First-SIGNAL: First-Line Single-Agent Iressa Versus Gemcitabine and Cisplatin Trial in Never-Smokers With Adenocarcinoma of the Lung

Han, Ji‐Youn; Park, Keunchil; Kim, Sang‐We; Lee, Dong Hoon; Kim, Hyae Young; Kim, Heung Tae; Ahn, Myung Ju; Yun, Tak; Ahn, Jin Seok; Suh, C.; Lee, Jung Shin; Yoon, Sung Jin; Han, Jiyou; Lee, Jae Won; Jo, Sook Jung; Lee, Jin Soo

doi:10.1200/jco.2011.36.8456

Cited by 660 publications

(435 citation statements)

References 23 publications

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“…Secondly, in the present study, patients with wild-type EGFR and no EGFR-TKI therapy were more likely to be smokers and to have brain metastasis and adrenal gland metastasis than those with wild-type EGFR and EGFR-TKI therapy. Finally, the response rate of EGFR-TKI therapy in patients with wild-type EGFR was 10-20% in previous reports [8,12,32,47,48].…”

Section: Discussionmentioning

confidence: 95%

Survival of lung adenocarcinoma patients with malignant pleural effusion

Tsai

et al. 2012

Eur Respir J

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In the era of targeted therapy, the association between lung adenocarcinoma patient survival and malignant pleural effusions (MPEs) remains unclear. This study investigated the clinical characteristics, survival and epidermal growth factor receptor (EGFR) gene (EGFR) mutation status of lung adenocarcinoma patients with MPE.From June 2005 to December 2010, consecutive pleural effusions were collected prospectively. Patient clinical characteristics, EGFR mutation status, and overall survival were analysed.We collected MPEs from 448 patients in stage IV lung adenocarcinoma at initial diagnosis. Median overall survival for patients with MPEs at initial diagnosis and following disease progression were 14.3 months and 21.4 months, respectively (p50.001). There were 296 (66.1%) patients harbouring EGFR mutations, the mutation rates among patients with an MPE at initial diagnosis and one following disease progression were 68.2% and 56.6%, respectively (p50.044); the L858R mutation rate was also higher among the former (32.6% versus 18.1%; p50.009). Multivariate analysis revealed that patients who: developed MPEs following disease progression, harboured EGFR mutations, and received EGFR-tyrosine kinase inhibitor therapy, had longer overall survival. Patients in stage IV lung adenocarcinoma with MPEs at initial diagnosis have shorter overall survival and higher EGFR mutation rate, especially for L858R, than patients who develop MPEs following disease progression.

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Section: Discussionmentioning

confidence: 95%

Survival of lung adenocarcinoma patients with malignant pleural effusion

Tsai

et al. 2012

Eur Respir J

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“…However, the efficacy has been rather disappointing 3. Molecular therapy has become a newly emerging regimen over the last decade 4. With lesser toxicity, patients with sensitive molecular alterations could benefit more from an inhibitor therapy than traditional chemotherapy 5, 6, 7, 8, 9, 10.…”

Section: Introductionmentioning

confidence: 99%

Mutation and prognostic analyses of PIK3CA in patients with completely resected lung adenocarcinoma

Song

Zhang

2016

Cancer Medicine

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PIK3CA mutation represents a clinical subset of diverse carcinomas. We explored the status of PIK3CA mutation and evaluated its genetic variability, treatment, and prognosis in patients with lung adenocarcinoma. A total of 810 patients with completely resected lung adenocarcinoma were recruited between 2008 and 2013. The status of PIK3CA mutation and other three genes, that is, EGFR mutation, KRAS mutation and ALK fusion were examined by reverse transcription‐polymerase chain reaction (RT‐PCR). Survival curves were plotted with the Kaplan–Meier method and log‐rank for comparison. Cox proportional hazard model was performed for multivariate analysis. Among the 810 patients, 23 cases of PIK3CA mutation were identified with a frequency of 2.8%. There were 14 men and 9 women with a median age of 61 years. Seventeen tumors revealed concurrent gene abnormalities of EGFR mutation (n = 12), KRAS mutation (n = 3), and ALK fusion (n = 2). Seven patients with EGFR & PIK3CA mutations recurred and administrated of EGFR‐TKIs yielded a median progression free‐survival of 6.0 months. Among four eviromous‐treated patients, stable disease was observed in three patients with a median Progression‐free survival (PFS) of 3.5 months. Patients with and without PIK3CA mutation had different overall survivals (32.2 vs. 49.6 months, P = 0.003). Multivariate analysis revealed that PIK3CA mutation was an independent predictor of poor overall survival (HR = 2.37, P = 0.017). The frequency of PIK3CA mutation was around 2.8% in the Chinese patients of lung adenocarcinoma. PIK3CA mutation was associated with reduced PFS of EGFR‐TKIs treatment and shorter overall survival.

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“…Randomized phase 3 studies have shown better progression-free survival (PFS) and responses with gefitinib or erlotinib than platinum-based chemotherapy for NSCLC harboring EGFR mutations (3)(4)(5)(6)(7)(8). However, most of NSCLC patients treated with EGFR tyrosine kinase inhibitors (TKI) eventually develop acquired resistance, necessitating alternative treatment strategies (9,10).…”

Section: Introductionmentioning

confidence: 99%

A Phase Ib/II Study of Afatinib in Combination with Nimotuzumab in Non–Small Cell Lung Cancer Patients with Acquired Resistance to Gefitinib or Erlotinib

Lee

Sun

Lim

et al. 2016

Clinical Cancer Research

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Purpose: In this phase Ib/II study, we aimed to assess the safety and efficacy of afatinib plus nimotuzumab (N) in advanced nonsmall cell lung cancer (NSCLC) patients with acquired resistance to gefitinib or erlotinib.Experimental Design: In phase Ib stage, patients received afatinib (40 mg or 30 mg once daily) plus nimotuzumab (100 mg or 200 mg once weekly) for 28-day cycles to determine the recommended phase II dose (RPIID). The safety and efficacy of RPIID dose was evaluated in phase II stage.Results: In total, 50 patients were enrolled (13 to phase Ib and 37 to phase II). In the first dose-finding cohort (afatinib 40 mg plus nimotuzumab 100 mg), one patient experienced dose-limiting toxicity (DLT) of grade 3 diarrhea and in the subsequent cohort (afatinib 40 mg plus nimotuzumab 200 mg), two DLTs (grade 3 diarrhea and grade 3 neutropenia) occurred in 2 of 6 patients. Accordingly, RPIID was determined as afatinib 40 mg plus nimotuzumab 100 mg. In 44 patients treated with RPIID, 7 (16%) patients had grade 3 toxicities; skin rash (7%), diarrhea (5%), acne (2%), and fatigue (2%). The overall response rate was 23% and the median duration of response was 4.3 months (range, 0.7-16.2 months). The median progression-free survival and overall survival were 4.0 months [95% confidence interval (CI), 2.3-5.7 months] and 11.7 months (95% CI, 9.4-14.0 months), respectively.Conclusions: Combination treatment of afatinib and nimotuzumab demonstrated an acceptable safety profile and encouraging antitumor activity in advanced NSCLC patients with acquired resistance to gefitinib or erlotinib. Larger phase III trial is warranted to confirm its efficacy and safety.

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First-SIGNAL: First-Line Single-Agent Iressa Versus Gemcitabine and Cisplatin Trial in Never-Smokers With Adenocarcinoma of the Lung

Abstract: Gefitinib failed to demonstrate superior OS compared with GP as first-line therapy for NSLAs.

Cited by 660 publications

References 23 publications

Survival of lung adenocarcinoma patients with malignant pleural effusion

Survival of lung adenocarcinoma patients with malignant pleural effusion

Mutation and prognostic analyses of PIK3CA in patients with completely resected lung adenocarcinoma

A Phase Ib/II Study of Afatinib in Combination with Nimotuzumab in Non–Small Cell Lung Cancer Patients with Acquired Resistance to Gefitinib or Erlotinib

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