Phase II trial of neoadjuvant temozolomide in resectable melanoma patients Journal Article


Authors: Shah, G. D.; Socci, N. D.; Gold, J. S.; Wolchok, J. D.; Carvajal, R. D.; Panageas, K. S.; Viale, A.; Brady, M. S.; Coit, D. G.; Chapman, P. B.
Article Title: Phase II trial of neoadjuvant temozolomide in resectable melanoma patients
Abstract: Background: We treated melanoma patients with temozolomide (TMZ) in the neoadjuvant setting and collected cryopreserved tumor samples before and after treatment. The primary objective was to determine whether the response proportion was higher than previously reported in widely metastatic patients. A secondary objective was to test the feasibility of obtaining adequate tissue before and after treatment for genetic testing. Materials and methods: Chemotherapy-naive melanoma patients who were candidates for surgical resection were eligible. TMZ was administered orally at 75 mg/m2/day for 6 weeks of every 8-week cycle. Cycles were repeated until complete response (CR), progression, or stable disease (SD) for two cycles. Results: Of 19 assessable patients, 2 had CRs and 1 had partial response. Four patients had SD; 12 progressed. Tumor O-6-methylguanine-DNA methyltransferase (MGMT) promoter was unmethylated in all nine patients analyzed including from the two CR patients. Pretreatment tumor microarray results were obtained in 16 of 19 patients. Conclusions: The response proportion to TMZ in the neoadjuvant setting was 16%, not different than in the metastatic setting. Responses were seen even in tumors with a methylated MGMT promoter. Pretreatment cryopreserved tumor adequate for microarray analysis could be obtained in most, but not all, patients. Post-treatment tumor was unavailable in complete responders. © The Author 2010. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved.
Keywords: adult; clinical article; human tissue; aged; promoter region; clinical trial; fatigue; neutropenia; cancer growth; side effect; cancer patient; temozolomide; cancer staging; melanoma; multiple cycle treatment; phase 2 clinical trial; anemia; skin biopsy; leukopenia; dna methylation; hyperglycemia; lymphocytopenia; feasibility study; microarray analysis; adjuvant chemotherapy; drug response; hyperbilirubinemia; metastasis potential; methylated dna protein cysteine methyltransferase; microarray; mgmt; international normalized ratio
Journal Title: Annals of Oncology
Volume: 21
Issue: 8
ISSN: 0923-7534
Publisher: Oxford University Press  
Date Published: 2010-08-01
Start Page: 1718
End Page: 1722
Language: English
DOI: 10.1093/annonc/mdp593
PROVIDER: scopus
PUBMED: 20080829
DOI/URL:
Notes: --- - "Export Date: 20 April 2011" - "CODEN: ANONE" - "Source: Scopus"
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MSK Authors
  1. Jedd D Wolchok
    905 Wolchok
  2. Richard D Carvajal
    148 Carvajal
  3. Gaurav D Shah
    12 Shah
  4. Paul Chapman
    326 Chapman
  5. Katherine S Panageas
    512 Panageas
  6. Mary Sue Brady
    203 Brady
  7. Agnes Viale
    245 Viale
  8. Daniel Coit
    542 Coit
  9. Nicholas D Socci
    266 Socci