Continuous monitoring of mobility performance trajectory in patients receiving chemotherapy.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e14104-e14104
Author(s):  
Sudha Yarlagadda ◽  
Bijan Najafi ◽  
Jinna Chu ◽  
Changhong Wang ◽  
Yvonne Sada
Keyword(s):  
Technology Acceptance ◽  
Effect Size ◽  
Statistical Significance ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Real Life ◽  
Activity Level ◽  
Mobility Performance ◽  
Baseline Activity ◽  
Ecog Ps

e14104 Background: Accurate performance status (PS) assessment is important for chemotherapy decisions, but current tools such as the Eastern Cooperative Oncology Group (ECOG) PS assessment are subjective, static, and prone to inter-observer and recall biases. Continuous patient monitoring technology can enhance PS assessment by providing an objective and dynamic measurement of mobility performance (MP), defined as mobility in real-life situations. This study examined the feasibility of a pendant sensor to continuously track MP during a 4-week period of chemotherapy. Methods: Patients on chemotherapy were recruited from a single center. Patients were asked to continuously wear a water-resistant pendant sensor (PAMSys, Biosensics, USA) for 4-weeks during the day and night. Patients completed psychosocial surveys (cognitive, depression, and fatigue) and a technology acceptance survey measured on a Likert scale from 1 (strongly disagree) to 5 (strongly agree). Chart review was completed for demographics, medical history, and baseline ECOG PS. Using a validated algorithm, postures (lying and sitting postures: LSP) and walking parameters (cadence, longest walking bout, total steps per day) were extracted from the pendant. We also calculated percent change from baseline activity to the lowest activity level during the 4-week period. To determine clinically meaningful digital biomarkers, we compared these MP measures between two groups: ECOG 0 or ECOG ≥1. Results: Fifteen patients (median age 68), with either a solid (n = 14) or hematologic (n = 1) malignancy, stages II-IV, with ECOG 0 (n = 7) and ECOG ≥1 (n = 8) were evaluated. Baseline psychosocial parameters were not significantly different. ECOG ≥1 tend to have poorer baseline walking compared to ECOG 0 with the largest effect size observed for cadence (79.2 ± 10.0 vs 73.3±3.7, Cohen’s d effect size d = 0.78). The percentage of MP decline was higher in ECOG 0 compared to ECOG ≥1 (89.0±22.9% vs 79.9±34.5%). None of the observed trends reached statistical significance. Patients reported that the pendant was comfortable to wear (4.9±0.30) and did not interfere with activities (4.9±0.25). Conclusions: This study showed the feasibility of a pendant sensor to continuously monitor MP and its trajectory during chemotherapy. Results suggest continuous MP monitoring may provide objective information to enhance PS assessment. Larger studies are needed to confirm statistical significance of digital MP metrics and its potential effect on clinical decisions such as dose reduction, rehabilitation, and palliative care.

Clinical Outcomes and Safety of Patients Treated with NAb-Paclitaxel Plus Gemcitabine in Metastatic Pancreatic Cancer: The NAPA Study

2020 ◽  
Vol 20 (11) ◽  
pp. 887-895 ◽  
Author(s):  
Martina Catalano ◽  
Giandomenico Roviello ◽  
Raffaele Conca ◽  
Alberto D’Angelo ◽  
Valeria Emma Palmieri ◽  
...  
Keyword(s):  
Performance Status ◽  
Real Life ◽  
Progression Free Survival ◽  
Phase Iii ◽  
Ductal Adenocarcinoma ◽  
Hematological Toxicity ◽  
Free Survival ◽  
Grade 3 ◽  
Ecog Ps ◽  
Prognostic And Predictive Markers

Background: The phase III MPACT trial demonstrated the superiority of gemcitabine (Gem) combined with Nab-paclitaxel (Nab-P) versus gemcitabine alone in previously untreated patients with metastatic pancreatic ductal adenocarcinoma (PDAC). The purpose of this study was to evaluate the effect of Gem/Nab-P in routine clinical practice. Methods: From January 2015 to December 2018, patients with metastatic PDAC receiving firstline treatment with a combination of gemcitabine and Nab-paclitaxel were included in a multicentre retrospective observational study. Exploratory analyses of efficacy, and prognostic and predictive markers, were performed. Results: The cohort comprised 115 patients (median age 65 [range 50-84] years) with good performance status (ECOG PS 0-1). The median overall survival (OS) was 11 months (95% CI; 9-13) and the median progression-free survival (PFS) was 6 months (95% CI 5-7). Partial response and stable disease were achieved in 44 and 30 patients, respectively, yielding an overall disease control rate (DCR) of 64.3%. Grade 3-4 hematological toxicity frequency was 22.61% for neutropenia, 5.22% for anemia, and 3.48% for thrombocytopenia. Grade 3 asthenia was recorded in 2.61% of patients. No grade 4 non-hematological events were reported. Dose reduction was necessary in 51.3% of the patients. Conclusions: Our results confirm the efficacy and safety of a first-line regimen comprising gemcitabine and Nab-paclitaxel in metastatic PDAC in a real-life population.

scholarly journals Palliative Performance Scale: Polish validation in hospice setting - a prospective observational study

2020 ◽  
Author(s):  
Tomasz Dzierżanowski ◽  
Tomasz Gradalski ◽  
Michael Kozlowski
Keyword(s):  
Palliative Care ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Karnofsky Performance Score ◽  
Care Providers ◽  
Free Standing ◽  
Ecog Performance Status ◽  
Rehabilitation Outcomes ◽  
Ecog Ps ◽  
Performance Scale

Abstract Background: Measuring functional status in palliative care may help clinicians to assess a patient’s prognosis, recommend adequate therapy, avoid futile or aggressive medical care, consider hospice referral, and evaluate provided rehabilitation outcomes. An optimized, widely used, and validated tool is preferable. The Palliative Performance Scale Version 2 (PPSv2) is currently one of the most commonly used performance scales in palliative settings. The aim of this study is the translation and validation process of a Polish translation of this tool (PPSv2-Polish). Methods: Two hundred patients consecutively admitted to a free-standing hospice were evaluated twice during 2 consecutive days for test-retest reliability. In the first evaluation, two different care providers independently evaluated the same patient to establish inter-rater reliability values. PPS-Polish was compared with the Karnofsky Performance Score (KPS), Eastern Cooperative Oncology Group (ECOG) Performance Status (ECOG PS), and Barthel Activities of Daily Living (ADL) Index to determine its construct validity. Results: A high level of full agreement between test and retest was seen (63%), and a good intra-class correlation coefficient of 0.85 (P<0.0001) was achieved. Excellent agreement between raters was observed when using PPSv2-Polish (Cohen’s kappa 0.91; P<0.0001). Satisfactory correlations with the KPS and good correlations with ECOG PS and Barthel ADL were noticed. Persons who had shorter prognoses and were predominantly bedridden also had lower scores measured by the PPSv2-Polish, KPS and Barthel ADL. A strong correlation of 0.77 between PPSv2-Polish scores and survival time was noted (P<0.0001). Moderate survival correlations were seen between KPS, ECOG PS, and Barthel ADL of 0.41; -0.62; and 0.58, respectively (P<0.0001). Conclusion: PPSv2-Polish is a valid and reliable tool measuring performance status in a hospice population and can be used in daily clinical practice in palliative care and research.

scholarly journals Performance Status Assessment by Using ECOG (Eastern Cooperative Oncology Group) Score for Cancer Patients by Oncology Healthcare Professionals

2019 ◽  
Vol 12 (3) ◽  
pp. 728-736 ◽  
Author(s):  
Faisal Azam ◽  
Muhammad Farooq Latif ◽  
Ayesha Farooq ◽  
Syed Hammad Tirmazy ◽  
Saad AlShahrani ◽  
...  
Keyword(s):  
Health Care Professionals ◽  
Karnofsky Performance Status ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Treatment Decision ◽  
Oncology Group ◽  
Group Score ◽  
Clinical Scenarios ◽  
Status Assessment ◽  
Ecog Ps

Medical literature does not have clear consensus on inter-rater reliability of PS assessment by different oncology health care professionals (HCPs) although it plays an important role in treatment decision and prognosis for oncology patients. Eastern Cooperative Oncology Group (ECOG) and Karnofsky performance status (KPS) scores are commonly used for this purpose by oncology HCPs around the world. This study was conducted to find variability or similarities in assessment of PS among the different oncology HCPs. A survey based on four hypothetical clinical scenarios was devised and sent to 50 oncology HCPs to assess the PS using ECOG PS tool. No significant variations in PS assessment by oncology HCPs was noted in our study sample.

Complications following symptom-limited thoracentesis using suction

2020 ◽  
Vol 56 (5) ◽  
pp. 1902356 ◽  
Author(s):  
Ala Eddin S. Sagar ◽  
Maria F. Landaeta ◽  
Andres M. Adrianza ◽  
Grecia L. Aldana ◽  
Leonardo Pozo ◽  
...  
Keyword(s):  
Pleural Fluid ◽  
Group Performance ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Chest Discomfort ◽  
Mediastinal Shift ◽  
Increased Risk ◽  
Procedural Complications ◽  
Ecog Ps ◽  
Current Guidelines

BackgroundThoracentesis using suction is perceived to have increased risk of complications, including pneumothorax and re-expansion pulmonary oedema (REPO). Current guidelines recommend limiting drainage to 1.5 L to avoid REPO. Our purpose was to examine the incidence of complications with symptom-limited drainage of pleural fluid using suction and identify risk factors for REPO.MethodsA retrospective cohort study of all adult patients who underwent symptom-limited thoracentesis using suction at our institution between January 1, 2004 and August 31, 2018 was performed, and a total of 10 344 thoracenteses were included.ResultsPleural fluid ≥1.5 L was removed in 19% of the procedures. Thoracentesis was stopped due to chest discomfort (39%), complete drainage of fluid (37%) and persistent cough (13%). Pneumothorax based on chest radiography was detected in 3.98%, but only 0.28% required intervention. The incidence of REPO was 0.08%. The incidence of REPO increased with Eastern Cooperative Oncology Group performance status (ECOG PS) ≥3 compounded with ≥1.5 L (0.04–0.54%; 95% CI 0.13–2.06 L). Thoracentesis in those with ipsilateral mediastinal shift did not increase complications, but less fluid was removed (p<0.01).ConclusionsSymptom-limited thoracentesis using suction is safe even with large volumes. Pneumothorax requiring intervention and REPO are both rare. There were no increased procedural complications in those with ipsilateral mediastinal shift. REPO increased with poor ECOG PS and drainage ≥1.5 L. Symptom-limited drainage using suction without pleural manometry is safe.

scholarly journals Nomogram to Predict Cycle-One Serious Drug-Related Toxicity in Phase I Oncology Trials

2014 ◽  
Vol 32 (6) ◽  
pp. 519-526 ◽  
Author(s):  
David M. Hyman ◽  
Anne A. Eaton ◽  
Mrinal M. Gounder ◽  
Gary L. Smith ◽  
Erika G. Pamer ◽  
...  
Keyword(s):  
Phase I ◽  
Group Performance ◽  
Statistical Significance ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Study Drug ◽  
Cancer Therapeutics ◽  
Phase I Trials ◽  
Concordance Index ◽  
Data Set

Purpose All patients in phase I trials do not have equivalent susceptibility to serious drug-related toxicity (SDRT). Our goal was to develop a nomogram to predict the risk of cycle-one SDRT to better select appropriate patients for phase I trials. Patients and Methods The prospectively maintained database of patients with solid tumor enrolled onto Cancer Therapeutics Evaluation Program–sponsored phase I trials activated between 2000 and 2010 was used. SDRT was defined as a grade ≥ 4 hematologic or grade ≥ 3 nonhematologic toxicity attributed, at least possibly, to study drug(s). Logistic regression was used to test the association of candidate factors to cycle-one SDRT. A final model, or nomogram, was chosen based on both clinical and statistical significance and validated internally using a bootstrapping technique and externally in an independent data set. Results Data from 3,104 patients enrolled onto 127 trials were analyzed to build the nomogram. In a model with multiple covariates, Eastern Cooperative Oncology Group performance status, WBC count, creatinine clearance, albumin, AST, number of study drugs, biologic study drug (yes v no), and dose (relative to maximum administered) were significant predictors of cycle-one SDRT. All significant factors except dose were included in the final nomogram. The model was validated both internally (bootstrap-adjusted concordance index, 0.60) and externally (concordance index, 0.64). Conclusion This nomogram can be used to accurately predict a patient's risk for SDRT at the time of enrollment. Excluding patients at high risk for SDRT should improve the safety and efficiency of phase I trials.

Actigraphy as an objective measure of performance status in patients with advanced cancer.

2015 ◽  
Vol 33 (29_suppl) ◽  
pp. 62-62 ◽  
Author(s):  
William F. Pirl ◽  
Daisuke Fujisawa ◽  
Jamie Stagl ◽  
Justin Eusebio ◽  
Lara Traeger ◽  
...  
Keyword(s):  
Physical Activity ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Objective Measure ◽  
Stage Iv ◽  
Self Report ◽  
Subjective Rating ◽  
Metabolic Equivalents ◽  
Patient Reported ◽  
Ecog Ps

62 Background: Treatment decisions are often based on performance status (PS), a subjective rating of patient functioning derived from observation and patient-report. Devices that monitor physical activity, such as wrist actigraphs, can accurately measure the percent of time a person is immobile while awake (awake immobile). Thus, actigraphy may have potential to better estimate true PS. We compared actigraphy to both Eastern Cooperative Oncology Group PS (ECOG PS) and patient-reported physical activity as predictors of survival in patients with stage IV non-small cell lung cancer (NSCLC). Methods: Participants (n = 41) were ambulatory patients with stage IV NSCLC receiving care at MGH. Participants wore a watch-sized accelerometer device (ACTIWATCH 2) for three consecutive 24-hour periods (72 hours) and completed a self-report questionnaire about physical activity, scored as METS (metabolic equivalents) per week. Patients’ oncologists rated their ECOG PS (0-5) at the end of the 72-hour actigraphy period. Relationships among ECOG PS, awake immobile, and METs per week were tested with Pearson correlations. A ROC curve for 6-month survival was used to determine a meaningful cut-off for awake immobile. Unadjusted Cox regression models tested associations with survival from assessment times. Results: Participants’ ECOG PS ratings were: 0 (22%), 1 (63%), 2 (12%), and 3 (2%). ECOG PS and awake immobile were correlated (r = .42, p < .01). METS per week was correlated only with ECOG PS (r = -.35, p = .03). At time of analysis, 15 patients had died with a minimum follow up of 9 months. Among all patients, survival was predicted by ECOG PS, HR = 3.77 (95% CI 1.70-8.35), p < .01; awake immobile as both as a continuous (percentage points) and categorical ( > 23%) variable, HR = 1.04 (95% CI 1.00-1.09), p = .05 and HR = 4.12 (95% CI 1.37-12.39), p = .01, respectively; but not METS per week. Among patients with good EGOC PS (0-1), only awake immobile ( > 23%) predicted survival, HR = 5.80 (95% CI 1.39-24.12), p = .02. Moreover, within the largest ECOG group (PS1), awake immobile ( > 23%) still predicted survival, HR = 5.53 (95% CI 1.18-25.94), p = .03. Conclusions: Actigraphy, an objective measure of patient activity, may have utility in determining patient PS.

Real world eligibility of treatment-refractory stage IV colorectal cancer patients for palliative intent regorafenib monotherapy.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e15007-e15007 ◽  
Author(s):  
Arkhjamil Angeles ◽  
Wayne Hung ◽  
Winson Y. Cheung
Keyword(s):  
Colorectal Cancer ◽  
Overall Survival ◽  
Real World ◽  
Group Performance ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Stage Iv ◽  
Correct Trial ◽  
Eligibility Criteria ◽  
Ecog Ps

e15007 Background: The CORRECT trial demonstrated overall survival benefits of regorafenib monotherapy in patients with metastatic colorectal cancer (CRC) who were refractory to prior chemotherapy and biological therapy. However, stringent criteria used to determine treatment eligibility in the trial setting may limit its external validity in the real world. We aimed to examine treatment attrition rates and eligibility of regorafenib in routine clinical practice. Methods: All patients diagnosed with metastatic CRC between 2009 and 2014 who received 2 or more lines of systemic therapy at the British Columbia Cancer Agency were identified. During the study timeframe, cetuximab (cmab) and panitumumab (pmab) were only used in the chemo-refractory setting. Data on clinical factors, pathological variables and outcomes were ascertained and analyzed. Eligibility was defined based on criteria outlined in the CORRECT trial. Results: A total of 391 patients were included among whom only 39% were considered eligible for regorafenib. Median age was 61 (range 22-84) years. 247 (63%) were men, 305 (78%) were Caucasian, and 237 (60%) had a colonic primary. The disease burden at diagnosis was high: 267 (81%) had lymph node involvement, and 225 (59%) had distant metastases. In patients previously treated with cmab, main reasons for regorafenib ineligiblity were Eastern Cooperative Oncology Group performance status (ECOG PS) > 1 (26.9%), aspartate aminotransferase (AST) > 2 x upper limit of normal (ULN) (6.5%), and arterio-venous thrombotic or embolic events in the preceding 6 months (6.5%). In the group treated with pmab previously, main reasons for ineligibility were ECOG PS > 1 (46.6%), total bilirubin > 1.5 x ULN (14.1%), and thrombotic or embolic events in the past 6 months (5.7%). Additional analyses showed that regorafenib-eligible patients had increased median overall survival compared to ineligible patients (44.0 vs 37.1 months, P= 0.028). Conclusions: The strict trial eligibility criteria disqualified the majority of real world patients with metastatic CRC for regorfenib. As ineligibility predicts poorer outcomes, trials aimed at serving protocol-ineligible patients are warranted.

Influence of tumor size and Eastern Cooperative Oncology Group performance status (ECOG PS) at baseline on patient (pt) outcomes in lenvatinib-treated radioiodine-refractory differentiated thyroid cancer (RR-DTC).

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 6081-6081 ◽  
Author(s):  
Lori J. Wirth ◽  
Sophie Leboulleux ◽  
Naomi Kiyota ◽  
Makoto Tahara ◽  
Kei Muro ◽  
...  
Keyword(s):  
Tumor Size ◽  
Group Performance ◽  
Performance Status ◽  
Objective Response ◽  
Eastern Cooperative Oncology Group ◽  
Progression Free Survival ◽  
Disease Characteristics ◽  
Kaplan Meier ◽  
Ecog Ps ◽  
Post Hoc

6081 Background: In SELECT, lenvatinib significantly improved progression-free survival (PFS) of pts with RR-DTC versus placebo (18.3 v 3.6 months; hazard ratio [HR]: 0.21 [99% CI: 0.14, 0.31]; P<0.001). Here we examine the treatment of RR-DTC with lenvatinib in relation to tumor size (sum of all targeted lesions) and ECOG PS. Methods: In this post hoc analysis of SELECT with pts randomized to receive lenvatinib, Kaplan-Meier estimates of time to ECOG PS ≥2 were calculated for subgroups of pts according to baseline ECOG PS or tumor size. Objective response rate (ORR) and Kaplan-Meier estimates of overall survival (OS) and PFS according to ECOG PS (0 or 1) at baseline were calculated. Correlations between ECOG PS at baseline (0 or 1) and maximum tumor shrinkage were calculated using one-way analysis of variance. Results: Pts with ECOG PS 0 or 1 at baseline had similar demographic and disease characteristics. ORR was 78.5% and 51.0% for pts with ECOG PS 0 and 1 at baseline, respectively (odds ratio [95% CI]: 3.508 [2.018, 6.097]). Mean maximum percent decrease in tumor size was significantly greater in pts with baseline ECOG PS 0 (-46.13%) versus pts with ECOG PS 1 (-37.16%; P=0.0017). For pts with ECOG PS 1 at baseline, time to ECOG PS ≥2 was numerically shorter with tumor size >60 mm versus tumor size ≤60 mm (HR [95% CI]: 1.450 [0.708, 2.967]). Additional results are summarized in the table. Conclusions: Among pts with RR-DTC, PFS, OS, ORR, and time to ECOG ≥2 were generally better for patients with lower ECOG PS or smaller tumor size at baseline. These results may indicate that it is beneficial to start lenvatinib in pts with RR-DTC early, before ECOG PS worsens and tumor size increases. Clinical trial information: NCT01321554. [Table: see text]

scholarly journals Digital Detection of Sarcopenia in Pancreatic Cancer: Additional Utilization to Plan Patient Management

2021 ◽  
Author(s):  
Mustafa Jalal ◽  
Jennifer A Campbell ◽  
Jonathan Wadsley ◽  
Andrew D Hopper
Keyword(s):  
Skeletal Muscle ◽  
Pancreatic Cancer ◽  
Group Performance ◽  
Performance Status ◽  
Locally Advanced ◽  
Eastern Cooperative Oncology Group ◽  
Advanced Pancreatic Cancer ◽  
Skeletal Muscle Index ◽  
Ecog Ps ◽  
Cancer Network

Abstract Purpose: The presence of a sarcopenia adversely affects the prognosis of patients with pancreatic cancer. There is an emerging role for using computed tomography (CT) to calculate skeletal muscle index (SMI) and the presence of sarcopenia. The aim of this study was to assess if detecting ‘digital sarcopenia’ is feasible and can contribute to the management of patients with locally advanced pancreatic cancer (LAPC).Methods: Patients diagnosed with LAPC referred for endoscopic ultrasound guided biopsy (EUS-B) by our regional cancer network were identified. Age, body mass index (BMI), and Eastern Cooperative Oncology Group performance status (ECOG-PS) was noted. CT images were analysed for SMI and the presence of sarcopenia. Decision outcomes on receiving chemotherapy or not were collected from the regional oncology database. Results: In total 51/204 (25%) patients with LAPC who underwent EUS-B were not given chemotherapy and received BSC only. The prevalence of sarcopenia (p=0.0003), age ≥ 75 years old (p=0.03) and ECOG-PS 2-3 (p=0.01) were significantly higher in the patents receiving BSC only. Logistic regression analysis demonstrated that SMI was the only independent associated factor identifying patients with LAPC who were treated with BSC only and not chemotherapy after adjusting for age and ECOG-PS. Conclusion: Our study has shown that digital skeletal muscle analysis at the time of a diagnostic CT for patients with pancreatic cancer is feasible and can detect sarcopenia and malnourished patients who are much less likely to take up chemotherapy. These patients could be triaged to oncology assessment prior to EUS-B to avoid unnecessary investigations.

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