title: Long-term survival in metastatic melanoma patients treated with sequential biochemotherapy: report of a Phase II study.
abstract: The overall survival for patients with metastatic melanoma is very poor, with a median survival of 8.5 months. In this Phase II trial, we assessed the efficacy, safety, and tolerability of a sequential biochemotherapy schedule, using dacarbazine as antiblastic agent and immunomodulant doses of interleukin-2 and interferon-alfa. Thirty-one eligible patients with metastatic melanoma received dacarbazine IV as antiblastic therapy and interluekin-2, plus interferon-alfa SC as sequential immunotherapy, for 6 months. Responding and nonprogressing patients were subsequently maintained on immunotherapy treatment for further 6 months. Twenty-nine patients had an adequate trial, and were assessable for both response and toxicities, with a median follow-up of 49 months. The overall response rate was 52 percent (3 CR and 12 PR), SD was 8 (27 percent) and PD were achieved in 6 patients (21 percent). The median survival duration of responders was 28 months, significantly longer (p < 0.001) than the 16 months of nonresponders. Therapy was well tolerated and produced a significant improvement in progressive-free survival. Further studies, thus, are recommended for larger groups of patients not only to confirm these results, but also to apply this biochemotherapy regimen as adjuvant postsurgical treatment in early stages of malignant melanoma.
authors.affiliation: Department of Internal Medicine-Centre of Experimental and Clinical Oncology, Postgraduate School of Oncology, University of Florence, Italy. bruno.neri@unifi.it
authors.forename: B
authors.initials: B
authors.lastname: Neri
authors.forename: L
authors.initials: L
authors.lastname: Vannozzi
authors.forename: C
authors.initials: C
authors.lastname: Fulignati
authors.forename: P
authors.initials: P
authors.lastname: Pantaleo
authors.forename: D
authors.initials: D
authors.lastname: Pantalone
authors.forename: C
authors.initials: C
authors.lastname: Paoletti
authors.forename: F
authors.initials: F
authors.lastname: Perfetto
authors.forename: M
authors.initials: M
authors.lastname: Turrini
authors.forename: R
authors.initials: R
authors.lastname: Mazzanti
mesh_terms: D000328:Adult; D000368:Aged; D018906:Antineoplastic Agents, Alkylating / Q000008:administration & dosage / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D003606:Dacarbazine / Q000008:administration & dosage / Q000627:therapeutic use; D018450:Disease Progression; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007155:Immunologic Factors / Q000008:administration & dosage / Q000627:therapeutic use*; D016898:Interferon-alpha / Q000008:administration & dosage / Q000627:therapeutic use; D007376:Interleukin-2 / Q000008:administration & dosage / Q000627:therapeutic use; D008297:Male; D008545:Melanoma / Q000188:drug therapy* / Q000401:mortality; D008875:Middle Aged; D009362:Neoplasm Metastasis; D016019:Survival Analysis
chemical_list: D018906:Antineoplastic Agents, Alkylating; D007155:Immunologic Factors; D016898:Interferon-alpha; D007376:Interleukin-2; D003606:Dacarbazine