Among patients treated with the FOLFOX7 chemotherapy regimen for metastatic colorectal cancer, the addition of Celebrex® (celecoxib) did not further improve outcomes. These results were published in Annals of Oncology.
Colorectal cancer is the second leading cause of cancer-related deaths in the United States. The disease develops in the large intestine, which includes the colon (the longest part of the large intestine) and the rectum (the last several inches).
Treatment of colorectal cancer may involve a combination of chemotherapy agents. Two commonly used chemotherapy combinations are referred to as FOLFOX and FOLFIRI. FOLFOX includes the chemotherapy agents Eloxatin® (oxaliplatin), 5-flourouracil, and leucovorin, while FOLFIRI includes Camptosar® (irinotecan), 5-fluorouracil, and leucovorin. Both of these regimens have demonstrated improved outcomes over the historical standard 5-fluorouracil/leucovorin.
Celebrex belongs to the class of drugs known as non-steroidal anti-inflammatory drugs (NSAIDs). Celebrex inhibits the COX-2 enzyme, which plays a role in inflammation. Though studies have suggested that Celebrex may reduce the risk of certain types of cancer, it has also been linked with an increased risk of serious cardiovascular problems.
To explore the safety and effectiveness of combining Celebrex with a FOLFOX regimen known as FOLFOX7, researchers in France conducted a Phase II clinical trial among 42 patients with previously untreated, metastatic colorectal cancer.
Study participants initially received six cycles of FOLFOX7, and those who responded or had stable disease had a chemotherapy-free interval until cancer progression. Celebrex was given during chemotherapy as well as during the chemotherapy-free interval.
- 43% of patients experienced a reduction in detectable cancer.
- Half the patients survived for more than six months without cancer progression.
- Median overall survival was 15.8 months.
The researchers note that these results are on the lower end of what has been observed with FOLFOX7 alone. They conclude that although the combination of Celebrex and FOLFOX7 had an acceptable safety profile, it does not appear to improve outcomes compared to FOLFOX7 alone. Furthermore, use of Celebrex alone during the chemotherapy-free interval appears to be less effective than other approaches that have been evaluated.
Reference: Andre T, Tournigand C, Mineur L et al. Phase II study of an optimized 5-fluourouracil-oxaliplatin strategy (OPTIMOX2) with celecoxib in metastatic colorectal cancer: A GERCOR Study. Annals of Oncology. 2007;18:77-81.
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