Capecitabine plus oxaliplatin (XELOX) versus 5‐fluorouracil/leucovorin plus oxaliplatin (FOLFOX‐6) as first‐line treatment for metastatic colorectal cancer

Abstract

A regimen consisting of 5-fluorouracil/leucovorin plus oxaliplatin (FOLFOX-6) is widely used in France in the first-line treatment of metastatic colorectal cancer (MCRC). The aim of our study was to demonstrate the non-inferiority of capecitabine plus oxaliplatin (XELOX) versus FOLFOX-6 for this indication. Patients were randomly assigned to receive XELOX or FOLFOX-6 for 6 months. The primary endpoint was overall response rate (ORR) in the per-protocol (PP) population; however, progression-free and overall survival (OS), time to response and response duration were also assessed. A total of 306 patients were enrolled (XELOX n 5 156; FOLFOX-6 n 5 150). ORR was 42 and 46% with XELOX and FOLFOX-6, respectively, in the PP population. The difference between groups was 4.7%; the upper limit of the unilateral 95% confidence interval (14.4%) was below the non-inferiority margin of 15%. In the intent-to-treat population, median progression-free survival was 8.8 months with XELOX and 9.3 months with FOLFOX-6, and median OS was 19.9 and 20.5 months, respectively. XELOX patients had significantly more grade 3/4 thrombocytopenia (12% vs. 5%) and diarrhoea (14% vs. 7%), but significantly less grade 3/4

The clinical effectiveness and cost-effectiveness of cetuximab (review of technology appraisal no. 176) and panitumumab (partial review of technology appraisal no. 240) for previously untreated metastatic colorectal cancer: a systematic review and economic evaluation

“…Of the studies included in Amgen's NMA [n = 21, reported in 22 publications 28 [78][79][80][81][82][83][84][85][86][87][88][89][90][91][92][93][94] The reason for their exclusion was that they did not evaluate the effectiveness of the interventions in the RAS WT population. In addition to the abstracts for the OPUS 33 and CRYSTAL 34 trials included in the Amgen NMA, the Assessment Group identified the full publications.…”

Capecitabine plus oxaliplatin compared with 5-fluorouracil plus oxaliplatin in metastatic colorectal cancer: Meta-analysis of randomized controlled trials

“…Recently, more attention has been paid to combination chemotherapy of CRC with the regimen of capecitabine and oxaliplatin for safe, reliable and convenient medication. In certain randomized studies it was concluded that XELOX is non-inferior in terms of efficacy to the FOLFOX regimen in the first-line treatment of MCRC (5)(6)(7)9,11 Regarding adverse reactions during treatment, 5% of patients had Grade ≥3 hematologic toxicity, 8% of patients had Grade 3 peripheral neuropathy and 13% of patients had severe hand-foot syndrome (19). Similar results were obtained in another phase II trial that included a total of 50 patients aged ﹥70 years with MCRC, using the XELOX regimen as first-line therapy.…”

Combination therapy with zoledronic acid and cetuximab effectively suppresses growth of colorectal cancer cells regardless of KRAS status

“…Despite recent advances in the development of various diagnostic tools, in many patients, colorectal cancer is still diagnosed at an advanced stage, and recurrent tumors are often detected even after curative surgery. On the other hand, new chemotherapeutic regimens such as FOLFOX, FOLFIRI, and XELOX have been developed to exert a more potent activity 3, 4, 5, 6. More recently, molecular targeted therapies such as tyrosine kinase inhibitors and monoclonal antibodies have been shown to enhance tumor regression in combination with chemotherapy 7, 8…”