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TMZ, thalidomide and whole brain radiation ineffective for CNS metastatic melanoma
A combination of temozolomide, thalidomide and whole brain radiation therapy was found to have poor efficacy among patients with brain metastases from melanoma.
Previous studies combining temozolomide (Temodar, Schering) and thalidomide (Thalomid, Celgene) had shown high response rates among patients with metastatic melanoma, including some shrinkage of brain metastases. Researchers conducted a phase-2 study of 39 patients with CNS metastases; patients received whole brain radiation therapy, 30 Gy in 10 fractions on days one to five and eight to 12, along with temozolomide 75 mg/m2 per day for six weeks and thalidomide 100 mg/day for four weeks escalated through week nine to a maximum of 400 mg/day.
Of the 39 patients who received treatment, there were two partial responses and one complete response for a total response rate of 7.6% (95% CI, 0.7%-16.1%). Seven patients had stable CNS disease after 10 weeks, and there were no systemic responses.
The median OS was four months, and patients had a median time to disease progression of seven weeks. A total of seven patients required hospital admission due to side effects; grade 3-4 side effects included DVT, pulmonary embolism and CNS events.
“The combination of temozolomide, thalidomide and whole brain radiation therapy tested in this study does not appear to provide a substantial advantage in the treatment of patients with CNS metastasis from melanoma,” the investigators wrote. “The addition of thalidomide appears to add toxicity, particularly fatigue and an increased risk of thromboembolic events, without meaningfully increasing the modest CNS antitumor activity previously noted with the temozolomide and whole brain radiation therapy combination or either temozolomide or whole brain radiation therapy alone.”
Cancer. 113:2139-2145.