tbuckley/cabot-search huggingface dataset:
Quality-of-life and performance status results from the phase III RAINBOW study of ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated gastric or gastroesophageal junction adenocarcinoma
Authors: S.-E. Al-Batran, E. Van Cutsem, S.C. Oh, G. Bodoky, Y. Shimada, S. Hironaka, N. Sugimoto, O.N. Lipatov, T.-Y. Kim, D. Cunningham, P. Rougier, K. Muro, A.M. Liepa, K. Chandrawansa, M. Emig, A. Ohtsu, H. Wilke
Journal: Annals of Oncology (2016)

The phase III RAINBOW trial demonstrated that the addition of ramucirumab to paclitaxel improved overall survival, progression-free survival, and tumor response rate in fluoropyrimidine-platinum previously treated patients with advanced gastric/gastroesophageal junction (GEJ) adenocarcinoma. Here, we present results from quality-of-life (QoL) and performance status (PS) analyses.Patients with Eastern Cooperative Oncology Group PS of 0/1 were randomized to receive ramucirumab (8 mg/kg i.v.) or placebo on days 1 and 15 of a 4-week cycle, with both arms receiving paclitaxel (80 mg/m(2)) on days 1, 8, and 15. Patient-reported outcomes were assessed with the QoL/health status questionnaires EORTC QLQ-C30 and EQ-5D at baseline and 6-week intervals. PS was assessed at baseline and day 1 of every cycle. Time to deterioration (TtD) in each QLQ-C30 scale was defined as randomization to first worsening of ≥10 points (on 100-point scale) and TtD in PS was defined as first worsening to ≥2. Hazard ratios (HRs) for treatment effect were estimated using stratified Cox proportional hazards models.Of the 665 patients randomized, 650 (98%) provided baseline QLQ-C30 and EQ-5D data, and 560 (84%) also provided data from ≥1 postbaseline time point. Baseline scores for both instruments were similar between arms. Of the 15 QLQ-C30 scales, 14 had HR < 1, indicating similar or longer TtD in QoL for ramucirumab + paclitaxel. Treatment with ramucirumab + paclitaxel was also associated with a delay in TtD in PS to ≥2 (HR = 0.798, P = 0.0941). Alternate definitions of PS deterioration yielded similar results: PS ≥ 3 (HR = 0.656, P = 0.0508), deterioration by ≥1 PS level (HR = 0.802, P = 0.0444), and deterioration by ≥2 PS levels (HR = 0.608, P = 0.0063). EQ-5D scores were comparable between treatment arms, stable during treatment, and worsened at discontinuation.In patients with previously treated advanced gastric/GEJ adenocarcinoma, addition of ramucirumab to paclitaxel prolonged overall survival while maintaining patient QoL with delayed symptom worsening and functional status deterioration.NCT01170663.
Aerosolized BCG (Tice Strain) Treatment of Bronchogenic Carcinoma: Phase I Study&lt;xref ref-type="fn" rid="fn2"&gt;2&lt;/xref&gt;
Authors: C L Cusumano, J A Jernigan, R H Waldman
Journal: JNCI Journal of the National Cancer Institute (1975)

Journal Article Aerosolized BCG (Tice Strain) Treatment of Bronchogenic Carcinoma: Phase I Study Get access C. L. Cusumano, M. D., C. L. Cusumano, M. D. Search for other works by this author on: Oxford Academic PubMed Google Scholar J. A. Jernigan, M.D., J. A. Jernigan, M.D. Search for other works by this author on: Oxford Academic PubMed Google Scholar R. H. Waldman, M.D. R. H. Waldman, M.D. Search for other works by this author on: Oxford Academic PubMed Google Scholar JNCI: Journal of the National Cancer Institute, Volume 55, Issue 2, August 1975, Pages 275–279, https://doi.org/10.1093/jnci/55.2.275 Published: 01 August 1975 Article history Received: 30 October 1974 Revision received: 11 March 1975 Accepted: 07 April 1975 Published: 01 August 1975
Efficacy and safety of oral lactoferrin supplementation associated with rHuEPOβ for the treatment of anemia in advanced cancer patients submitted to chemotherapy.
Authors: A. Macciò, C. Madeddu, G. Gramignano, C. Mulas, E. Sanna, G. Mantovani
Journal: Journal of Clinical Oncology (2010)

e19515 Background: Advanced stage cancer patients often suffer from anemia which closely resembles the anemia of chronic inflammatory diseases characterized by peculiar changes in iron homeostasis and absorption. Intravenous (IV) iron improves the efficacy of recombinant human erythropoietin (rHuEPO) in anemic cancer patients undergoing chemotherapy. Methods: We report the results of a phase III randomized trial aimed to test the non-inferiority in terms of efficacy and safety of a treatment with oral lactoferrin versus IV iron, both in association to rHuEPO, for the treatment of anemia in a population of 85 advanced cancer patients submitted to chemotherapy. All patients received subcutaneously rHuEPO β 30000 IU once weekly for 12 weeks and were randomly assigned to ferric gluconate 125 mg IV weekly or oral lactoferrin 200 mg/day. Results: Both arms showed a significant hemoglobin increase. No difference in mean hemoglobin increase as well as hematopoietic response, time to hematopoietic response, mean changes of serum iron, C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR) were observed between arms. Vice versa, ferritin decreased in lactoferrin arm while it increased in IV iron arm. Conclusions: These results showed a similar efficacy of oral lactoferrin in comparison to IV iron, in association of rHuEPO, for the treatment of anemia in advanced cancer patients submitted to chemotherapy. No significant financial relationships to disclose.
Improving Surgical Research by Involving Stakeholders
Authors: Peter C. Minneci, Kristine M. Nacion, Daniel L. Lodwick, Jennifer N. Cooper, Katherine J. Deans
Journal: JAMA Surgery (2016)

Improving Surgical Research by Involving StakeholdersEnrolling patients in prospective surgical trials is difficult, especially in the urgent and/or emergent care setting.However, there is growing support for including patients, caregivers, and other health care stakeholders in all phases of research to assist with identifying and incorporating outcomes important to the public, developing strategies to improve enrollment and retention rates, and accelerating the dissemination and implementation of results. [1]2][3][4][5] We report the effect of stakeholder involvement in an ongoing randomized clinical trial (RCT) (Clini-calTrials.gov,NCT02110485) of pediatric appendicitis.Methods | A 20-member multidisciplinary stakeholder group has been engaged in all phases of the RCT described above, which is funded by the Patient-Centered Outcomes Research Institute and is investigating the effects of a patient activation tool in uncomplicated pediatric appendicitis.The stakeholder group began working with our research team at Nationwide Children's Hospital in Columbus, Ohio, in October 2012, and the RCT began enrolling patients on March 10, 2014.Patient activation involves providing families with the knowledge and skills they need to be willing, confident, and engaged participants in their child's care. 6 The patient activation tool is an interactive tablet-based application designed to improve shared decision making by educating and engaging families and helping them resolve decisional uncertainty.The stakeholder group consists of children aged 7 to 17 years and their families, community-based pediatricians, emergency medicine physicians, surgeons, nurses, patient educators, and payers.The stakeholders have participated in all phases of this project including trial design, intervention development, outcome selection, recruitment, and retention.Collective stakeholder meetings occur semiannually, with additional quarterly email updates throughout the course of the project to discuss issues related to the current phase of the trial.Stakeholder suggestions are discussed to determine which can be reasonably implemented given financial, logistical, and ethical limitations.The 2 most
The effect of pulmonary rehabilitation toward expiratory airflow limitation in patients with chronic obstructive pulmonary disease
Authors: Weili Gu, Rongchang Chen, Yin Xi
Journal: European Respiratory Journal (2011)

Background and objective:  Patients with chronic obstructive pulmonary disease (COPD) are commonly referred for pulmonary rehabilitation (PR), but there is limited evidence on the effect of home-based PR. The aim of this study was to determine the effect of a new home-based PR toward expiratory airflow limitation method among COPD patients.   Methods:  40 stable COPD patients (FEV1,37.7±13.0% predicted) were randomized to PR group (n=20) undergoing a 8 weeks home-based PR programme more suitable to respiratory physiology and control group (n=20). Baseline and post-PR variables were recorded, and changes in pulmonary function, respiratory muscle strength and quality of life (St. George9s Respiratory Questionnaire, SGRQ), as well as the body mass index, airway obstruction, dyspnea, and exercise capacity (BODE) index, were evaluated.   Results:  After the PR programme, there were a significant increase in respiratory muscle strength (P 0.05).   Conclusion:  We conclude that PR toward expiratory airflow limitation substantially improved respiratory muscle strength, exercise capacity, dyspnea, quality of life and the BODE index. Therefore, it could be considered as a new effective home-based PR method in stable COPD patients.
Neoadjuvant chemotherapy (NC) in cervical cancer (CC) stage IB2, IIA and IIB: An analysis of 109 patients
Authors: C. Tosello, M. T. Laloni, F. Moura Silva, R. L. R. Costa, E. M. Fukazawa, F. Medina, J. C. G. S. Góes
Journal: Journal of Clinical Oncology (2004)

5087
A phase II open-label study of cetuximab in unresectable hepatocellular carcinoma
Authors: V. Gruenwald, L. Wilkens, M. Gebel, T. Wirth, T. Greten, S. Kubicka, M. P. Manns, A. Ganser, N. P. Malek
Journal: Journal of Clinical Oncology (2006)

14079 Background: The majority of hepatocellular carcinomas (HCC) express the epidermal growth factor receptor (EGFR). The monoclonal anti-EGFR antibody cetuximab blocks EGFR activation. In the current study, we tested the activity of cetuximab in this disease. Methods: Pts with advanced or metastatic HCC and measurable disease with adequate renal, hematologic and hepatic function (bilirubin &lt;2×UNL; AST/ALT &lt;3×UNL) were eligible. Prior regional or systemic therapy was permitted. A total of 15 pts have been enrolled to date. Primary endpoint: rate of progression free survival (PFS) at 24 weeks of treatment. Secondary endpoints: overall survival (OS), objective response rate (ORR), tolerability and identification of surrogate markers. Tumor biopsies were performed prior to treatment, after 4 wks and at time of progression. Specimens were analyzed for genetic instability (FISH analyses) and cell cycle regulation (p27 Kip1 , skp2, EGFR) by immunohistochemistry. Cetuximab was administered 400 mg/m 2 iv week 1, and 250 mg/m 2 weekly thereafter until disease progression. Demographics: male 14, female 1, age 46–78 yrs (median 65), cirrhosis 13/15 pts, liver transplantion 2/15pts, Childs-Pugh class A: 14/15, B:1/15; distant metastases 6/15; risk factors: hepatitis C virus (HCV) 2/15, HBV 1/15. Contrast enhanced ultrasound examinations were performed on all pts at −2, 4, and at the time of progression to evaluate tumor blood flow. Results: At the time of the first tumor evaluation (8 wks) 2/15 pts (13%) achieved stable disease (SD). Tumor specimens showed a significant increase in copy numbers for centromeric probes against chromosome 1 and 8 in patients with progressive disease. Toxicity: all pts developed skin rash: Grade (Gr) 1 in 12/15 pts, Gr 2 in 3/15. Allergic reaction Gr 1 was seen in 1 pt. 2 pts required dose reduction for drug-related toxicity Conclusions: Cetuximab is well tolerated in pts HCC and liver cirrhosis, without additional toxicity. To date only modest activity has been detected in these unfavorably advanced pts. Accrual will continue to 35 pts total. At time of disease progression tumor specimens showed chromosomal instability with an increase in copy numbers of chr. 1 and 8. Updated results will be presented at the meeting. [Table: see text]
Randomized study of decitabine versus conventional care (CC) in patients (pts) with intermediate- and high-risk acute myeloid leukemia (AML) in first or subsequent complete remission (CR).
Authors: F. Ravandi Kashani, J. Jorgensen, S. Faderl, J. Issa, J. Autry, G. Garcia-Manero, G. Borthakur, X. Huang, J. E. Cortes, H. Kantarjian
Journal: Journal of Clinical Oncology (2010)

6527 Background: Maintenance therapy in AML is not standard. Methylation of tumor suppressor genes in CR predicts relapse. Hypomethylating therapy may be effective in maintaining CR. Methods: We compared DAC to conventional care (CC, low dose subcutaneous ara-C, prolonged chemotherapy, or observation) in pts with AML in first (CR1) or subsequent CR (CR>1). Pts with non-favorable risk AML received induction and consolidation, were stratified by age (≤ 60 vs. > 60) and cytogenetics (CG; intermediate vs. poor risk), and randomized to DAC 20 mg/m2 IV daily x 5 every 4 to 8 wks for 12 cycles, or CC. Pts in CR>1 were randomized after salvage. Primary endpoint was no relapse at 1 year. MRD was monitored by multicolor flow cytometry (MFC) by custom staining panels based on the phenotypes in BM. Serial samples for methylation studies were collected. Results: 50 pts have been enrolled; 41 (17 M, 24 F) pts (including 32 in CR1 and 9 in CR>1) were evaluable. Median age is 57 yrs (range, 24-77). 28 pts are ≤ 60 yrs. CG at diagnosis was intermediate in 37 pts, poor-risk in 3 pts, and favorable [inv(16)] in one relapsed patient. 19 evaluable pts were randomized to DAC and have received a median of 4 cycles (range 1-12). 22 evaluable pts were randomized to CC. With a median duration of follow up for the entire group of 69 wks (range, 12-159 wks); 7 of 19 (36.8%) on DAC versus 14 of 22 (63.6%) on CC are alive in CR (p = 0.02). Toxicity in the DAC arm was reversible G 3/4 neutropenia (13), G 3/4 thrombocytopenia (9), and G 2 anemia (1). Other G 3/4 adverse events on the DAC arm include hypertension (1), fatigue (1) and line related infection (1). No treatment-related deaths on the study. MRD assays by MFC were done on BM in 39 pts. MRD was detected in 11 pts, involving 0.04% to 1% (mean 0.5%) of total cells; 9 pts subsequently relapsed 1.5 to 10 mths after first positive MFC; the other 2 died within 2 mths from other causes. MRD was detected in 9 of 19 (47%) pts who relapsed. In 18 pts remaining in CR, no MRD was identified. Conclusions: DAC in CR is well tolerated. MFC can predict relapse in CR. Higher incidence of relapse in the DAC arm may be due to different patterns of methylation and response to DAC in younger AML pts. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Eisai, MGI Pharma Eisai Eisai, MGI Pharma
Economic analysis of adjuvant interferon alfa-2b in high-risk melanoma based on projections from Eastern Cooperative Oncology Group 1684.
Authors: B E Hillner, J M Kirkwood, M B Atkins, E R Johnson, T J Smith
Journal: Journal of Clinical Oncology (1997)

PURPOSE Interferon alfa-2b (IFN) in a randomized clinical trial (E1684) prolonged relapse-free and total survival in high-risk resected melanoma. However, the costs and toxicities of IFN are barriers to its widespread use. This study was undertaken to analyze the projected costs and long-term benefits of IFN by combining prospectively collected data on IFN actual dosage, time of recurrence, and survival with secondary data on long-term melanoma recurrence risks to project the cost-effectiveness of adjuvant IFN compared with observation. PATIENTS AND METHODS Two hypothetical cohorts of 50-year-old melanoma patients whose mean IFN dosage and clinical results were directly taken from E1684 were included in the study. Melanoma recurrence risks beyond 5 years were derived from international databases. Melanoma recurrence care costs and quality-of-life adjustments, when considered, were based on expert consensus. End points were incremental costs, life-years gained, and cost per life-year gained with and without quality-of-life adjustments. RESULTS The IFN cohort was projected to have an increased (undiscounted) survival of 0.52 years at 7 years and 1.90 years over a lifetime. The projected incremental cost (in 1996 United States dollars) per life-year gained in the IFN cohort ranged from $13,700 after 35 years to $32,600 at 7 years, the median follow-up of E1684. Using assigned quality-of-life values for IFN and recurrence, the lifetime cost per quality adjusted life-year increased to $15,200. Even if treatment costs for recurrence were excluded, the lifetime incremental cost per life-year gained was $21,600. CONCLUSION The cost and toxicity of IFN must be balanced against its projected benefits in high-risk melanoma. The derived cost-effectiveness and cost-utility ratios for IFN were comparable to other cancer interventions for which cost-effectiveness analysis has been performed.
Long-Term Mortality and Major Adverse Cardiovascular Events in Sepsis Survivors. A Nationwide Population-based Study
Authors: Shuo-Ming Ou, Hsi Chu, Pei-Wen Chao, Yi-Jung Lee, Shu-Chen Kuo, Tzeng-Ji Chen, Ching-Min Tseng, Chia-Jen Shih, Yung-Tai Chen
Journal: American Journal of Respiratory and Critical Care Medicine (2016)

Patients with sepsis who survive to hospital discharge may present with ongoing high morbidity and mortality. However, little is known about the risk of long-term, all-cause mortality and cardiovascular outcomes after sepsis.Our study aimed to investigate the long-term clinical outcomes in sepsis survivors.In this nationwide population-based study, data from patients with sepsis were retrieved from Taiwan's National Health Insurance Research Database between 2000 and 2002. Each sepsis survivor was 1:1 propensity-matched to control subjects from two different control populations: subjects who were in the general population and subjects who were hospitalized for a nonsepsis diagnosis. The primary outcomes were all-cause mortality, major adverse cardiovascular events, myocardial infarction, heart failure, stroke, and sudden cardiac death or ventricular arrhythmia.Compared with matched population control subjects, sepsis survivors had higher risks of all-cause mortality (hazard ratio [HR], 2.18; 95% confidence interval [CI], 2.14-2.22), major adverse cardiovascular events (HR, 1.37; 95% CI, 1.34-1.41), ischemic stroke (HR, 1.27; 95% CI, 1.23-1.32), hemorrhagic stroke (HR, 1.36; 95% CI, 1.26-1.46), myocardial infarction (HR, 1.22; 95% CI, 1.14-1.30), heart failure (HR, 1.48; 95% CI, 1.43-1.53), and sudden cardiac death or ventricular arrhythmia (HR, 1.65; 95% CI, 1.57-1.74). Similar results, although slightly attenuated risks, were found when comparisons were made with hospitalized control subjects without sepsis.These data indicate that sepsis survivors had substantially increased risks of subsequent all-cause mortality and major adverse cardiovascular events at 1 year after discharge, which persisted for up to 5 years after discharge.
Tolerability/safety of sunitinib (SU) on schedule 2/1 in combination with capecitabine (C) in patients (pts) with advanced solid tumors (STs): A phase I dose-finding study
Authors: E. G. Chiorean, C. J. Sweeney, C. F. Verschraegen, F. C. Lee, S. F. Jones, I. Rabinowitz, L. Tye, A. Bello, R. Chao, H. A. Burris
Journal: Journal of Clinical Oncology (2008)

3562 Background: SU is an oral, multitargeted tyrosine kinase inhibitor of VEGFRs, PDGFRs, KIT, RET, FLT3 and CSF-1R approved internationally for the treatment of advanced RCC and imatinib-resistant/-intolerant GIST. Three SU+C treatment arms have been tested: 4 wks on/2 wks off (4/2), continuous dosing (CD), and 2 wks on/1 wk off (2/1). The MTD for both 4/2 and CD schedules was SU 37.5 mg/d + C 1,000 mg/m2 bid (Sweeney et al, ASCO 07; Verschraegen et al, ECCO 07). This abstract reports the maximum tolerated dose (MTD), tolerability and safety of SU+C given on a 3-wk schedule (arm 2/1) in pts with advanced STs. Methods: Eligible pts had incurable, advanced STs, prior treatment with ≤2 chemotherapy regimens, no prior antiangiogenic therapy and ECOG PS ≤1. C was given po bid for 14 days in 3-wk cycles. Using a standard 3+3 design, C and SU doses were alternately escalated in serial pt cohorts to determine the MTD of SU+C. Safety/tolerability was evaluated using adverse event (AE) data and laboratory analyses. In pts with measurable disease, objective response was determined by RECIST. Pharmacokinetic (PK) analyses were performed. Results: As of Dec 2007, 67 pts have been enrolled: 28 on 4/2, 13 on 2/1 and 26 on CD. On the 2/1 schedule, MTD was determined to be SU 50 mg/d + C 1,000 mg/m2 bid based on the following dose-limiting toxicities (DLTs) observed on SU 50 mg/d + C 1,250 mg/m2 bid: G3 fatigue ≥7 days (n=1/3) and recurring neutropenia requiring dose reduction/interruption (n=1). This dose level was therefore assessed as not tolerable. At the MTD, 1 DLT was observed: G3 hand-foot syndrome ≥7 days (n=1/7). Most frequent AEs were: diarrhea n=9 (69%), fatigue n=9 (69%), hand-foot syndrome n=8 (62%), vomiting n=7 (54%), nausea n=6 (46%), dyspepsia and mucosal inflammation, each n=5 (39%). G4 laboratory abnormalities included neutropenia and lymphopenia (both n=1). Two pts (SU 50 mg/d + C 1,000 or 1,250 mg/m2 bid [bladder cancer; cholangiocarcinoma]) achieved a confirmed partial response. There was no clinically significant PK drug-drug interaction. Conclusions: Consistent with data from 4/2 and CD schedules, SU+C administered on the 2/1 schedule was tolerable and showed antitumor activity. Further studies are ongoing in breast cancer pts. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Pfizer Pfizer Pfizer