Biweekly irinotecan plus cisplatin versus irinotecan alone as second-line treatment for advanced gastric cancer: A randomised phase III trial (TCOG GI-0801/BIRIP trial)

Chemotherapy for Gastric Cancer — What Comes Next?

“…In the TCOG GI-0801 trial [17], median PFS was significantly longer (3.8 months, n=64) by biweekly irinotecan plus cisplatin than by irinotecan alone (2.8 months, n=63), but median OS did not differ between the arms (10.7 months versus 10.1 months). Notably, the proportion of patients receiving third-line therapy was the same (75%) in both groups.…”

“…The agents investigated by these trials include chemotherapeutic drugs [17][18][19][20], a molecular targeting agent [21], and their combinations [22][23][24][25][26].…”

Meta-analysis of patient-level data on biweekly irinotecan plus cisplatin versus irinotecan alone as second-line treatment for advanced gastric cancer with the TCOG GI-0801 BIRIP and ECRIN TRICS RCTs: protocol paper

“…We selected two studies, the TRICS trial 18) and the TCOG GI-0801/BIRIP trial 17) . We selected these two trials because they were randomized phase III trials employing the same regimen of biweekly CPT-11 plus CDDP versus CPT-11 alone in a second-line setting for advanced or recurrent gastric cancer.…”

“…Higuchi et al reported (n = 130) that biweekly CPT-11 plus CDDP significantly prolonged progression free survival (PFS) (HR: 0.68) compared with CPT-11 alone, but did not demonstrate an overall survival (OS) benefit (HR: 1.00) in patients with metastatic or recurrent gastric cancer that progressed after S-1-based first-line chemotherapy 17) . Nishikawa et al reported (n = 168) that CPT-11/CDDP combination therapy did not show significant benefit in terms of OS (HR: 0.83) or PFS (HR: 0.86) compared with CPT-11 alone in patients with progressive AGC previously treated with S-1 monotherapy 18) .…”

“…Recently, two randomized trials employing the same regimen of biweekly CPT-11 plus CDDP versus CPT-11 alone in the second-line setting have been reported 17,18) . Higuchi et al reported (n = 130) that biweekly CPT-11 plus CDDP significantly prolonged progression free survival (PFS) (HR: 0.68) compared with CPT-11 alone, but did not demonstrate an overall survival (OS) benefit (HR: 1.00) in patients with metastatic or recurrent gastric cancer that progressed after S-1-based first-line chemotherapy 17) .…”