Temozolomide (Temodal®) is een oncolyticum dat onlangs is geregistreerd voor de behandeling van patiënten met de hersentumor glioblastoma multiforme, die een recidief of progressie vertonen na een standaardtherapie. Op dit moment is voor deze patiënten geen effectieve therapie voorhanden. De indicatie wordt onderbouwd door de resultaten van twee fase 2- klinische onderzoeken met respectievelijk 138 en 225 patiënten met een eerste recidief van glioblastoma multiforme. Alle patiënten hadden een progressie na voorgaande radiotherapeutische behandeling. Het eerste onderzoek was ongecontroleerd. In het tweede, open onderzoek werden 225 patiënten (Karnofsky-index ³ 70) gerandomiseerd over een behandeling met temozolomide of procarbazine. Dit laatste middel had in drie niet-vergelijkende onderzoeken een bescheiden respons gegeven. De progressievrije overleving was met temozolomide (21%) significant hoger dan die met procarbazine (8%). De progressie werd vastgesteld als progressie op een MRI-scan en/of als een neurologische verslechtering. De gegevens van de helft van de patiënten konden post-hoc worden geanalyseerd op de klinische progressie. Deze uitkomsten ondersteunden, evenals de analyse van de kwaliteit van leven, de bevindingen bij het MRI-onderzoek. Het gunstige effect van temozolomide bij patiënten die eerder chemotherapie ondergingen, lijkt beperkt te zijn tot degenen met een Karnofsky-index ³ 80. De meest voorkomende bijwerkingen waren trombocytopenie, neutropenie, misselijkheid en braken. Minder vaak kwamen voor vermoeidheid, constipatie, hoofdpijn en anorexie. De bijwerking die een beperking stelde aan de hoogte van de dosering was myelosuppressie, die bij 8% ernstig was. Bij het advies tot registratie erkende de CPMP dat temozolomide een gering palliatief effect heeft. Tot de registratie werd besloten omdat de indicatie een groep patiënten betreft met een korte levensverwachting voor wie momenteel geen andere behandelingsopties beschikbaar zijn. Verder heeft temozolomide een lage en hanteerbare toxiciteit en kan het oraal, poliklinisch worden toegediend. Nader onderzoek in gerandomiseerde klinische onderzoeken zou wenselijk zijn.

Temozolomide is a chemotherapy drug that is given as a treatment for some types of cancer. This factsheet describes temozolomide, how it is given and some of its possible side effects. It will help you to read it with CancerBACUP's booklet Understanding chemotherapy, which gives more information and advice.

What it looks like

Temozolomide is available as white capsules with a blue line, in 5mg, 20mg, 100mg, and 250mg

How it is given

By mouth. The capsules should be swallowed whole with plenty of water and taken at the same time every day, on an empty stomach.

Possible side effects

Each person's reaction to chemotherapy is unique. Some people have very few side effects, while others may experience more. The side effects described in this factsheet will not affect everyone who is given temozolomide, and may be different if you are having more than one chemotherapy drug.

We have outlined the common side effects and those which are less common, so you can be aware of them if they occur. However, we have not included those which are very rare and therefore extremely unlikely to affect you. If you do notice any effects which you think may be due to the drug, but which are not listed in the factsheet, please discuss these with your doctor or chemotherapy nurse.

You will see your doctor regularly while you have this treatment so that s/he can monitor the effects of the chemotherapy. This factsheet should help you to discuss any queries about your treatment and its side effects with your doctor or chemotherapy nurse, as they are in the best position to help and advise you.

Temporary reduction in bone marrow function.
This can result in anaemia, risk of bruising or bleeding, and infection. This effect can begin some time after the treatment has been given and if it occurs your doctor is likely to stop the medication for a short time and possibly restart at a lower dose. After stopping the temozolomide your blood count will then increase steadily and will usually return to normal within 7-14 days. Your blood count will be checked regularly to see how well your bone marrow is working.

If your temperature goes above 38°C (100.5°F) or if you develop any unexplained bruising or bleeding, or suddenly feel unwell, even with a normal temperature, contact your doctor or the hospital straight away.

Feelings of sickness (nausea) and vomiting
There are now very effective anti-sickness drugs to prevent or substantially reduce nausea and vomiting. If it does happen and if the sickness is not controlled, or continues, tell your doctor. S/he can prescribe other anti-sickness drugs which may be more effective.

Diarrhoea
This can usually be easily controlled with medicine but it is important to let your doctor know if it is severe or carries on for more than a few days. It is important to drink plenty of fluids if you do get diarrhoea.

Constipation
This usually can be relieved by drinking plenty of fluids, eating a high fibre diet and taking gentle exercise. Sometimes you may need to take laxatives. These can be prescribed by your doctor.

Loss of appetite and temporary taste alterations
Both of these may occur. A dietician or specialist nurse at your hospital can give advice. CancerBACUP's booklet Diet and the cancer patient has tips on boosting appetite, coping with eating difficulties and maintaining weight. We would be pleased to send this to you.

Rashes
Temozolomide can cause a rash which may be itchy. Your doctor can prescribe treatment to help reduce this.

Headache
Let your doctor know if you have headaches while having treatment with temozolomide

Tiredness and a general feeling of weakness

It is important to allow yourself plenty of time to rest.

Less common side effects

Hair loss
Hair loss is uncommon but hair may thin, or occasionally be lost completely. If this occurs, it usually begins 3-4 weeks after starting treatment, although it may occur earlier. It is temporary, and the hair will return to normal once treatment is finished. CancerBACUP has a booklet Coping with hair loss which we would be pleased to send to you.

Dizziness
This side effect should be reported to your doctor.

Shortness of breath
Let your doctor know if this occurs.

Fever and chills
These usually do not last for long. Your doctor may prescribe tablets to reduce this side effect.

Additional information

Fertility
Your ability to conceive or father a child may be affected by taking this drug. You may wish to discuss fertility with your doctor before starting treatment. Contraception
It is not advisable to become pregnant or father a child while taking temozolomide as it may harm the developing foetus. Again, discuss this with your doctor.

Things to remember about your capsules

Storage
It is important to take your capsules at the right times. You must take them as directed by your doctor.

Keep the capsules in a safe place where children cannot reach them as temozolomide could harm them.

If your doctor decides to stop treatment, return any remaining capsules to the pharmacist. Do not flush them down the toilet or throw them away.

If you vomit just after taking the capsules let your doctor know as you may need to take another one. Do not take another capsule without first informing your doctor.

If you do forget to take a capsule do not take a double dose. Tell your doctor and keep to a regular dose schedule.

We thank the specialist advisors who have helped with the production of this factsheet.