Who really knows the performance status: The physician or the patient?

Higgins, Michelle; Master, Viraj A.

doi:10.1002/cncr.33236

Cited by 10 publications

(6 citation statements)

References 18 publications

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“…This and other eligibility inclusion criteria provide prognostic power and a patient's functional status as a predictor of survival from a clinician's and trials's perspective but lack holistic screening for cachexia. 28,29 Thus, a cachexia and ECOG score may identify patients at eligibility with an increased risk for developing severe toxicity events during chemotherapy treatment for gastrointestinal cancer. 23 In addition, our study showed that PROs tools were mentioned infrequently, and there was an association between (the lack of) tools and health professionals.…”

Section: Discussionmentioning

confidence: 99%

“…As expected, almost all protocols used a performance status tool, with ECOG as the most often used. This and other eligibility inclusion criteria provide prognostic power and a patient's functional status as a predictor of survival from a clinician's and trials's perspective but lack holistic screening for cachexia 28,29 . Thus, a cachexia and ECOG score may identify patients at eligibility with an increased risk for developing severe toxicity events during chemotherapy treatment for gastrointestinal cancer 23 …”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Are measures and related symptoms of cachexia recorded as outcomes in gastrointestinal cancer chemotherapy clinical trials?

Valaire,

Garden,

Razmovski‐Naumovski

2024

J cachexia sarcopenia muscle

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BackgroundCachexia is prevalent in gastrointestinal cancers and worsens patient outcomes and chemotherapy compliance. We examined to what extent registered gastrointestinal cancer chemotherapy clinical trials record measures and related symptoms of cachexia as outcomes, and whether these were associated with trial characteristics.MethodsFour public trial registries (2012–2022) were accessed for Phase II and/or III randomized controlled pancreatic, gastric, and colorectal cancer chemotherapy trial protocols. Trial outcome measures of overall survival and toxicity/side effects, and those related to cachexia [physical activity, weight/body mass index (BMI), dietary limitations, caloric intake, lean muscle mass] and symptoms (appetite loss, diarrhoea, pain, fatigue/insomnia, constipation, nausea, vomiting, and oral mucositis) were extracted, along with the number and types of performance status and patient‐reported outcomes (PROs) tools. Data were summarized descriptively. Chi‐square tests examined associations between outcomes and trial characteristics (cancer type, trial location, funding source, PROs tools, and commencement year). Statistical significance was set at P < 0.05.ResultsWe included 540 trial protocols (pancreatic (35.2%), colorectal (33.3%) and gastric (31.5%)), with most trials from Europe (44.1%). Trial lead investigator was from academia (28.3%), industry (27.6%) and government (26.3%). Allied health professional involvement (26.9%) occurred at eligibility. Adjuvant therapy in trials was mainly treatment‐related (68.1%). Additional medication included anti‐nausea (2.2%) and analgesia (0.9%). Trial protocols mostly recorded overall survival (90.4%) and toxicity (78.9%), and the symptoms appetite loss (26.1%) and diarrhoea (19.1%), with the other symptoms recorded in <10% of the trials. Reporting of physical activity (P = 0.001), dietary limitations (P = 0.002), lean muscle mass (P = 0.027), appetite loss (P < 0.001), pain (P = 0.001), nausea (P = 0.012), and oral mucositis (P = 0.049) varied depending cancer type. Toxicity/side effects (P = 0.022), physical activity (P < 0.001), appetite loss, nausea, and vomiting (all P < 0.001), diarrhoea (P = 0.010), pain (P = 0.001), fatigue/insomnia (P = 0.001) varied depending on the trial location. Trial funding was predominantly from private/industry (34.3%) and influenced the reporting of overall survival (P = 0.049), weight/BMI (P = 0.005), caloric intake (P = 0.015), and pain (P = 0.031). Performance status and PROs tools were mentioned in 91.2% and 46.3% of the trials, respectively. Trials that incorporated PROs tools were more likely to report cachexia related outcomes, except for overall survival, lean muscle mass, and oral mucositis. The proportion of trials measuring weight/BMI increased with trial commencement year (P = 0.04).ConclusionsCachexia‐related outcomes were under‐recorded in gastrointestinal cancer chemotherapy trials. As trial patients experience a high symptom burden, cachexia‐relevant measures and symptoms should be assessed throughout the trial, and integrated with primary endpoints to support their progress.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Are measures and related symptoms of cachexia recorded as outcomes in gastrointestinal cancer chemotherapy clinical trials?

Valaire,

Garden,

Razmovski‐Naumovski

2024

J cachexia sarcopenia muscle

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“…The patient's health status was defined according to the ECOG general status scale [59]. The presence of cirrhosis was defined based on clinical and radiological criteria [60]; the diagnosis of HCC was achieved through invasive or radiological methods in cirrhotic livers with typical behavior, distinguishing between patients included in HCC screening programs with semi-annual ultrasound and those not undergoing close surveillance.…”

Section: Study Datamentioning

confidence: 99%

Application of Machine Learning Techniques to Assess Alpha-Fetoprotein at Diagnosis of Hepatocellular Carcinoma

Gil-Rojas,

Suárez,

Martínez-Blanco

et al. 2024

IJMS

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Hepatocellular carcinoma (HCC) is the most common primary liver tumor and is associated with high mortality rates. Approximately 80% of cases occur in cirrhotic livers, posing a significant challenge for appropriate therapeutic management. Adequate screening programs in high-risk groups are essential for early-stage detection. The extent of extrahepatic tumor spread and hepatic functional reserve are recognized as two of the most influential prognostic factors. In this retrospective multicenter study, we utilized machine learning (ML) methods to analyze predictors of mortality at the time of diagnosis in a total of 208 patients. The eXtreme gradient boosting (XGB) method achieved the highest values in identifying key prognostic factors for HCC at diagnosis. The etiology of HCC was found to be the variable most strongly associated with a poorer prognosis. The widely used Barcelona Clinic Liver Cancer (BCLC) classification in our setting demonstrated superiority over the TNM classification. Although alpha-fetoprotein (AFP) remains the most commonly used biological marker, elevated levels did not correlate with reduced survival. Our findings suggest the need to explore new prognostic biomarkers for individualized management of these patients.

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“… 9 Eastern Cooperative Oncology Group performance status (ECOG PS) is a clinician-interpreted tool used to evaluate the daily living abilities of patients. 9 ECOG PS is often used for oncology trial stratification and in clinical practice to evaluate prognosis and toxicity to anticancer treatment, thus supporting shared decision making. Patient-reported outcomes (PROs) are structured self-reported tools that provide the patients’ perspective and voice to their physical, social, emotional, and functional abilities.…”

Section: Introductionmentioning

confidence: 99%

“… 8 Shared decision making is an essential component of providing patient-centered care. 9 Eastern Cooperative Oncology Group performance status (ECOG PS) is a clinician-interpreted tool used to evaluate the daily living abilities of patients. 9 ECOG PS is often used for oncology trial stratification and in clinical practice to evaluate prognosis and toxicity to anticancer treatment, thus supporting shared decision making.…”

Section: Introductionmentioning

confidence: 99%

Patient-reported outcomes predict survival and adverse events following anticancer treatment initiation in advanced HER2-positive breast cancer

et al. 2022

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Who really knows the performance status: The physician or the patient?

Cited by 10 publications

References 18 publications

Are measures and related symptoms of cachexia recorded as outcomes in gastrointestinal cancer chemotherapy clinical trials?

Are measures and related symptoms of cachexia recorded as outcomes in gastrointestinal cancer chemotherapy clinical trials?

Application of Machine Learning Techniques to Assess Alpha-Fetoprotein at Diagnosis of Hepatocellular Carcinoma

Patient-reported outcomes predict survival and adverse events following anticancer treatment initiation in advanced HER2-positive breast cancer

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