publications

(1,396 citation statements)

References 29 publications

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“…Although recognized in the tumorigenesis of non-small-cell lung carcinoma, only rare studies have suggested a prognostic role. Indeed, although one study reported no significant prognostic value, 40 increased EGFR gene and chromosome 7 copy numbers were reportedly associated with poor tumor differentiation but were less frequent in T4 compared to T1 tumors. 28 Also, increased EGFR gene and chromosome 7 copy numbers tended to be less frequent in tumors with lymph node metastasis.…”

Section: Discussionmentioning

confidence: 97%

Salivary gland-type lung carcinomas: an EGFR immunohistochemical, molecular genetic, and mutational analysis study

Macarenco¹,

Uphoff

Gilmer

et al. 2008

Modern Pathology

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Salivary gland-type lung carcinomas are uncommon neoplasms of the lung, the two most common being adenoid cystic carcinoma and mucoepidermoid carcinoma. Although they usually have an indolent behavior, adenoid cystic carcinomas can be more aggressive, with 5-year survival as low as 55%. Unfortunately, these tumors do not respond well to chemotherapy. In contrast to the most common subtypes of lung carcinomas, epidermal growth factor receptor studies have not been carried out in this group of tumors. Herein we report a series of 24 cases (12 adenoid cystic and 12 mucoepidermoid carcinomas) tested for epidermal growth factor receptor protein expression, epidermal growth factor receptor gene copy gains, and epidermal growth factor receptor gene mutational status, through immunohistochemistry, fluorescence in situ hybridization, and sequencing of the exons 18-21, respectively. Overall, 91 and 92% of the adenoid cystic carcinomas and mucoepidermoid carcinomas expressed epidermal growth factor receptor protein. Chromosome 7 polysomy occurred in 25% of the cases (four adenoid cystic carcinomas and two mucoepidermoid carcinomas). No epidermal growth factor receptor gene amplification was detected and no mutation was found in exons 18-21 of the epidermal growth factor receptor gene. Immunoexpression of epidermal growth factor receptor in salivary gland-type lung carcinomas is not related to epidermal growth factor receptor gene copy number or mutational status. Keywords: salivary gland-type lung carcinoma; adenoid cystic carcinoma; mucoepidermoid carcinoma; epidermal growth factor receptor; immunohistochemistry; FISH Salivary gland-type lung carcinomas are uncommon, representing less than 1% of all lung tumors. Adenoid cystic carcinoma and mucoepidermoid carcinoma are the two most common subtypes. 1,2 Salivary gland-type lung carcinomas are generally reported as having a good prognosis. Indeed, mucoepidermoid carcinoma usually presents as a localized disease that can be completely resected with surgery and the reported 5-and 10-year survivals rates are both 87%. 3 However, patients with mucoepidermoid carcinomas can develop local or distant metastasis, which are typically unresponsive to conventional chemotherapy and radiation. In contrast, adenoid cystic carcinoma tends to present at a higher stage, is often unresectable, or, if resected, often has positive margins and subsequent local recurrences. The prognosis is also poorer with recent reported 5-and 10-year survivals of 55 and 39%, respectively. 3 As with mucoepidermoid carcinoma, the survival does not appear to be affected by traditional chemotherapy and radiation. Therefore, there appears to be a potential use for targeted novel therapies in the care of these patients.

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Section: Discussionmentioning

confidence: 97%

Salivary gland-type lung carcinomas: an EGFR immunohistochemical, molecular genetic, and mutational analysis study

Macarenco¹,

Uphoff

Gilmer

et al. 2008

Modern Pathology

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“…6,7 EGFR mutation status is well known as a predictor of response to treatment by EGFR tyrosine kinase inhibitor (EGFR-TKI) and as the target of EGFR-TKIs. [8][9][10] In 2007, Suehisa and colleagues reported that adjuvant chemotherapy with uraciltegafur significantly prolonged survival rates among patients with EGFR wild-type adenocarcinoma but not among patients with EGFR mutant tumors. 11 In vitro studies also demonstrated that EGFR-wild type cells are more sensitive to 5-FU than mutant cells.…”

Section: Introductionmentioning

confidence: 99%

High Expression of Dihydropyrimidine Dehydrogenase in Lung Adenocarcinoma is Associated With Mutations in Epidermal Growth Factor Receptor: Implications for the Treatment of Non–Small-Cell Lung Cancer Using 5-Fluorouracil

Mochinaga

Tsuchiya

Nagasaki

et al. 2014

Clinical Lung Cancer

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“…In two large Phase II trials (IDEAL: IRESSA Dose Evaluation in Advanced Lung cancer 1 and 2) gefitinibinduced tumour regression and provided symptom relief in previously treated patients with non-small-cell lung cancer (NSCLC) (Fukuoka et al, 2003;Kris et al, 2003). Although a placebo-controlled Phase III study (ISEL) in previously-treated patients with NSCLC has not shown a statistically significant improvement in survival associated with gefitinib, preplanned subgroup analysis suggested survival benefits in patients of Asian origin and never-smokers (Thatcher et al, 2005). Patient selection criteria were not incorporated in this comparative study, which most likely contributed to the absence of a positive survival benefit in the overall population.…”

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confidence: 99%

Predictive factors associated with prolonged survival in patients with advanced non-small-cell lung cancer (NSCLC) treated with gefitinib

et al. 2007

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This study aimed to identify predictive factors associated with prognostic benefits of gefitinib. A total of 221 Japanese patients who received gefitinib (250 mg day À1 ) were examined retrospectively and potential predictive factors analysed. Overall response rate (ORR) was 24.4% and median survival time (MST) was 8.0 months. In a log-rank test, survival was significantly better in females, patients with adenocarcinoma, never-smokers, favourable performance status (PS) and patients with epidermal growth factor receptor (EGFR) mutation. The lower the smoking exposure (Brinkman Index (BI) ¼ cigarettes per day Â years smoked), the better the MST (BI 0: 14.5 months, BI o500: 9.5 months, BI 500 to o1000: 6.9 months, BI X1000: 4.0 months). Positive-EGFR mutation status and PS 0 -1 were independent predictors of favourable prognosis by multivariate analysis. Prognosis was significantly different according to EGFR mutation status (with the same smoking status), but not according to smoking status (with the same EGFR mutation status). EGFR mutation status is the most important independent predictor of survival benefit with gefitinib treatment. Although differences in prognosis were observed according to relative smoking status and smoking exposure, the results suggested that smoking is not a direct predictor of prognosis, yet is a surrogate marker of EGFR mutation status.

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Gefitinib plus best supportive care in previously treated patients with refractory advanced non-small-cell lung cancer: results from a randomised, placebo-controlled, multicentre study (Iressa Survival Evaluation in Lung Cancer)

Cited by 1,935 publications

References 29 publications

Salivary gland-type lung carcinomas: an EGFR immunohistochemical, molecular genetic, and mutational analysis study

Salivary gland-type lung carcinomas: an EGFR immunohistochemical, molecular genetic, and mutational analysis study

High Expression of Dihydropyrimidine Dehydrogenase in Lung Adenocarcinoma is Associated With Mutations in Epidermal Growth Factor Receptor: Implications for the Treatment of Non–Small-Cell Lung Cancer Using 5-Fluorouracil

Predictive factors associated with prolonged survival in patients with advanced non-small-cell lung cancer (NSCLC) treated with gefitinib

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