Temozolomide plus thalidomide in patients with brain metastases from melanoma: A phase II study Journal Article

  

Authors:	Hwu, W. J.; Lis, E.; Menell, J. H.; Panageas, K. S.; Lamb, L. A.; Merrell, J.; Williams, L. J.; Krown, S. E.; Chapman, P. B.; Livingston, P. O.; Wolchok, J. D.; Houghton, A. N.
Article Title:	Temozolomide plus thalidomide in patients with brain metastases from melanoma: A phase II study
Abstract:	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/m2 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 a 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. © 2005 American Cancer Society.
Keywords:	adult; cancer survival; clinical article; human tissue; treatment outcome; aged; aged, 80 and over; disease-free survival; middle aged; cancer surgery; survival rate; thalidomide; clinical trial; disease course; drug efficacy; drug safety; temozolomide; brain neoplasms; neoplasm staging; dacarbazine; melanoma; skin neoplasms; antineoplastic combined chemotherapy protocols; deep vein thrombosis; histology; rash; lung embolism; brain metastasis; craniotomy; brain hemorrhage
Journal Title:	Cancer
Volume:	103
Issue:	12
ISSN:	0008-543X
Publisher:	Wiley Blackwell
Date Published:	2005-06-15
Start Page:	2590
End Page:	2597
Language:	English
DOI:	10.1002/cncr.21081
PUBMED:	15861414
PROVIDER:	scopus
DOI/URL:	http://www.scopus.com/inward/record.url?eid=2-s2.0-20444387198&partnerID=40&md5=c2fb38898974762a4f213f13eb7fa97a
Notes:	--- - "Cited By (since 1996): 55" - "Export Date: 24 October 2012" - "CODEN: CANCA" - "Source: Scopus"

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