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• W2223200070 abstract "19104 Background: In clinical development of pemetrexed, an association was identified with febrile neutropenia and mucositis and elevated levels of homocysteine and methylmalonic acid, markers of deficiencies of folate and vitamin B12 respectively. Since the end of 1999 supplementation with these vitamins became mandatory. This analysis assesses the impact on pemetrexed’s toxicity profile. Methods: Serious adverse event (SAE) reports for pemetrexed arising from clinical trial (CT) and spontaneous sources were retrieved from the Lilly safety database. The proportion of possibly related SAEs arising from the MedDRA Blood and Gastrointestinal Disorders (GI) System Organ Classes (SOCs) was compared for two time periods: pre and post supplementation. Agranulocytosis, cytopenia, leukopenia and thrombocytopenia and several GI terms were of special interest. Results: Although there was an increase CT exposure post supplementation of 10 fold, this resulted in only a 4.7 fold (388 to 2235) in the number of possibly related SAEs cases. Pre supplementation 84.8% of SAEs originated from the Blood and GI disorders SOCs falling to 67.3% post supplementation (p<0.001). Significant reductions were also seen within individual SOCs: Blood (49.5 to 43.0%, p=0.015), GI (26.5 to 12.9%, p<0.001) and events associated with severe toxicity when experienced at high grade: diarrhoea (17.8 to 7.9%, p<0.001), vomiting (26.0% to 13.9%, p<0.001), neutropenia (36.6 to 12.8%, p<0.001) and thrombocytopenia (16.5 to 10.1%, p<0.001). For spontaneously reported cases, reporting rates were generally lower compared with the supplemented CT period (49.7% vs 67.3%, p<0.001) largely due to relative under-reporting in the Blood SOC (39.8% vs 54.4%, p<0.001) with use of the single term pancytopenia; there was no difference in reporting rates in the GI SOC (9.9% vs 12.9%, p=0.055). Conclusions: A sustained reduction in relative reporting rates of serious haematological and GI AEs has been seen since the introduction of vitamin supplementation. The safety profile of pemetrexed improved significantly with the introduction of risk minimisation measures in CTs and subsequently everyday use. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Eli Lilly Eli Lilly" @default.
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• W2223200070 date "2008-05-20" @default.
• W2223200070 modified "2023-09-27" @default.
• W2223200070 title "Pemetrexed—Limitation of toxicity through supplementation treatment" @default.
• W2223200070 doi "https://doi.org/10.1200/jco.2008.26.15_suppl.19104" @default.
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