tbuckley/cabot-search huggingface dataset:
ANITA: Phase III adjuvant vinorelbine (N) and cisplatin (P) versus observation (OBS) in completely resected (stage I-III) non-small-cell lung cancer (NSCLC) patients (pts): Final results after 70-month median follow-up. On behalf of the Adjuvant Navelbine International Trialist Association
Authors: J.-Y. Douillard, R. Rosell, M. Delena, A. Legroumellec, A. Torres, F. Carpagnano
Journal: Journal of Clinical Oncology (2005)

7013 Background: Adjuvant chemotherapy demonstrated a 5–15% benefit in 5-year survival in the IALT, JBR10 and CALGB9633 trials. However, other trials were negative (ALPI, ECOG 3590) and the role of chemotherapy for each disease stage has not yet been completely clarified. The randomized, prospective phase III trial ANITA compared the effectiveness of adjuvant NP versus OBS in early NSCLC. Methods: Completely resected pts were randomized to receive adjuvant NP (N 30 mg/m2/week, 16 administrations plus P 100 mg/m2 d1 q4 weeks for 4 cycles) or OBS. Eligibility criteria included histologically proven NSCLC, age 18–75 years, post-operative stage I (T2N0), II or IIIA. Radiotherapy policy was predetermined by each center. Study design: open, multicenter, randomized (1:1), stratified by center, stage and histology. Main endpoint: overall survival. Assuming 5% alfa error and 90% power to demonstrate a 10% improvement in survival at 2 years, 400 patients per arm had to be included. Results: 840 patients (NP 407; OBS 433) from 101 centers in 14 countries were included between 12/94 and 12/00. Median age: 59 (range 18–75); 86% male; 95% WHO PS 0–1; 59% squamous cell carcinoma; 35% stage I, 30% II, 35% IIIA. Pneumonectomy was performed in 37% of pts and lobectomy in 58%. Arms were well-balanced with regard to age, gender, histology, staging and resection type. Median follow-up is currently >70 months. Median survival was 65.8 months in NP and 43.7 months in OBS (P=0.0131; hazard ratio, 1.264 [1.05–1.52]). Survival at 2/5/7 years was 68%/51%/45% in NP and 63%/43%/37% in OBS. 5-year survival by stage I/II/IIIA were 62%/52%/42% in NP and 63%/39%/26% in OBS. Grade 3/4 toxicities in NP were manageable: neutropenia 86%; febrile neutropenia 8.5%; nausea-vomiting 27%; constipation 5%; peripheral neuropathy 3%. 5 pts (1%) died of drug-related toxicity. Conclusion: The ANITA results demonstrate that NP significantly improves survival in completely resected stage II and IIIA NSCLC pts, although no benefit was observed in stage I. No significant financial relationships to disclose.
Two Patients With Sarcoma
Authors: M. Sekeres, M.J. Vasconcelles, M. Mcmenamin, M. Rosenfeld-Darling, R. Bueno
Journal: Journal of Clinical Oncology (2000)

Article Tools Two Patients With Sarcoma Article Tools OPTIONS & TOOLS Export Citation Track Citation Add To Favorites Rights & Permissions COMPANION ARTICLES No companion articles ARTICLE CITATION DOI: 10.1200/JCO.2000.18.11.2341 Journal of Clinical Oncology - published online before print September 21, 2016 PMID: 10829055 Two Patients With Sarcoma M. SekeresxM. SekeresSearch for articles by this author , M.J. VasconcellesxM.J. VasconcellesSearch for articles by this author , M. McmenaminxM. McmenaminSearch for articles by this author , M. Rosenfeld-DarlingxM. Rosenfeld-DarlingSearch for articles by this author , R. BuenoxR. BuenoSearch for articles by this author Show More Dana-Farber Cancer Institute, Brigham and Women’s Hospital, and Harvard Medical School, Boston, MA https://doi.org/10.1200/JCO.2000.18.11.2341 First Page Full Text PDF Figures and Tables © 2000 by American Society of Clinical Oncology
A prospective phase II study on photodynamic therapy with photofrin II for centrally located early-stage lung cancer. The Japan Lung Cancer Photodynamic Therapy Study Group.
Authors: K Furuse, M Fukuoka, H Kato, T Horai, K Kubota, N Kodama, Y Kusunoki, N Takifuji, T Okunaka, C Konaka
Journal: Journal of Clinical Oncology (1993)

PURPOSE A phase II study was conducted between June 1989 and February 1992 to evaluate the activity and toxicity of photodynamic therapy (PDT) with photofrin II in centrally located early-stage lung cancer and to determine the complete response (CR) rate as the primary end point. PATIENTS AND METHODS Patients had histologically proven lung cancer and endoscopically superficial thickening or small protrusions. All lesions were located in subsegmental or larger bronchi. All patients had a performance status (PS) of 0 to 2 and arterial oxygen pressure tension (PaO2) &gt; or = 60 mm Hg. No lymph node or distant metastases were present. All patients received photofrin II (2 mg/kg) intravenously 48 hours before PDT. Tumor lesions were superficially photoradiated by an argon dye laser or an excimer dye laser. RESULTS Of 54 patients with 64 carcinomas, 51 with 61 carcinomas were eligible for toxicity evaluation and 49 with 59 carcinomas were assessable for response. Of the 59 assessable carcinomas, 50 (84.8%; 95% confidence interval, 73.0% to 92.8%) showed a CR after initial PDT. The median duration of CR was 14.0+ months (range, 2.0+ to 32.4+). The multiple regression model indicates that estimated length of longitudinal tumor extent was the only independent prognostic factor for CR (P = .002). Five carcinomas that had a CR had a local recurrence at 6, 10, 12, 16, and 18 months after initial PDT, respectively. Toxicity assessment (World Health Organization [WHO] grade 2) showed transient elevation of ALT (1.9%), pulmonary toxicity (7.7%), and allergic reaction (7.7%), as well as sunburn (1.9%). CONCLUSION PDT with photofrin II has an excellent effect on patients with centrally located early-stage lung cancer who have limited tumor invasion extending over a small area (&lt; or = 1 cm).
Abstract P391: Metabolic Syndrome Does Not Associate with an Increase Mortality in End Stage Renal Disease Patients: a Systematic Review and Meta-Analysis
Authors: Sikarin Upala, Anawin Sanguankeo
Journal: Circulation (2015)

Background: Metabolic syndrome (Mets) is documented to increase mortality in the general population. However, there are reports of lower mortality in end stage renal disease (ESRD) patients with obesity. We conducted a meta-analysis to determine the association of all-cause and cardiovascular disease (CVD) mortality, and residual renal function with Mets in ESRD subjects. Objectives: PubMed/MEDLINE, EMBASE, and CENTRAL from their inception to September 2014 were comprehensively searched for eligible studies assessing the effects of the metabolic syndrome in ESRD subjects. Inclusion criterion was ESRD participants who had hemodialysis (HD or peritoneal dialysis (PD). Renal transplant subjects were excluded. Two authors independently assessed article quality and extracted the data. The primary outcome was all-cause mortality and secondary outcomes were CVD death and residual renal function. Results: From 23 full-text articles, 7 studies involving 613 (all-cause mortality), 284 (CVD death) and 383 (residual renal function) participants were included in the meta-analysis that was based on the random effects model. Compared with the non-Mets, ESRD subjects with Mets had no significant difference in risk of all-cause mortality (pooled odds ratio= 1.65; 95% CI, 0.86, 3.17) (figure 1) or CVD death (pooled odds ratio= 1.67; 95% CI, 0.75, 3.69). There was also no difference in residual renal function between the two groups with pooled standard mean difference of -0.26 ml/min/1.73 m2 (95% CI: -0.62, 0.10). Conclusion: Metabolic syndrome is not associated with an increased risk of all-cause or CVD mortality in ESRD patients who underwent HD or PD.
Anticipating the needs of the neuro-oncology caregiver.
Authors: Margaretta S Page, Idonah Molina, Judy Patt, Susan M Chang
Journal: Journal of Clinical Oncology (2015)

228 Background: It is well documented that CGs of neuro-oncology patients have complex needs that vary across the disease trajectory. It has also been suggested that needs vary by individual and further work to better understand the expectations of support, as well as the timing and nature of support is needed. Methods: In September 2013, the UCSF Neuro-Oncology Division launched a program to specifically provide care to CGs. We focused initial efforts on the needs of CGs of patients with newly diagnosed glioblastoma (NDGBM) who were offered services over the first 4 months of the illness. For high risk (HR) patients characterized either at the time of progression or transition to hospice, CGs were offered services as much as needed after referral. The needs assessment spanned several domains. We report on the first 18 months of providing care to these two groups of CGs. Results: Of 65 CGs of NDGBM patients, 21% identified no needs, and of those that did, 52% had more than one need. 82% of 144 CGs of HR patients had multiple needs. Both groups had highest needs around emotional support and advocacy, with the HR CGs expressing significant higher need for emotional support at 80%. HR CGs had higher percentage of needs when compared to the NDGBM CGs around obtaining caregiver resources ( 42% vs. 28%), family relations (30% vs. 11 %), health care navigation and obtaining psychological services (26% vs. 6 %), and health information (21% vs. 8%). Conclusions: CGs express the need for increasingly complex support as the illness progresses with a differential demand compared to the time of initial diagnosis. This suggests that developing specific modules of care for high demand needs throughout the trajectory of the illness will improve the QOL of CGs of neuro-oncology patients.
HMGA2 expression and response to anthracycline-based preoperative chemotherapy in patients with operable breast cancer
Authors: F. Puglisi, P. Ermacora, P. Driol, P. Masolini, B. Alessi, F. E. Pisa, M. Pandolfi, M. Mansutti, V. Giancotti, C. Di Loreto
Journal: Journal of Clinical Oncology (2008)

22035 Background: Preclinical data suggest that increased expression of high mobility group A2 (HMGA2) protein could enhance chemosensitivity towards doxorubicin in breast cancer cells. The present study investigated the predictive value of HMGA2 immunoreactivity in patients (pts) with operable breast cancer (BC) treated preoperatively with regimens including anthracyclines. Methods: We reviewed the pretreatment biopsies of 94 pts with large (> 2 cm) operable BC treated with preoperative anthracycline-based chemotherapy, performing immunohistochemistry for HMGA2 and other biological markers (ER, PgR, HER2, MIB1, topoisomerase II α). Characteristics of preoperative chemotherapy (i.e. number of courses, type of anthracycline or taxane) were also analyzed. Association between clinico-biological factors and pathological, clinical (by caliper) and radiological (by mammography, ultrasound and MRI) response was assessed. Results: In univariate analysis, high expression of HMGA2 was significantly associated with clinical complete response [odds ratio (OR) = 4.9, 95% CI 1.3–18.9] and with tumor shrinkage assessed by MRI (OR = 2.9, 95% CI 1.1–7.7). No statistically significant association was observed between HMGA2 and clinical or pathological response in multivariate analysis. Among the other variables, the following were associated with complete pathological response (pCR): ER (p = 0.005), MIB-1 (p = 0.01) and topoisomerase II alfa (p = 0.05). In multivariate analysis, ER was the only independent predictor of pCR (OR = 0.2, 95% CI 0.03–0.9). The number of chemotherapeutic courses was independently associated with tumor shrinkage assessed by caliper (OR = 9.9, 95% CI 2.4–40.5) and by mammography (OR = 4.02, 95% CI 1.4–11.3). MIB-1 expression was independently associated with tumor shrinkage assessed by ultrasound (OR = 3.8, 95% CI 1.1–13.4) and by MRI (OR = 3.6, 95% CI 1.2–11.3). Conclusions: Immunohistochemical evaluation ofHMGA2 significantly predicted clinical complete response and tumor shrinkage assessed by MRI in patients treated with preoperative anthracycline-based chemotherapy. Although no independent association with response was observed, the potential predictive role of this protein deserves further evaluation. No significant financial relationships to disclose.
O066 : Bcl-3 regulates hepatic glucose and lipid metabolisms through insulin and associated metabolic transcription factors
Authors: N. Gehrke, M.A. Wörns, A. Schad, Y. Alt, A. Waisman, N. Hoevelmeyer, P.R. Galle, J.M. Schattenberg
Journal: Journal of Hepatology (2015)
Phenothiazine-induced bulbar palsy-like syndrome and sudden death
Authors: K Solomon
Journal: American Journal of Psychiatry (1977)

There have been periodic case reports of sudden death due to aspiration or asphyxiation in patients receiving phenothiazines. The mechanism of death is unknown. The author reports a case of a drug-induced bulbar palsy-like syndrome in a man receiving fluphenazine enanthate and reviews the literature on sudden respiratory death and phenothiazines. He postulates that phenothiazine-induced bulbar palsy may cause laryngeal and/or pharyngeal dysfunctions that are responsible for aspiration.
A phase I pharmacokinetic study of a liposomal formulation of paclitaxel administered weekly to Asian patients with solid malignancies
Authors: W. T. Lim, S. S. Leong, C. K. Toh, C. S. Ang, N. S. Wong, E. H. Tan, B. Chowbay
Journal: Journal of Clinical Oncology (2009)

2581 Background: Genexol-PM is a sterile, lyophilized polymeric micellar formulation of paclitaxel which is devoid of Cremophor EL and hence is more tolerable and less toxic. This phase 1 study sought to determine the maximum tolerated dose and the pharmacokinetic profile of Genexol-PM in Asian cancer patients with solid malignancies. Methods: Patients (N=35) refractory to previous chemotherapy were enrolled in a phase 1, open-label, dose-escalating study to assess safety, tolerability ad pharmacokinetics of Genexol-PM administered as a 1h infusion on a weekly basis for 3 weeks followed by a resting week. The starting dose was 80mg/m2. Cohorts of 1–6 patients were treated at 100, 120, 140, 160, 180 and the maximum administered dose was 200 mg/m 2 . Results: The median age was 56 years (range: 39 - 67 years) and two thirds of the enrolled patients were male (67%). Twenty-three patients (96%) had received prior chemotherapy, including eleven patients (46%) who had previously received taxane-based chemotherapy. The majority of patients had lung, nasopharyngeal and breast cancers. DLT was reached at 200 mg/m 2 . The MTD was 180 mg/m 2 . Grade 3 granulocytopenia was common in patients receiving Genexol-PM at doses of 120 mg/m 2 or higher in the first cycle. The most common grade 3 non-haematologic adverse events in cycle 1 were fatigue, myalgia and neuropathy and occurred mainly at dose level 7 (200 mg/m 2 ) in 4%, 4% and 8% of the patients. Five (21%) patients had partial response, 9 (38%) had stable disease and seven (29%) patients had disease progression. The pharmacokinetics of Genexol-PM displayed dose-proportionality, with both C max and AUC 0-∞ values increasing by approximately 4- and 3-fold as the dose of Genexol-PM was increased from 80mg/m 2 to 200mg/m 2 with no significant change in clearance. The median total-body clearance of Genexol-PM for all patients was 43.9 L/hr. Conclusions: The weekly regimen of Genexol-PM was found to be well-tolerated and responses were observed in patients with refractory tumours, including patients who had failed taxane-based chemotherapy previously. No significant financial relationships to disclose.
Abstract 51: Prognostic Implication of Initial Coagulopathy in Out-of-Hospital Cardiac Arrest
Authors: Joonghee Kim, Kyuseok Kim, Jae Hyuk Lee, You Hwan Jo, Tae Yun Kim, Joong Eui Rhee, Kyeong Won Kang
Journal: Circulation (2012)

Objective: We sought to investigate the prognostic implication of early coagulopathy represented by initial DIC score in out-of-hospital cardiac arrest (OHCA). Methods: OHCA registry was analyzed to identify patients with ROSC without recent use of anticoagulant between 2008 and 2011. Patients were assessed for prehosptial factors, initial laboratory results and therapeutic hypothermia. Outcome variables were survival discharge, 6-month CPC and survival duration within the first week after ROSC. Logistic regression and Cox-proportional hazards model were used for both univariate and multivariate analysis. Results: Among 273 eligible patients, initial DIC score was available in 252 (92.3%). Higher DIC score was associated with increased inhospital death (odds ratio [OR], 1.89 per unit; 95% confidence interval [CI], 1.48-2.41) and unfavorable long-term outcome (6-month CPC 3-5; OR, 2.21 per unit; 95% CI, 1.60-3.05). The adjusted ORs for both outcomes were 1.61 (95% CI, 1.17-2.22) and 1.84 (95% CI, 1.26-2.67), respectively. We categorized DIC score in five groups as &lt;3, 3, 4, 5 and &gt;5 and analyzed differential mortality risk using Cox- proportional hazards model. Compared with reference group (DIC score &lt;3), the adjusted HR for early mortality in each remaining group was 1.96 (95% CI, 1.13-3.40), 2.26 (95% CI, 1.27-4.02), 2.77 (95% CI, 1.58-4.85) and 4.29 (95% CI, 2.22-8.30), respectively (p-trend &lt;.001). The area under the receiver operating characteristic of DIC score for prediction of unfavorable long-term outcome was 0.79 (95% CI, 0.69-0.88). Conclusion: Increased initial DIC score in OHCA was an independent predictor for poor outcomes and early mortality risk. Uploaded image: Kaplan-Meier plots for cumulative 1-week survival of five DIC score groups; Log-rank test for difference (p &lt;.001, p-trend &lt;.001)
High prevalence of psychiatric disorders in patients with skin-restricted lupus: a case-control study
Authors: I. Jalenques, F. Rondepierre, C. Massoubre, E. Haffen, J.P. Grand, B. Labeille, J.L. Perrot, F. Aubin, F. Skowron, A. Mulliez, M. D'Incan
Journal: British Journal of Dermatology (2016)

Psychiatric disorders have been extensively documented in patients with systemic lupus erythematosus (SLE). However, the prevalence of psychiatric disorders in patients with skin-restricted lupus (SRL) remains unknown, although SRL is more common than SLE.To assess current and lifetime prevalence of Axis I psychiatric disorders among outpatients with SRL and to examine the factors associated with psychiatric disorders among such patients.A multicentre case-control study involving outpatients with SRL and controls matched for sex, age and education level. The Mini International Neuropsychiatric Interview was used for psychiatric evaluation.We evaluated 75 patients and 150 controls. Of these, 49% of patients vs. 13% of controls fulfilled the criteria for at least one current psychiatric disorder (P < 0·001). The following disorders were significantly more frequent among patients than controls: current and lifetime major depressive disorder (9% vs. 0%, P < 0·001 and 44% vs. 26%, P = 0·01), generalized anxiety disorder (23% vs. 3%, P < 0·001 and 35% vs. 19%, P = 0·03), panic disorder (7% vs. 0%, P = 0·004 and 21% vs. 3%, P < 0·001), current suicide risk (24% vs. 7%, P = 0·003), alcohol dependence (7% vs. 0%, P = 0·004) and lifetime agoraphobia (20% vs. 9%, P = 0·01). Lupus duration and lupus past treatment by thalidomide were significantly higher among patients with current psychiatric disorders.This study demonstrates a high prevalence of several psychiatric disorders (anxiety, depression, suicide risk, alcohol dependence) in patients with SRL.
Piperacillin-tazobactam versus cefepime monotherapy for pediatric febrile neutropenia
Authors: R. Kebudi, I. Ayan, Ö. Görgün, N. Gürler
Journal: Journal of Clinical Oncology (2005)

8550 Background: Febrile neutropenia is a major acute side effect of therapy in pediatric cancer, necessitating prompt initiation of empirical broad-spectrum antibiotics. Methods: Since 1994, monotherapy has been used for empiric initial treatment in our center. Cefepime (C), a fourth generation cephalosporin, was found as effective and safe as ceftazidime in a previous randomized trial in our center (Kebudi R et al, Med Pediatr Oncol 36:434–441,2001). Piperacillin-tazobactam (PT) is an extended spectrum penicillin combined with a beta-lactam inhibitor tazobactam. The aim of this single institution, prospective randomized study is to compare the efficacy of PT and C as empiric monotherapy of febrile neutropenic children with cancer. 40 episodes of fever and neutropenia were randomized to recieve treatment with either PT or C. Patients were analyzed for absolute neutrophil count (ANC) at entry, days with fever, neutropenia, hospitalization and side effects of drugs. Success with or without modifications of the initial antibiotic was defined as survival through neutropenia, failure was death due to infection. Results: In our study group, with a median age of 13 (2–14)years, PT was administered in 20 episodes [16 patients],and C in 20 episodes [15 patients]. There was no statistical difference in the median ANC at entry (28 vs 62/mm3),days with fever (2 vs 2), days with neutropenia (7 vs 6.5), days with antibiotics (7.5 vs 9.5) and days in hospitalization (7.5 vs 9.5) in the PT and C group respectively. An infection was documented microbiologically in 4(%20) vs in 5(%25) episodes and clinically in 9 (%45) vs in 10 (%50) episodes in the PT vs C arm. Episodes with severe neutropenia (% with ANC<100/mm3) was 70 vs 75% ; episodes with ≥7 days of neutropenia were 60 vs 50% in the PT vs C arm. The success rate with initial therapy was 65 vs 60% and the modification was 35 and 40% in the PT vs C arm. Modifications included aminoglicosides in 30 vs 25%, glycopeptides in 15 vs 25%, antifungals in 10 vs 10% in the PT vs C arm. There were no deaths. No major adverse effects were observed in either group. Conclusions: Piperacilin-tazobactam seems to be as effective and safe as cefepime for the empirical treatment of febrile episodes in neutropenic children with cancer. No significant financial relationships to disclose.