First-Line Gefitinib for Patients With Advanced Non–Small-Cell Lung Cancer Harboring Epidermal Growth Factor Receptor Mutations Without Indication for Chemotherapy

Inoue, Akira; Kobayashi, Kunihiko; Usui, Kazuhiro; Maemondo, Makoto; Okinaga, Shoji; Mikami, Iwao; Ando, Masahiro; Yamazaki, Koichi; Saijo, Yasuo; Gemma, Akihiko; Miyazawa, Hitoshi; Tanaka, Tomoaki; Ikebuchi, Kenji; Nukiwa, Toshihiro; Morita, Satoshi; Hagiwara, Koichi

doi:10.1200/jco.2008.18.7658

Cited by 468 publications

(323 citation statements)

References 29 publications

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“…As the introduction of first-line gefitinib in each case was dependent on the decision of the attending physician, our results may have included the clinical outcomes in elderly patients who were reluctant to receive first-line cytotoxic chemotherapy. For frail patients with EGFR-mutated NSCLC, e.g., poor PS over grade 3 or elderly (> 75 years old) with PS > 2, it was demonstrated that first-line gefitinib therapy showed a high RR (66%) and relatively long OS 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 (17.8 months) [12]. Therefore, we believe that gefitinib is a good alternative as a first-line treatment for elderly patients.…”

Section: Discussionmentioning

confidence: 99%

Clinical outcomes in elderly patients administered gefitinib as first-line treatment in epidermal growth factor receptor-mutated non-small-cell lung cancer: retrospective analysis in a Nagano Lung Cancer Research Group Study

et al. 2013

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ABSTRACT[214 words (do not exceed 250)]Purpose: The clinical efficacy and outcomes of gefitinib therapy as a first-line treatment for elderly patients with non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations were analyzed retrospectively. Patients and methods:We analyzed chemotherapy-naïve NSCLC patients aged 75 years or older who had EGFR mutations (exon 19 deletion mutation or L858R), who were initially treated with gefitinib (250 mg) once daily in Nagano Prefecture.Results: A total of 55 patients (16 men, 39 women) with a median age of 81.1 years (range: 75 -94 years) treated between April 2007 and July 2012, were analyzed. The overall response rate and disease control rate were 72.7% (95% confidence interval (CI); 59.5% -82.9%) and 92.7% (95% CI: 82.0% -97.6%), respectively. Median progression-free survival and overall survival from the start of gefitinib treatment were 13.8 months (CI: 9.9 -18.8 months) and 29.1 months (95% CI: 22.4 -not reached), respectively. Two-year survival rate was 59.5% (95% CI; 41.0% -78.8%). Major grade 3 toxicities were skin rash (1.8%) and increased levels of aspartate aminotransferase or alanine aminotransferase (7.3%). Conclusion:First-line treatment with gefitinib for elderly EGFR-mutated NSCLC patients was effective and well tolerated. The results suggest that first-line gefitinib should be considered as a preferable standard treatment in elderly patients with advanced NSCLC harboring EGFR mutations.

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Section: Discussionmentioning

confidence: 99%

Clinical outcomes in elderly patients administered gefitinib as first-line treatment in epidermal growth factor receptor-mutated non-small-cell lung cancer: retrospective analysis in a Nagano Lung Cancer Research Group Study

et al. 2013

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“…Recently, a greater understanding of the molecular pathways driving carcinogenesis led to the development of novel agents in NSCLC. Patients with epidermal growth factor receptor-activating (EGFR-activating) mutations or anaplastic lymphoma kinase (ALK) rearrangements have demonstrated unprecedented outcomes when treated with a first-line tyrosine kinase inhibitor (TKI) [4,[7][8][9][10][11][12][13]. Recognizing the importance of a timely and accurate diagnosis-including tumor stage, histology, and molecular subtyping-several professional societies have incorporated recommendations for biomarker testing into clinical practice guidelines for the diagnosis and management of NSCLC (Table 1) [4,7,14].…”

Section: Introductionmentioning

confidence: 99%

Molecular Testing for Treatment of Metastatic Non-Small Cell Lung Cancer: How to Implement Evidence-Based Recommendations

et al. 2015

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The recent discovery of relevant biomarkers has reshaped our approach to therapy selection for patients with non-small cell lung cancer.The unprecedented outcomes demonstrated with tyrosine kinase inhibitors in molecularly defined cohorts of patients has underscored the importance of genetic profiling in this disease. Despite published guidelines on biomarker testing, successful tumor genotyping faces significant hurdles at both academic and community-based practices. Oncologists are now faced with interpreting large-scale genomic data from multiple tumor types, possibly making it difficult to stay current with practice standards in lung cancer. In addition, physicians' lack of time, resources, and face-to-face opportunities can interfere with the multidisciplinary approach that is essential to delivery of care. Finally, several challenges exist in optimizing the amount and quality of tissue for molecular testing. Recognizing the importance of biomarker testing, a series of advisory boards were recently convened to address these hurdles and clarify best practices. We reviewed these challenges and established recommendations to help optimize tissue acquisition, processing, and testing within the framework of a multidisciplinary approach. The Oncologist 2015; 20:1175-1181 Implications for Practice: Although several professional societies have incorporated biomarker testing recommendations into clinical practice guidelines for the diagnosis and management of non-small cell lung cancer (NSCLC), health care providers still face considerable challenges when establishing and implementing these standards. Developing and instituting protocols to ensure that all appropriate patients are tested for molecular biomarkers requires communication among the various specialists involved in the care of patients with NSCLC. This report provides insights into key challenges and recommendations for molecular testing of patients with metastatic NSCLC, summarized from a multidisciplinary team of experts spanning academic, community, and integrated health systems.

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“…Gefitinib showed markedly better efficacy than standard chemotherapy in this subset of patients [7,8]. Deletions in exon 19 and the single L858R point mutation in exon 21 account for 90% of all EGFR mutations [1][2][3]6].…”

Section: Introductionmentioning

confidence: 99%

Assessment of Epidermal Growth Factor Receptor and K-Ras Mutation Status in Cytological Stained Smears of Non-Small Cell Lung Cancer Patients: Correlation with Clinical Outcomes

et al. 2011

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Objective. Epidermal growth factor receptor (EGFR) and K-ras mutations guide treatment selection in nonsmall cell lung cancer (NSCLC) patients. Although mutation status is routinely assessed in biopsies, cytological specimens are frequently the only samples available. We determined EGFR and K-ras mutations in cytological samples.Methods. DNA was extracted from 150 consecutive samples, including 120 Papanicolau smears (80%), 10 cell blocks (7%), nine fresh samples (6%), six ThinPrep tests (4%), and five body cavity fluids (3.3%). Papanicolau smears were analyzed when they had >50% malignant cells. Polymerase chain reaction and direct sequencing of exons 18 -21 of EGFR and exon 2 of K-ras were performed. EGFR mutations were simultaneously determined in biopsies and cytological samples from 20 patients. Activity of EGFR tyrosine kinase inhibitors (TKIs) was assessed.Results. The cytological diagnosis was adenocarcinoma in 110 samples (73%) and nonadenocarcinoma in 40 (27%) samples. EGFR mutations were identified in 26 samples (17%) and K-ras mutations were identified in 18 (12%) samples. EGFR and K-ras mutations were mutually exclusive. In EGFR-mutated cases, DNA was obtained from stained smears in 24 cases (92%), pleural fluid in one case (4%), and cell block in one case (4%). The response rate to EGFR TKIs in patients harboring mutations was 75%. The mutation status was identical in patients who had both biopsies and cytological samples analyzed.Conclusion. Assessment of EGFR and K-ras mutations in cytological samples is feasible and comparable with biopsy results, making individualized treatment selection possible for NSCLC patients from whom tumor biopsies are not available. The Oncologist 2011;16: 877-885

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First-Line Gefitinib for Patients With Advanced Non–Small-Cell Lung Cancer Harboring Epidermal Growth Factor Receptor Mutations Without Indication for Chemotherapy

Cited by 468 publications

References 29 publications

Clinical outcomes in elderly patients administered gefitinib as first-line treatment in epidermal growth factor receptor-mutated non-small-cell lung cancer: retrospective analysis in a Nagano Lung Cancer Research Group Study

Clinical outcomes in elderly patients administered gefitinib as first-line treatment in epidermal growth factor receptor-mutated non-small-cell lung cancer: retrospective analysis in a Nagano Lung Cancer Research Group Study

Molecular Testing for Treatment of Metastatic Non-Small Cell Lung Cancer: How to Implement Evidence-Based Recommendations

Assessment of Epidermal Growth Factor Receptor and K-Ras Mutation Status in Cytological Stained Smears of Non-Small Cell Lung Cancer Patients: Correlation with Clinical Outcomes

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