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The importance of consistent use of denominators across patient groups in assessing responses in clinical trials – response to Davies & Cavenagh

We have read the comments of Davies & Cavenagh (2006) concerning the use of two different denominators to calculate the proportion of the two arms (FLAI versus ICE) patients who were eligible for the postinduction consolidation and intensification treatment program (Table 2, p. 175). This mistake was probably due to the fact that, initially, the number of patients who were enrolled in the FLAI arm was 67. This number included10patientswhowereenrolledafterthedecisiontoclose therandomisation,duetotheobservedlowefficacyandthehigh toxicity of ICE. In the first revision of the paper, as suggested by the Referees, these 10 patients were excluded from the study. Re-analysing the data based on the 57 patients randomised to receiveFLAI,wereportedthedenominatorofthe46CRpatients instead of the 57 randomised patients, while the denominator in the ICE arm was unchanged (55 randomised patients). The use of two different denominators is not correct, and, thus, the statistically significant difference (P ¼ 0.0003) that we have found between the number of patients eligible for intensification in FLAI arm and ICE arm is wrong. We should have properly reported that ‘the patients who were eligible for intensification with auto or allo-SCT in FLAI arm were more than those who were eligible in the ICE arm (41/57 (72%) in FLAI arm vs 31/55 (56%) in ICE arm; P ¼ 0.09)’. The lack of a statistically significant difference, indeed, reduces the strength of the original sentence reported in the discussion (p. 177, line 27). Although this difference was not statistically significant, it was confirmed that more patients previously induced with FLAI were eligible for intensification. We thus believe that this error does not substantially change the meaning and the conclusions of our paper: ‘FLAI is more effective and less toxic than ICE’, but we thank you very much for having cleared this mistake.