tbuckley/cabot-search huggingface dataset:
Functioning profile changes in cancer patients participating in comprehensive cancer rehabilitation
Authors: C. A. Dennehy
Journal: Journal of Clinical Oncology (2007)

19518 Background: Recommendations for inclusion of cancer rehabilitation as part of cancer care are notable. Treatment impact on patients’ functional status suggests integrating supportive and therapeutic care would be appropriate for most patients. Methods: Data were from two outpatient cancer rehabilitation centers (N=515) on referred patients receiving or completing treatment. Patients performed an initial assessment for cardiopulmonary (CP), physical therapy (PT), quality of life (QOL), and nutritional status evaluations. Qualifying patients completed 8 weeks of supportive and rehabilitative therapies specifically prescribed for side effect and presenting symptoms. Data were collected pre and post intervention. Measurements included descriptives with crosstabulations for all variables, acuity (A), stress (S), pain (P), energy (E), resting, target and highest heart rates (RHR) (TRH) (HHR), blood pressure (BP), treadmill speed and grade (S) (G) and QOL (total (T), health/function (HF), social/economic (SE), psychological/spiritual (PS) and family (F). Descriptive statistics are determined using means and frequencies. Pre and post intervention differences were determined using paired T-tests. Subsequent factor analyses were performed using principle component analysis with varimax rotation. Results: Descriptive statistics yielded characteristics on 53 different cancer types. Factor analysis produced 7 factors: heart rate (HR p=0.279), blood pressure (p=0.060), pulmonary (p=0.721), O 2 saturation (p=0.387), intensity (p=0.598), SPE (p=0.000), AS (p=0.002). Differences were not expected for pulmonary function and O 2 saturation. QOL differences were (T: p=0.000), (HF: p=0.000), (SE: p=0.022), (PS: p=0.001), (F: p=0.099). Conclusions: While many studies have noted a significant decline in functioning during and following treatments, patients participating in therapeutic cancer rehabilitation maintained or improved functional status and quality of life. Comprehensive cancer rehabilitation can be utilized for a number of cancer types and should be strongly considered as part of the continuum of care. No significant financial relationships to disclose.
A dose escalation (DE), pharmacokinetic (PK), and pharmacodynamic (PD) study of OSI-930 and erlotinib (E) in patients (pts) with advanced solid tumors
Authors: I. Macpherson, K. Stewart, J. Chick, K. Brock, S. Poondru, R. Gedrich, A. W. Stephens, T. R. Evans
Journal: Journal of Clinical Oncology (2009)

3550 Background: EGFR and VEGFR are important targets in a number of human cancers with common downstream signalling pathways. Combined blockade of EGFR-VEGFR with E and OSI-930 has shown additional antitumor activity compared to either agent alone with long-term remissions in multiple xenograft models. Methods: Sequential cohorts of pts with advanced refractory solid tumors were treated with OSI-930 BID with addition of E QD from Day 8 and beyond to determine the maximum tolerated dose (MTD) and to evaluate safety, PK and efficacy of the combination. Escalation followed a standard 3+3 design until dose-limiting toxicity (DLT) was observed in ≥ 2/6 pts. PK of OSI-930, E and its metabolite OSI-420 were determined. Levels of soluble VEGFR2 (sVEGFR2) in plasma were also measured. Results: 16 pts have been entered (13M/3F); median age 63 years (range 41–78), PS ≤2 and 38% pts with mCRC. OSI-930/E were administered at 3 levels [mg(pts entered/evaluable)]; 200 BID/100 QD (7/6), 200 BID/150 QD (4/3), and 300 BID/150 QD (5/5). Median duration of therapy was 8 weeks (range 1–22). DLT was seen in 1/6 pts at 200 BID/100 QD (&gt;5 day interruption due to G4 neutropenia); and 1/5 at 300 BID/150 QD (G3 Asthenia/lethargy). Other common related toxicities (% all grades:% g3/4) were: skin-related (rash, HFS etc) (85:23), Asthenia/lethargy/fatigue (69:15), diarrhea (77:8), anorexia (92:0), and transaminitis (31:15). Reduction and/or interruptions of one or both study drugs during or beyond the initial 28 days were required in 8/14 pts. Six of 11 pts evaluable for response achieved SD ≥12 weeks. Median plasma C max (and AUC Tau ) of OSI -930 for Cohort 3 (300 BID/150 QD) were: 0.826 (6.08), 0.947 (5.57), and 1.66 (14.3) μg/mL (μg.hr/mL) on Days 7, 8 and 22, respectively. Exposure of OSI-930 increased approximately 2-fold upon co-administration with E at steady-state. OSI-930 appeared not to alter the PK properties of E or the ratio of OSI-420 to E. Decreases in plasma sVEGFR2 were observed, indicating a PD effect of OSI-930. Conclusions: Additional patients are being added to confirm the MTD of the combination. PK data indicate a drug-drug interaction with doubling of the OSI-930 exposure on co-administration with E. [Table: see text]
Acupuncture for the management of hot flashes in women with early stage breast cancer treated with tamoxifen or an aromatase inhibitor: A pilot study of efficacy, safety and feasibility
Authors: A. T. Perez, A. Sear, C. Frankel, S. X. Franco, E. Tan-Chiu, F. Gokce, C. L. Vogel
Journal: Journal of Clinical Oncology (2005)

703 Background: With the increasing use and duration of endocrine therapies in the treatment of adjuvant breast cancer (BC), the control of vasomotor symptoms is paramount. Complementary and alternative therapies are popular and widely available, but rigorous data evaluating their safety and efficacy are lacking. Given concerns regarding the use of hormone replacement therapy in BC symptom management, other nonhormonal means for treating hot flashes (HF) are required. Based on anecdotal information regarding the efficacy of acupuncture (AP) for treating HF, the trial was developed. Methods: We are evaluating the efficacy of 30-minute AP treatments given for 10 weeks in patients with early BC. Eligible patients had at least 14 HF/week of sufficient severity for therapeutic intervention. Use of antidepressants at a stable dose for at least 3 months was allowed. The primary objective was efficacy as measured by HF frequency (number of HF reported per day) and HF score (average intensity x frequency). The secondary objectives were safety and quality of life. The AP treatment plan was based on 6 recognized Traditional Chinese Medicine patterns of disharmony and treated accordingly by a licensed AP physician. The incidence of HF was recorded with the use of a HF diary for 14 weeks. Results: Data from 14 patients are available from 20 enrolled in this ongoing study. Nine (64%) patients had been treated with tamoxifen and 5 (36%) with an aromatase inhibitor. Six (43%) patients were taking venlafaxine when they started the study. The median HF frequency went from 6.5 (range 3.0–26.0) to 3.0 (range 1.0 to 9.0) for a 54% reduction. The mean HF score went from 19.4 to 8.7 for a 55% reduction. An improvement in HF score was greater that 30% in 11 (79%) patients and greater than 50% in 9 (64%) patients. Grade I bruising and pain were reported at the AP site in 5 patients (36%) and in 1 (7%) respectively. Patients reported improvement in several other symptoms such as night sweats and insomnia. Conclusion: The available data suggest that AP is a safe and effective therapy in BC patients with HF. This study is being sponsored by the AVON foundation. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Avon Foundation
Weekly paclitaxel combined with monthly carboplatin versus single-agent therapy in patients age 70 to 89: IFCT-0501 randomized phase III study in advanced non-small cell lung cancer (NSCLC).
Authors: E. A. Quoix, J. Oster, V. Westeel, E. Pichon, G. Zalcman, L. Baudrin, A. Lavole, J. Dauba, M. Lebitasy, B. J. Milleron
Journal: Journal of Clinical Oncology (2010)

2 Background: Incidence of advanced NSCLC in the elderly is increasing. Specific trials for elderly are seldom and those patients are not optimally treated. Current recommendations are monotherapies with gemcitabine or vinorelbine. Methods: French multicentric randomized phase III study in pts aged 70 to 89, PS 0-2 with advanced NSCLC not irradiable, comparing a 3-weekly single agent therapy (gemcitabine 1,150 mg/m 2 or vinorelbine 30 mg/m 2 , d1, d8: arm A) with carboplatin AUC 6 every 4 weeks + paclitaxel 90 mg/m 2 (d1,8,15) doublet (arm B). Five cycles of single agent and 4 cycles of the doublet were to be given. Second-line in case of toxicity or progressive disease was fixed with erlotinib 150 mg/d. The main endpoint was overall survival. Results: 451 pts were included from 04/2005 to 12/2009 by 60 centers. Males were 73.8%, median age was 77.2 years (range 70-89). PS was 0-1 in 73.6%. The 2 arms were well-balanced for pts characteristics. At time of second planned intermediate analysis (after two-third of expected deaths, i.e. 224), 451 pts were randomized, out of the 522 initially planned. The steering committee advice was to stop the inclusions. Overall survival of the 313 pts analysed at this time was significantly longer in arm B (median: 10.4 months, 95%CI: [8.2; 15.0] vs. 6.2 months, 95%CI: [5.3; 7.5] for arm A, (HR = 0.60, 95%CI : [0.46; 0.78], p = 0.0001). Median PFS was 6.3 months, 95%CI: [5.5; 6.9] in arm B vs. 3.2 months, 95%CI: [0.44; 0.70] (HR = 0.55, 95%CI: [0.44; 0.70], p &lt; 0.0001). Grade 3-4 haematological toxicities were significantly more frequent in arm B (17.9% vs. 54.1%). No significant difference was observed in early deaths (arm A: 23.7%, arm B: 16.6%). Survival, response and toxicity data for the whole series of 451 pts will be updated at time of the meeting. Conclusions: Paclitaxel and carboplatin doublet provides a significantly longer survival in elderly pts with advanced NSCLC than current standard single agent therapy, with acceptable toxicity, making it a new treatment paradigm for PS 0-2 pts ≥ 70 years. [Table: see text]
COPD telemonitoring: Analysis of hospital admissions
Authors: Michael Crooks, Ghassan Hamad, Mike Cosgrove, Christine Alexander, Alyn Morice
Journal: European Respiratory Journal (2014)

Introduction 

Acute exacerbations of COPD (AECOPD) are a common reason for hospital admission. Remote monitoring in COPD aims to detect AECOPD early, thus reducing hospitalisation. We examined COPD-related admissions of patients undergoing tele-monitoring.

Methods 

We prospectively followed COPD patients undergoing daily monitoring by the local telehealth service. Electronic care records and telehealth records were reviewed to obtain data on demographics, hospital admissions, community interventions and to identify changes in monitored data in the 7 days prior to admission.

Results 

183 patients were followed-up for mean±SD 80.7±27 days accounting for 14,611 monitored days. A total of 3533 system alerts were recorded with 30 COPD related admissions. The mean inpatient stay was 6 days with 6/30 staying <2 days. Chest x-ray revealed infective changes in 6/30 admissions. Patients admitted with AECOPD alerted more frequently than those not admitted (31.4±12.3 vs 24.7±11 alerts per patient respectively, p<0.01). Clinically meaningful changes in telehealth data occurred in 24/30 admissions, however, a system alert was generated in only 20. Increased respiratory symptoms were common (24/30 patients) with a clinically significant drop in oxygen saturations detected in 7/30 patients.

Conclusion 

Increased symptoms prior to admission with an AECOPD can be detected using remote monitoring. However, standard monitoring and alert algorithms are insufficiently specific to identify true clinical deterioration from day to day variation. Further work is required to develop methods of identifying impending AECOPD with greater specificity allowing targeted community interventions.
Abstract 13103: Fusion Imaging of Intravascular Ultrasound and Multi-Detector Computed Tomography: A Novel Technique of Tissue Characterization of Coronary Plaques
Authors: Yusaku Fukumoto, Yuji Kamikawa, Takafumi Hiro
Journal: Circulation (2012)

Background and Purpose: The spectral analyses of radio-frequency ultrasound signals obtained by intravascular ultrasound (RF-IVUS) as well as the CT value of multi-detector coronary CT (MDCT) have been proven to be useful in order to characterize tissue composition within atheroscrelotic plaques. The purpose of this study was to evaluate the feasibility of a novel technique, fusion imaging of RF-IVUS, iMap™ and a 64-row MDCT. Methods: A total of 38 coronary lesions in patients with coronary artery disease, 18 from patients with unstable angina (UAP) and 20 from stable angina (SAP), were imaged with IVUS and MDCT. The results of tissue characterization according to iMap algorithm as well as CT value-derived classification (calcified area, >200HU, fibrotic area, 50-100HU, lipidic are, 0-50HU) were first compared. Then, fusion imaging of the iMap and MDCT-plaque mapping was performed (Figure). Results: The necrotic plus lipidic component areas measured by iMap were significantly correlated with lipidic area ...
High-dose photon-beam radiation therapy in chordoma: A single-institution retrospective analysis.
Authors: C. Sangalli, S. Stacchiotti, A. Gronchi, P. G. Casali, E. Pignoli, P. Pittoni, E. Palassini, P. Olmi
Journal: Journal of Clinical Oncology (2010)

10063 Background: Chordoma is a rare bone tumor. Radical surgery is standard treatment, but it is often unfeasible due to the tumor location. Besides, the disease is marked by a high local relapse rate. With the availability of high-dose hadron (proton or carbo-ion particles) radiation therapy (H-RT), the role of RT has increased, in a disease known to be insensitive to doses <65Gy. Recently, Intensity Modulated Radiation Therapy (IMRT) has allowed to deliver high-dose RT even with photons. We report on a series of locally advanced chordoma treated with high- dose photon-beam RT (X-RT) alone or in combination with imatinib at Istituto Nazionale Tumori (INT), Milan, Italy. Methods: We retrospectively reviewed all cases referred to the RT department from 2004 to 2009 to be evaluated for definitive RT. In 6 patients (pts) X-RT was administered with concomitant imatinib, at the dose of 400 mg/day. Toxicity, radiological response (tumor shrinkage and signal changes on MRI) and symptomatic improvement were reviewed. Results: In 31 consecutive chordoma pts evaluated, 16 (13M/3F; median age/range: 65/32-80 yrs; site: 71% sacrum; 19% lumbar spine, 10% cervical spine) received high-dose X-IMRT. Averaged delivered dose to gross tumor volume (GTV) was 74Gy/32 fractions (range: 70-78Gy). Median (range) follow-up is40 months (3-63). Therapy was well tolerated (1 case of G2 gastrointestinal toxicity) without neurological side effects, even in the subgroup receiving concomitant imatinib. All 16 pts had a radiological tumor response (increased necrosis in 16/16 pts, tumor shrinkage in 10/16 pts, i.e. 62%), along with symptomatic improvement. After a good radiological response, one pt progressed 14 months after the end of RT, and is now on medical treatment.. 15 pts were excluded from definitive X-IMRT: 5 underwent surgery + adjuvant RT and are alive and disease-free; 2 skull-base + 1 sacral chordoma were sent for definitive H-RT elsewhere and are alive and progression-free; 6 are lost to follow-up; 1 died. Conclusions: Our series provides preliminary evidence that high-dose X-IMRT in extra-cranial chordoma is feasible, even in combination with imatinib. Further studies are needed to compare these results to of H-RT. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Novartis Novartis Novartis Travel coverages for medical meetings
A NOVEL, RISK STRATIFICATION MODEL USING BAYESIAN NETWORKS FOR CONTINUOUS-FLOW LEFT VENTRICULAR ASSIST DEVICE 90-DAY SURVIVAL
Authors: Manreet Kanwar, Natasha Loghmanpour, Yajuan Wang, Trevor Snyder, Douglas Horstmanshof, James Long, John Gorcsan, James Antaki, Srinivas Murali
Journal: Journal of the American College of Cardiology (2013)
Final reporting of a phase I clinical trial of the oral PPAR-gamma agonist, CS-7017, in patients with advanced malignancies.
Authors: M. J. Pishvaian, I. Cotarla, A. J. Wagner, J. F. Deeken, A. R. He, J. J. Hwang, G. D. Demetri, A. Halim, C. Copigneaux, J. Marshall
Journal: Journal of Clinical Oncology (2010)

2526 Background: CS-7017 is a novel, third-generation peroxisome proliferator activated receptor gamma (PPARg) agonist that has demonstrated potent anti-cancer effects in preclinical models. Methods: Patients (pts) with advanced malignancies and adequate hepatic and renal function were eligible for enrollment in this phase I trial. Pts with significant pre-existing fluid retention were excluded. CS-7017 was administered orally twice daily (BID) in a dose escalating fashion starting at 0.1 mg, and restaging occurred every 6 weeks. Pharmacodynamic (PD) and pharmacokinetic (PK) samples were collected at day 1 and 22. Archived tumor specimens were assayed for relevant biomarkers by immunohistochemistry. Results: 32 pts were enrolled, 31 received CS-7017 (22 male; age range 40–72 years) at doses ranging from 0.10–1.15 mg BID. The most common cancers were colorectal (n=12), liposarcoma (n=5), and leiomyosarcoma (n=2). 27 pts were evaluable for response. There was 1 sustained partial response (PR) in a pt with myxoid liposarcoma, who remains on CS-7017 after more than 553 days. 12 patients had SD, 7 of whom had SD for ≥81 days (range 81–290 days). CS-7017 was well tolerated. Most patients experienced peripheral edema (17/31), often requiring diuretics. 3 dose-limiting toxicities, all related to fluid retention, were observed, but without clear relation to dose. The protocol-defined maximum tolerated dose was not reached, but 0.50 mg BID was selected as the recommended phase II dose based on PK/PD and safety analyses. CS-7017 increased plasma adiponectin levels by 6–14-fold at 4 weeks. The plasma concentrations of CS-7017 appeared dose proportional. Analysis of pretreatment tumor specimens demonstrated that PPARg and RXR protein expression was significantly higher in patients with prolonged SD or PR (1-sided O'Brien's nonparametic global test: p=0.0079), suggesting a possible predictive biomarker for response. Conclusions: CS-7017 demonstrates promising evidence of antitumor activity and disease stabilization with acceptable tolerability. Biomarkers of drug exposure were consistent with PPARg pathway activation, and a possible predictive biomarker for response was identified. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Daiichi Sankyo Daiichi Sankyo Daiichi Sankyo Daiichi Sankyo Daiichi Sankyo
Quality of life in young men after radical prostatectomy: Results from the CaPSURE registry
Authors: J. L. Wright, D. W. Lin, J. E. Cowan, J. Duchane, P. R. Carroll, M. S. Litwin
Journal: Journal of Clinical Oncology (2006)

4576 Background: Over the past two decades, the age at diagnosis and treatment of men with prostate cancer (CaP) has steadily declined. Previous work suggests that younger men have similar or improved pathologic and clinical outcomes compared to older men. The literature on quality of life (QOL) following local treatment for CaP has primarily focused on comparing treatment modalities rather than specific age groups. This analysis explored QOL outcomes in younger men following primary curative treatment for localized prostate cancer. Methods: This was a secondary analysis of a prospectively collected cohort from the CaPSURE (Cancer of the Prostate Strategic Urologic Endeavor) registry. Men who underwent radical prostatectomy (RP) for localized disease and completed the UCLA Prostate Cancer Index (PCI) pre- and one-year post-surgery were identified. Men were grouped based on age (&lt; 55, 55–64, ≥ 65 years). A severe decline in PCI domains from pre- to post-RP was defined as a decrease of one standard deviation from the pre-RP score. PCI scores were compared across age groups, and a multivariate model created to analyze the predictors of severe declines in PCI domains. Results: 1,143 men were identified, with 190, 526 and 427 men in the three age groups, respectively. Younger men had significantly higher mean scores one-year after RP in the urinary function (UF), urinary bother (UB) and sexual function (SF) domains of the PCI. The proportion of men with a severe decline in UF, UB and SF was not significantly different in the age groups (range 49–54%, 32–38%, 58–51% respectively). However, a severe decline in SB was more common in the youngest age group than in the oldest (54% vs. 36%, p &lt; 0.01). With the youngest men as the reference group in the multivariate model, the oldest age group was 40% less likely to have a severe decline of SB (OR = 0.60, 95% CI 0.41–0.90, p = 0.04) but trended toward a higher risk of severe decline in UB (OR = 1.27, 95% CI 0.85–1.89, p = 0.08). Conclusions: Age predicts disease-specific QOL changes at one-year following RP. Younger men had significantly better mean UF, UB, and SF domain scores one-year after RP than did their older counterparts. Men &lt; 55 years old are more likely than older men to experience a severe decline of sexual bother but trend toward a lower risk of a severe urinary bother. No significant financial relationships to disclose.
Adjuvant therapy (Adj) in intraductal papillary mucinous neoplasm cancer (IPMN-Ca) versus pancreatic ductal adenocarcinoma (PDAC): Comparison of survival analyses.
Authors: Kavya Krishna, Somashekar Gopala Krishna, Mark Bloomston, Peter Muscarella, Carl Richard Schmidt, Darwin Conwell, Tanios S. Bekaii-Saab
Journal: Journal of Clinical Oncology (2015)

385 Background: Incidence of IPMN-Ca is increasing and due to lack of large prospective trials to evaluate optimal management of IPMN-Ca following resection, benefit of Adj is unknown. Methods: Retrospective review of patients (pts) who underwent pancreatic resection for invasive cancer from 2004 to 2012 at a single institution. Univariate and multivariate Cox regression models were used to determine association between different characteristics and survival. Results: From a total of 225 pancreatic resections (IPMN-Ca = 39, PDAC = 186), data regarding Adj was available in 179 pts (IPMN-Ca = 30, PDAC = 149). As shown in the Table, IPMN-Ca pts were less likely to receive Adj than PDAC (53% vs. 85% p = &lt;0.001). There was no significant difference in tumor stage (stg) (early T vs advanced T) and Nodal stg (N0 vs. N1) distribution between pts who received Adj with IPMN-Ca or PDAC. Univariable survival analysis (SA): In PDAC, Adj improved overall survival (OS) (Hazard ratio [HR]: 0.46, 95% CI 0.28, 0.77), but there was no improvement in OS in IPMN-Ca pts with Adj (HR: 1.6, 95% CI 0.56, 4.64). Multivariable SA adjusting for age, Adj, resection margin, T, N stg: For PDACs, Adj was singularly associated with improved OS (HR 0.50, 95% CI 0.30, 0.82). In contrast, SA for IPMN-Ca did not reveal any significant contributing variable. For all pancreatic cancers, multivariable SA adjusting for IPMN-Ca vs. PDAC, age, Adj, resection margin, T, N stg revealed that a diagnosis of IPMN-Ca (HR: 0.52, 95% CI 0.30, 0.91) and a negative resection margin (HR: 0.65, 95% CI 0.43, 0.96) were significantly associated with better OS. Conclusions: Post resection, although pts with IPMN-Ca have better OS than PDACs, Adj fails to influence OS in IPMN-Ca pts. Larger studies are needed to confirm these findings. [Table: see text]