tbuckley/cabot-search huggingface dataset:
Validation of the Living With Cancer (LWC) PRO tool for identifying patients (pts) with cancer appropriate for end-of-life care consultations.
Authors: Dhakshila Paramanathan, Andrew Pecora, Eric Schultz, Hyun gi Noh, Katherine DeMarco, Jose Contreras, Kelly Choi, Stuart L. Goldberg
Journal: Journal of Clinical Oncology (2016)

85 Background: End-of-life care (EOLC) discussions for pts with advanced malignancies are often delayed resulting in unwanted, wasteful treatment. COTA Inc has developed a 7-item PRO instrument (LWC) to facilitate identification of pts in distress. A pilot study of 433 pts at a single institution was able to determine a threshold distress score (&gt; 28) correlating with physician assessment of appropriateness for EOLC consultation (2015 ASCO Palliative Care Symposium). Methods: LWC explores 4 personhood and clinical domains (performance status, pain, burden, and depression). Each question presents a 5-level Likert scale supplemented by a pt derived weighting of importance. The PRO was completed by 700 pts at Regional Cancer Care Associates throughout NJ between Sept 2015 and Apr 2016. The primary oncologists separately/independently classified 611 pts as appropriate to continue therapy (Group 1) and 89 pts as appropriate to curtail therapy (Group 2). Results: A score of 29 on LWC (range 0-112) was the threshold achieving optimal sensitivity (51%) and specificity (78%) in identifying pts in Group 2 (51% of pts whose oncologists felt appropriate to curtail therapy scored &gt; 29; 78% of pts whose oncologists felt appropriate to continue therapy scored &lt; 29). The threshold had positive predictive value 25% and 8% false omission rate (1 - negative predictive value) (25% pts scoring &gt; 29 should be in Group 2; 8% scoring &lt; 29 should be in group 2). A score 29 was 2.3 times more likely in pts belonging to Group 2 (likelihood ratio), and was a predictor of physician category (logistic regression p &lt; 0.0001). LWC had a Cronbach’s alpha coefficient 0.85, indicating internal consistency and ability to measure a single latent construct. 3 questions (Performance Status, Wants, and Lack of Pleasure) contained the most information (estimate the latent trait with precision) and had high discrimination parameters (discriminate between pts lacking latent trait and displaying latent trait). Conclusions: The LWC instrument is able to identify cancer pts for whom EOLC discussions may be appropriate. A study to determine the correlation between the threshold score, EOLC consultation rate and overall survival is underway.
Perspective on Clinical Application of Biomarkers in AKI
Authors: Chirag R. Parikh, Sherry G. Mansour
Journal: Journal of the American Society of Nephrology (2017)

Several biomarkers of renal injury have been identified but the utility of these biomarkers is largely confined to research studies, whereas widespread clinical applicability is limited. This is partly because the use of serum creatinine as the comparator has several limitations and restricts the full interpretation of biomarker performance. To highlight the potential for clinical application of biomarkers, the most pertinent biomarker data are summarized here, using clinically relevant scenarios in which biomarkers could assist with diagnostic and management dilemmas. The paradigms proposed in this review aim to enhance the clinical diagnosis, management, and prognosis of AKI through the combined use of available clinical markers and novel inflammatory, injury, and repair biomarkers.
Can health-related quality-of-life outcome measures predict patient satisfaction with service quality in oncology?
Authors: C. G. Lis, M. Rodeghier, J. F. Grutsch, D. Gupta
Journal: Journal of Clinical Oncology (2011)

e16505 Background: Patient satisfaction with service quality is a useful tool to measure and manage patient experience. As a result, identifying modifiable determinants of patient satisfaction can help providers design interventions to improve overall patient experience. Health-related quality of life (QoL) is hypothesized to be one such determinant. We investigated whether patient QoL could predict satisfaction with service quality in cancer. Methods: A cohort of 1207 cancer patients treated at Cancer Treatment Centers of America was assessed. A questionnaire covering the following dimensions of patient satisfaction was used: hospital operations and services, physicians and staff, and patient endorsements for themselves and others. The outcome variable on overall patient satisfaction was dichotomized into 2 groups: “very satisfied” and “not very satisfied”. QoL was assessed using EORTC QLQ-C30. Study patients were dichotomized into 2 groups based on median scores for all QoL scales to yield “above median” and “below median” scores. The relationship between QoL and patient satisfaction was assessed using logistic regression. Results: The mean age was 54.2 years (SD = 9.9, range 17-87), with a slight preponderance of females (56.5 %). Breast (n= 277), lung (n= 207), prostate (n=133), colorectal (n=111) and pancreas (n=106) were the most frequent cancers. 1109 (91.9%) patients were “very satisfied” with their overall experience. Several QoL function (physical, role, cognitive and social) and symptom (fatigue, nausea/vomiting, insomnia and appetite loss) scales were predictive of overall patient satisfaction on univariate analysis. In multivariate analysis, above median (worse) appetite loss scores were associated with a reduced odds of 0.39 of being “very satisfied” compared below median (better) scores; p<0.001. Conclusions: We found appetite loss to be an independent predictor of overall patient satisfaction with service quality, a new finding in the literature. Given that appetite loss is one of the most frequently reported symptoms in cancer, specific treatment interventions targeting appetite loss aiming to improve patient satisfaction should be prospectively evaluated.
Impact of preoperative sarcopenia on recurrecnce in gastric cancer surgery.
Authors: Tsutomu Sato, Toru Aoyama, Yukio Maezawa, Kazuki Kano, Kenki Segami, Tetsushi Nakajima, Kosuke Ikeda, Tsutomu Hayashi, Takanobu Yamada, Takashi Oshima, Yasushi Rino, Munetaka Masuda, Haruhiko Cho, Takashi Ogata, Takaki Yoshikawa
Journal: Journal of Clinical Oncology (2016)

120 Background: Our previous study clarified that morbidity was a negative prognostic factor and sarcopenia defined by of the handgrip strength was a risk factor for the morbidity in gastric cancer surgery. Sarcopenia was reportedly a negative prognostic factor in colorectal cancer, hepatocellular carcinoma and malignant melanoma. This study aimed to evaluate impact of preoperative sarcopenia on recurrence-free survival (RFS) in gastric cancer surgery. Methods: Between May 2011 and June 2013, 256 consecutive primary gastric cancer patients who underwent curative surgery were retrospectively examined. Patients who received neoadjuvant chemotherapy or were diagnosed with pathological stage IV were excluded. Preoperative skeletal muscle mass was evaluated by bioelectrical impedance analysis and was expressed as skeletal muscle index or SMI (muscle mass/height 2 ) by adjusting absolute muscle mass with height. Preoperative muscle function was measured by hand grip strength (HGS). Each cutoff value was determined as the gender-specific lowest 20% of the distribution of each measurement. Univariate and multivariate analyses were preformed to identify risk factors for RFS using a Cox proportional hazards model. Results: Median age (range) was 66 years (37-85 years). Male to female ratio was 168:88. Median follow-up period was 33.4 months. Pathological stage was I in 160, II in 48 and III in 48 patients. Univariate analysis showed that age, adjuvant chemotherapy, pT, pN, histological type, tumor size, total gastrectomy, low SMI and low HGS were significant risk factors for RFS. Multi-variate Cox’s proportional hazard analyses demonstrated that pT (HR 2.76, p = 0.0001), pN (HR 1.375, p = 0.037), histological type (HR 3.46, p = 0.014), low SMI (HR2.17, p = 0.036) were the significant risk factors for RFS. The three-year RFS was 89.1% in the patients with high SMI and 73.2% in those with low SMI (p = 0.007). Conclusions: Low SMI was an independent risk factor for RFS in Stage I-III gastric cancer. Low HGS, a risk factor for morbidity shown in our previous study, was not a risk independent factor for RFS. Preoperative sarcopenia as the short- and long-term outcomes has a value to be tested in the future prospective studies in gastric cancer surgery.
Differences in prior estrogen exposure may explain the difference in magnitude of breast cancer risk reduction observed in raloxifene breast cancer prevention trials
Authors: B. S. Mann, P. Cortazar, J. R. Johnson, K. He, R. Sridhara, A. T. Farrell, R. Justice, R. Pazdur
Journal: Journal of Clinical Oncology (2008)

1519 Background: Sep 2007, raloxifene (RLXF) approved for invasive breast cancer (IBC) risk reduction (RR) in postmenopausal women (PMW) with osteoporosis (OP) based on two placebo-controlled trials: RLXF Use for The Heart (RUTH) in PMW at increased risk of coronary events and Multiple Outcomes of RLXF Evaluation (MORE) in PMW with OP, later: Continuing Outcomes Relevant to Evista (CORE). Each trial showed statistically significant reduction in IBC risk, but Number Needed to Treat (NNT: women who need to take RLXF for 1 year to prevent one IBC) was 862 and 323 in RUTH and MORE: a difference >500. Impressive MORE results, attributed to RLXF, later on, led to Study of Tamoxifen and Raloxifene (STAR trial). Methods: IRs of IBC in RLXF and placebo (PLCB) arms of RUTH and MORE were compared and trial publications searched for history of prior estrogen exposure. Results: IRs of IBC in RUTH and MORE = 2.66 and 4.36 in PLCB arms & 1.50 and 1.26 in RLXF arms; corresponding absolute RR = 1.16 and 3.10 per 1,000 person-years, respectively. IRs of IBC are similar in RLXF arms but remarkably different in PLCB arms, and derive the observed difference in RR magnitude: 2.66 to 1.50 (RUTH) vs 4.36 to 1.26 (MORE). Prior to enrollment, a smaller fraction of women was on estrogen replacement in RUTH than MORE: 20% vs 28%; differences in duration of estrogen therapy and estrogen exposure free time prior to randomization are not known. Conclusions: It is the higher IBC IR in MORE PLCB arm that seems to derive the effect size of the observed risk reduction. High IBC IR in MORE PLCB arm is unexpected: publications show lower IBC incidence in women with OP (attributed to lower lifetime estrogen exposure) or no difference. Differences in prior OP estrogen treatment might have led to different IBC IRs in RUTH and MORE PLCB arms, ie, the observed remarkable RR of IBC in MORE resulted from interplay of two factors: 1) Persisting estrogen exposure effect in MORE PLCB arm with the consequent higher than expected IBC IR, & 2) Starting RLXF in RLFX arms. Possibility remains that impressive RR in MORE was a random finding: IBC IR was a safety endpoint in MORE. Notably, since Women's Health Initiative publication, lowering of IBC IR has been reported: attributed to a decline in estrogen use. No significant financial relationships to disclose.
Activity observed in a phase I dose escalation trial of the hypoxia-activated, NO prodrug, RRx001.
Authors: Tony R. Reid, Jeffrey R. Infante, Howard A. Burris, Curtis Scribner, Susan Jane Knox, Bryan Oronsky, Janet L. Stephens, Jan Scicinski
Journal: Journal of Clinical Oncology (2013)

241 Background: RRx-001, the first member of a new class of anticancer compounds sourced from the defense industry, is a hypoxia-selective, nitrite reductase-activated prodrug of nitric oxide (NO). The active metabolites selectively enhance oxidative and nitrosative stress in cancer cells through glutathione depletion, ROS formation, and the generation of high local concentrations of NO. The objectives of this Phase 1 dose-escalation trial were to investigate safety, dose-limiting toxicities (DLTs), pharmacodynamics and pharmacokinetics (PK) of RRx-001. Methods: Eligible patients had advanced solid tumor malignancies; ECOG PS 0-2; adequate bone marrow function. In a 3+3 escalation design, RRx-001 was administered intravenously (IV) over 2-3 hours once weekly for 8 weeks to patients with advanced cancer in successive dose-escalating cohorts. PK was collected on days 1 and 50, and tumor blood flow, assessed by CEUS or DCE/DWI-MRI, was performed on days 1 and 8. Tumor response was determined every 8 weeks. Results: To date 12 patients have been dosed across 3 successive cohorts (10, 16.7, and 24.6 mg/m 2 ). Tumor types included pancreas (3), colorectal (5), head and neck (2), melanoma (1), and cholangiocarcinoma (1). No DLTs or treatment-associated SAEs were observed. Transient infusion site pain was reported in 10/12 patients, grade 1 (9/10) or grade 2 (1/10), generally managed by lengthening the infusion duration and using peripheral venous access. No relevant treatment-related changes in laboratory values were observed. Seven patients were evaluable for response, with 1 partial response (parotid tumor). Three patients had stable disease ≥ 2 months (2 pancreas, 1 colorectal with treatment duration 10+ months, exceeding the response to his previous chemo regimen). One pancreas patient with an increase in tumor size due to treatment-related central necrosis was diagnosed with pseudoprogression and remained on study for 4 months. Conclusions: RRx-001, an anticancer agent with a novel structure and mechanism of action, is well tolerated with mild infusion-site pain. PK and PD data will be presented. Escalation is ongoing, but preliminary evidence of anti-tumor activity is promising. Clinical trial information: NCT01359982.
Adjuvant surgery in patients undergoing post-chemotherapy retroperitoneal lymph node dissection.
Authors: S. Daneshmand, H. Djaladat, C. R. Nichols
Journal: Journal of Clinical Oncology (2011)

e15151 Background: To evaluate the clinico-pathological characteristics of patients undergoing adjuvant surgery during post-chemotherapy retroperitoneal lymph node dissection (PC-RPLND). Methods: From 2004 to 2010, 85 patients underwent PC-RPLND by a single surgeon (SD). A bilateral template approach was utilized with nerve sparing technique whenever feasible. The clinico-pathologic and outcome of patients who underwent removal of any organ or structure during PC-RPLND were reviewed. Results: Of 85 patients undergoing PC-RPLND, 28 (33%) required adjuvant procedures. Thirteen (15%) required vascular procedures including cavotomy/ caval resection in 6, aortic resection in 8, common iliac vessels resection in 4 and renal vessels resection/reimplant in 2. Twelve patients (14%) required adjuvant nephrectomy (10/12 left sided). There was 1 ureteral resection with appendiceal substitution, 1 partial duodenectomy, 2 cholecystectomy, 2 thoracotomies, 4 liver resection/ biopsy, and 1 neck dissection. There were 8 early complications (28%) including vocal cord paralysis, brachial plexus injury, lower extremities compartment syndrome, thigh numbness, UGI bleeding, retroperitoneal hematoma and alcohol withdrawal. No peri-operative death was reported. Retroperitoneal pathology revealed mature teratoma in 11 (39%), fibrosis in 8 (28%) and viable germ cell tumor (GCT) in 9 (32%) patients. 75%, 82% and 66% of patients with fibrosis, teratoma and viable GCT had no evidence of recurrence in mean follow up of 18 months. Conclusions: A significant number of patients undergoing PC-RPLND require adjuvant surgery including vascular procedures and nephrectomy. The excellent outcomes associated with low operative morbidity/ mortality validates such aggressive surgical approaches performed by experienced surgeons.
High-volume centers for pancreatic cancer surgery: Does the media message matter?
Authors: Zeling Chau, Jillian K Smith, James K. West, Zheng Zhou, Theodore P. McDade, Sing Chau Ng, Giles Francis Whalen, Arthur J. Moser, Jennifer F. Tseng
Journal: Journal of Clinical Oncology (2013)

297 Background: Hospital procedure volume is associated with pancreatic cancer outcomes. However, differences between high-volume hospitals are less clear. Furthermore, consumers are barraged with grading systems for hospitals, whose relationship to volume and real outcomes are poorly delineated. Methods: Massachusetts Division of Health Care Finance and Policy Hospital Inpatient Discharge Database was queried to identify 5 highest-volume hospitals performing resection for pancreatic cancer 2005-2009. Primary outcomes included mortality, complications, median length of stay (LOS) and composite outcomes score (COS) including above. Ranks were determined for each outcome and compared to procedure volume order (highest to lowest), as well as ratings identified from popular media and internet-based hospital ratings including US News and World Reports (USN) Consumer Reports (CR), Healthgrades (HG) and Hospital Compare (HC). An inter-rater reliability analysis was performed with Spearman’s rank correlation coefficients calculated between outcomes and ratings. Results: 5 hospitals performing 82% (n=681) of statewide resections for pancreatic cancer were identified. In-hospital mortality ranged from 0-5.1%, complications 9.0-32.0%, median LOS 7-11 days. Within 5 highest-volume centers, outcomes did not improve in a consistent linear fashion with increased volume; however, volume remained more correlated with outcomes than consumer ratings. Of consumer ratings, HG ratings were most correlated with mortality, but had Spearman correlation coefficient of only 0.32. Complication measures were correlated with HG and USN equally at 0.22. USN rankings were highly correlated with LOS measures at 0.85. When all outcome measures were combined, HG was most correlated at 0.32. CR ratings were inversely correlated with all outcome measures. Conclusions: Between high-volume hospitals, outcome variation exists that does not completely correlate with either absolute volume numbers or by popular media grading systems, which can be discordant. Both consumer-directed ratings and volume data, where available, should be used only in appropriate contexts to direct patient care.
Quantification of WT1 Gene Expression for Minimal Residual Disease Detection as Predictor of Relapse in Patients with AML After Allogeneic Stem Cell Transplantation Compared to Flow Cytometry and Chimerism.
Authors: Mi Kwon, Maria Stefania Infante, Beatriz Fernandez, Javier Anguita, Ana Perez Corral, David Serrano, Jorge Gayoso, Gabriela Rodriguez, Alfonso Gomez Pineda, Jose Luis Diez-Martin, Ismael Buno
Journal: Blood (2009)
Allogeneic Myeloma GVAX with Lenalidomide Enhances Progression Free Survival through the Generation of Tumor Specific Immunity in Patients in Near Complete Remission
Authors: Ivan M. Borrello, Kimberly Noonan, Carol Ann Huff, Anna Ferguson, Amy Sidorski, Lakshmi Rudraraju, Raffaello Cimbro, Luigi Marchionni
Journal: Blood (2015)
Enhancing risk stratification in primary mediastinal nonseminomatous germ cell tumors (PMNSGCT): A 27-year experience at a tertiary cancer center.
Authors: Andrea Necchi, Salvatore Lo Vullo, Patrizia Giannatempo, Elena Farè, Daniele Raggi, Nicola Nicolai, Luigi Piva, Davide Biasoni, Tullio Torelli, Mario Catanzaro, Silvia Stagni, Massimo Maffezzini, Paolo Scanagatta, Alessandro M. Gianni, Luigi Mariani, Roberto Salvioni, Ugo Pastorino
Journal: Journal of Clinical Oncology (2014)

373 Background: Mediastinal GCTs and PMNSGCTs poorly benefit from CT and half of patients (pts) still die for disease. Enhancing the risk stratification may result in tailoring a personalized treatment strategy since diagnosis. Methods: Between 1985 and 2012, 87 pts with PM-GCT were treated at our center. Of them, pure seminomatous histology was excluded. Cox proportional hazards regression analysis was conducted to examine the prognostic impact of these candidate factors on overall survival (OS): type of 1st-line CT (high [HDCT] vs conventional dose [CDCT]), post-CT surgery, type of baseline elevated serum tumor marker (STM), presence of lung or liver-bone-brain metastases (LBB), STM response (still elevated vs normal or normalized), and histology (viable cancer [VC] vs necrosis/teratoma [NT]). OS curves were compared by Kaplan Meier method with the log-rank test. Results: The study included 68 cases with PMNSGCT. Median age was 28.5 yrs (IQR: 23-35). 12 pts (17.7%) presented with mediastinal syndrome, 23 (33.8%) had lung and 7 (10.3%) LBB metastases. 12 pts received upfront HDCT and 45 pts (66.2%) underwent post-CT surgery. The final model of poor prognostic factors included no surgery (HR: 8.74, 95%CI, 1.77-43.01), surgery + VC (HR: 6.97, 95%CI, 1.46-33.30), and lung metastases (HR: 2.92, 95%CI, 0.99-8.64). The model demonstrated moderate discriminatory ability for OS (c-statistic=0.68). A risk stratification model based on the combination of these factors and accounting for a 50% five-year survival cutoff identified 2 groups (poor prognosis, N=28 vs good prognosis, N=26) with distinct overall survival curves (p&lt;0.001). Pre-operative STM and final histology were not associated (p=0.574 at Chi squared test). 5-yr OS after receiving 2nd line CT (n=25) was 18.7% (95%CI, 7.9-44.5). Results are limited by small numbers. Conclusions: Pts with PMNSGCT classified as having a good prognosis in this model had a fairly high survival estimate, while a strategy of consolidation CT for pts with poorest risk features warrants investigation, once the model is confirmed. The effect of surgery on survival was independent of post-CT STM, which also poorly predicted final histology.
Prognostic factors for survival in patients with advanced gastric cancer treated with chemotherapy.
Authors: Montserrat Mangas, Alberto Carmona Bayonas, Maria Luisa Sanchez Lorenzo, Avinash Ramchandani, Teresa Garcia, Ana B. Custodio, Jose Enrique Lorenzo Barreto, Isabel Echavarria Diaz Guardamino, Asuncion Diaz Serrano, Juana Maria Cano, Aitor Azkarate, Federico Longo, Maitane Mugica, Rodrigo Sanchez, Raquel Serrano, Felipe Jose Alvarez Manceñido, Maria Alsina, Paula Jiménez-Fonseca, Marcelo Garrido, Javier Gallego Plazas
Journal: Journal of Clinical Oncology (2016)

142 Background: A prognostic model in advanced gastric cancer that integrates the Her2 status,histopathological classifications and other patient’s or treatment-dependent parameters is lacking. The aim is to identify clinicopathological factors for overall survival in a cohort of patients with advanced gastric cancer. Methods: 526 consecutive patients with advanced adenocarcinoma of the distal esophagus, gastroesophageal junction or stomach were analyzed. All patients were treated with poly-chemotherapy ( ≥ 2 drugs) at 19 Spanish and one Chilean centers between 2012 and 2015. Characteristics of patients, tumors, therapies and pathological factors, were analyzed by a Cox proportional hazards model. Results: The median overall survival was 10.3 months [95% confidence interval (CI), 9.5-11.1], and the time to progression was 6.7 months (95% CI, 6.1-7.2). Independent prognostic factors associated with overall survival were: distal non-diffuse histopathological subtype (hazard ratio, (HR) 0.73), Her2 positive 3+ (HR 0.54), Her2 positive 2+ with FISH + (HR 0.68), surgery of metastases (HR 0.34), Eastern Cooperative Group performance status (ECOG PS) 2 (HR 2.5), ECOG PS 3 (HR 7.37), and only distant lymph node metastases (HR 0.63) (Table 1). Conclusions: We have identified clinicopathological prognostic factors that could be important to stratify advanced gastric cancer, with potential implications in research and treatment. [Table: see text]