Clinical study of irinotecan plus cisplatin regimen versus irinotecan alone as second-line chemotherapy for advanced gastric cancer

LI Jiangwang; HUANG Chunzhen; YUAN Jianhua; CHEN Qionghui; LIU Yingping; ZHANG Shubo

Abstract：Objective To investigate the therapeutic effect, long term survival and side effects on advanced gastric cancer patients treated with irinotecan(CPT?11) plus cisplatin(DDP) regimen and CPT?11 alone as second?line chemotherapy. Methods A total of 168 gastric cancer patients enrolled from June 2012 to January 2014 failed in first?line chemotherapy were randomly allocated to CPT?11+DDP group(CPT?11 250mg/m2 iv, d1;DDP 70 mg/m2 iv, d1, 21 days as a cycle) or CPT?11 group(250 mg/m2 iv, d1, 21 days as a cycle) with 68 cases in each group. Short?term efficacy was evaluated after 2 cycles’ therapy, and long?term efficacy, as well as side effects was compared between both groups. Results Efficacy could be evaluated in 168 cases. In CPT?11+DDP group, there were 3 cases in CR, 11 in PR, 44 in SD, and the response rate( RR) and disease control rate( DCR) were 16. 7% and 89. 0%. In CPT?11 group, there were 1 case in CR, 12 in PR, 41 in SD,and RR, DCR were 15. 5% and 64. 3%. The difference of RR and DCR had no significance between both groups(P=0. 834, P=0. 513). The median progression?free survival were 4. 6 and 4. 1 months in CPT?11+DDP group and CPT?11 group( P=0. 522) , and the median overall survival( OS) were 13. 8 and 12. 5 months, respectively ( P=0. 185) . The incidences of grade 3?4 anemia, grade 3?4 liver impairment and grade 1?4 kidney impairment were higher in CPT?11+DDP group than in CPT?11 group(P<0. 05). The incidences of grade 1?4 constipation and mucositis were lower in CPT?11/DDP group than in CPT?11group( P<0. 05) . Subgroup analysis revealed that the median OS of CPT?11/DDP group was significantly better than that of CPT?11 group(15. 6 months vs. 13. 6 months, P=0. 016). Conclusion Compared with CPT?11monotherapy, CPT?11/DDP regimen shows no survival benefit as second?line treatment for advanced gastric cancer. However, intestinal type of gastric cancer can benefit from CPT?11/DDP regimen, and side effects are well tolerated, worthy of further observation.