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Capecitabine viable alternative to 5-fluorouracil in treating metastatic colorectal cancer
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Capecitabine, a tumor-activated 5-fluorouracil prodrug, is an effective, safe, convenient and economically viable alternative to 5-fluorouracil as a first-line treatment for metastatic colorectal cancer, according to recent study data.
Researchers from Hospital Clinico San Carlos, Madrid, reviewed safety and efficacy results from randomized studies and meta-analyses of oral capecitabine vs. 5-fluorouracil (5-FU), and also evaluated quality of life, patient preference and cost analysis data.
Results from three large phase 3 studies demonstrated that capecitabine was equivalent or superior to combination 5-FU/leucovorin (LV) in overall response rate (ORR=18.9% vs. 15%, P=.013; ORR=24.8% vs. 15.5%, P=.005; ORR=26% vs. 17%, P<.0002; respectively), progression-free survival rate (5.2 vs. 4.7 months, HR=0.96, P=.65; 4.3 vs. 4.7, HR=1.03, P=.72; 4.6 vs. 4.7, HR=0.99, P=.95) and overall survival rate (13.2 vs. 12.1 months, HR=0.92, P=.33; 12.5 vs. 13.3, HR=1, P=.97; 12.9 vs. 12.8, HR=0.95, P=.48).
The same comparison studies and one similar also revealed a superior safety profile of capecitabine, with lower incidence of neutropenia (2% vs. 19.8%, 2.6% vs. 25.9%, 2.3% vs. 22.8%; all P<.05) and stomatitis (1.3% vs. 13.3%, 3% vs. 16%, 2% vs. 14.7%; all P<.05), though a spike in hand-foot syndrome was observed (16.2% vs. 0.3%, 18.1% vs. 0.7%, 17.1% vs. 1%; all P<.05). One study further revealed a greater number of dose reductions due to adverse events in the 5-FU group (33.9% vs. 42.2%; P=.0037), as well as increased hospitalizations (11.6% vs. 18%; P<.005).
In trials that compared capecitabine vs. 5-FU when paired with combinations of oxaliplatin, and irinotecan, comparable efficacy and safety data were observed. Researcher said some exceptions, primarily related to dose adjustments with the irinotecan combination, existed.
Data from several studies also indicated that oral capecitabine therapy reduced hospital visits (70% in one study), and lowered incidence of associated AEs resulted in “significant reduction in pharmaceutical expenditures.” Furthermore, patients overwhelmingly (90% in one study) preferred oral treatment to IV as long as they did not have to sacrifice efficacy.
“Capecitabine has proved to be an effective substitute for 5-FU as monotherapy or in combination with oxaliplatin and irinotecan,” the researchers concluded. “However, in combination with the latter drug, controversy persists regarding its safety profile.”
Disclosure: Relevant financial disclosures were not provided by researchers.
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