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Kanazu M.,Kinki chuo Chest Medical Center | Maruyama K.,Hyogo College of Medicine | Ando M.,Nagoya University | Asami K.,Kinki chuo Chest Medical Center | And 10 more authors.
Clinical Lung Cancer | Year: 2014

Early prediction of therapeutic outcome is important in determining whether the ongoing therapy is beneficial. In addition to anatomical response determined using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria, recent studies have indicated that change in tumor glucose use on or after treatment correlates with histopathologic tumor regression and patient outcomes. This Perspective discusses the use of 18F- fluorodeoxyglucose-positron emission tomography (FDG-PET) for pharmacodynamic evaluation in a very early phase of treatment to predict clinical outcomes in patients with advanced non-small-cell lung cancer. We conducted a study to assess whether early metabolic response determined using FDG-PET correlated with clinical outcomes in patients treated with gefitinib or those treated with carboplatin plus paclitaxel (CP). Early metabolic response to gefitinib, but not CP, correlated with the late metabolic response, anatomical response, progression-free survival, and even overall survival. A rapid effect of molecular targeted agents might not be aptly evaluated using the conventional criteria, eg, RECIST, in a very early phase of treatment before volumetric shrinkage of the tumor. Based on the findings of several studies, and on the findings from our study, use of FDG-PET might enable prediction of clinical outcomes at a very early stage of treatment, especially in patients treated with molecular targeted agents with rapid clinical efficacy. © 2014 Elsevier Inc. All rights reserved. Source

Kawaguchi T.,Kinki chuo Chest Medical Center | Ando M.,Nagoya University | Asami K.,Kinki chuo Chest Medical Center | Okano Y.,National Hospital Organization | And 15 more authors.
Journal of Clinical Oncology | Year: 2014

Purpose: To investigate the efficacy of erlotinib versus docetaxel in previously treated patients with advanced non-small-cell lung cancer (NSCLC) in an epidermal growth factor receptor (EGFR) -unselected patient population. Patients and Methods: The primary end point was progression-free survival (PFS). Secondary end points included overall survival (OS), response rate, safety, and analyses on EGFR wild-type tumors. Patients with stage IIIB or IV NSCLC, previous treatment with one or two chemotherapy regimens, evaluable or measurable disease, and performance status of 0 to 2 were eligible. Results: From August 2009 to July 2012, 150 and 151 patients were randomly assigned to erlotinib (150 mg daily) and docetaxel (60 mg/m2 every 3 weeks), respectively. EGFR wild-type NSCLC was present in 109 and 90 patients in the erlotinib and docetaxel groups, respectively. Median PFS for erlotinib versus docetaxel was 2.0 v 3.2 months (hazard ratio [HR], 1.22; 95% CI, 0.97 to 1.55; P = .09), and median OS was 14.8 v 12.2 months (HR, 0.91; 95% CI, 0.68 to 1.22; P = .53), respectively. In a subset analysis of EGFR wild-type tumors, PFS for erlotinib versus docetaxel was 1.3 v 2.9 months (HR, 1.45; 95% CI, 1.09 to 1.94; P = .01), and OS was 9.0 v 10.1 months (HR, 0.98; 95% CI, 0.69 to 1.39; P = .91), respectively. Conclusion: Erlotinib failed to show an improvement in PFS or OS compared with docetaxel in an EGFR-unselected patient population. © 2014 by American Society of Clinical Oncology. Source

Background. Univariate analyses from several randomized phase III trials seemed to suggest ever-smokers with advanced mutated epidermal growth factor receptor (EGFRm) non-small cell lung cancer (NSCLC) did not seem to benefit from EGFR tyrosine kinase inhibitors (TKIs) as first-line treatment when compared with platinum-doublet chemotherapy as measured by progression-free survival (PFS). Methods. A literature-based meta-analysis of PFS outcomes as measured by log-transformed pooled hazard ratio (HR) was performed using a random-effect model. Pooled HRs for smoking status, age, gender, ethnicity, type of EGFR mutation, and EGFR TKI were obtained. Comparison of the pooled HRwas performed by metaregression analysis. Results. Among the 1,649 EGFRm NSCLC patients analyzed from 7 prospective randomized trials (WJTOG3405, NEJ002, EURTAC, OPTIMAL, LUX Lung-3, LUX Lung-6, and ENSURE), 83.7% were Asians, and 30.0% were ever-smokers. An equal percentage of ever-smokers received doublet chemotherapy (30.2%) or EGFR TKI (30.0%). The pooled HRfor PFS was 0.29 (95% confidence interval [CI]: 0.21-0.39) for never-smokers and 0.54 (95% CI: 0.38-0.76) for ever-smokers (p <.007 by metaregression).The pooled PFS HRforexon 19 deletion was 0.25 (95% CI: 0.19-0.31) and 0.44 for exon 21 substitution (95% CI: 0.34-0.57) (p <.001 by metaregression analysis). The pooled PFS HR was 0.33 (95% CI: 0.24-0.46) for Asians and 0.48 for non-Asians (95% CI: 0.28-0.84) (p =.261 by metaregression analysis). Conclusion. EGFRm NSCLC patients derived significant PFS benefit from TKI over platinum-doublet chemotherapy as first-line treatment regardless of smoking status; however, PFS benefit is significantly better in never-smokers by metaregression analysis. © AlphaMed Press 2015. Source

Bunno M.,Koyo Hospital
Journal of the Wakayama Medical Society | Year: 2015

Objective We retrospectively elucidated the usefulness and problems of endoscopic submucosal dissection (ESD) for early gastric neoplasm in the very elderly patients( ≥ 85 years) in comparison with the non-elderly patients. Patients and methods 270 patients (273 lesions) treated with ESD from June 2005 to October 2014 were enrolled in our study. Subjects were classified into two groups very elderly (age ≥ 85 years) or non-elderly (age < 85 years). We investigated lesion characteristics, treatment outcomes and complications during the postoperative periods of ESD among two groups. Results No significant differences in clinical Characteristics, en bloc resection rate and operation time were observed. Pneumonia, but not post operative bleeding or perforation, developed in association with ESD were more frequently in the very elderly patients by 8.3 %. Conclusion Although pneumonia in association with ESD was more frequently observed in the very elderly patients in this study, ESD for early gastric neoplasm was managed appropriately even in the very elderly patients. Source

Hasegawa Y.,Izumi Municipal Hospital | Ando M.,Nagoya University | Kubo A.,Aichi Medical University | Isa S.-I.,National Hospital Organization Kinki chuo Chest Medical Center | And 6 more authors.
Lung Cancer | Year: 2014

Non-small cell lung cancer (NSCLC) in never smokers has emerged as a global public health issue. The cause is still unclear, and few studies have focused on the prevalence of human papillomavirus (HPV) in the never smokers. We performed a systematic search of PubMed for articles of HPV infection in human subjects with NSCLC up to September 2012. Although smoking status was not fully reported in all studies, we contacted the authors by e-mail to supplement this information. Differences in the distribution of patients with and without HPV infection were tested with the Chi squared test. We identified 46 eligible articles, including 23 from Asian countries (N= 2337 NSCLC cases), 19 from European countries (N= 1553) and 4 from North and South America (N= 160). The HPV prevalence was 28.1% (95% confidence interval (CI) 26.6-30.3%), 8.4% (95% CI 7.1-9.9%) and 21.3% (95% CI 15.2-28.4%), respectively. Eleven studies from East Asia (N= 1110) and 4 from Europe (N= 569) provided information on smoking status. The number of never smoker was 392 patients (33.9%) in East Asia and 54 patients (14.8%) in Europe. The HPV prevalence in East Asian countries was similar between never and ever smokers (33.9% vs 39.2%, P= 0.080). Based on the literature confirming the presence of HPV in lung cancer in never smokers, the virus plays a role in carcinogenesis in the disease. There were different patterns of HPV prevalence between Asian and European countries in the never smokers as well as in ever smokers. © 2013 Elsevier Ireland Ltd. Source

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