tbuckley/cabot-search huggingface dataset:
The incidence of MDR-TB in new and retreatment cases of HIV and pulmonary tuberculosis co-infection
Authors: P.D. Motiani, Sivaresmi Unnithan
Journal: European Respiratory Journal (2013)

MDR TB has become a posing threat to the control of TB along with the scourge of HIV.The proportion of new MDR-TB ranges from 0%- 28.3% globally, in fact in more than 10 countries it is around 12%.The primary MDR-TB in India is 2-3%.This study was done on 43 HIV positive patients diagnosed with Pulmonary Tuberculosis in our institute, Jodhpur.Their sputum samples were sent to the IRL in Ajmer for mycobacterial culture and Drug Sensitivity for 4 drugs- H,R,S and E.7 out of the30 males were truck drivers and all the females in this study were housewives!22/30 males are migrants.The default rate in this study is 25.58%. 4/11 [36.36%] of the defaulters turned out to be MDRTB.Out of the 43 patients in the study, 51.16% are fresh cases.Of the rest 48.84%, 26% are defaulters, 8% are failure cases and 16% are relapse cases.In this study, 81.4% [35/43]were sputum positive and 18.6% [8/43] were sputum negative, though 5 of these 8 smear negative patients yielded results when cultured.The mean CD4 count was 116/cumm.12 cases were MDR.Of these 12, 5 were New TB cases [PRIMARY DRUG RESISTANCE is 11.63% (5/43)]& 7 Retreatment cases [ACQUIRED DRUG RESISTANCE is 16.29%].This increased incidence of primary drug resistance may be attributed to many factors- delayed diagnosis,prolonged infectiousness in HIV patients,drug toxicity and interactions,socio-behavioural and physiological reasons,misuse of ATT and primary transmission of the MDR TB bacillus. Overall association between MDR-TB and HIV or acquired MDR-TB and HIV could not be demonstrated,but the results suggest that HIV infection is associated with primary MDR-TB.  R:Is HIV Infection a Risk Factor for MDR TB?Sujit Suchindran et al May2009.
Phase I, Dose-Escalation Study of 2 Dosing Regimens of AS703569, An Inhibitor of Aurora and Other Kinases, Administered Orally in Patients with Advanced Hematological Malignancies
Authors: Anne Sonet, Carlos Graux, Johan Maertens, Christine-Maria Hartog, Justus Duyster, Katharina Götze, Jochen Greiner, Marie-Luise Hütter, Alois Gratwohl, Dominik Heim, Dagmar Hess, Yves Chalandon, Athos Gianella-Borradori, Narmyn Rejeb, Oliver Ottmann
Journal: Blood (2008)
Late-breaking abstract: Clinical and radiological characteristics of cytomegalovirus pneumonia in immunocompromised patients
Authors: Siwasak Juthong, Apinya Jirarat
Journal: European Respiratory Journal (2011)

Cytomegalovirus (CMV) has long been recognized as a cause of pneumonia in the immunocompromised host. There are few studies reported the correlation of clinical, and pulmonary infiltration with histopathological evidence of CMV pneumonia.   Objective:  To define the clinical, radiological features CMV pneumonia diagnosed by bronchoscopy with transbronchial lung biopsy.   Materials and methods:  The medical records of CMV pneumonia patients in Songklanagarind hospital between 1 January 2000 and 31 December 2009 were reviewed. CMV pneumonia was confirmed by the identification of cytomegalic inclusion bodies and surrounding tissue inflammation without other pathogen in lung tissue biopsy specimens.   Results:  Thirty-one CMV pneumonia patients were identified. Twenty –two patients had HIV-positive with a mean CD4 cell count of 18 cells/mL (1-49 cells/mL) and 8 patients had a history of corticosteroid use. All patients of CMV pneumonia had dyspnea, 90% had fever and 71% had cough. The onset of symptoms varied from acute onset in 38%, subacute onset in 25% to chronic onset in 35%.The most chest radiographic finding was bilateral symmetrical infiltration (53%), including patchy and linear infiltration. Focal lesions were detected in 47% of patients exclusively in middle and lower lobe. The hospital mortality rate was 45%.   Conclusion:  Most of patient with CMV pneumonia had dyspnea, fever and cough. Bilateral symmetrical infiltration is the most chest radiographic finding. CMV pneumonia was seen in severely immunosupressed HIV-positive patients and had a high mortality rate.
Randomized double-blind placebo-controlled phase II/III trial in adjuvant NSCLC patients with the candidate cancer vaccine IGN101
Authors: H. Loibner, H. Eckert, W. Stoiber, F. Groiss, E. Stoelben
Journal: Journal of Clinical Oncology (2008)

3012 Background: IGN101 is a cancer vaccine acting via the epithelial cell adhesion molecule (EpCAM) expressed on epithelial cancers. It consists of 0.5 mg alum-adsorbed murine Mab 17–1A that bears EpCAM epitopes to trigger an immune response by repeated s.c. injections. Vaccination may lower the incidence of relapse in adjuvant NSCLC without major side effects. Methods: Between 12/2001 and 04/2005 NSCLC patients (pts) were randomly assigned in 26 European centers to receive IGN101 (382 pts) or placebo (380 pts). Within 1–3 weeks after R0 resection in stage Ib-IIIa, treatment was applied subcutaneously on days 1, 15, 29, 71 and then every 3 months up to 3 years and every 6 months thereafter. No other pre- or postoperative therapy was permitted except postoperative radiotherapy in stage IIIaN2. Data lock was in 04/2007, 2 years after accrual of the last pt. Primary endpoint was relapse-free survival (RFS), secondary endpoints were tolerability, immunogenicity, overall survival and quality of life. As in a different placebo controlled trial with IGN101 and based on an exploratory analysis, pts with low lymphocyte and low neutrophil counts at entry had improved survival when treated with IGN101 (AACR 2007), for this NSCLC trial a prospectively defined subgroup analysis was performed for pts presenting with low neutrophil and low lymphocyte counts at entry. Results: Based on ITT, there was no difference in RFS (median IGN101 819 days, placebo 736 days; P=0.793). However, pts with lower neutrophil counts at entry (threshold 5x10E9/L) showed a trend to improved RFS when treated with IGN101 (median 1,096 vs 726 days; HR=0.735, P=0.196). For pts presenting both with lower neutrophil and lower lymphocyte counts at entry (thresholds 5x10E9/L and 1.6x10E9/L resp.) a significantly longer RFS was found (median IGN101 not reached, placebo 459 days; HR=0.482, P=0.034). Vaccinations were very well tolerated. Conclusions: NSCLC pts stage Ib, II and IIIa vaccinated with the cancer vaccine IGN101 following R0 resection have improved RFS when neutrophil and lymphocyte counts at baseline are below 5x10E9/L and 1.6x10E9/L resp. A further randomized trial with IGN101 using above predictive parameters as inclusion criteria is warranted to finally confirm these results. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Altropus Altropus Altropus Altropus
Postoperative liver function recovery after hepatic resection for colorectal metastases previously treated with bevacizumab
Authors: R. Adam, D. A. Wicherts, R. J. de Haas, F. Lévi, B. Paule, D. Azoulay, D. Castaing
Journal: Journal of Clinical Oncology (2009)

4093 Background: The influence of bevacizumab on postoperative morbidity in patients with colorectal liver metastases (CLM) submitted to hepatectomy has been evaluated. However, in spite of a potential inhibition of liver regeneration, its impact on postoperative liver function recovery remains unknown. Methods: From July 2005 to December 2007, we evaluated 37 patients treated with bevacizumab prior to hepatectomy. Postoperative evolution of liver function variables was compared with that of 70 bevacizumab-naïve patients. Recorded parameters included prothrombin time, serum aspartate and alanine aminotransferase levels, and serum gamma-glutamyltransferase and total bilirubin levels. Results: Most patients of the bevacizumab group received 1 line of chemotherapy (62% vs 54% in the control group) (P=0.43). Bevacizumab was combined to 5-fluorouracil (5-FU), leucovorin (LV) and irinotecan or 5-FU, LV and oxaliplatin in the last preoperative line, in 57% and 30% of cases, respectively. Patients received a mean total number of 10.4+5.7 and 11.1+6.2 cycles of preoperative chemotherapy in the bevacizumab and control group (P=0.56). The median number of administered bevacizumab cycles was 6 (range: 3–25). Bevacizumab administration was stopped at a median of 7.9 weeks before surgery (range: 3.6–18.0). Major hepatectomies were performed in 41% and 36% of bevacizumab and control patients, respectively (P=0.62). Baseline liver function tests as well as postoperative liver function recovery were similar between patients treated with or without bevacizumab (Table). Postoperative morbidity occurred in 35% of bevacizumab patients and in 43% of control patients (P=0.44). Conclusions: Preoperative bevacizumab treatment has no impact on short-term liver function recovery after hepatic resection for CLM and has no deleterious effect on the incidence of postoperative morbidity. [Table: see text] No significant financial relationships to disclose.
Phase I/II study of combined granulocyte colony-stimulating factor and granulocyte-macrophage colony-stimulating factor administration for the mobilization of hematopoietic progenitor cells.
Authors: J N Winter, H M Lazarus, A Rademaker, M Villa, C Mangan, M Tallman, L Jahnke, L Gordon, S Newman, K Byrd, B W Cooper, N Horvath, E Crum, E A Stadtmauer, E Conklin, A Bauman, J Martin, C Goolsby, S L Gerson, J Bender, M O'Gorman
Journal: Journal of Clinical Oncology (1996)

PURPOSE To study the toxicity and efficacy of combined granulocyte colony-stimulating factor (G-CSF) and granulocyte-macrophage colony-stimulating factor (GM-CSF) administration for mobilization of hematopoietic progenitor cells (HPCs). MATERIALS AND METHODS Cohorts of a minimum of five patients each were treated subcutaneously as follows: G-CSF 5 micrograms/kg on days 1 to 12 and GM-CSF at .5, 1, or 5 micrograms/kg on days 7 to 12 (cohorts 1, 2, and 3); GM-CSF 5 micrograms/kg on days 1 to 12 and G-CSF 5 micrograms/kg on days 7 to 12 (cohort 4); and G-CSF and GM-CSF 5 micrograms/kg each on days 1 to 12 (cohort 5). Ten-liter aphereses were performed on days 1 (baseline, pre-CSF), 5, 7, 11, and 13. Colony assays for granulocyte-macrophage colony-forming units (CFU-GM) and erythroid burst-forming units (BFU-E) were performed on each harvest. RESULTS The principal toxicities were myalgias, bone pain, fever, nausea, and mild thrombocytopenia, but none was dose-limiting. Four days of treatment with either G-CSF or GM-CSF resulted in dramatic and sustained increases in the numbers of CFU-GM per kilogram collected per harvest that represented 35.6 +/- 8.9- and 33.7 +/- 13.0-fold increases over baseline, respectively. This increment was attributable both to increased numbers of mononuclear cells collected per 10-L apheresis and to increased concentrations of progenitors within each collection. The administration of G-CSF to patients already receiving GM-CSF (cohort 4) caused the HPC content to surge to nearly 80-fold the baseline (P = .024); the reverse sequence, ie, the addition of GM-CSF to G-CSF, was less effective. The CFU-GM content of the baseline aphereses correlated with the maximal mobilization achieved (r = .74, P = .001). CONCLUSION Combined G-CSF and GM-CSF administration effectively and predictably mobilizes HPCs and facilitates apheresis.
Individualized neoadjuvant treatment strategy in adenocarcinoma of the esophago-gastric junction (AEG): Interim report on the MUNICON trial
Authors: F. Lordick, W. A. Weber, H. J. Stein, C. Schuhmacher, A. Beer, M. Hennig, K. Ott, C. Peschel, M. Schwaiger, J. R. Siewert
Journal: Journal of Clinical Oncology (2004)

4060 Background: 18-Fluorodeoxyglucose-PET (FGD-PET) was found to be a valuable tool for the prediction of response during neoadjuvant chemotherapy (CTx) in locally advanced AEG. Major histological remissions were seen in 53% of metabolic responders whereas in unselected patients the rate was found to be only 24% (Weber et al. JCO 2001: 3058–65). The MUNICON trial implements response prediction by means of FDG-PET into clinical decision making. Methods: Patients (pts) with cT3 AEG receive platin-based neoadjuvant CTx. Metabolic responders (decline of FDG tumor uptake > 35% 2 weeks after the onset of CTx compared to baseline PET) continue with CTx for a duration of 3 months. Metabolic non-responders discontinue CTx and proceed to surgery. Clinical response is assessed according to RECIST. Major histological response is defined as <10% vital tumor cells in the resected tumor. The recruitment goal is 108 pts within 3 yrs. The primary endpoint is survival. Results: From 6/02–3/03 34 pts (median age 62 yrs, range 36–75; 32 males) have been enrolled. 22 pts (65%) were classified as metabolic responders. 11 pts (32%) were non-reponders. 1 patient (3%) died before metabolic response assessment. 31 pts (91%) underwent resection. R0 resection was achieved in 26/34 pts (76%), thereof 18/22 responders (82%) and 8/11 non-responders (73%). In metabolic responders, clinical remission was achieved in 14 pts (64%; 95% CI 0.41–0.83) and major histological response was seen in 11 pts (50%, 95% CI 0.28 – 0.72). In all metabolic non-reponders clinical staging (cT3) was confirmed histopathologically (pT2b/3). None of the metabolic non-responders had achieved any grade of histological regression. After a median follow-up of 12 (8–18) months 6 pts have died. Further survival endpoints were not subject of this interim analysis. Conclusion: The interim analysis of the MUNICON trial confirms previous findings. An individualized treatment approach in locally advanced AEG proves to be feasible. Early metabolic response assessment aids to select patients for neoadjuvant chemotherapy who have a good chance for clinical and histological response. No significant financial relationships to disclose.
Electronic health records (EHR) adapted for clinical trials.
Authors: N. E. Shklovskiy-Kordi, B. Zingerman, L. Varticovski
Journal: Journal of Clinical Oncology (2011)

e16582 Background: The design of clinical trials requires standardized analysis of individual patients at presentation, their disease progression and treatment outcomes. ASCO “Practical Guide for Selecting and Implementing Electronic Health Records” has complies with the National Standard of Russia “The Electronic Health Record”, operating since 2008. Methods: The EHR National Standard of Russia based on experience acquired by design and implementation of EHR system of the NCH in Moscow. Our platform allows integrated data presentations on a uniform axis of time and access to all information, including laboratory data, diagnostic images, etc. It allows the integration of these data from multiple sources. This approach is important for evaluation of correlations and dynamic changes of clinical parameters Results: NCH EHR system has been used for more than 10 years by over 400 physicians. It contains a collection of approximately 3 million personal medical records on over 50 thousand patients treated NCH during this period. The use of this EHR resulted in a decrease of medical errors. It also proved to be an effective tool of clinical decision management, and allowed economizing time of the medical staff. We developed recommendations for the use of Internet technologies, for personal health records (PHR) collection on www.medarhiv.ru can be used in clinical trials, making patients active participants of treatment and reporting outcomes. It allows personal privacy and unites Internet-based PHR with clinical and administrative instruments Conclusions: Our PHR system uses currently available computer programs, and offers a fast integration of data. It also provides an option of active participation of patients and is compatible with most basic computer systems. The world community of hematologists and oncologists will greatly benefit from uniform approaches to conducting EHR. This approach will improve efficiency of therapy, telemedicine, referrals and recruiting patients for clinical trails
CYP2D6*4 polymorphism as blood predictive biomarker of breast cancer relapse in patients receiving adjuvant tamoxifen
Authors: S. Gonzalez-Santiago, R. Zárate, J. Haba-Rodríguez, A. Gómez, E. Bandrés, S. Moreno, P. Borrega, J. García-Foncillas, E. Aranda
Journal: Journal of Clinical Oncology (2007)

590 Background: Polymorphisms in cytochrome P450 2D6 gene affect the plasma concentration of tamoxifen active metabolites (endoxifen). Some drugs are known to be CYP2D6 inhibitors. We aim to determine the relationship between CYP2D6*4 polymorphisms, concomitant CYP2D6 inhibitors use and clinical outcomes of breast cancer patients receiving adjuvant tamoxifen (TAM). Patients and Methods: CYP2D6*4 (1934 G&gt;A+1) genotype was determinated from DNA of blood samples using PCR-RFLP technique and Taqman Allelic Discrimination Assay in a series of 84 breast cancer patients receiving adjuvant TAM. CYP2D6 inhibitors were recorded. Chi-square test and logistic regression models were used to determinate association between genotype, use of concomitant CYP2D6 inhibitors and disease relapse rate. Results: In our 84 patients series mean age was 51.5y. (33–71). 14.8% were stage I, 58.0% stage II and 27.2% stage III. 61.4% were nodes positive and 98.7% tumors had positive hormonal receptors. We observed disease recurrence in 36.9% of cases. The mean following-up was 5.5 y. Genotype frequency was: wt/wt (57.1%), wt/*4 (40.5%) and *4/*4 (2.4%). 50% (18 of 36) of patients with the wt/*4 + *4/*4 genotypes had disease relapse compared with 27% (13 of 48) with wt/wt genotype (P= 0.041). Only 6 patients received concomitants CYP2D6 inhibitors, mainly antidepressants, all of them with the wt/*4 genotype. 50% presented disease relapse. Clinical pathological variables were evaluated and significant relation was found between stage and disease relapse by univariate analysis (P= 0.001). We investigated whether CYP2D6*4 genotype and stage to diagnosis could influence in disease relapse. For these analyses we use as reference group the genotype wt/wt. We observed that combined genotype wt/*4 + *4/*4 was more strongly associated with disease recurrence than wt/wt genotype (adjusted hazard ratio [HR], 2.82, 95% confidence interval [CI] 1.0- 7.9) P= 0.049. Conclusions: Breast cancer patients with the CYP2D6 *4/*4 or wt/*4 genotype could have lower benefit of TAM adjuvant treatment and tend to have a higher risk of disease relapse. Pre-treatment CYP2D6 genotype determination from blood sample could predicts TAM clinical outcomes and help to oncologist in treatment decision. No significant financial relationships to disclose.
UK vaccine damage scheme must pay 120 000 to boy who developed narcolepsy after swine flu vaccination
Authors: C. Dyer
Journal: BMJ (2015)

A 12 year old boy who developed narcolepsy and cataplexy after being vaccinated against swine flu at age 7 has been awarded £120 000 (€165 000; $186 000) in compensation, in a ruling that opens the way for dozens of similar awards from the United Kingdom’s statutory vaccine damage compensation scheme.

Claims by the unnamed boy and dozens of others who developed the chronic neurological disorders after being given the vaccine Pandemrix during the swine flu outbreak in 2009-10 had …
Update of cladribine in the treatment of adults with Langerhans-cell histiocytosis (LCH)
Authors: A. P. Hampshire, A. Saven
Journal: Journal of Clinical Oncology (2004)

6602 Background: LCH is a neoplasm of the monocytic-phagocytic system for which treatment is palliative. We previously reported on the activity of cladribine (2-CdA [2-chlorodeoxyadenosine]; Leustatin, Ortho Biotech, Raritan, NJ) in adults with LCH (Saven, A. et al., Blood; 93, 4125–30, 1999). Herein we update previous results and expand on the original observations. Methods: Cladribine was administered at 0.14 mg/kg/d IV over 2 hours for 5 consecutive days, every 4 wks. for a maximum of 6 cycles. Results: 16 pts. (9 female), median age 44 yrs. (range, 19–72) were treated. Median duration from diagnosis to cladribine was 82 mos. (range, 1–288). 14/16 pts. (88%) had received prior treatment; median number 3 (range, 1–6). At study entry, 11 pts. (69%) had stage I, 4 pts.(25%) had stage II, and 1 pt. (6%) had stage 3 disease. Organ involvement included skin in 10 pts., bone in 6, lung in 6, adenopathy in 5, diabetes insipidus in 4, colon in 2, and thyroid in 1 pt.. Median of 3 cycles of cladribine (range, 1–6) was administered. 16 were evaluable for toxicity, and 15 for response. 1 pt. was removed from the study after an allergic reaction during the first infusion. CR was achieved in 7 (44%) and PR in 3 pts. (19%), ORR of 63%. Median response duration was 36.2 mos. (range, 0.9- 112.5); 5 of the CRs remain in remission at 97.1+ mos. (range, 40.8–114.8+). Leukopenia was the principal toxicity with 8 pts. (50%) experiencing grade 3/4 neutropenia. Febrile neutropenia developed in 2 pts., and 1 pt. developed dermatomal zoster. The following second malignancies were observed in single pts.: recurrent thyroid cancer, nonmelanoma skin cancer, CMMoL (>3 years from cladribine), and refractory anemia (9 years from treatment). With a median follow-up of 105.6 mos. (range, 8.5–149.3), 3 pts. died (2 from progressive LCH and 1 from CMMoL), and 13 remain alive (7 NED, 2 on salvage therapy, and 4 remain alive at last contact). Conclusions: Bolus cladribine is a safe, convenient and effective therapy for adults with LCH, even when heavily pretreated; unmaintained durable remissions can be achieved in a subset of pts.. Long term follow-up of these pts. is necessary since myelodysplasia may complicate cladribine treatment. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Ortho Biotech Ortho Biotech
Patients’ experiences with navigation for cancer care
Authors: J. Carroll, S. G. Humiston, C. M. Salamone, P. Jean-Pierre, R. M. Epstein, K. Fiscella
Journal: Journal of Clinical Oncology (2009)

e17520 Background: Patient navigation is a promising strategy for improving cancer care. We examined (1) how navigation influences patients’ perspectives on their cancer care and (2) the most effective (i.e., meaningful or valuable) aspects of navigation from the patient's viewpoint. Methods: We conducted post-study patient interviews from a randomized controlled trial (usual care vs. patient navigation services) from cancer diagnosis through treatment completion. Patients were recruited from 11 primary care, hospital and community oncology practices in Monroe County, NY. We interviewed patients about their specific experiences with cancer care including their expectations and experience of patient navigation or, for non-navigated patients, other sources of assistance. Results: Thirty-five patients (32 female, 3 male) newly diagnosed with breast (n = 28) or colorectal (n = 7) cancer who completed the study and were interviewed from May 2007 through March 2008. Patients who received navigation were very positive about their experience. Valued aspects of navigation included emotional support, assistance with information needs and problem-solving (such as with insurance or financial stressors), and logistical coordination of cancer care. Unmet cancer care needs expressed by patients randomized to usual care consisted of lack of assistance or support with childcare, household responsibilities, coordination of care, and emotional support. Conclusions: Cancer patients value navigation. Instrumental benefits were the most important expectations for navigation from navigated and non-navigated patients. However, when describing their actual experience of navigation, navigated patients frequently mentioned receiving emotional support as well as assistance with information needs, problem-solving, and logistical aspects of cancer care coordination. No significant financial relationships to disclose.