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Dose dense temozolomide: activity and management of toxicity

Temozolomide (TMZ) is an orally absorbed, cytotoxic alkylating agent (second-generation imidozotetrazine derivative). Unlike dacarbazine (DTIC), TMZ does not require hepatic activation and is degraded spontaneously at physiological pH to its active metabolite, the cytotoxic species 5-(3-methyltriazen-1-yl) imidazole-4-carboxamide (MTIC). Most of the cytotoxicity of MTIC is attributed to DNA alkylation at the O6 position of guanine, with additional alkylation at the N3 and N7 position. In preclinical experiments, TMZ cytotoxicity was schedule dependent, and therefore the drug initially was developed as a once-daily oral administration on 5 consecutive days every 28 days (5/28d TMZ).1,2 The recommended dose was established at 150 mg/m²/ day for the first cycle, with an increase of the dose to 200 mg/m²/day for subsequent courses if no major toxicity is detected. Phase II studies for the treatment of patients with recurrent glioma and advanced melanoma established the activity and toxicity of this regimen.3-13 Currently, TMZ administered by the 5 out of 28 day regimen is approved for the adjuvant treatment of newly diagnosed glioblastoma multiforme (GBM) and recurrent glioma as well as ad vanced melanoma.

The most common adverse events, nausea and vomiting, can readily be controlled with anti-emetics. Dose-limiting toxicity mainly consists of myelosuppression (mainly grade 3/4 thrombocytopenia with an incidence of 8 to 17% across phase II and observational studies and neutropenia to a lesser extend).14,15 Limiting toxicity usually is evident in the first two treatment cycles. Platelet and neutrophil nadirs occur late in the cycle and recovery can usually be observed within 1-2 weeks. Unlike nitrosureas, treatment with TMZ is not associated with cumulative toxicity. Only very rarely, unpredictable, severe myelosuppression prohibits the continuation of TMZ treatment in responding patients.

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What is Temozolomide?

TMZ has been an approved drug treatment for patients with high grade gliomas (tumours arising from glial cells) in the UK since 2007. Even though TMZ may cause some side-effects, just as other chemotherapy drugs do, the results of large-scale clinical trials have shown that the possible benefits far outweigh the risks for the treatment of high-grade gliomas. (See our ‘Chemotherapy’ fact sheet for more information). In terms of effectiveness, large-scale clinical trials have shown that TMZ alongside radiotherapy improves average survival for glioblastoma patients compared to those who only receive radiotherapy. Today, TMZ is referred to as the ‘international gold standard’ of treatment as it is the main chemotherapy drug used globally for the treatment of glioblastoma.

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Temozolomide (Temodar)

Temozolomide (Temodar) is an oral alkylating agent approved by the FDA for use in the first-line treatment of glioblastoma multiforme as well as for recurrent anaplastic astrocytoma.1Alkylating agents are some of the oldest drugs in the chemotherapy arsenal and were originally developed as chemical weapons during the early part of the twentieth century. Their anti-neoplastic aspects were only further investigated after World War II.2 Traditional alkylating agents act by producing DNA cross-linkages, thus inhibiting DNA and cellular replication. Other similarly acting drugs, such as temozolomide, work by methylating DNA, which also results in inhibited DNA and cellular replication.2 All such agents act nonspecifically and affect both cancerous and normal cells alike. However, cancer cells divide more rapidly than normal tissue and thus should be more sensitive to these effects.

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Temozolomide Is Used To Treat Cancer

Nausea and vomiting (throwing up)

• Constipation (not able to move bowels)

• Tiredness

• Decreased appetite (decreased hunger)

• Headache

• Seizure. Common symptoms of a seizure can include confusion, blacking out, passing out, loss of hearing or vision, blurred vision, unusual smells or tastes (such as burning rubber), trouble talking, tremors or shaking in parts or all of the body, repeated body movements, tense muscles that do not relax, and loss of control of urine and bowels. There are other less common symptoms of seizures. If you or your family member suspects you are having a seizure, call 911 right away.

• Hair loss. Hair loss is often temporary, although with certain medicine, hair loss can sometimes be permanent. Hair loss may happen suddenly or gradually. If you lose hair, you may lose it from your head, face, armpits, pubic area, chest, and/or legs. You may also notice your hair getting thin.