Are we ignoring sex differences in haematological malignancies? A call for improved reporting

Abstract

There are clear sex-based differences in the incidence, risk factors and mortality of most haematologic malignancies (HM). Despite known differences in physiology, haematopoiesis, molecular profiles, drug pharmacokinetics, treatment-related toxicities and treatment experience, males and females receive standardized and identical treatment for most HMs. Previous published work has demonstrated disparities in female representation in cancer clinical trials and highlighted a paucity of information on differential treatment outcomes and toxicities by sex. We analysed references of 182 clinical trials which form the basis of recent treatment guidelines from the National Comprehensive Cancer Network and found a minority (17/9.3%) did not report the sex distribution of trial participants. However, a majority (165/90.6%) did not report sex-disaggregated outcomes. Of those that did, 36.5% showed outcome differences by sex. Academic leadership by women in the assessed trials as well as in guidelines committees was disproportionately lower than their representation in the profession. We call on all clinical trials leaders, consortia and guideline builders to include sex-disaggregated data in their analyses, reporting these in a transparent manner (as per regulations mandating such reporting), and for investigators to assess whether aetiological factors differ by sex. These actions will enhance personalized prevention, therapy and follow-up.