Leucovorin (folinic acid) Fluorouracil Oxaliplatin
There are several different FOLFOX regimens, including FOLFOX-4, FOLFOX-6, modified FOLFOX-6 (mFOLFOX-6), and FOLFOX-7. They differ in the doses and ways in which the three drugs are given.
Rectal cancer
- Used in RAPIDO and OPRA Trial - both trails used either CAPOX or FOLFOX in the Total Neoadjuvant Treatment regime
The addition of oxaliplatin demonstrated improved outcome when added to 5-FU with Leucovorin
- MOSAIC, page 1
- Randomised 2246 patients with high-risk stage II (40%) and stage III (60%) colon cancer. The 5-year disease-free survival was 73.3% and 67.4% and the 6-year overall survival 78.5% versus 76% in favour of the oxaliplatin doublet. When the stage III subset is analysed separately, the 6-year OS is 72.9% versus 68.7% (P = 0.02) in favour of the oxaliplatin doublet
- In Stage II disease 1.7% improvement in high risk and 0.1% in low risk
- In Stage III disease 4.2% increase in overall survival
- NSABP C-07, page 1
- Compared the addition of oxaliplatin to 5-FU/LV as an infusion and 5-FU/LV as a bolus, respectively
- Overall, 2409 patients were randomised, with 29% stage II and 71% stage III patients. The 5-year disease-free survival was 69.4% versus 64.2% and 5-year overall survival was 80.2% versus 78.4% in favour of the oxaliplatin doublet. When the stage III subset is analysed separately, the 5-year OS is 76.5% versus 73.8% in favour of the oxaliplatin doublet.
Toxicity
- Lethargy, mucositis, and diarrhoea and hand-foot syndrome
- Neutropenic sepsis is uncommon
- The adittion of Oxaliplatin increased risk of diarrhoea and neutropenia.
- The most significant toxicity, however, is neurotoxicity. This is seen during treatment, with paraesthesia and cold sensitivity of the extremities and larynx/upper oesophagus.
- The incidence and severity of this peripheral sensory neuropathy (PNS) reduces over time.
- In the MOSAIC trial, grade 3 PNS (functional impairment) reduced from 12.5% during treatment to 0.7% by 10 months. The incidence of grade 3 PNS remained at 0.7% at 48 months post-treatment