Xeliri is supported by current medical literature for first or second line treatment of metastatic colon cancer. There are several phase II studies that indicate effectiveness. For example, a 2009 study enrolled 53 patients: 29 (55%) were 65 years old. In an intention-to-treat analysis, complete response was achieved in three patients for an overall response rate (ORR) of 32%. The disease control rate (ORR + stable disease) was 66% and the median duration of response was 7.3 months. Median time to progression and overall survival were 9.0 and 19.2 months, respectively. Grade 4 neutropenia was reported in one patient: no other grade 4 toxicities were recorded. Grade 3 diarrhea occurred in 8 (15%) patients and grade 1–2 hand–foot syndrome in 7 (13%) patients. It concluded that Capecitabine and irinotecan, given every 2 weeks, as first-line treatment of MCRC is an active regimen with a manageable toxicity profile, even in older patients.
Whereas Xelox and irinotecan alone are listed by NCCN (REC-E, 2011), Xeliri is not. However it is a compendia supported indication for with or without bevacizumab as: Primary therapy for patients with unresectable synchronous liver and/or lung metastases, with synchronous abdominal/peritoneal metastases, or with unresectable metachronous metastases.
Anna Pessino, Alberto Sobrero Optimal treatment of metastatic colorectal cancer Expert Review of Anticancer Therapy 2006 6:5, 801-812
Dan S. Zuckerman, Jeffrey W. Clark Systemic therapy for metastatic colorectal cancer Cancer
CP Garcia-Alfonso et al, apecitabine in combination with irinotecan (XELIRI), administered as a 2-weekly schedule, as first-line chemotherapy for patients with metastatic colorectal cancer: a phase II study of the Spanish GOTI groupBritish Journal of Cancer (2009) 101, 1039–1043
Capecitabine (X) plus irinotecan (XELIRI) as first-line treatment for metastatic colorectal cancer (MCRC): Final safety findings from a phase II trial.Journal of Clinical Oncology, 2004 ASCO Annual Meeting Proceedings (Post-Meeting Edition). Vol 22, No 14S (July 15 Supplement), 2004: 3602