What is it?
FOLFIRINOX is a combination of five chemotherapy agents and is used in the UK for patients with metastatic (spread to other parts of the body) pancreatic cancer, locally advanced (inoperable but not spread elsewhere) pancreatic cancer and occasionally used as a neo-adjuvant (before surgery) agent to try to shrink a tumour for surgical removal to be possible.
FOLFIRINOX started as a clinical trial where a combination of the chemotherapy drugs fluorouracil [5-FU], leucovorin, irinotecan and oxaliplatin or standard single-drug treatment, gemcitabine. were given to patients with metastatic pancreatic cancer.
Patients in the FOLFIRINOX arm received oxaliplatin (85 mg/m2 over two hours), leucovorin (400 mg/m2 over two hours), irinotecan (180 mg/m2 over 90 minutes), and 5-FU(400 mg/m2 bolus then 2,400 mg/m2 over 46 hours), all on day 1, and then repeated every two weeks. Patients in the control arm received gemcitabine (1,000 mg/m2 IV over 30 minutes weekly for seven of eight weeks, one week rest, and then weekly for three of four weeks). Recent results from this french study have shown this combination is promising.
The study’s authors1, presenting at ASCO 2010, reported 48% of patients on FOLFIRINOX were alive after 1 year compared to 20% on the gemcitabine arm and, for the first time in a study involving patients with metastatic pancreatic cancer, a median overall survival of 11.1 months was obtained on the FOLFIRINOX arm.
FOLFIRINOX is not approved by either NICE (National Institute of Clinical Excellence) in England and Wales nor the SMC (Scottish Medicines Consortium) for pancreatic cancer so is not available as standard treatment for pancreatic cancer.
Some centres in the UK will offer FOLFIRINOX to pancreatic cancer patients if they get approval from the PCT (Primary Care Trust)
However, the FOLFIRINOX regime can be very toxic and side effects can be greater than the standard therapy – so it is not suitable for all patients.
To find out if you are eligible for any current clinical trials in the UK, speak to your oncologist or click here to see a list of pancreatic cancer clinical trials
How is it given?
The treatment will usually consist of the following:
- Day 1 Oxaliplatin (a colourless fluid) infusion (by drip) over 2 hours, followed by Irinotecan (a clear, slightly yellow fluid) and folinic acid (a clear, pale yellow fluid) infusion over 2 hours, followed by Fluorouracil (a colourless fluid) as a fast infusion over 15 minutes, followed by Fluorouracil as a slow infusion over 46 hours (at home) via a pump through a central venous catheter (PICC line).
- Day 3 District nurse home visit to take pump off and flush line.
- Day 15 Repeat of day 1 and start of next cycle of treatment
This treatment is repeated every 2 weeks for a total of 6 to 12 cycles.
What are the side effects?
The side effects of a combination of drugs are usually a mixture of those of each individual drug. It has been found that more than one in ten people will have one or more of the following side effects:
- Increased risk of an infection due to a drop in white blood cells
- Tiredness and breathlessness due to a drop in red blood cells
- Bruising more easily due to a drop in platelets also you may have bleeding gums, nosebleeds or tiny red spots known as petechial.
It is important you tell your medical team if you have any of the above side effects, especially if you develop a temperature above 38oC.
Other common side effects include:
- Tiredness during treatment and sometimes up to 6 months afterwards
- Feeling or being sick (you will be given anti-sickness tablets to help with this)
- Diarrhoea—this can be severe in about 11% of patients (11 in 100)
- Hair loss—affects about 10% (1 in 10) patients
- Sore mouth and ulcers
- Some liver changes (mild and unlikely to cause symptoms)
- Gritty or watery eyes, blurred vision
- Sore, red peeling on palms of hands and soles of the feet (known as palmar-plantar syndrome)
- A brown skin marking following the line of the vein where chemotherapy was injected
- Skin rashes which may cause itching
- Some women may find their periods stop (amenorrhoea) this is often temporary
Occasional Side Effects:
- Numbness or tingling in the fingers and toes—this can start within a few weeks and usually goes away a few months after finishing treatment.
- Brittle, chipped or ridged nails
- Sensitivity to sunlight
- Loss of appetite
- Heart problems
- Blood clots
- Difficulty swallowing or breathing which is triggered by cold air.
Rare Side effects:
- Tinnitus (ringing in the ears) which usually gets better once you’ve finished your treatment
- Allergic reactions—tell your medical team if you go red in the face, you have an itchy rash or feel breathless or faint. This happens is only 1 in 200 people (0.5%)
Remember—you will not have all of the side effects listed here. You may only have 1 or 2 or several. Talk to your medical team if you are experiencing any form of side effect while on FOLFIRINOX chemotherapy treatment.
Infections can be serious. Let your doctor or nurse know immediately if your temperature goes above 38o C (100.4o F) or you suddenly feel unwell even with a normal temperature.
Other FOLFIRINOX-type Combinations:
FOLFIRI (Folinic Acid, Fluorouracil (5FU), Irinotecan)
FOLFOX (Folinic Acid, Fluorouracil (5-FU), Oxaliplatin
These regimes are similar to the FOLFIRINOX treatment but without the Oxaliplatin for FOLFIRI and without the Irinotecan for the FOLFOX regime
Treatment will usually consist of the following:
- Irinotecan or Oxaliplatin and folinic acid are given as an infusion via two separate drips over two hours.
- 5FU (a colourless fluid) is given as an injection into your cannula or central line.
- After this, you will be given an infusion of fluorouracil (5-FU) through a drip or pump – some people have this for 22 hours and some people have it for 46 hours . This means that you will need to stay in hospital unless you have a central or PICC line, in which case the long 5-FU infusion can be given to you through a small, portable pump.
This treatment is repeated every two weeks for a total of 6 or 12 cycles
Conroy et al., (2010) Randomized phase III trial comparing FOLFIRINOX (F: 5FU/leucovorin [LV], irinotecan [I], and oxaliplatin [O]) versus gemcitabine (G) as first-line treatment for metastatic pancreatic adenocarcinoma (MPA): Preplanned interim analysis results of the PRODIGE 4/ACCORD 11 trial. J. Clin Oncol 28: 303s ↩
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