Erratum

Extract

Erratum: “Phase I Trial Design for Solid Tumor Studies of Targeted, Non-Cytotoxic Agents: Theory and Practice” by Parulekar and Eisenhauer [J Natl Cancer Inst 2004;96:990–7 (Issue 13)]. Three of the studies examined and counted as separate trials were in fact duplicates of three trials already included. Thus, a total of 57 (rather than 60) trials were reviewed. Below are minor corrections to the data on primary outcomes (reasons for halting dose escalation and major determinant of recommended dose), that take this finding into account.

Table 3: Thirty-six (63%) of 57 trials, rather than 36 (60%) of 60, had dose escalation halted for reasons of toxicity. Seven (12%) of 57 trials, rather than 8 (13%) of 60, halted escalation for pharmacokinetic data. Finally, 3 (5%) of 57 trials, rather than 5 (8%) of 60, were halted on the basis of the maximum planned dose.

Table 4: Five (9%) of 57 trials, rather than 6 (10%) of 60, had no dose recommendation stated. Nine (16%) of 57 trials, rather than 11 (18%) of 60, had pharmacokinetic data as the primary basis for dose recommendation.