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. In general, NCCN lists only capecitabine combinations with oxaliplatin and not irinotecan. 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. In general, Xeliri is usually accepted as equivalent to Folfiri, which is recommended for second line by NCCN.
Garcia-Alfonso studied XELIRI treatment in 53 patients, more than half (55%) of whom were 65 years of age or older. The overall response rate (ORR) to XELIRI in this group was 32% and the disease control rate was estimated to be 66%. The median (similar to “average”) survival in the group was 19.2 months, showing that even in people with metastatic (advanced) colorectal cancer, the appropriate treatments can extend life in a meaningful way. Very serious side effects, which are known as grade 4 toxicity, occurred in only 1 patient. Overall, this study supports that XELIRI, which is a combination of two chemotherapy medications – capecitabine and irinotecan – is a promising first-line treatment of advanced colon cancer
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