Filipovich, Elena, Razola, Paula, Andrés, Raquel, Sousa, Ramón, Mayordomo, José, Prats, Enrique, Güemes, Antonio, Lázaro, Jesús, Banzo, Javier, Puig, Susana, and Tres, Alejandro
Abstract: Background. Significant activity (50% objective responses) plus a small fraction of long term survivors have been reported in pilot trials of chemoimmunotherapy (CT-IT) for disseminated melanoma. Requirement for hospitalization is a major inconvenience. Aims. To assess the feasibility of fully ambulatory CT-IT with single-day cisplatine+dacarbacine (DTIC) combined with subcutaneous interleukin-2 +interferon-α for patients with metastatic melanoma in a multicenter phase II trial. Patients and methods. Courses, to be repeated every 21 days, included cisplatin 80 mg/m2 and DTIC 800 mg/m2, both i.v. on day one, plus subcutaneous injections of interleukin-2, 9 million/m2 IU, day two to 5 and interferon-α, 5 million m2 IU day one to 5. No corticosteroids were allowed except for 20 mg dexamethasone before cisplatine on day one for antiemesis. After 6 courses patients without progression received 6 additional courses of IT alone. Results. Forty four patients with metastasic melanoma have been treated. Male/female: 30/14. Median age: 47 years. Performance status (ECOG): 1 (0–2). Full doses of therapy have been delivered in 224 courses. Toxicity was acceptable: grade 3 toxicity included nausea (6% of courses), vomiting (10%), fever (1%), neutropenia (1%), anemia (0.8%), asthenia (2%), elevation of transaminases (0.8%) and elevation of serum creatinine (0.8%). Response (39 patients evaluable after three or more courses; rest too early): complete response 4 patients (10.2%); partial response 13 patients (33%); stable disease 8 patients (20.5%); progression 14 patients (35.8%). With median follow-up of 20 months or to death, median survival was 11.6 months. Conclusions. The activity and limited toxicity of this regimen allow its ambulatory use. The superiority of CT-IT over each modality alone remains to be confirmed.