Biotech Values

[DewDiligence]

ECOG Performance Status depends a lot on who measures it:

http://www.asco.org/ac/1,1003,_12-002636-00_18-0017-00_19-0016106,00.asp

[See definitions at end of this post.]

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The validity of the assessment of performance status (PS) by health professionals has not well been evaluated. We investigated for a possible discrepancy in the assessment of PS among patients, nurses and oncologists. The proportion of patients assessed as ECOG PS 0--1 by oncologist and patient was estimated to be 70 and 55%, respectively, and 200 consecutive patients with lung cancer were investigated prospectively. This accruarial [sic] goal was sufficient to have more than 85% power to detect the difference with a significance level of 5%. Further, survival analysis was conducted using the 109 patients with non-small cell lung cancer (NSCLC) of stage IIIB or IV. The percentage of patients assessed as ECOG PS 0--1 was 68% by oncologists and 53% by the patients themselves (p = 0.039, by chi-squared test). There was a significant difference among the assessment by the three groups (p < 0.001, by Friedman test). The oncologists gave the healthiest PS assessment, the nurses an intermediate assessment (although significantly healthier than patient-assessed PS), and the patients the poorest. In the Cox model, the PS assessments by the oncologists and the patients (not the nurses), as well as gender, liver metastasis, lymph node metastasis, number of organs involved with metastasis, hemoglobin, and serum lactate dehydrogenase, were significantly correlated with the survival. The cut-off of performance status associated with significant difference in survival was 0 v 1 v 2--4 in oncologist-rating, and 0--2 v 3--4 in patient-rating; this is of interest because many investigators argue that only fully ambulatory patients should be candidates for chemotherapy for advanced NSCLC. In conclusion, oncologists' assessment of PS is sufficiently valid to stratify patients in clinical trials, although the assessment is significantly different from that by patients themselves.
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Definitions of ECOG Performance Status (from www.ecog.org):

Grade Descirption
0 Fully active, able to carry on all pre-disease performance without restriction
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
2 Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours
3 Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours
4 Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair
5 Dead