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Annals of Oncology Advance Access originally published online on September 15, 2006
Annals of Oncology 2006 17(12):1835-1841; doi:10.1093/annonc/mdl311
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© 2006 European Society for Medical Oncology

melanoma

Temozolomide in combination with celecoxib in patients with advanced melanoma. A phase II study of the Hellenic Cooperative Oncology Group

H Gogas1,*, A Polyzos1, I Stavrinidis2, K Frangia3, D Tsoutsos4, P Panagiotou4, C Markopoulos1, O Papadopoulos1, D Pectasides5, M Mantzourani1, M Middleton6, G Vaiopoulos1 and G Fountzilas7

1 First Department of Medicine, University of Athens, Medical School, Athens, Greece
2 First Department of Medical Oncology, St Savas Anticancer Hospital, Athens, Greece
3 Department of Pathology, Sotiria General Hospital, "WHO Melanoma Program", Athens, Greece
4 Department of Plastic Surgery and Microsurgery, G. Gennimatas General Hospital, Athens, Greece
5 Second Department of Pr. Medicine, "Attikon" Hospital, University of Athens, Athens, Greece
6 Cancer Research UK Medical Oncology Unit, Churchill Hospital, University of Oxford, UK
7 Department of Medical Oncology, Papageorgiou Hospital, Aristotle University of Thessaloniki, School of Medicine, Thessaloniki, Greece

* Correspondence to: Dr H. Gogas, Assistant Professor in Medical Oncology, First Department of Internal Medicine, Medical School, University of Athens, PO Box 14120, Athens 115 10, Greece. Tel: 0 30 944 68 11 59; Fax: 0 30 10 77 81 517; E-mail: hgogas{at}hol.gr

Background: There is now increasing evidence that a constitutive expression of cyclooxygenase (COX)-2 plays a role in the development and progression of malignant epithelial tumors. Expression of COX-2 is seen in 93% of melanomas, as determined by immunohistochemistry. Temozolomide (TMZ) has demonstrated activity against melanoma and has been investigated as single agent or in combination. We designed a phase II study to assess the efficacy and toxicity of the combination of TMZ and celecoxib (a COX-2 inhibitor) in patients with advanced melanoma.

Patients and methods: From January 2003 to July 2004, 52 patients were enrolled in the study. Nineteen patients were M1a, six M1b and 27 M1c. Patients received TMZ 200 mg/m2 per day p.o. for 5 consecutive days every 4 weeks and celecoxib 400 mg b.i.d. p.o. for a maximum of six cycles. Celecoxib was continued until progression.

Results: The median age was 63 years. There were 29 males and 23 females. Among 50 assessable patients, there were 11 (21.5%) objective responses including five complete responses and six partial responses. Twenty patients (38.5%) had stabilization of their disease, and 19 (36.5%) progressed. The median time to progression was 4.6 months and the median survival 9.5 months. Twenty-two patients (41.5%) completed all cycles of treatment. Median relative dose intensity of TMZ was 0.99 (range 0.6–1.2). Most commonly seen toxic effects included anemia (27.5%), neutropenia (17.5%), thrombocytopenia (33%), nausea/vomiting (75%), gastrointestinal (52%) and fatigue (46.5%). One patient discontinued due to severe toxicity. COX-2 was determined by immunohistochemistry and was expressed in all cases.

Conclusion: The combination of TMZ and celecoxib is safe and potentially effective in the treatment of metastatic melanoma. Randomized studies are needed to explore the role of celecoxib in combination with chemotherapy or as maintenance treatment in these patients.

Key words: celecoxib, metastatic melanoma, temozolomide


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