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Background  This study evaluated the efficacy and safety of irinotecan/cisplatin ( IP ) and etoposide/cisplatin ( EP ) in extensive‐stage small cell lung cancer ( ES‐SCLC ) and the distribution of uridine diphosphate glucuronosyltransferase ( UGT1A1) . The relationship between  UGT1A1  genotypes and patient outcomes was also assessed.    Method  Patients with untreated  ES‐SCLC  were randomly assigned to receive either  IP  or  EP , and blood specimens were collected to test the genotypes of  UGT1A1 *28 and  UGT1A1 *6. The association of efficacy and toxicity of an  IP  regimen with  UGT1A1  genotype was analyzed.    Results  Of the 62 patients enrolled from three institutions, 30 patients were in the  IP  and 32 patients were in the  EP  arms, respectively. Disease control rates with  IP  and  EP  were 83.3% and 71.9%, respectively ( P  = 0.043). Median progression‐free survival for  IP  and  EP  were both six months. Median overall survival for  IP  and  EP  were 18.1 and 15.8 months respectively, without significant difference. Grade 3‐4 thrombocytopenia was more common with  EP  (18.8% vs. 6.7%;  P  = 0.035), while the incidence of diarrhea was higher with  IP  (70% vs. 15.6%;  P  = 0.008). The incidence of grade 1‐4 late‐onset diarrhea of wild‐type, heterozygous, and homozygous  UGT1A1 *28 were 65.0%, 85.7%, and 66.7%, respectively ( P  = 0.037).  UGT1A1 *28 polymorphisms, Eastern Cooperative Oncology Group performance status, and chemotherapy cycles were essential factors affecting grade 1‐4 late‐onset diarrhea in logistic regression analysis.    Conclusions  The efficacy of the  IP  regimen was similar to the  EP  regimen for untreated  ES‐SCLC .  UGT1A1  polymorphisms were associated with late‐onset diarrhea; however, there was no influence on efficacy.

thoracic cancer

Cisplatin combined with irinotecan or etoposide for untreated extensive‐stage small cell lung cancer: A multicenter randomized controlled clinical trial