Effects of Shengjiangxiexin decoction on irinotecan-induced toxicity in patients with UGT1A1*28 and UGT1A1*6 polymorphisms

OBJECTIVE：To evaluate the efficacy of Shengjiangxiexin decoction （SXD）, prepared with a formula from Traditional Chinese Medicine （TCM）, in reducing irinotecan-induced hematological and gastrointestinal toxicities in patients with UDP-glucuro-nosyltransferase （tJGT）1A1＊28 and UGTIA1＊6 poly-morphisms. METHODS： This clinical trial included 115 patients receiving irinotecan combined with 5-fluorouracil plus I-leucovorin （FOLFIRI） treatment. All patients consented to UGT1A1＊28 and ＊6 gene polymorphism detection prior to chemotherapy. SXD were administered from 1 day prior to chemotherapy to 6 day post chemotherapy. Chemotherapy induced adverse reactions （neutropenia, diarrhea, nausea, vomiting, anorexia and infection） were recorded, and short-term effect of chemotherapy was evaluated regularly. RESULTS： A total of 50 patients had ＊1/＊1 wild gen-otype, 58 patients had single allele variants with genotype ＊1/＊6 or ＊/＊28, and 7 patients had two alleles variants with genotype ＊6/＊6, ＊28/＊28 or ＊6/＊ 28. In ＊1/＊6 or ＊1/＊28 patients （high risk group）, 9 patients （15.5%） developed Ⅰ-Ⅱ grade diarrhea and no patient developed severe diarrhea; neutro-penia occurred in 19 patients （32.8%） and only 3 patients （8.6%） developed sever neutropenia. There were no significant differences in any toxic effects （neutropenia, diarrhea, nausea, vomiting, anorexia or infection） between ＊6 or ＊28 variant patients （high risk group） and wild type patients. No sever toxicity was found in high risk two alleles variants patients （＊6/＊6, ＊6/＊28 or ＊28/＊28）. No significant differences were observed between UGTIA1＊6/＊28 polymorphisms and clinical response of chemotherapy. CONCLUSION： SXD could significantly reduce irinotecan-induced hematological and gastrointestinal toxicities in UGT1A1＊28 or ＊6 variant patients （high risk group）, while this treatment didn＇t affect clinical response of chemotherapy.