ECOG Performance Status - ECOG-ACRIN
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`ECOG Performance Status
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`To conduct clinical trials for the treatment of cancer in a consistent manner across many
`participating hospitals, cancer centers, and clinics requires the use of standard criteria for measuring
`how the disease impacts a patient’s daily living abilities (known to physicians and researchers as a
`patient’s performance status). The ECOG Scale of Performance Status is one such measurement. It
`describes a patient’s level of functioning in terms of their ability to care for themself, daily activity,
`and physical ability (walking, working, etc.).
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`Researchers worldwide take the ECOG Performance Status into consideration when planning trials to
`study a new treatment method. This numbering scale is one way to define the population of patients
`to be studied in the trial, so that it can be uniformly reproduced among physicians who enroll
`patients. It is also a way for physicians to track changes in a patient’s level of functioning as a result
`of treatment during the trial.
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`The scale was developed by the Eastern Cooperative Oncology Group (ECOG), now part of the
`ECOG-ACRIN Cancer Research Group, and published in 1982. It circulates in the public domain and is
`therefore available for public use. It is displayed below both for future reference and to spur further
`standardization among researchers who design and evaluate cancer clinical research.
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`ECOG Performance Status
`Developed by the Eastern Cooperative Oncology Group, Robert L. Comis, MD, Group Chair.*
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`GRADE
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`ECOG PERFORMANCE STATUS
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`0
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`1
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`2
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`3
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`4
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`5
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`Fully active, able to carry on all pre-disease performance without restriction
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`Restricted in physically strenuous activity but ambulatory and able to carry out work of a light
`or sedentary nature, e.g., light house work, office work
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`Ambulatory and capable of all selfcare but unable to carry out any work activities; up and
`about more than 50% of waking hours
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`Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours
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`Completely disabled; cannot carry on any selfcare; totally confined to bed or chair
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`Dead
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`*Oken M, Creech R, Tormey D, et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin
`Oncol. 1982;5:649-655.
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`Comparing the ECOG Performance Status to the Karnofsky
`Performance Status
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`The ECOG Performance Status and the Karnofsky Performance Status are two widely used methods
`to assess the functional status of a patient. Both scales have been in the public domain for many
`years as ways to classify a patient according to their functional impairment, compare the
`effectiveness of therapies, and assess the prognosis of a patient. The Karnofsky index, between 100
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`http://ecog-acrin.org/resources/ecog-performance-status
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`3/14/2017
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`JANSSEN EXHIBIT 2158
`Wockhardt v. Janssen IPR2016-01582
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`

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`ECOG Performance Status - ECOG-ACRIN
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`Page 2 of 2
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`and 0, was introduced in a textbook in 1949.* Key elements of the ECOG scale first appeared in the
`medical literature in 1960.**
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`There are several ways to map the two scales. The table below displays one commonly used
`comparison.
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`ECOG PERFORMANCE STATUS
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`KARNOFSKY PERFORMANCE STATUS
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`0—Fully active, able to carry on all pre-
`disease performance without restriction
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`100—Normal, no complaints; no evidence of
`disease
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`90—Able to carry on normal activity; minor
`signs or symptoms of disease
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`1—Restricted in physically strenuous activity
`but ambulatory and able to carry out work of a
`light or sedentary nature, e.g., light house
`work, office work
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`80—Normal activity with effort, some signs or
`symptoms of disease
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`70—Cares for self but unable to carry on
`normal activity or to do active work
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`2—Ambulatory and capable of all selfcare but
`unable to carry out any work activities; up and
`about more than 50% of waking hours
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`60—Requires occasional assistance but is
`able to care for most of personal needs
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`50—Requires considerable assistance and
`frequent medical care
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`3—Capable of only limited selfcare; confined
`to bed or chair more than 50% of waking
`hours
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`4—Completely disabled; cannot carry on any
`selfcare; totally confined to bed or chair
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`5—Dead
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`40—Disabled; requires special care and
`assistance
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`30—Severely disabled; hospitalization is
`indicated although death not imminent
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`20—Very ill; hospitalization and active
`supportive care necessary
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`10—Moribund
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`0—Dead
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`*Karnofsky D, Burchenal J, The clinical evaluation of chemotherapeutic agents in cancer. In: MacLeod C, ed. Evaluation
`of Chemotherapeutic Agents. New York, NY: Columbia University Press; 1949:191–205.
`**Zubrod C, et al. Appraisal of methods for the study of chemotherapy in man: Comparative therapeutic trial of nitrogen
`mustard and thiophosphoramide. Journal of Chronic Diseases; 1960:11:7-33.
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`http://ecog-acrin.org/resources/ecog-performance-status
`
`3/14/2017
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