Abstract
e176 malignancy was present prior to trial enrolment (57.1%), no evidence of malignancy found on further investigation (23.8%), reports related to non-malignant skin conditions (14.3%), and spontaneous resolution of cytopenia’s upon cessation of treatment (4.8%). Overall trial associated SPM incidence has been 2.45%. We have shown that careful review of trial reported second malignancies has led to the rejection of almost a quarter of cases. We believe the incorporation of such a review process and adoption of rejection criteria should form an essential component of future trials to ensure accurate assessment of the possible impact of treatment on SPM development.
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