Phase II study of temozolomide plus thalidomide for the treatment of metastatic melanoma.

Abstract

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.

• Authors: Wen-Jen Hwu, Susan E Krown, Jennifer H Menell, Katherine S Panageas, Janene Merrell, Lynne A Lamb, Linda J Williams, Carolyn J Quinn, Theresa Foster, Paul B Chapman, Philip O Livingston, Jedd D Wolchok, Alan N Houghton
• Journal: Journal of clinical oncology : official journal of the American Society of Clinical Oncology (J Clin Oncol) Vol. 21 Issue 17 Pg. 3351-6 (Sep 01 2003) ISSN: 0732-183X [Print] United States
• PMID: 12947072 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article)

Chemical References

• Thalidomide
• Dacarbazine
• Temozolomide

Topics

• Adult
• Aged
• Aged, 80 and over
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Brain Neoplasms (secondary)
• Dacarbazine (administration & dosage, analogs & derivatives)
• Dose-Response Relationship, Drug
• Female
• Humans
• Male
• Melanoma (drug therapy, pathology)
• Middle Aged
• Survival Analysis
• Temozolomide
• Thalidomide (administration & dosage)
• Treatment Outcome