Document Detail

Imatinib mesylate as a preoperative therapy in dermatofibrosarcoma: results of a multicenter phase II study on 25 patients.
MedLine Citation:
PMID:  20439456     Owner:  NLM     Status:  MEDLINE    
AIMS: The treatment of dermatofibrosarcoma protuberans (DFSP) involves wide local excision with frequent need for reconstructive surgery. A t(17;22) translocation resulting in COL1A1-PDGFB fusion is present in >95% of cases. Certain patient observations and a report on nine patients suggest that imatinib mesylate, targeting platelet-derived growth factor receptor beta, has clinical potential in DFSP. The primary aim of this phase II multicenter study was to define the percentage of clinical responders (Response Evaluation Criteria in Solid Tumors) to a 2-month preoperative daily administration of 600 mg of imatinib mesylate before wide local excision. The secondary aims were to determine tolerance, objective response from imaging results (ultrasound and magnetic resonance imaging), and pathologic responses observed in sequential tissue specimens. PATIENTS AND METHODS: A two-stage flexible design was used with interim analysis after the recruitment of six patients. Twenty-five adults suffering from primary or recurrent DFSP were included from July 2004 to May 2006. RESULTS: The COL1A1-PDGFB fusion gene was detected in 21 out of 25 patients following fluorescence in situ hybridization analysis (two cases were noninformative). A clinical response was achieved in nine (36%) patients (95% confidence interval, 18.9-57.5). The median relative tumoral decrease was 20.0% (range, -12.5 to 100). Apart from expected grade 1 or 2 side effects, we observed one grade 3 neutropenia, one grade 3 maculopapular rash, and one grade 4 transient transaminitis. CONCLUSION: Our results support the use of imatinib in a neoadjuvant setting in nonresectable DFSP, or when surgery is difficult or mutilating. These results will be useful for setting hypotheses in the evaluation of new drugs to treat primary or secondary resistance to imatinib.
Delphine Kérob; Raphael Porcher; Olivier Vérola; Stephane Dalle; Eve Maubec; François Aubin; Michel D'Incan; Isaak Bodokh; Serge Boulinguez; Isabelle Madelaine-Chambrin; Anne Mathieu-Boue; Jean-Marie Servant; Eric de Kerviler; Anne Janin; Fabien Calvo; Florence Pedeutour; Celeste Lebbe
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Publication Detail:
Type:  Clinical Trial, Phase II; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't     Date:  2010-05-03
Journal Detail:
Title:  Clinical cancer research : an official journal of the American Association for Cancer Research     Volume:  16     ISSN:  1078-0432     ISO Abbreviation:  Clin. Cancer Res.     Publication Date:  2010 Jun 
Date Detail:
Created Date:  2010-06-16     Completed Date:  2010-08-20     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9502500     Medline TA:  Clin Cancer Res     Country:  United States    
Other Details:
Languages:  eng     Pagination:  3288-95     Citation Subset:  IM    
Copyright Information:
(c) 2010 AACR.
AP-HP Department of Dermatology, Hôpital Saint-Louis, Universite Paris 7 Denis Diderot, Paris, France.
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MeSH Terms
Antineoplastic Agents / therapeutic use*
Dermatofibrosarcoma / drug therapy*,  pathology,  surgery
Middle Aged
Neoadjuvant Therapy
Piperazines / adverse effects,  therapeutic use*
Pyrimidines / adverse effects,  therapeutic use*
Skin Neoplasms / drug therapy*,  pathology,  surgery
Treatment Outcome
Reg. No./Substance:
0/Antineoplastic Agents; 0/Piperazines; 0/Pyrimidines; 152459-95-5/imatinib

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