Chemotherapy and Bio-Chemotherapy in Patients with Advanced Melanoma: Combination Therapy with a Nitrosourea

• Published in: Journal of chemotherapy (Florence) Vol. 15; no. 2; pp. 198 - 202
• Main Authors: Ridolfi, R., Tanganelli, L., Scelzi, E., Manente, P., Palmeri, S., Ravaioli, A., Fiammenghi, L., Romanini, A.
• Format: Journal Article
• Language: English
• Published: Firenze Taylor & Francis 01-04-2003; EIFT
• Subjects: Adult; Aged; Antineoplastic agents; Antineoplastic Agents - administration & dosage; Antineoplastic Agents - adverse effects; Antineoplastic Agents - pharmacology; Antineoplastic Agents, Alkylating - administration & dosage; Antineoplastic Agents, Alkylating - adverse effects; Antineoplastic Agents, Alkylating - pharmacology; Biological and medical sciences; Carmustine - administration & dosage; Carmustine - adverse effects; Carmustine - pharmacology; Chemotherapy; Combined Modality Therapy; Female; Humans; Interferon-alpha - administration & dosage; Interferon-alpha - adverse effects; Interferon-alpha - pharmacology; Interleukin-2 - administration & dosage; Interleukin-2 - adverse effects; Interleukin-2 - pharmacology; Male; Medical sciences; Melanoma - drug therapy; Melanoma - pathology; Middle Aged; Pharmacology. Drug treatments; Skin Neoplasms - drug therapy; Skin Neoplasms - pathology; Survival Analysis; Treatment Outcome; Human; immunomodulation; Drug combination; Nitrosoureas; Carmustine; Treatment efficiency; Controlled therapeutic trial; melanoma; Malignant tumor; Advanced melanoma; Chemotherapy; Treatment; Interleukin 2; Malignant melanoma; Advanced stage; Interferon; nitrosourea; bio-chemotherapy
• ISSN: 1120-009X; 1973-9478
• DOI: 10.1179/joc.2003.15.2.198

The treatment of advanced melanoma is still disappointing. In a multicenter randomized clinical trial to compare a chemotherapy (CT) with or without low doses of IL-2 and IFN (Bio-CT), the participating centers chose whether or not to add a nitrosourea, carmustine (BCNU) to the therapy. The aim of the present paper is to report the clinical results of the patients (pts) treated in both arms with BCNU. One hundred and seventy-six pts with advanced melanoma were enrolled in the study from 27 centers and a total of 18 pts also received BCNU in 3 centers. No further changes to the protocol criteria were allowed. One patient refused the treatment. No complete responses were observed. Irrespectively of the treatment arm, 9/17 pts showed a partial response to therapy (53%) (5/9 in the CT and 4/8 in the BioCT arm). The most important adverse events observed were hematological: 12 pts presented grade 3 (6 pts) or grade 4 (6 pts) leukocytopenia and 9 pts had grade 4 thrombocytopenia, all of which resolved spontaneously. The addition of a nitrosourea to CT or Bio-CT appears to improve response rates compared to the same regimens without nitrosourea. Patient tolerability is acceptable. Further studies using this combination are warranted.