Chemotherapy with S-1 and oxaliplatin plus bevacizumab (B-SOX) is a new treatment for advanced or metastatic colorectal cancer. SOFT strial proved B-SOX which is non-inferior to mFOLFOX6 plus Bmab with respect to progression free survival as first-line chemotherapy for advanced or metastatic colorectal cancer. In contrast, there has been few reports on an efficacy and safety of combination chemotherapy as B-SOX in clinical situation. We aimed to recognize whether B-SOX is able to be an alternative first line chemotherapy against advanced or metastatic colorectal cancer in clinical situation or not.
This trial was retrospective trial. There were 60 advanced or metastatic colorectal patients enrolled. Treatment regimen; Bmab (7.5kg/kg) and L-OHP (130mg/m2) were administrated intravenously on day 1, while S-1 was administrated orally (80 mg/m2/day, twice a day) for 14-days followed by a 7-days break. Eligibility criteria. 1:histrogically proven colorectal adenocarcinoma, 2:ECOG PS score: 0–2, 3:presence of assessable lesions as confirmed by CT or MRI, 4:no previous chemotherapy or radiotherapy, 5:1) no age restrictions; 2) major organ function preserved; 3) no active multiple primary cancers seen; 4) recovered from postoperative complications; 5) no serious complications (intestinal obstruction, diarrhea, fever); 6) able to begin within 4–8 weeks after surgery; 7) provided written consent based on informed consent. Primary endpoints were best overall response and disease control rate, secoundary endpoints was safety.
|Patients Characteristics||No. of Patients(N = 60)|
|Best overall response||CR/PR/SD/PD||0/50/8/2|
|Disease contorol rete||CR + PR + SD||96.7%|
In this study, SOX + BV chemotherapy showed tolerable toxicities and non-inferior response rate and diseases control to mFOLFOX6 + Bmab. And our result was similar PFS compare to SOFT trial. B-SOX chemotherapy is seemed to be valid choice for ambulatory chemotherapy.
Clinical trial identification
Investigator initiated trials
All authors have declared no conflicts of interest.