This Article Full Text Full Text (PDF) Purchase Article View Shopping Cart Alert me when this article is cited Alert me if a correction is posted Services Email this article to a colleague Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Save to my personal folders Download to citation manager Rights & Permissions Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Hwu, W.-J. Articles by Houghton, A. N. Search for Related Content PubMed PubMed Citation Articles by Hwu, W.-J. Articles by Houghton, A. N. Social Bookmarking                            What's this?

Phase II Study of Temozolomide Plus Thalidomide for the Treatment of Metastatic Melanoma

From the Memorial Sloan-Kettering Cancer Center, New York, NY.

Address reprint requests to Wen-Jen Hwu, MD, PhD, Memorial Sloan-Kettering Cancer Center, 1275 York Ave, New York, NY 10021; e-mail: hwuw{at}mskcc.org.

Purpose: To further investigate the efficacy and safety of temozolomide plus thalidomide in patients with metastatic melanoma without brain metastases.

Patients and Methods: Patients with histologically confirmed advanced-stage metastatic melanoma were enrolled in an open-label, phase II study. The primary end point was response rate. Patients received temozolomide (75 mg/m²/d x 6 weeks with a 2-week rest between cycles) plus concomitant thalidomide (200 mg/d with dose escalation to 400 mg/d for patients < 70 years old, or 100 mg/d with dose escalation to 250 mg/d for patients 70 years old). Treatment was continued until unacceptable toxicity or disease progression occurred.

Results: Thirty-eight patients (median age, 62 years) with stage IV (three patients with M1a, eight with M1b, and 26 with M1c) or stage IIIc (one patient) melanoma and a median of four metastatic sites were enrolled, and received a median of two cycles of therapy. Twelve patients (32%) had an objective tumor response, including one with an ongoing complete response of 25+ months’ duration and 11 with partial responses. Five patients achieving partial response with a more than 90% reduction of disease were converted to a complete response with surgery. Treatment was generally well tolerated. Median survival was 9.5 months (95% confidence interval, 6.05 to 19.38 months), with a median follow-up among survivors of 24.3 months.

Conclusion: The combination of temozolomide plus thalidomide seems to be a promising and well-tolerated oral regimen for metastatic melanoma that merits further study.

CiteULike    Complore    Connotea    Del.icio.us    Digg    Facebook    Reddit    Technorati    Twitter    What's this?

This article has been cited by other articles:

				M. Chen, I. Osman, and S. J. Orlow Antifolate Activity of Pyrimethamine Enhances Temozolomide-Induced Cytotoxicity in Melanoma Cells Mol. Cancer Res., May 1, 2009; 7(5): 703 - 712. [Abstract] [Full Text] [PDF]

				P. Rietschel, J. D. Wolchok, S. Krown, S. Gerst, A. A. Jungbluth, K. Busam, K. Smith, I. Orlow, K. Panageas, and P. B. Chapman Phase II Study of Extended-Dose Temozolomide in Patients With Melanoma J. Clin. Oncol., May 10, 2008; 26(14): 2299 - 2304. [Abstract] [Full Text] [PDF]

				I. Quirt, S. Verma, T. Petrella, K. Bak, and M. Charette Temozolomide for the Treatment of Metastatic Melanoma: A Systematic Review Oncologist, September 1, 2007; 12(9): 1114 - 1123. [Abstract] [Full Text] [PDF]

				S. N. Markovic, L. A. Erickson, R. D. Rao, R. H. Weenig, B. A. Pockaj, A. Bardia, C. M. Vachon, S. E. Schild, R. R. McWilliams, J. L. Hand, et al. Malignant Melanoma in the 21st Century, Part 2: Staging, Prognosis, and Treatment Mayo Clin. Proc., April 1, 2007; 82(4): 490 - 513. [Abstract] [Full Text] [PDF]

				H Gogas, A Polyzos, I Stavrinidis, K Frangia, D Tsoutsos, P Panagiotou, C Markopoulos, O Papadopoulos, D Pectasides, M Mantzourani, et al. Temozolomide in combination with celecoxib in patients with advanced melanoma. A phase II study of the Hellenic Cooperative Oncology Group Ann. Onc., December 1, 2006; 17(12): 1835 - 1841. [Abstract] [Full Text] [PDF]

				J. A. Sosman and I. Puzanov Molecular targets in melanoma from angiogenesis to apoptosis. Clin. Cancer Res., April 1, 2006; 12(7): 2376s - 2383s. [Abstract] [Full Text] [PDF]

				R. W. Weber, S. O'Day, M. Rose, R. Deck, P. Ames, J. Good, J. Meyer, R. Allen, S. Trautvetter, M. Timmerman, et al. Low-Dose Outpatient Chemobiotherapy With Temozolomide, Granulocyte-Macrophage Colony Stimulating Factor, Interferon-{alpha}2b, and Recombinant Interleukin-2 for the Treatment of Metastatic Melanoma J. Clin. Oncol., December 10, 2005; 23(35): 8992 - 9000. [Abstract] [Full Text] [PDF]

				D. Bafaloukos, D. Tsoutsos, H. Kalofonos, S. Chalkidou, P. Panagiotou, E. Linardou, E. Briassoulis, E. Efstathiou, A. Polyzos, G. Fountzilas, et al. Temozolomide and cisplatin versus temozolomide in patients with advanced melanoma: a randomized phase II study of the Hellenic Cooperative Oncology Group Ann. Onc., June 1, 2005; 16(6): 950 - 957. [Abstract] [Full Text] [PDF]

				S. K. Teo, K. H. Denny, D. I. Stirling, S. D. Thomas, S. Morseth, and A. M. Hoberman Effects of Thalidomide on Developmental, Peri- and Postnatal Function in Female New Zealand White Rabbits and Offspring Toxicol. Sci., October 1, 2004; 81(2): 379 - 389. [Abstract] [Full Text] [PDF]

				H. Tsao, M. B. Atkins, and A. J. Sober Management of Cutaneous Melanoma N. Engl. J. Med., September 2, 2004; 351(10): 998 - 1012. [Full Text] [PDF]

				V. Eleutherakis-Papaiakovou, A. Bamias, and M. A. Dimopoulos Thalidomide in cancer medicine Ann. Onc., August 1, 2004; 15(8): 1151 - 1160. [Abstract] [Full Text] [PDF]

				M. F. Paz, R. Yaya-Tur, I. Rojas-Marcos, G. Reynes, M. Pollan, L. Aguirre-Cruz, J. L. Garcia-Lopez, J. Piquer, M.-J. Safont, C. Balana, et al. CpG Island Hypermethylation of the DNA Repair Enzyme Methyltransferase Predicts Response to Temozolomide in Primary Gliomas Clin. Cancer Res., August 1, 2004; 10(15): 4933 - 4938. [Abstract] [Full Text] [PDF]

				S. Kumar, T. E. Witzig, and S. V. Rajkumar Thalidomide: Current Role in the Treatment of Non-Plasma Cell Malignancies J. Clin. Oncol., June 15, 2004; 22(12): 2477 - 2488. [Abstract] [Full Text] [PDF]

				M. S. Mitchell Chemotherapy for Melanoma: The Resultant of Conflicting Vectors J. Clin. Oncol., June 1, 2004; 22(11): 2043 - 2045. [Full Text] [PDF]