Phase II Study of SOXIRI (S-1/Oxaliplatin/Irinotecan) Chemotherapy in Patients with Unresectable Pancreatic Ductal Adenocarcinoma: A Prospective Study (Preprint)

Abstract

To provide data on the efficacy and safety of a combination chemotherapy regimen consisting of S-1, oxaliplatin, and irinotecan (SOXIRI) as a first-line therapy in patients with unresectable pancreatic ductal adenocarcinoma (UPDA). Patients with UPDA and no prior treatment chemotherapy in the UPDA setting were enrolled. The primary endpoint was the objective response rate (ORR). Secondary endpoints were adverse events (AEs), progression-free survival (PFS), and overall survival (OS). Patients received 80 mg/m2 S-1 twice a day for 2 weeks in an alternate-day administration cycle, 150 mg/m2 irinotecan on Day 1, and 85 mg/m2 oxaliplatin on Day 1 of a 2-week cycle. In these 62 enrolled patients, the ORR was 27.4%, median PFS was 6.5 months, and median OS was 12.1 months. Major grade 3 or 4 toxicity included neutropenia (22.3%), leucopenia (16.1%), nausea (9.7%), vomiting (9.7%), thrombocytopenia (6.5%), anorexia (8.5%), anemia (4.8%), and diarrhea (1.6%). No treatment-related deaths occurred. In addition, the analysis of 32 patients suffering pain revealed that the rate of pain relief was 34.4%. SOXIRI might be a standard regimen with favorable efficacy and an acceptable toxicity profile for use as chemotherapy in patients with UPDA. This trial was registered with Chinese Clinical Trials.gov identifier: ChiCTR1800018233 in 6 September 2018.