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Experimental Evaluation of Potential Anticancer Agents IV. Host Weight Loss as It Relates to False Positives in Drug Evaluation^*

( Kettering-Meyer Laboratory [Affiliated with Sloan-Kettering Institute], Southern Research Institute, Birmingham, Ala.)

Extensive caloric restriction studies have provided quantitative data on the relationship between induced host weight loss and associated inhibition of the in vivo growth of Carcinoma 755 and Sarcoma 180 as employed in the Cancer Chemotherapy National Service Center program. The data obtained indicate that these tumors are on the average inhibited by about 13 per cent per gram host weight change difference (control host weight change minus starved host weight change).

Consideration of the design of these assays and their statistical behavior in the light of knowledge of the effects of caloric restriction-induced host weight loss on tumor growth strongly suggests that the major single factor having to do with the sometimes observed lack of assay reproducibility on weakly "active" materials may lie in interpretation of the biologic data; i.e., failure to suspect that an agent which significantly inhibits growth of these tumors only at doses which also cause large host weight losses may be a "weight loss false positive."

The importance of minimizing acceptance of such possible "false positives" by use of maximal allowable host weight change differences in any criteria of "activity" is emphasized.

^* This work was supported by the Cancer Chemotherapy National Service Center, National Cancer Institute, under National Institutes of Health Contract No. SA-43-ph-1907.

Received 1/31/61.

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