Temozolomide and interferon-alpha in metastatic melanoma: A phase II study of the Italian Melanoma Intergroup

Ruggero Ridolfi, Antonella Romanini, Vanna Chiarion Sileni, Maria Michiara, Michele Guida, Guido Biasco, Paola Poletti, Laura Amaducci, Maurizio Leoni, Alessandra Ravaioli

Research output: Contribution to journalArticlepeer-review


Temosolomide (TMZ) is a new oral alkylating agent which has proven to be as active as dacarbazine (DTIC) in the treatment of melanoma, but with a lower toxicity. A multicentric phase 11 trial was conducted in an out-patient setting to determine the therapeutic activity and safety of TMZ in combination with interferon-alpha (IFN-α). From June 2000 to July 2001, 41 patients were recruited to receive TMZ 200 mg/m2 orally on days 1-5 every 28 days and with 5MU IFN-α subcutaneously three times a week, continuously for eight cycles or until disease progression occurred. Of the 40 treated patients, two complete responses (5%) and three partial responses (7.5%) were observed, with a median duration of 4 months (range, 1.5-13.5 months). Thirteen patients (32.5%) had stable disease for a median of 2.5 months. Time to progression was 2.6 months and the median overall survival was 11.8 months. Nine patients (22.5%) developed brain metastases. The grade 4 toxicity observed in seven patients was of a transient haematological nature. This combination therapy is well tolerated but does not appear to increase the response rate or overall survival with respect to TMZ alone or to chemotherapeutic regimens. Further and more complex associations of these two drugs could be investigated in specific subsets of patients, in particular to evaluate its real efficacy in preventing brain metastases.

Original languageEnglish
Pages (from-to)295-299
Number of pages5
JournalMelanoma Research
Issue number4
Publication statusPublished - Aug 2004


  • α-interferon
  • Metastatic melanoma
  • Temozolomide

ASJC Scopus subject areas

  • Cancer Research
  • Dermatology


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