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


Authors: Hwu, W. J.; Krown, S. E.; Menell, J. H.; Panageas, K. S.; Merrell, J.; Lamb, L. A.; Williams, L. J.; Quinn, C. J.; Foster, T.; Chapman, P. B.; Livingston, P. O.; Wolchok, J. D.; Houghton, A. N.
Article Title: 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/m 2/d × 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. © 2003 by American Society of Clinical Oncology.
Keywords: survival; adult; cancer survival; clinical article; controlled study; treatment outcome; treatment response; aged; aged, 80 and over; middle aged; survival analysis; thalidomide; clinical trial; constipation; fatigue; cancer combination chemotherapy; dose response; drug efficacy; drug safety; drug withdrawal; gastrointestinal hemorrhage; temozolomide; cancer staging; neurotoxicity; brain tumor; follow up; brain neoplasms; antineoplastic agent; dacarbazine; edema; melanoma; metastasis; controlled clinical trial; multiple cycle treatment; phase 2 clinical trial; thrombocytopenia; antineoplastic combined chemotherapy protocols; combination chemotherapy; deep vein thrombosis; pathology; dose-response relationship, drug; drug dose escalation; dyspnea; fever; lymphocytopenia; pneumonia; rash; drug fatality; drug derivative; humans; human; male; female; priority journal; article
Journal Title: Journal of Clinical Oncology
Volume: 21
Issue: 17
ISSN: 0732-183X
Publisher: American Society of Clinical Oncology  
Date Published: 2003-09-01
Start Page: 3351
End Page: 3356
Language: English
DOI: 10.1200/jco.2003.02.061
PUBMED: 12947072
PROVIDER: scopus
DOI/URL:
Notes: Export Date: 12 September 2014 -- Source: Scopus
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MSK Authors
  1. Jedd D Wolchok
    656 Wolchok
  2. Jennifer Menell
    16 Menell
  3. Wen-Jen Hwu
    28 Hwu
  4. Paul Chapman
    246 Chapman
  5. Katherine S Panageas
    327 Panageas
  6. Susan Krown
    84 Krown
  7. Alan N Houghton
    267 Houghton
  8. Lynne A Lamb
    7 Lamb
  9. Carolyn J Quinn
    5 Quinn
  10. Theresa   Foster
    2 Foster