Karnofsky performance status revisited: reliability, validity, and guidelines.
TL;DR: Oncologists may train themselves to use the Karnofsky Performance Status in a standard way, which should increase reliability and validity of the KPS and has implications for patients and research studies that use KPS as a stratifying variable.
Abstract: Little research has been conducted documenting the reliability and validity of the Karnofsky Performance Status (KPS) scale, and guidelines based on empirical data do not exist to govern its use. Two hundred ninety-three cancer patients completed a questionnaire that assesses their physical and psychosocial difficulties. Physicians rated patients on the KPS and a subsample of 75 patients was used to evaluate interrater reliability. Analyses were conducted to evaluate the interrater reliability and construct validity of the KPS. The KPS was shown to have good reliability and validity. Detailed examination of the reliability data suggested areas in which physicians err in their judgments. Multiple regression techniques were used to empirically identify seven behaviorally based questions that would be helpful in predicting KPS scores. The seven variables included weight loss, weight gain, reduced energy, difficulty walking, driving, grooming, and working part time. An interview approach with behaviorally based guidelines is presented using these variables to obtain relevant data and make more accurate KPS ratings. With the approach suggested and the guidelines presented, oncologists may train themselves to use the KPS in a standard way, which should increase reliability and validity of the KPS and has implications for patients and research studies that use KPS as a stratifying variable.
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Memorial Sloan Kettering Cancer Center1, Institut Gustave Roussy2, Harvard University3, Roswell Park Cancer Institute4, Johns Hopkins University5, Stanford University6, University of Washington7, Vanderbilt University8, Fox Chase Cancer Center9, Macquarie University10, Aarhus University11, University of Helsinki12, The Royal Marsden NHS Foundation Trust13, University of Duisburg-Essen14, Niigata University15, Swansea University16, University of British Columbia17, Bristol-Myers Squibb18, University of Texas MD Anderson Cancer Center19
TL;DR: Overall survival was longer and fewer grade 3 or 4 adverse events occurred with nivolumab than with everolimus among patients with previously treated advanced renal-cell carcinoma.
Abstract: BackgroundNivolumab, a programmed death 1 (PD-1) checkpoint inhibitor, was associated with encouraging overall survival in uncontrolled studies involving previously treated patients with advanced renal-cell carcinoma. This randomized, open-label, phase 3 study compared nivolumab with everolimus in patients with renal-cell carcinoma who had received previous treatment. MethodsA total of 821 patients with advanced clear-cell renal-cell carcinoma for which they had received previous treatment with one or two regimens of antiangiogenic therapy were randomly assigned (in a 1:1 ratio) to receive 3 mg of nivolumab per kilogram of body weight intravenously every 2 weeks or a 10-mg everolimus tablet orally once daily. The primary end point was overall survival. The secondary end points included the objective response rate and safety. ResultsThe median overall survival was 25.0 months (95% confidence interval [CI], 21.8 to not estimable) with nivolumab and 19.6 months (95% CI, 17.6 to 23.1) with everolimus. The haz...
4,643 citations
Memorial Sloan Kettering Cancer Center1, University of Texas MD Anderson Cancer Center2, Harvard University3, Fox Chase Cancer Center4, University of Strasbourg5, Queen Mary University of London6, Aarhus University7, Rabin Medical Center8, Tel Aviv University9, University of British Columbia10, Roswell Park Cancer Institute11, Cancer Research UK12, University of Jena13, Pontifícia Universidade Católica do Rio Grande do Sul14, Niigata University15, Complutense University of Madrid16, Cleveland Clinic17, Bristol-Myers Squibb18, Macquarie University19, Johns Hopkins University20, Université Paris-Saclay21
TL;DR: Overall survival and objective response rates were significantly higher with nivolumab plus ipilimumab than with sunitinib among intermediate‐ and poor‐risk patients with previously untreated advanced renal‐cell carcinoma.
Abstract: Background Nivolumab plus ipilimumab produced objective responses in patients with advanced renal-cell carcinoma in a pilot study. This phase 3 trial compared nivolumab plus ipilimumab with sunitinib for previously untreated clear-cell advanced renal-cell carcinoma. Methods We randomly assigned adults in a 1:1 ratio to receive either nivolumab (3 mg per kilogram of body weight) plus ipilimumab (1 mg per kilogram) intravenously every 3 weeks for four doses, followed by nivolumab (3 mg per kilogram) every 2 weeks, or sunitinib (50 mg) orally once daily for 4 weeks (6-week cycle). The coprimary end points were overall survival (alpha level, 0.04), objective response rate (alpha level, 0.001), and progression-free survival (alpha level, 0.009) among patients with intermediate or poor prognostic risk. Results A total of 1096 patients were assigned to receive nivolumab plus ipilimumab (550 patients) or sunitinib (546 patients); 425 and 422, respectively, had intermediate or poor risk. At a median follo...
2,984 citations
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...Increased lipase level 90 (16) 56 (10) 58 (11) 35 (7)...
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Cleveland Clinic1, Fox Chase Cancer Center2, Ivano-Frankivsk National Medical University3, Queen Mary University of London4, Laval University5, University of Colorado Colorado Springs6, University College Dublin7, University of Tübingen8, Taipei Veterans General Hospital9, Osaka City University10, Merck & Co.11, Georgetown University12
TL;DR: Treatment with pembrolizumab plus axitinib resulted in significantly longer overall survival and progression‐free survival, as well as a higher objective response rate, than treatment with sunitin ib among patients with previously untreated advanced renal‐cell carcinoma.
Abstract: Background The combination of pembrolizumab and axitinib showed antitumor activity in a phase 1b trial involving patients with previously untreated advanced renal-cell carcinoma. Whether pembrolizumab plus axitinib would result in better outcomes than sunitinib in such patients was unclear. Methods In an open-label, phase 3 trial, we randomly assigned 861 patients with previously untreated advanced clear-cell renal-cell carcinoma to receive pembrolizumab (200 mg) intravenously once every 3 weeks plus axitinib (5 mg) orally twice daily (432 patients) or sunitinib (50 mg) orally once daily for the first 4 weeks of each 6-week cycle (429 patients). The primary end points were overall survival and progression-free survival in the intention-to-treat population. The key secondary end point was the objective response rate. All reported results are from the protocol-specified first interim analysis. Results After a median follow-up of 12.8 months, the estimated percentage of patients who were alive at 12 months was 89.9% in the pembrolizumab-axitinib group and 78.3% in the sunitinib group (hazard ratio for death, 0.53; 95% confidence interval [CI], 0.38 to 0.74; P Conclusions Among patients with previously untreated advanced renal-cell carcinoma, treatment with pembrolizumab plus axitinib resulted in significantly longer overall survival and progression-free survival, as well as a higher objective response rate, than treatment with sunitinib. (Funded by Merck Sharp & Dohme; KEYNOTE-426 ClinicalTrials.gov number, NCT02853331.).
2,075 citations
Cites methods from "Karnofsky performance status revisi..."
...Karnofsky performance-status scores range from 0 to 100, with lower scores indicating greater disability.(12) The programmed death ligand 1 (PD-L1) combined positive score was calculated as the number of PD-L1–positive cells (tumor cells, lymphocytes, and macrophages) divided by the total number of tumor cells, multiplied by 100; patients with PD-L1 expression that could not be evaluated were excluded from the analysis of the subgroup defined according to PD-L1 combined positive score....
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01 Jan 2014
TL;DR: Lymphedema is a common complication after treatment for breast cancer and factors associated with increased risk of lymphedEMA include extent of axillary surgery, axillary radiation, infection, and patient obesity.
1,988 citations
TL;DR: In this paper, the authors translate, validate, and generate normative data on the SF-36 Health Survey for use among Dutch- speaking residents of the Netherlands, followed the stepwise, iterative procedures developed by the IQOLA Project.
1,957 citations
References
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TL;DR: In this article, the authors present a procedure for having two or more judges independently categorize a sample of units and determine the degree, significance, and significance of the units. But they do not discuss the extent to which these judgments are reproducible, i.e., reliable.
Abstract: CONSIDER Table 1. It represents in its formal characteristics a situation which arises in the clinical-social-personality areas of psychology, where it frequently occurs that the only useful level of measurement obtainable is nominal scaling (Stevens, 1951, pp. 2526), i.e. placement in a set of k unordered categories. Because the categorizing of the units is a consequence of some complex judgment process performed by a &dquo;two-legged meter&dquo; (Stevens, 1958), it becomes important to determine the extent to which these judgments are reproducible, i.e., reliable. The procedure which suggests itself is that of having two (or more) judges independently categorize a sample of units and determine the degree, significance, and
34,965 citations
TL;DR: It is suggested that the KPS has considerable validity as a global indicator of the functional status of patients with cancer and might be helpful for following other patients with chronic disease.
Abstract: The Karnofsky Performance Status Scale (KPS) was designed to measure the level of patient activity and medical care requirements. It is a general measure of patient independence and has been widely used as a general assessment of patients with cancer. Although there is a long history of use of the KPS for judging cancer patients, its reliability and validity have been assumed without formal investigation. The interrater reliability of the KPS was investigated in two ways, both of which gave evidence of moderately high reliability. The patients evaluated in their home were usually assigned a lower KPS score compared with a similar evaluation at the same time done in the outpatient clinic. Construct validity of the KPS was demonstrated by strong correlation with several variables relating to physical function. Onstudy KPS scores accurately predicted early death, but high initial KPS scores did not necessarily predict long survival. Patient deterioration with subsequent death within a few months could be predicted to a limited extent by a rapidly dropping KPS. These results suggest that the KPS has considerable validity as a global indicator of the functional status of patients with cancer and might be helpful for following other patients with chronic disease. Cancer 45:2220-2224, 1980. ITH THE INCREASE in clinical trials designed to W evaluate chemotherapeutic agents in the treatment of cancer, it became evident that some method of quantifying patients’ status relative to degree of independence in carrying out normal activities and selfcare was needed. In 1948, Karnofsky and Burchena15 described a numerical scale for this purpose. This has subsequently become known as the Karnofsky Performance Status Scale (KPS). Although the KPS is widely used for assessment of patients with cancer, its reliability and validity have generally been assumed without formal investigation. In this paper we evaluate the reliability and validity of the KPS and its usefulness as a clinical tool. An earlier study from this institution of patients on chronic hemodialysis demonstrated lower performance scores for patients when seen in the home as compared with the clinic.3 The conclusion was that a more realistic appraisal of activity was possible in the home. Concurrent home and clinic evaluations were planned as a part of this study.
822 citations
TL;DR: The three most important prognostic factors affecting survival were the Karnofsky initial performance status score, extent of disease, and weight loss in the previous 6 months.
Abstract: Seventy-seven prognostic factors were considered in an evaluation of more than 5,000 patients with inoperable bronchogenic carcinoma of the lung; these patients were entered on the Veterans Administration Lung Group protocols 9-15 (1968-78). Fifty prognostic factors for survival were identified, and their relative contributions to patient survival were considered. The three most important prognostic factors affecting survival were the Karnofsky initial performance status score, extent of disease, and weight loss in the previous 6 months. These factors denoted three general prognostic components: current physical status, current disease status, and prior physical status. Initial performance status was the dominant prognostic factor. Characterization of patient's function status with the use of the Karnofsky scale was preferred to a summarized scale or a dichotomization into ambulatory versus nonambulatory. The current practice of dichotomizing factors resulted in the loss of much prognostic information. Other factors, such as tumor size, histologic type, and institution, appeared to be important when considered alone. However, their contribution was relatively minor after a correction was made for the effects of initial performance status, extent of disease, and prior weight loss. Depending on these three prognostic factors alone, median survival varied between 6 weeks and over a year. Reporting of results without the consideration of such prognostic factors severly hampers any comparisons that may be made between investigations.
607 citations
TL;DR: Major sources of observer variability appeared to be the lack of operational criteria to define the major elements of the scale and the nonexhaustive aggregation of thescale's constituent elements.
235 citations