A Novel Nomogram for Early Identification and Intervention in Colorectal Cancer Patients at Risk for Malnutrition

2021 ◽  
pp. 000313482110586
Author(s):  
Joseph Tang ◽  
Gary Wong ◽  
Samer Naffouje ◽  
Seth Felder ◽  
Julian Sanchez ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
High Risk ◽  
Cancer Patients ◽  
Performance Status ◽  
External Validation ◽  
Eastern Cooperative Oncology Group ◽  
Receiver Operating Curve ◽  
Subjective Data ◽  
Patient Reported ◽  
Receiver Operating

Background Malnutrition is under-recognized in cancer patients and can lead to poor treatment outcomes. We aim to develop an outpatient-focused score based on the Malnutrition Screening Tool (MST) to help identify colorectal cancer (CRC) profiles at high risk for malnutrition. Methods 506 CRC patients during initial outpatient oncology consultation at our tertiary referral outpatient oncology clinic completed the MST. Objective and subjective data were collected through chart review. Data gathered are as follows: demographics, anthropometrics, laboratory values, patient-reported symptoms, MST score, cancer history, performance status, socioeconomic status, and Charlson Comorbidity. Predictors of malnutrition were identified by logistic regression. Receiver operating curve (ROC), area under the curve (AUC), and our model’s predictability were determined. Results Significant predictors of malnutrition are as follows: younger age (20-39 vs >40 years) (P = .007), normal-to-low body mass index at presentation (P = .019), Eastern Cooperative Oncology Group classification 2-3 (P = .012), metastatic disease (P = .046), albumin <3.0 g/dL (P = .033), fatigue (P < .001), and change in stool/bowel habits (P = .002). In our derived malnutrition score, risk of malnutrition increased from 11% for score 0, to 100% for scores 9-10. Receiver operating curve showed AUC .745 (95% CI, .697-.793). Discussion An outpatient clinic-derived malnutrition score obtained from objective and patient-reported variables may facilitate identification of CRC patients at highest risk for malnutrition. Rapid identification and intervention in high-risk patients may improve treatment recovery, therapy tolerance, and quality of life. Our tool requires external validation before application in clinical practice.

Defining mild, moderate, and severe fatigue in cancer patients and survivors: E2Z02, a trial of the Eastern Cooperative Oncology Group.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 9099-9099
Author(s):  
Xin Shelley Wang ◽  
Fengmin Zhao ◽  
Michael Fisch ◽  
Tito R. Mendoza ◽  
Ann M. O'Mara ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Cancer Survivors ◽  
Cancer Patients ◽  
Rating Scale ◽  
Performance Status ◽  
Fatigue Management ◽  
Severe Fatigue ◽  
Patient Reported ◽  
Fatigue Severity ◽  
Colorectal Cancer Patients

9099 Background: Although mild, moderate and severe categories have been used in clinical guidelines for fatigue management in cancer patients, the optimal cutpoints on a 0-10 scale for delineating these categories have not been replicated. Methods: A multicenter ECOG study (E2Z02) enrolled breast, lung, prostate, or colorectal cancer patients with any treatment status. Fatigue and symptom interference were measured on the 0-10 numerical rating scale of the M. D. Anderson Symptom Inventory (MDASI). The optimal boundaries for categorizing fatigue severity were determined by the largest F ratios from MANOVA (Serlin’s criteria, 1995). Logistic regression with robust standard errors was used to identify risk factors for moderate/severe fatigue for cancer survivors (defined as patients with no evidence of disease and receiving no cancer treatment). Results: The optimal cutpoints that identified 3 distinct levels of fatigue severity for the 2341 patients were: ratings of 1-3 as mild, 4-6 as moderate, and 7-10 as severe. Known-group validity for these cutpoints was established by significant differences of fatigue severity by ECOG performance status and patient-reported quality of life (all P<0.001). Using these cutpoints, 45% (983/2177) of patients undergoing active therapy had moderate/severe fatigue, with significant more mild fatigue in breast and colorectal cancer patients, while more severe fatigue in lung cancer patients (p<.001). Among cancer survivors, 29% (150/515) had moderate/severe fatigue (breast 31%, colorectal 27%, prostate 22%, lung 33%). Younger age (OR=0.97, 95% CI=0.95-0.99) and poor performance status (OR=4.21, 95% CI=2.36-7.51) were associated with more moderate/severe fatigue in cancer survivors. Survivor time was also associated with moderate/severe fatigue in breast and colorectal cancer survivors (>=5yrs vs. <5yrs: OR=0.23, P<0.01 for breast, OR=9.3, P=0.03 for colorectal). Conclusions: This multicenter study confirmed the standard cutpoints for fatigue severity used in NCCN fatigue management guidelines. It also provides a profile of moderate to severe fatigue prevalence for actively treated cancer patients and for cancer survivors.

scholarly journals Safety, efficacy and patient-reported outcomes with trifluridine/tipiracil in pretreated metastatic colorectal cancer: results of the PRECONNECT study

ESMO Open ◽  
2020 ◽  
Vol 5 (3) ◽  
pp. e000698
Author(s):  
Jean-Baptiste Bachet ◽  
Lucjan Wyrwicz ◽  
Timothy Price ◽  
Chiara Cremolini ◽  
Jean-Marc Phelip ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Group Performance ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Progression Free Survival ◽  
Open Label ◽  
Patient Reported ◽  
Registration Number ◽  
Grade 3

BackgroundIn RECOURSE (, trifluridine/tipiracil significantly improved overall survival and progression-free survival (PFS) versus placebo in patients with pretreated metastatic colorectal cancer (mCRC). PRECONNECT was designed to further characterise safety and clinical use of trifluridine/tipiracil.MethodsIn this ongoing, international, multicentre, open-label trial, patients with pretreated mCRC received oral trifluridine/tipiracil 35 mg/m2 twice daily on days 1–5 and 8–12 of each 28-day cycle. The primary endpoint was safety; secondary endpoints included PFS and quality of life (QoL).Results793 patients (median age 62 years) from 13 countries received trifluridine/tipiracil for a median of 2.84 months (IQR 2.64). Adverse events (AEs) were experienced by 96.7%; the most common (≥20% of patients) were neutropaenia, asthenia/fatigue, nausea, anaemia and diarrhoea. Grade ≥3 AEs occurred in 73.9% of patients, with the most common being neutropaenia (39.1% of patients), anaemia (9.8%) and asthenia/fatigue (5.0%). Median PFS was 2.8 months (95% CI 2.7 to 2.9). Median time to Eastern Cooperative Oncology Group performance status deterioration (≥2) was 8.9 months (range 0.03–14.72). There was no clinically relevant change from baseline in QoL.ConclusionsPRECONNECT showed consistent results with the previously demonstrated safety and efficacy profile of trifluridine/tipiracil, with no new safety concerns identified. QoL was maintained during treatment.Trial registration numberNCT03306394.

The relationship between symptom burden and perceived comorbidity in outpatients with common solid tumors.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 6080-6080
Author(s):  
Christine Ritchie ◽  
Judith Manola ◽  
Elizabeth Kvale ◽  
Claire Frances Snyder ◽  
Michael Fisch
Keyword(s):  
Cancer Patients ◽  
Weighted Least Squares ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Symptom Burden ◽  
Health Problems ◽  
Comorbid Conditions ◽  
Factors Associated ◽  
Physical Scale ◽  
Patient Reported

6080 Background: Cancer patients have high symptom burden, but it is unclear whether comorbid conditions are associated with patient-reported symptom burden (the number and severity of symptoms). Methods: The Eastern Cooperative Oncology Group (ECOG) enrolled 3106 patients with invasive cancer of the breast, colon/rectum, prostate and lung, regardless of phase of care or stage of disease. At baseline, patients completed the M.D. Anderson Symptom Inventory (MDASI) and were also asked how bothered they were by difficulties related to health problems other than cancer. Symptom burden (SB) was defined as the number of symptoms scored 7 or higher on the 13-item MDASI physical scale. Variance-weighted least squares regression was used to identify factors associated with increasing levels of being bothered by comorbid conditions. Results: About 65% of patients were at least a little bothered by symptoms associated with comorbidities. There was a strong association between increased bother by comorbidities and increased SB (p<0.0001). Among those not bothered by difficulties related to comorbidities, ≥1 symptom was rated 7 or worse by 29% of patients, compared to 51% in patients bothered by difficulties related to comorbidities (Fisher’s exact p<0.0001). Except for hair loss, the severity of all symptoms was higher in those patients reporting bother due to other perceived comorbidities. Factors associated with increased bother include SB (p<0.0001), taking medications for diabetes (p<0.0001), impaired ECOG performance status (p=0.03), older age (p=0.004), and being perceived by the clinician as having higher degree of difficulty for providing care (p<0.0001). Conclusions: Symptom burden varies significantly according to the degree to which cancer patients perceive bother that they attribute to comorbid health problems. Perception of comorbidity is worth exploring as a stratification factor in symptom research and as an indicator for complexity in patient care.

scholarly journals Validity of a single-item indicator of treatment side effect bother in a diverse sample of cancer patients

2022 ◽  
Author(s):  
Pip Griffiths ◽  
John Devin Peipert ◽  
Andrea Leith ◽  
Alex Rider ◽  
Lucy Morgan ◽  
...  
Keyword(s):  
Side Effects ◽  
Global Health ◽  
Cancer Patients ◽  
Real World ◽  
Side Effect ◽  
Convergent Validity ◽  
Group Performance ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Patient Reported

Abstract Purpose With higher efficacy of cancer therapies, the numbers and types of side effects experienced by patients have also increased, evidencing a need for brief assessments of side effect bother. The Functional Assessment of Cancer Therapy-General (FACT-G) includes the item “I am bothered by side effects of treatment” (GP5). This study aimed to confirm GP5’s validity in a large, diverse, real-world patient sample. Methods Real-world data were drawn from 10 Adelphi Disease Specific Programmes (DSP™) conducted between 2015 and 2019 in France, Germany, Italy, Spain, the UK and the USA, covering 10 cancer sites. We examined correlations between GP5 responses and varied measures of patient-reported global health and the number of side effects experienced. We explored whether more advanced patients and those with worse Eastern Cooperative Oncology Group Performance Status Rating (ECOG PSR) reported greater side effect bother. Finally, we conducted differential item functioning (DIF) assessment using the Mantel–Haenszel approach. Results The sample included 6755 advanced cancer patients. GP5 responses were distributed similarly across most cancer sites. A moderate, negative correlation (rpolyserial =  − 0.43) between GP5 responses and global health evidenced convergent validity. Known groups validity was evidenced by dichotomised distributions of GP5, showing expected results between cancer stage 2 vs. 3 and 4 and with ECOG PSR (p < 0.001). Little evidence of DIF was found. Conclusion GP5 exhibited evidence of validity across cancer sites and countries and appeared to measure the same construct across these countries. GP5 has significant promise as a summary indicator of side effect bother.

scholarly journals The Prognostic Value of the New Combined Hemo-Eosinophil Inflammation Index (HEI Index): A Multicenter Analysis of Anal Cancer Patients Treated with Concurrent Chemo-Radiation

Cancers ◽  
2021 ◽  
Vol 13 (4) ◽  
pp. 671
Author(s):  
Margherita Rimini ◽  
Pierfrancesco Franco ◽  
Berardino De Bari ◽  
Maria Giulia Zampino ◽  
Stefano Vagge ◽  
...  
Keyword(s):  
High Risk ◽  
Cancer Patients ◽  
Anal Cancer ◽  
Prognostic Score ◽  
Univariate Analysis ◽  
External Validation ◽  
Risk Groups ◽  
Anal Squamous Cell Carcinoma ◽  
Predictors Of Response ◽  
Risk Patients

Anal squamous cell carcinoma (SCC) is a rare tumor, and bio-humoral predictors of response to chemo-radiation (CT-RT) are lacking. We developed a prognostic score system based on laboratory inflammation parameters. We investigated the correlation between baseline clinical and laboratory variables and disease-free (DFS) and overall (OS) survival in anal SCC patients treated with CT-RT in five institutions. The bio-humoral parameters of significance were included in a new scoring system, which was tested with other significant variables in a Cox’s proportional hazard model. A total of 308 patients was included. We devised a prognostic model by combining baseline hemoglobin level, SII, and eosinophil count: the Hemo-Eosinophils Inflammation (HEI) Index. We stratified patients according to the HEI index into low- and high-risk groups. Median DFS for low-risk patients was not reached, and it was found to be 79.5 months for high-risk cases (Hazard Ratio 3.22; 95% CI: 2.04–5.10; p < 0.0001). Following adjustment for clinical covariates found significant at univariate analysis, multivariate analysis confirmed the HEI index as an independent prognostic factor for DFS and OS. The HEI index was shown to be a prognostic parameter for DFS and OS in anal cancer patients treated with CT-RT. An external validation of the HEI index is mandatory for its use in clinical practice.

472 Addressing the Quality of Hospital Care of Colorectal Cancer Patients Undergoing Surgery: What Did We Learn from the National Bowel Cancer Audit?

2021 ◽  
Vol 108 (Supplement_2) ◽  
Author(s):  
C Li ◽  
S Z Y Ooi ◽  
T Woo ◽  
P H M Chan
Keyword(s):  
Colorectal Cancer ◽  
Cancer Patients ◽  
External Validation ◽  
Distant Metastases ◽  
Management Plan ◽  
Bowel Cancer ◽  
Clinical Factors ◽  
Quality Outcomes ◽  
Colorectal Cancer Patients

Abstract Aim To identify the most relevant clinical factors in the National Bowel Cancer Audit (NBOCA) that contribute to the variation in the quality of care provided in different hospitals for colorectal cancer patients undergoing surgery. Method Data from 36,116 patients with colorectal cancer who had undergone surgery were retrospectively collected from the NBOCA and analysed from 145 and 146 hospitals over two years. A validated multiple linear regression was performed to compare the identified clinical factors with various quality outcomes. The quality outcomes defined in this study were the length of hospitalisation, 2-year mortality, readmission rate, 90-day mortality, and 18-month stoma rate. Results Four clinical factors (laparoscopy rate, abdominal-perineal-resection-of-rectum (APER), pre-operative radiotherapy and patients with distant metastases) were shown to have a significant (p &lt; 0.05) impact on the length of hospitalisation and 18-month stoma rate. 18-month stoma rate was also significantly associated with 2-year mortality. External validation of the regression model demonstrated the Root-Mean-Square-Error of 0.811 and 4.62 for 18-month stoma rate and 2-year mortality respectively. Conclusions Hospitals should monitor the four clinical factors for patients with colorectal cancer during perioperative care. Clinicians should consider these factors along with the individual patients’ history when formulating a management plan for patients with colorectal cancer.

Comprehensive Geriatric Assessment Adds Information to Eastern Cooperative Oncology Group Performance Status in Elderly Cancer Patients: An Italian Group for Geriatric Oncology Study

2002 ◽  
Vol 20 (2) ◽  
pp. 494-502 ◽  
Author(s):  
Lazzaro Repetto ◽  
Lucia Fratino ◽  
Riccardo A. Audisio ◽  
Antonella Venturino ◽  
Walter Gianni ◽  
...  
Keyword(s):  
Cancer Patients ◽  
Geriatric Assessment ◽  
Comprehensive Geriatric Assessment ◽  
Daily Living ◽  
Group Performance ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Geriatric Oncology ◽  
Oncology Group ◽  
Elderly Cancer Patients

PURPOSE: To appraise the performance of Comprehensive Geriatric Assessment (CGA) in elderly cancer patients (≥ 65 years) and to evaluate whether it could add further information with respect to the Eastern Cooperative Oncology Group performance status (PS). PATIENTS AND METHODS: We studied 363 elderly cancer patients (195 males, 168 females; median age, 72 years) with solid (n = 271) or hematologic (n = 92) tumors. In addition to PS, their physical function was assessed by means of the activity of daily living (ADL) and instrumental activities of daily living (IADL) scales. Comorbidities were categorized according to Satariano’s index. The association between PS, comorbidity, and the items of the CGA was assessed by means of logistic regression analysis. RESULTS: These 363 elderly cancer patients had a good functional and mental status: 74% had a good PS (ie, lower than 2), 86% were ADL-independent, and 52% were IADL-independent. Forty-one percent of patients had one or more comorbid conditions. Of the patients with a good PS, 13.0% had two or more comorbidities; 9.3% and 37.7% had ADL or IADL limitations, respectively. By multivariate analysis, elderly cancer patients who were ADL-dependent or IADL-dependent had a nearly two-fold higher probability of having an elevated Satariano’s index than independent patients. A strong association emerged between PS and CGA, with a nearly five-fold increased probability of having a poor PS (ie, ≥ 2) recorded in patients dependent for ADL or IADL. CONCLUSION: The CGA adds substantial information on the functional assessment of elderly cancer patients, including patients with a good PS. The role of PS as unique marker of functional status needs to be reappraised among elderly cancer patients.

scholarly journals Phase Ib/II trial evaluating the safety, tolerability and immunological activity of durvalumab (MEDI4736) (anti-PD-L1) plus tremelimumab (anti-CTLA-4) combined with FOLFOX in patients with metastatic colorectal cancer

ESMO Open ◽  
2018 ◽  
Vol 3 (4) ◽  
pp. e000375 ◽  
Author(s):  
Jean-David Fumet ◽  
Nicolas Isambert ◽  
Alice Hervieu ◽  
Sylvie Zanetta ◽  
Jean-Florian Guion ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Checkpoint Inhibitors ◽  
Target Therapy ◽  
Performance Status ◽  
Human Monoclonal Antibody ◽  
Eastern Cooperative Oncology Group ◽  
Predictive Biomarkers ◽  
Progression Free Survival ◽  
Mutational Status

Background5-Fluorouracil plus irinotecan or oxaliplatin alone or in association with target therapy are standard first-line therapy for metastatic colorectal cancer (mCRC). Checkpoint inhibitors targeting PD-1/PD-L1 demonstrated efficacy on mCRC with microsatellite instability but remain ineffective alone in microsatellite stable tumour. 5-Fluorouracil and oxaliplatin were known to present immunogenic properties. Durvalumab (D) is a human monoclonal antibody (mAb) that inhibits binding of programmed cell death ligand 1 (PD-L1) to its receptor. Tremelimumab (T) is a mAb directed against the cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). This study is designed to evaluate whether the addition of PD-L1 and CTLA-4 inhibition to oxaliplatin, fluorouracil and leucovorin (FOLFOX) increases treatment efficacy.MethodsThis phase II study (ClinicalTrials.gov NCT03202758) will assess the efficacy and safety of FOLFOX/D/T association in patients with mCRC (n=48). Good performance status patients (Eastern Cooperative Oncology Group <2) with untreated, RAS mutational status mCRC will be eligible. Prior adjuvant therapy is allowed provided recurrence is >6 months postcompletion. There is a safety lead in nine patients receiving FOLFOX/D/T. Assuming no safety concerns the study will go on to include 39 additional patients. Patients will receive folinic acid (400 mg/m²)/5-fluorouracil (400 mg/m² as bolus followed by 2400 mg/m2 as a 46-hour infusion)/oxaliplatin (85 mg/m2) every 14 days with D (750 mg) D1 every 14 days and T (75 mg) D1 every 28 days. After six cycles of FOLFOX only D/T will continue until disease progression, death, intolerable toxicity, or patient/investigator decision to stop. Primary endpoint is safety and efficacy according to progression-free survival (PFS); secondary endpoints include overall response rate and quality of life. Hypothesis is that a PFS of 50% at 6 months is insufficient and a PFS of 70.7% is expected (with α=10%, β=10%). Blood, plasma and tumour tissue will be collected and assessed for potential prognostic and predictive biomarkers.

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