Reporting results from chemotherapy trials. Does response make a difference in patient survival?
R. K. Oye and M. F. Shapiro
Patients with many common tumors are treated with chemotherapy despite
limited evidence of treatment effectiveness. To determine if chemotherapy
trials reporting effectiveness actually demonstrated increased survival in
treated patients, we reviewed trials published over a two-year period
involving four common solid tumors. Of 80 studies, 95% reported response to
chemotherapy as an end point. Of 38 studies demonstrating 15% or greater
objective response, 76% reported significantly greater survival of
responders than of nonresponders. Of 21 studies containing statements
supporting treatment effectiveness, 95% based this claim at least in part
on the superior survival of responders compared with nonresponders. Because
responders may have lived longer without treatment, such comparisons are
not valid and may lead to overly optimistic views of chemotherapy
effectiveness. Journal editors should be wary of allowing survival
comparisons between responders and nonresponders in published reports.
