| General information |
| Database: | DB00917 |
| Objective: | In Japan, a study comparing the effectiveness and safety of irinotecan plus S1 (IRIS) with those of a combination of 5fluorouracil, leucovorin, and irinotecan (FOLFIRI) as secondline treatment in patients with advanced or recurrent colorectal cancer demonstrated that IRIS was noninferior to FOLFIRI. they previously reported that IRIS is also effective as firstline treatment. |
| Authors: | Komatsu Y, et al |
| Title: | Phase II study of combined chemotherapy with irinotecan and S1 (IRIS) plus bevacizumab in patients with inoperable recurrent or advanced colorectal cancer. |
| Journal: | Acta Oncol. |
| Year: | 2012 |
| PMID: | 22554343 |
| Trial Design |
| Clinical Trial Id: | NCT00569790 |
| Agent: | bevacizumab
|
| Target: | Vascular endothelial growth factor
|
| Cancer Type: | colorectal cancer |
| Cancer Subtype: | colorectal cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | combined chemotherapy with irinotecan + S1 (IRIS) + bevacizumab |
| Study Type: | Phase II study |
| Key Patients Feature: | Eligibility criteria included inoperable recurrent colorectal cancer with a confirmed diagnosis of adenocarcinoma, age more than and equal to 20 years, and no history of prior chemotherapy. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | S1 (4060 mg twice daily) was given orally on Days 1 to 14, and irinotecan (100 mg/m(2)) and bevacizumab (5 mg/kg) were given intravenously on Days 1 and 15 of a 28day cycle. |
| Primary End Point: | safety. |
| Secondary End Point: | overall response (OR), progression free survival (PFS), and overall survival (OS). |
| Patients Number: | 52 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 57.70% |
| Disease Control Rate: | 90.40% |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 16.7 months (95% CI 13.1-18.7) |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | In safety analysis, the incidences of grade 3 or 4 adverse reactions were as follows: neutropenia, 27%; hypertension, 21%; and diarrhea, 17% |
| Conclusions: | IRIS plus bevacizumab is a welltolerated, highly effective chemotherapeutic regimen that is easy to administer |