tbuckley/cabot-search huggingface dataset:
Quality of life assessment in CLEOPATRA, a phase III study combining pertuzumab with trastuzumab and docetaxel in metastatic breast cancer.
Authors: Javier Cortes, José Baselga, Young-Hyuck Im, Graham Ross, Emma Clark, Adam Knott, Sandra M. Swain
Journal: Journal of Clinical Oncology (2012)

598^ Background: CLEOPATRA compared the efficacy and safety of the HER2 dimerization inhibitor pertuzumab (P) plus trastuzumab (T) and docetaxel (D) with placebo (Pla)+T+D in HER2-positive 1 st -line MBC. Pts in both arms received a median of 8 cycles of D; Pla/P+T was continued until progressive disease (PD). The safety profile in both arms was similar with a substantial decrease in adverse events (AEs) once chemotherapy finished. The independently assessed progression-free survival was significantly improved with P+T+D compared with Pla+T+D; objective response and duration of response were also improved with P+T+D (Baselga NEJM 2012). Here we report health-related quality of life (HRQoL) data from CLEOPATRA. Methods: Time to deterioration of HRQoL was evaluated using the FACT-B questionnaire and defined as decrease from baseline (BL) of ≥5 points in the TOI-PFB subscale score. Female pts completed questionnaires every 3 rd cycle of therapy within 3 days before each tumor assessment until independently determined PD. An exploratory analysis investigated time to deterioration in breast cancer symptoms and functions. Results: 56.7% (Pla+T+D) and 59.5% (P+T+D) of pts experienced deterioration of HRQoL during the study based on TOI-PFB. The median time to deterioration was 18.3 vs 18.4 wks (~6 cycles) (HR 0.97; P = .7161). At Cycle 6, the mean reduction in TOI-PFB score from BL was –3.5 (Pla+T+D) vs –3.0 (P+T+D). At subsequent cycles, when most pts had discontinued D, mean reductions were smaller, suggesting that after an early decline patients’ scores improved slightly. Overall, mean changes were small in both arms. Compliance with completion of the FACT-B questionnaire was ≥75% beyond the 1 st year in both arms. An exploratory analysis suggested that time to deterioration in BCS score, which measures symptoms and issues relevant in breast cancer, was delayed with P+T+D (18.3 vs 26.7 wks; HR 0.77; P = .0061). Conclusions: Combining P with T+D appears to have no detrimental effect on HRQoL. Results suggest that P+T+D is associated with a substantial delay in the time to deterioration in BCS score as would be expected given the improved efficacy and the low incidence of AEs once D is discontinued.
Capnographic monitoring of midazolam and propofol sedation during ERCP: a randomized controlled study (EndoBreath Study)
Authors: Peter Klare, Johanna Reiter, Alexander Meining, Stefan Wagenpfeil, Tim Kronshage, Christoph Geist, Stefan Heringlake, Christoph Schlag, Monther Bajbouj, Gerhard Schneider, Roland Schmid, Till Wehrmann, Stefan von Delius, Andrea Riphaus
Journal: Endoscopy (2015)

<b>Background and study aims:</b> This was to determine whether intervention based on additional capnographic monitoring reduces the incidence of hypoxemia during midazolam and propofol sedation for endoscopic retrograde cholangiopancreatography (ERCP). <b>Methods:</b> Patients (American Society of Anesthesiologists [ASA] I – IV) scheduled for ERCP under midazolam and propofol sedation were randomly assigned to a control arm with standard monitoring or an interventional arm with additional capnographic monitoring. In both arms detection of apnea prompted withholding of propofol administration, stimulation of the patient, insertion of a nasopharyngeal tube, or further measures. The primary study end point was incidence of hypoxemia (oxygen saturation [Sa<sc>o</sc> <sub>2</sub>] below 90 %); secondary end points included occurrences of severe hypoxemia (Sa<sc>o</sc> <sub>2</sub> ≤ 85 %), bradycardia, and hypotension, and sedation quality (patient cooperation and satisfaction). <b>Results:</b> 242 patients were enrolled at three German endoscopy centers. Intention-to-treat analysis revealed no significant reduction in hypoxemia incidence in the capnography arm compared with the standard arm (38.0 % vs. 44.4 %, <i>P</i> = 0.314). Apnea was more frequently detected in the capnography arm (64.5 % vs. 6.0 %, <i>P</i> < 0.001). There were no differences regarding rates of bradycardia and hypotension. Per-protocol analysis showed lower incidence of hypoxemia in the capnography arm compared with the standard arm (31.5 % vs. 44.8 %, <i>P</i> = 0.048). There was one death related to sedation in the standard arm. Sedation quality was similar in the two groups. <b>Conclusion:</b> Intention-to-treat analysis showed hypoxemia incidence was not significantly lower in the additional capnography arm compared with standard monitoring. Additional capnographic monitoring of ventilatory activity resulted in improved detection of apnea. ClinicalTrials.gov identifier: NCT01072474.
The Nature of the “Partial” Tolerance Induced by Parity&lt;xref ref-type="fn" rid="FN2"&gt;2&lt;/xref&gt;
Authors: Edward J. Breyere, Sumner O. Burhoe
Journal: JNCI Journal of the National Cancer Institute (1963)

Previous studies showed prolonged survival of DBA/2 skin grafts on BALB/c females parous by DBA/2 males, but none survived permanently. The present experiments revealed that this apparent partial maternal tolerance resulted from complete and permanent tolerance to some graft antigens, while reactivity to others remained either unchanged or partially suppressed. This partial tolerance was studied in F2 hybrid females of the BALB/c and DBA/2 strains. They were mated to either BALB/c or DBA/2 males, and after bearing 3 litters, each female received a skin graft from each parental strain. Virgin F2 females were similarly grafted. A low percentage of permanently surviving grafts was obtained with virgins and females parous by males unrelated to the graft. The percentage of permanently surviving grafts in these 2 groups combined was 2.2 (12/541). A genetic concordance between the graft and breeding sire increased this percentage to 24.7 (74/300). Thus strain-specific matings resulted in the induction of complete and permanent tolerance in females to the transplantation antigens which were determined by a minimum of approximately 8 of the 13 pairs of independently segregating histocompatibility loci that differ between these 2 strains. These results further demonstrate the specificity of this reaction and suggest that the mechanisms involved might be applied to the successful transplantation of allogeneic tissues and the biology of choriocarcinoma.
Development of quality indicators for non-Hodgkin lymphoma
Authors: L. Wennekes, P. B. Ottevanger, J. M. Raemaekers, H. C. Schouten, P. H. De Mulder, R. P. Grol, R. P. Hermens
Journal: Journal of Clinical Oncology (2007)

17017 Background: Indicator development to monitor quality of care for non-Hodgkin lymphoma's (NHL) is difficult because NHL represents variable disorders with different and fast changing treatment policies. This study aimed to generate a set of valid indicators for NHL, using a systematic consensus method. Methods: Recommendations from evidence-based guidelines were collected as potential indicators. A multidisciplinary panel of 14 experts rated and discussed these recommendations on the usefulness as an indicator in three rounds using the Rand-modified Delphi procedure. This procedure was innovated with a flow chart from diagnostics to follow-up that showed which recommendations were crucial for the continuation of the care process. Experts were enforced to develop indicators for diagnostics, treatment and follow-up and the organization of care. Results: From a list of 99 recommendations 10 potential indicators for diagnostics, 10 for treatment and follow-up and 8 for the organization of care were selected. All potential indicators for diagnostics and treatment were crucial according to the flow chart. Six indicators were relevant for only a few patients and were rejected. Another six were merged into two. For diagnostics 8 indicators remained including taking a biopsy, evaluation of morphology and immune phenotype, the World Health Organization- classification, staging with CT-scanning of neck, thorax and abdomen, bone marrow aspirate and crista biopsy according to Ann Arbor, blood counts and the International Prognostic Index. For treatment 3 indicators remained regarding treatment with R-CHOP in optimal dose intensity for diffuse large B-cell lymphoma and response evaluation according to Cheson. For organization of care 7 indicators remained including waiting times, multidisciplinary consultations, adequate reporting and accredited expertise and facilities. Conclusions: This study showed that relevant quality indicators can be developed for a complex malignancy like NHL. Our innovations with the flow chart made a relevant contribution to the selection method and we managed to develop indicators for each part of the care process. They are currently tested for validity and feasibility. The use of these indicators makes it possible to monitor and improve the quality of care for NHL. No significant financial relationships to disclose.
Prediction of Axillary Lymph Node Response to Neoadjuvant Chemotherapy (Nac) By Changes in Maximum Standard Uptake Values (Suvmax) with 18Fdg-Pet (Pet) Imaging of the Primary Breast Tumour
Authors: M. Alamgeer, M. White, J. Stuckey, M. Harris, B. Kumar, S. Hart, J. Fox, D.N. Watkins, V. Ganju
Journal: Annals of Oncology (2014)
Role of interferon alfa-2b in the induction and maintenance treatment of low-grade non-Hodgkin's lymphoma: results from a prospective, multicenter trial with double randomization.
Authors: R Arranz, P García-Alfonso, P Sobrino, P Zamora, R Carrión, J García-Laraña, G Pérez, J López, E Lavilla, M Lozano, C Rayón, R Colomer, M G Barón, E Flores, G Pérez-Manga, J M Fernández-Rañada
Journal: Journal of Clinical Oncology (1998)

PURPOSE To evaluate the effectiveness of adding interferon (IFN) alfa-2b to chemotherapy in the induction treatment of low-grade non-Hodgkin's lymphoma (NHL), and to assess the role of maintenance IFN. PATIENTS AND METHODS A multicenter, two-phase controlled trial with double randomization was conducted in 155 patients with low-grade NHL. In the first randomization, 78 patients received cyclophosphamide, vincristine, and prednisone (CVP) and IFN, 3 MU/m2 three times a week for 3 months, and 77 patients received CVP alone. Responding patients were randomized to receive IFN for 1 year versus observation. RESULTS Of 144 assessable patients, 73 received CVP + IFN and 71 received CVP. Responses were similar: CVP + IFN 79% versus CVP 76% (P = .62). The number of patients who did not complete the treatment was higher in the CVP + IFN group than in the CVP group (18% v 4%; P = .009), although the received dose-intensity of chemotherapy was comparable. Duration of response and progression-free survival (PFS) were significantly higher in the CVP + IFN group than in the CVP group (P = .0004). However, we observed no differences in overall survival (OS) (P = .30), with a median follow-up for the surviving patients of 3 years. Grade 3/4 granulocytopenia was the most frequent toxicity and was similar in both groups (33% v32%). Eighty-three (74%) of the 112 responding patients were randomized to maintenance IFN or observation. The duration of response was similar between 42 patients that received IFN compared with 41 control patients (P = .83), independently of treatment previously administered. CONCLUSION Adding IFN alfa-2b to induction CVP in low-grade NHL did not induce a higher response rate, but it significantly increased the duration of the responses. We found significant differences in PFS that favored the patients who received CVP + IFN, but not in OS. To date, no additional benefit has been seen from the administration of IFN for maintenance.
Delay in breast cancer diagnosis by race/ethnicity
Authors: S. N. Sheinfeld Gorin, J. E. Heck
Journal: Journal of Clinical Oncology (2005)

6004 Background: Although white women have the highest incidence of breast cancer, black women have higher death rates from the disease. An important contributor to these disparities is delay in completion of referral follow-up after abnormal screening. The purpose of this study is to examine delay by race using a population-based database. Methods: Data were derived from the Surveillance, Epidemiology, and End Results (SEER)-Medicare linked database for women age 64 and older who were diagnosed with primary breast cancer only between 1992 and 1999. Race/Ethnicity was the primary predictor; the major outcomes were; diagnosis delay of 1 and 2 months, treatment delay of 1 month, and total clinical delay of 3 months. Covariates included; age, urban/rural, marital status, stage, tumor size, ER status, lymph node involvement, comorbidity (using Deyo-Charleson index), and an ecologic measure of census tract percent in poverty. Results: We identified 49,865 women with breast cancer; 2982 were African American. African-American women experienced the most diagnostic delay, with 20.9% of subjects delayed 1–2 months and 23.5% over 2 months, and the greatest amount of treatment delay, with 29.6% of subjects delayed over one month. Over one-fourth of African-American women experienced three or more months of clinical delay, significantly higher than any other racial group, and a 76% increase over the rate of white women. In mixed-level analyses, African-American race was a strong predictor of delay. After controlling for age, presence of comorbidities, marital status, size of the city of residence, and neighborhood percent under poverty, African-American women had an 89% (95% CI: 1.70–2.10) increased risk of diagnostic delay beyond one month and 58% (95% CI: 1.42–1.76) treatment delay beyond one month. African-Americans had an 81% (95% CI: 1.61–2.04) increased risk of total clinical delay. Conclusions: This study found a strong connection between African-American race and delay. These differences appear to persist irrespective of the degree of illness. Since reviews have found that patients with a delay of three months or more have 12% lower 5-year survival than those without delay, the study’s findings have important clinical and policy ramifications. No significant financial relationships to disclose.
Therapist guided internet based cognitive behavioural therapy for body dysmorphic disorder: single blind randomised controlled trial
Authors: Jesper Enander, Erik Andersson, David Mataix-Cols, Linn Lichtenstein, Katarina Alström, Gerhard Andersson, Brjánn Ljótsson, Christian Rück
Journal: BMJ (2016)

<b>Objectives</b>&nbsp;To evaluate the efficacy of therapist guided internet based cognitive behavioural therapy (CBT) programme for body dysmorphic disorder (BDD-NET) compared with online supportive therapy. <b>Design</b>&nbsp;A 12 week single blind parallel group randomised controlled trial. <b>Setting</b>&nbsp;Academic medical centre. <b>Participants</b>&nbsp;94 self referred adult outpatients with a diagnosis of body dysmorphic disorder and a modified Yale-Brown obsessive compulsive scale (BDD-YBOCS) score of ≥20. Concurrent psychotropic drug treatment was permitted if the dose had been stable for at least two months before enrolment and remained unchanged during the trial. <b>Interventions</b>&nbsp;Participants received either BDD-NET (n=47) or supportive therapy (n=47) delivered via the internet for 12 weeks. <b>Main outcome measures</b>&nbsp;The primary outcome was the BDD-YBOCS score after treatment and follow-up (three and six months from baseline) as evaluated by a masked assessor. Responder status was defined as a ≥30% reduction in symptoms on the scale. Secondary outcomes were measures of depression (MADRS-S), global functioning (GAF), clinical global improvement (CGI-I), and quality of life (EQ5D). The six month follow-up time and all outcomes other than BDD-YBOCS and MADRS-S at 3 months were not pre-specified in the registration at clinicaltrials.gov because of an administrative error but were included in the original trial protocol approved by the regional ethics committee before the start of the trial. <b>Results</b>&nbsp;BDD-NET was superior to supportive therapy and was associated with significant improvements in severity of symptoms of body dysmorphic disorder (BDD-YBOCS group difference −7.1 points, 95% confidence interval −9.8 to −4.4), depression (MADRS-S group difference −4.5 points, −7.5 to −1.4), and other secondary measures. At follow-up, 56% of those receiving BDD-NET were classed as responders, compared with 13% receiving supportive therapy. The number needed to treat was 2.34 (1.71 to 4.35). Self reported satisfaction was high. <b>Conclusions</b>&nbsp;CBT can be delivered safely via the internet to patients with body dysmorphic disorder. BDD-NET has the potential to increase access to evidence based psychiatric care for this mental disorder, in line with NICE priority recommendations. It could be particularly useful in a stepped care approach, in which general practitioner or other mental health professionals can offer treatment to people with mild to moderate symptoms at low risk of suicide. <b>Trial registration</b>&nbsp;ClinicalTrials.gov ID: NCT02010619.
Changes in the kinetics and biopotency of luteinizing hormone in hemodialyzed men during treatment with recombinant human erythropoietin.
Authors: F Schaefer, B van Kaick, J D Veldhuis, G Stein, K Schärer, W R Robertson, E Ritz
Journal: Journal of the American Society of Nephrology (1994)

To investigate the effect of recombinant human erythropoietin (rh-EPO) on the hypothalamo-pituitary-gonadal axis in end-stage renal failure, plasma luteinizing hormone (LH) concentration release was assessed by frequent blood sampling (every 10 min), both during an 8-h baseline period and after stimulation with an iv bolus of gonadotropin-releasing hormone (GnRH). Seven adult hemodialyzed men were studied before and after partial correction of anemia by rh-EPO treatment. LH was determined by an in vitro Leydig cell bioassay (bio-LH) and a highly sensitive immunoradiometric assay. Pulsatile bio-LH secretion and clearance characteristics were assessed by multiple-parameter deconvolution analysis. Although the rh-EPO treatment did not lead to a change in average concentrations of plasma bio-LH, the mass of hormone released per secretory burst more than doubled, and the estimated bio-LH production rate increased from 8.8 +/- 2.3 to 15.6 +/- 5.2 IU/L per hour (P = 0.05). The lack of change in mean plasma bio-LH is explained by a simultaneous decrease in plasma half-life from 106 +/- 27 to 67 +/- 19 min (P < 0.02). The decrease in the plasma half-life of bio-LH was closely associated with the rise in hematocrit, suggesting an effect of the increased red blood cell mass on LH distribution space and elimination kinetics. As a consequence of the changes in hormone kinetics, the incremental amplitudes of the plasma concentration pulses of bio-LH increased from 112 to 121% of nadir levels (P < 0.05), resulting in a more distinctly pulsatile pattern of hormone signals.(ABSTRACT TRUNCATED AT 250 WORDS)
Recurrence score and clinicopathologic characteristics of TAILORx participants by race and ethnicity.
Authors: Joseph A. Sparano, Robert J Gray, Jo Anne Zujewski, Timothy Joseph Whelan, Kathy S. Albain, Daniel Hayes, Charles E Geyer, Elizabeth Claire Dees, Edith A. Perez, Maccon M. Keane, Carlos Vallejos Sologuren, Timothy F Goggins, Ingrid A. Mayer, Adam Brufsky, Deborah L Toppmeyer, Virginia G Kaklamani, James N Atkins, Jeffrey L Berenberg, George W. Sledge
Journal: Journal of Clinical Oncology (2014)

36 Background: Black race is associated with worse outcomes in localized breast cancer. We evaluated the characteristics of patients enrolled in the Trial Assigning Individualized Options for Treatment (TAILORx) by race and ethnicity. Methods: The analysis included 10,071 evaluable patients with Recurrence Score (RS) data. Eligibility criteria included: (1) T1-2, N0 disease, (2) estrogen receptor (ER) and/or progesterone receptor (PR) positive disease that was also HER2/neu negative, (3) age 75 years or younger and medically appropriate for adjuvant systemic chemotherapy. Results: The study population included 8,501 whites (84%), 722 blacks (7%), 423 Asians (4%), and the remainder other/unknown race. With regard to ethnicity, 7,916 were nonHispanic (79%), 919 were Hispanic (9%), and 1,236 were of unreported ethnicity (12%). There was no significant difference in RS distribution (p = 0.14), median RS (17 vs. 17), and mean RS (19.6 vs. 18.4) in blacks compared with nonblacks. There was likewise no difference in Hispanic vs. nonHispanic ethnicity for RS distribution (p = 0.53), median RS (17 vs. 17), and mean RS (18.6 vs. 18.4). Blacks were significantly more likely to be younger (39% vs. 30% &lt; 50 years), have larger tumors (37% vs. 31% &gt; 2 cm), poor histologic grade (25% vs. 17%), and PR-negative disease (14% vs. 10%) (Chi square test p &lt; 0.05). Hispanic women were also significantly younger (39% vs. 30% &lt; 50 years), and demonstrated marginal but statistically significant differences in tumor size (65% vs. 69% &gt; 2 cm), histologic grade (20% vs. 18% poor), and PR expression (12% vs. 10% negative) (Chi square test &lt; 0.05). In 974 patients with information on body mass index (BMI), there was no correlation between BMI and RS (r = -0.04). BMI was higher for blacks than whites (medians 31.6 vs. 28.9, p = 0.02, Wilcoxon test), but not in Hispanics. Conclusions: In patients selected for participation in TAILORx there were no significant differences in RS by race, ethnicity, and BMI. Black and Hispanic patients were significantly younger, and blacks had tumors that were larger and more likely to be associated with poor grade. Clinical trial information: NCT00310180.
A Transmissible Virus-Induced Lymphocytic Leukemia of the Cat&lt;xref ref-type="fn" rid="FN2"&gt;2&lt;/xref&gt;
Authors: Charles G. Rickard, John E. Post, Fernando Noronha, Louise M. Barr
Journal: JNCI Journal of the National Cancer Institute (1969)

A spontaneous lymphocytic leukemia in a cat was transmitted to 56 of 68 inoculated kittens through 7 serial cell-free passages. The latent periods ranged from 30–139 days, with a median of 53 days. The induced lesions were, typically, a generalized lymphadenopathy with slight or moderate splenomegaly in some kittens. Histologically, the lesion was a malignant lymphoma of mixed histiocytic-lymphocytic cell type. A few experimental kittens developed a malignant lymphoma of more differentiated lymphocytic type. The experimental kittens had type C virus particles in, and budding into, intercellular spaces and, occasionally, cytoplasmic vesicles. The particles were approximately 110 mμ in diameter and morphologically similar to murine leukemia viruses. They occurred regularly in sections of bone marrow and less frequently in sections of plasma pellets, tissue cultures from neoplastic tissues, thymus, neoplastic lymph nodes, spleen, and liver. Electron microscopic examination of bone marrow biopsies was useful in monitoring experimental cats. The 107 negative biopsies on 50 cats and 34 positive biopsies on 18 cats were well correlated with other biological and pathological data. Tissue cultures derived from neoplastic lymph nodes or thymus or from bone marrow of the experimentally infected kittens produced large amounts of biologically active (leukemogenic) feline leukemia virus. Four experimental leukemic kittens that had received cell-free inocula also had liposarcomas. These solid tumors were multiple in 3 of the 4 cats. Type C virus particles budded from the surface of the liposarcoma cells.