medwireNews: Treatment with a modified XELIRI (mXELIRI) regimen offers an alternative to standard second-line therapy with FOLFIRI in patients with metastatic colorectal cancer, research conducted in Asia shows.
Tae Won Kim (University of Ulsan College of Medicine, Seoul, South Korea) and colleagues report that “mXELIRI with or without bevacizumab is well tolerated and non-inferior to FOLFIRI with or without bevacizumab in terms of overall survival,” and could therefore be used as a “second-line backbone therapy for patients with metastatic colorectal cancer, at least in Asian populations.”
The phase III AXEPT trial, conducted at 98 hospitals in Japan, China, and South Korea, involved 650 patients aged 20 years or older with unresectable, metastatic colorectal adenocarcinoma, all of whom had withdrawn from first-line chemotherapy.
The patients were randomly assigned to receive treatment with mXELIRI (capecitabine plus irinotecan; n=326) or FOLFIRI (leucovorin, fluorouracil, and irinotecan; n=324), with approximately 83% in each group also being treated with concurrent bevacizumab.
After a median follow-up period of 15.8 months, 242 patients in the mXELIRI group and 248 in the FOLFIRI group had died. Median overall survival was 16.8 and 15.4 months, respectively.
The corresponding hazard ratio for survival with mXELIRI versus FOLFIRI was 0.85, with an upper confidence interval of 1.02, which the researchers explain was less than both the predefined noninferiority margin of 1.30 and the more stringent margin of 1.25.
This indicates the treatment with mXELIRI was noninferior to treatment with FOLFIRI.
Furthermore, the results remained consistent irrespective of the receipt of concomitant bevacizumab and when adjusted for KRAS mutation status.
The researchers also found no significant differences between the two treatment groups in progression-free survival, time to treatment failure, overall response, or disease control.
The incidence of grade 3 or 4 adverse events was lower in the mXELIRI group than in the FOLFIRI group (54 vs 72%), which was mainly due to a lower rate of grade 3–4 neutropenia with mXELIRI than with FOLFIRI (17 vs 43%).
By contrast, grade 3–4 diarrhea occurred at a higher rate in the former group than in the latter (7 vs 3%).
There were two treatment-related deaths (one pneumonitis and one lung infection) in the mXELIRI group and one (lung infection) in the FOLFIRI group.
In a comment that accompanies the study published in The Lancet Oncology, Timothy Price, from the University of Adelaide in Southern Australia, says that the findings “have the potential to change practice by giving an alternative option when using an irinotecan-based schedule in selected patients.”
However, he cautions that it is currently unclear “whether or not these results are transferable to non-Asian patient populations,” due to ongoing debates surrounding differences in pharmacogenomics between White and Asian patients for both capecitabine and irinotecan.
By Laura Cowen
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