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Temozolomide plus thalidomide in patients with brain
metastases from melanoma
Hwu WJ, Lis E, Menell JH, Panageas KS, Lamb LA, Merrell J, Williams LJ,
Krown SE, Chapman PB, Livingston PO, Wolchok JD, Houghton AN
Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York,
New York.
Background. Temozolomide plus thalidomide is a promising oral combination
regimen for the treatment of metastatic melanoma.
The current Phase II study
examined the efficacy and safety of this combination in chemotherapy-naive
patients with brain metastases.
Methods. Patients with histologically
confirmed metastatic melanoma and measurable brain metastases received
temozolomide (75 mg/m(2) per day for 6 weeks with a 2-week break between
cycles) plus concomitant thalidomide (200 mg/day escalating to 400 mg/day
for patients < 70 years or 100 mg/day escalating to 250 mg/day for
patients >/= 70 years).
The primary end point was tumor response in the
brain assessed every 8 weeks.
Results. Twenty-six patients with a median age
of 60 years were treated.
All patients had progressive brain metastases: 16
were symptomatic and 25 had extensive extracranial metastases.
Eight
patients had received whole-brain radiotherapy, 4 had received stereotactic
radiotherapy, and 8 had received craniotomy with resection of hemorrhagic
lesions.
Fifteen patients completed >/= 1 cycle (median, 1 cycle; range,
0-4 cycles), and 11 discontinued treatment before completing 1 cycle (7 for
intracranial hemorrhage, 2 for pulmonary embolism, 1 for deep vein
thrombosis, and 1 for Grade 3 rash).
Of 15 patients assessable for response,
3 had a complete or partial response (12% intent to treat) and 7 had minor
response or stable disease in the brain.
However, 5 of these 10 patients had
disease progression at extracranial sites.
The median survival period was 5
months for all 26 patients and 6 months for the 15 assessable patients.
Conclusions. Temozolomide plus thalidomide was an active oral regimen for
patients with brain metastases from malignant melanoma.
Cancer 2005. (c)
2005 American Cancer Society.
PMID: 15861414 [PubMed - as supplied by publisher]
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