Several studies have demonstrated a relationship between rodent body weight
and tumor incidence for some tissue/organ sites. It is not uncommon for a
chemical tested for carcinogenicity to also affect body weight. In such cas
es, comparisons of tumor incidence may be biased by body-weight differences
across dose groups. A simple procedure was investigated for reducing this
bias. This procedure divides the animals into a few groups based on body we
ight. Body weight at 12 months was used, before the appearance of a tumor w
as likely to affect body weight. Statistics for dose-response trend tests a
re calculated within body weight strata and pooled to obtain an overall dos
e-response trend test. This procedure is analogous to that currently used,
of stratifying animals, based on their age at the time of removal from a st
udy. Age stratification is used to account for differences in animal age ac
ross dose groups, which can affect comparisons of tumor incidence. Several
examples were investigated where the high-dose group had reduced body weigh
ts and associated reductions in tumor incidence, When the data were analyze
d by body-weight strata, some positive dose-response trends for tumor incid
ence were demonstrated. In one case, the weight-adjusted analysis indicated
that a negative dose-response trend in tumor incidence was a real effect,
in addition to a body weight reduction. These examples indicate that it is
important to consider the effects of body weight changes as low as 10%, and
perhaps below, that were caused by chemicals in 2-year bioassays for carci
nogenesis. The simple procedure of analyzing tumor incidence within bodywei
ght strata can reduce the bias introduced by weight differences across dose
groups.