Sato T.,Kyoto University |
Teramukai S.,Kanazawa University |
Kondo H.,Kyorin University |
Watanabe A.,Sapporo Medical University |
And 13 more authors.
Journal of Thoracic and Cardiovascular Surgery | Year: 2014
Objective: The study objective was to examine the incidence, risk factors, and mortality rate of acute exacerbation of interstitial lung diseases in patients with lung cancer undergoing pulmonary resection in a large-scale multi-institutional cohort. Methods: We retrospectively analyzed 1763 patients with non-small cell lung cancer who had undergone pulmonary resection and presented with a clinical diagnosis of interstitial lung diseases between January 2000 and December 2009 at 61 hospitals in Japan. The incidence and outcomes of acute exacerbation within 30 days from the operation were investigated. Univariate and multivariate logistic regression analyses were used to identify independent risk factors of acute exacerbation. Results: Acute exacerbation occurred in 164 patients (9.3%; 95% confidence interval, 8.0-10.8), with a mortality rate of 43.9%, and was the top cause of 30-day mortality (71.7%). The following 7 independent risk factors of acute exacerbation were identified: surgical procedures, male sex, history of exacerbation, preoperative steroid use, serum sialylated carbohydrate antigen KL-6 levels, usual interstitial pneumonia appearance on computed tomography scan, and reduced percent predicted vital capacity. Surgical procedures showed the strongest association with acute exacerbation (using wedge resection as the reference, lobectomy or segmentectomy: odds ratio, 3.83; 95% confidence interval, 1.94-7.57; bi-lobectomy or pneumonectomy: odds ratio, 5.70; 95% confidence interval, 2.38-13.7; P <.001). The effect of perioperative prophylactics, such as steroids and sivelestat, was not confirmed in this study. Conclusions: Pulmonary resection for patients with lung cancer with interstitial lung diseases may provoke acute exacerbation at a substantially high rate and has high associated mortality. Surgical procedures that proved to be a risk factor for acute exacerbation should be chosen cautiously for these high-risk patients. Copyright © 2014 by The American Association for Thoracic Surgery.
Yonezawa K.,Hakodate National Hospital |
Fuse J.,Tokyo Medical Center |
Shimizu N.,Tokyo Metropolitan Childrens Medical Center |
Hayashi T.,Osaka Medical College |
And 7 more authors.
Circulation Journal | Year: 2011
Background: In-hospital cardiopulmonary arrest (CPA) is an important issue, but data in Japan are limited. Methods and Results: To investigate in-hospital CPA, we conducted a prospective multicenter observational registry of in-hospital CPA and resuscitation in Japan (J-RCPR). During January 2008 to December 2009, patients were registered from 12 participating hospitals. All patients, visitors and employees within the facility campus who experience a cardiopulmonary resuscitation event defined as either a pulseless or a pulse with inadequate perfusion requiring chest compressions and/or defibrillation of ventricular fibrillation (VF) or pulseless ventricular tachycardia (VT) were registered. Data were collected in 6 major categories of variables: facility data, patient demographic data, pre-event data, event data, outcome data, and quality improvement data. Data for 491 adults were analyzed. The prevalence of pulseless VT/VF as first documented rhythm was 28.1%, asystole was 29.5% and pulseless electrical activity was 41.1%. Immediate causes of event were arrhythmia 30.6%, acute respiratory insufficiency 26.7%, and hypotension 15.7%. Return of spontaneous circulation was 64.7%; the proportion of survival 24 h after CPA was 49.8%, the proportion of survival to hospital discharge was 27.8% and proportion of favorable neurological outcome at 30 days was 21.4%. Conclusions: This is the first report of the registry for in-hospital CPA in Japan and shows that the registry provides important observational data.
Prolonged treatment with three-weekly docetaxel plus daily prednisolone for metastatic castration-resistant prostate cancer: A multicenter, phase II, open-label, non-comparative, extension study in Japan
Nishimura K.,Japan National Cardiovascular Center Research Institute |
Nonomura N.,Osaka University |
Hashine K.,National Hospital Organization |
Kanayama H.-O.,Tokushima University |
And 11 more authors.
International Journal of Clinical Oncology | Year: 2013
Background: There are few reports of long-term treatment with docetaxel in castration-resistant prostate cancer (CRPC) because of the limit of a maximum of ten cycles of treatment in TAX327 showing a survival benefit. Therefore, this study, ARD6563, was conducted to evaluate the safety of more than ten cycles of docetaxel in metastatic CRPC. Methods: We enrolled patients who had received ten cycles of docetaxel in the preceding study, ARD6562. For ARD6563, patients received docetaxel every 3 weeks, at the last dose (70, 60, or 50 mg/m 2) received for cycle 10 in ARD6562, with prednisolone 5 mg orally twice daily. Results: The safety analysis set comprised 15 patients (median age, 64 years; performance status, 0 in 87%) out of 43 patients treated in ARD6562. The median initial dose of docetaxel was 60 mg/m2, and the median number of additional cycles administered was 8 (range, 1-42). The relative dose intensity was 78.0% for docetaxel and 98.0% for prednisolone. Dose reduction was needed in 3 cycles because of grade 3 infection, febrile neutropenia, and grade 2 neuropathy. Administration delay was necessitated in 6 cycles because of grade 1-2 nonhematological toxicities. The major grade 3-4 toxicities were myelosuppression. Five patients who had an observed partial response or stable disease in ARD6562 maintained their clinical response in ARD6563. The study treatment was discontinued in 10 patients because of disease progression and in 4 patients for serious toxicities. There were no treatment-related deaths. Conclusions: Long-term docetaxel with prednisolone is feasible in selected Japanese patients with CRPC. © 2012 Japan Society of Clinical Oncology.
PubMed | Aichi Cancer Center Hospital, Showa University, Saitama University, Hirosaki University and 18 more.
Type: Journal Article | Journal: International journal of clinical oncology | Year: 2016
Laparoscopic surgery is becoming the preferred technique for most colorectal interventions. This study aimed to clarify the time trend of surgical treatment for familial adenomatous polyposis (FAP) and its relevance to clinical outcomes in Japan over a 13-year period.This was a multicenter retrospective cohort study comprising 23 specialist institutions for colorectal disease and a cohort of 282 FAP patients who underwent total colectomy or proctocolectomy during 2000-2012. Patient clinical backgrounds and surgical outcomes were compared between the first and second halves of the study period.The proportion of surgical types adopted over the entire study period was 46, 21, 30, and 3% for ileoanal anastomosis (IAA), ileoanal canal anastomosis, ileorectal anastomosis, and permanent ileostomy, respectively. FAP patients undergoing laparoscopic surgery have increased since 2008 and reached 74% in the past 3years. In particular, the number of patients undergoing laparoscopic proctocolectomy with IAA increased approximately four-fold from the first to the second half of the study period. A laparoscopic approach was increasingly used in patients with coexisting colorectal malignancies. Despite this trend, surgical results of the laparoscopic approach between the two study periods showed similar morbidity, pouch operation and stoma closure completion rates. No postoperative mortality was observed in this series, and laparoscopic surgery was comparable to open surgery in terms of stoma closure rate, incidence of intra-abdominal/abdominal desmoid tumors, and postoperative survival rate in both study periods.Laparoscopic approach is increasingly being adopted for prophylactic FAP surgery in Japan and may provide clinically acceptable practical outcomes.
PubMed | University of Occupational and Environmental Health Japan, National Cancer Center Research Institute, Hyogo College of Medicine, Cancer Institute Hospital of Japanese Foundation for Cancer Research and 13 more.
Type: Journal Article | Journal: Anticancer research | Year: 2016
To elucidate the causes of cancer death in Japanese families with Lynch syndrome (LS).The distributions of cancer deaths in 485 individuals from 67 families with LS (35, 30, and two families with MutL homologue 1 (MLH1), MSH2, and MSH6 gene mutations, respectively), obtained from the Registry of the Japanese Society for Cancer of the Colon and Rectum were analyzed.Among 98 cancer deaths of first-degree relatives of unknown mutation status, 53%, 19%, 13% (among females), 7% (among females) and 5% were due to colorectal, gastric, uterine, ovarian, and hepatobiliary cancer, respectively. The proportion of deaths from extra-colonic cancer was significantly higher in families with MSH2 mutation than in those with MLH1 mutation (p=0.003).In addition to colonic and uterine cancer, management and surveillance targeting gastric, ovarian and hepatobiliary cancer are considered important for Japanese families with LS. Extra-colonic cancer in families with MSH2 mutation might require for more intensive surveillance.
Phase II trial of gefitinib in combination with bevacizumab as first-line therapy for advanced non-small cell lung cancer with activating EGFR gene mutations: The okayama lung cancer study group trial 1001
Ichihara E.,Okayama University |
Ichihara E.,Vanderbilt University |
Hotta K.,Okayama University |
Nogami N.,Shikoku Cancer Center |
And 18 more authors.
Journal of Thoracic Oncology | Year: 2015
Purpose: Whether bevacizumab enhances the effect of the epidermal growth factor receptor (EGFR) inhibitor gefitinib on EGFR mutant non-small cell lung cancers (NSCLCs) remains unknown. We conducted a phase II trial to investigate the efficacy and safety of gefitinib when combined with bevacizumab as first-line therapy in patients with advanced NSCLC harboring EGFR gene mutations. Methods: In this trial, 42 patients with a performance status of 0 to 2 received gefitinib (250 mg/d) and bevacizumab (15 mg/kg, every 3 weeks). The primary end point of this study was the 1-year progression-free survival (PFS) rate. We assumed that a 1-year PFS rate of 55% would indicate potential usefulness and that a 1-year PFS rate of 40% would constitute the lower limit of interest. Results: Forty-two patients were enrolled in the study with a median age of 73 (range 42-86) years. Activating EGFR gene mutations included exon 19 deletion (57%) and L858R point mutations in exon 21 (38%). The objective response rate was 73.8% and included two complete responses. The 1-year PFS rate and median PFS time were 56.7% (95% confidence interval [CI] 39.9-70.5) and 14.4 months (95% CI 10.1-19.2), respectively. The median PFS differed significantly between EGFR exon 19 deletion and the L858R point mutation (18.0 versus 9.4 months, respectively; p = 0.006). The median overall survival had not yet been reached. Severe adverse events included grade 3 skin rash (15%), hypertension (17%), aspartate transaminase/alanine aminotransferase elevation (17%), proteinuria (7%), intracranial hemorrhage (2%), and grade 4 perforation of the digestive tract (2%). There were no treatment-related deaths. Conclusion: Gefitinib in combination with bevacizumab as first-line therapy seems to be a favorable and well-tolerated treatment for patients with advanced NSCLC with activating EGFR gene mutations, especially those with EGFR exon 19 deletion mutations, although the primary end point was not met because the lower limit of the CI was less than 40%. © 2014 by the International Association for the Study of Lung Cancer.
PubMed | Saitama Cancer Center, Saitama University, Fukushima Medical University and Iwakuni Clinical Center
Type: Journal Article | Journal: Familial cancer | Year: 2016
Genetic testing for hereditary colorectal polyposis/cancers has become increasingly important. Therefore, the development of a timesaving diagnostic platform is indispensable for clinical practice. We designed and validated target enrichment sequencing for 20 genes implicated in familial gastrointestinal polyposis/cancers in 32 cases with previously confirmed mutations using the HaloPlex enrichment system and MiSeq. We demonstrated that HaloPlex captured the targeted regions with a high efficiency (99.66% for covered target regions, and 99.998% for breadth of coverage), and MiSeq achieved a high sequencing accuracy (98.6% for the concordant rate with SNP arrays). Using this approach, we correctly identified 33/33 (100%) confirmed alterations including SNV, small INDELs and large deletions, and insertions in APC, BMPR1A, EPCAM, MLH1, MSH2, MSH6, PMS2, and SKT11. Our approach yielded the sequences of 20 target genes in a single experiment, and correctly identified all previously known mutations. Our results indicate that our approach successfully detected a wide range of genetic variations in a short turnaround time and with a small sample size for the rapid screening of known causative gene mutations of inherited colon cancer, such as familial adenomatous polyposis, Lynch syndrome, Peutz-Jeghers syndrome, and Juvenile polyposis syndrome.
Haga Y.,National Hospital Organization Kumamoto Medical Center |
Haga Y.,Kumamoto University |
Ikejiri K.,Kyushu Medical Center |
Wada Y.,Himeji Medical Center |
And 2 more authors.
Gastric Cancer | Year: 2015
Conclusions: The current study suggests the possibility of surgical audit for postoperative OS in gastric cancer. Further studies including high-volume centers will be necessary to validate this idea.Background: Previous studies for surgical audit have focused on short-term outcomes, such as perioperative mortality. There has been no gold standard how to evaluate quality of care for long-term outcomes in surgical oncology. This preliminary study aims to propose a method for surgical audit targeting long-term outcome following gastrectomy for gastric cancer.Methods: We prospectively investigated a set of variables relating to physiologic conditions, tumor characteristics and operations in patients who underwent gastrectomy for gastric cancer between June 2005 and July 2008 in 18 referral hospitals in Japan. Overall survival (OS) is the endpoint. Cox hazard regression analysis was used to generate a model to predict OS. The calibration and discrimination power of the model were assessed using the Hosmer-Lemeshow (H-L) test and area under the receiver-operating characteristic curve (AUC), respectively. The ratio of observed-to-estimated 5-year OS rates (OE ratio) was defined as a measure of quality.Results: Among 762 patients analyzed, 697 (91 %) completed the 5-year follow-up. The constructed model for OS exhibited a good discrimination power (AUC, 95 % confidence interval 0.89, 0.86–0.91), which was significantly better than that for the UICC stage (0.81, 0.77–0.84). This model also demonstrated a good calibration power (H-L: χ2 = 27.2, df = 8, P = 0.77). The OE ratios among the participating hospitals revealed no significant variation between 0.74 and 1.1. © 2014, The International Gastric Cancer Association and The Japanese Gastric Cancer Association.