title: A phase II study of biochemotherapy for the treatment of metastatic malignant melanoma.
abstract: The use of interleukin-2 (IL-2) and interferon-alpha (IFNalpha) in combination with chemotherapy for the treatment of advanced malignant melanoma has generated considerable interest. In particular, the relatively high number of durable complete responses has suggested this may be a significant advance in the treatment of malignant melanoma. We report our experience at the University of Colorado in 43 patients, including many with poor prognostic factors. Patients received cisplatin 20 mg/m2 on days 1-4, vinblastine 1.6 mg/m2 on days 1-4, dacarbazine 800 mg/m2 on day 1, IL-2 9 x 10(6) IU/m2 per day intravenously over 24h on days 1-4 and IFNalpha 5 x 10(6) IU/m2 per day subcutaneously on days 1-5 every 3 weeks. The median follow-up for all patients was 34 months. Responses were seen in 20 patients (47%, 95% confidence interval 31-62%) and comprised five complete responses (CRs) (12%) and 15 partial responses (PRs) (35%). Two patients achieving a CR remain disease free at 45 and 47 months follow-up. In addition three patients who obtained a surgical CR and another with only minor residual changes on computed tomography scan have not progressed at 27, 30, 40 and 27 months, respectively. Toxicity was manageable, but all patients had at least one grade 3 or 4 toxicity, predominantly hypotension and neutropenia. There were no treatment-related deaths. In conclusion, the response rate and duration is within the range previously reported for biochemotherapy. The results of ongoing randomized studies are awaited to better define the value of biochemotherapy in the treatment of advanced melanoma.
authors.affiliation: Division of Medical Oncology, University of Colorado Cancer Center, Denver 80262, USA.
authors.forename: P
authors.initials: P
authors.lastname: Gibbs
authors.forename: A
authors.initials: A
authors.lastname: Iannucci
authors.forename: M
authors.initials: M
authors.lastname: Becker
authors.forename: J
authors.initials: J
authors.lastname: Allen
authors.forename: M
authors.initials: M
authors.lastname: O'Driscoll
authors.forename: K
authors.initials: K
authors.lastname: McDowell
authors.forename: P
authors.initials: P
authors.lastname: Williams
authors.forename: P
authors.initials: P
authors.lastname: Rosse
authors.forename: J
authors.initials: J
authors.lastname: Murphy
authors.forename: R
authors.initials: R
authors.lastname: Gonzalez
mesh_terms: D000008:Abdominal Neoplasms / Q000188:drug therapy / Q000401:mortality / Q000556:secondary; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001932:Brain Neoplasms / Q000188:drug therapy / Q000401:mortality / Q000556:secondary / Q000628:therapy; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D003120:Colorado / Q000453:epidemiology; D003131:Combined Modality Therapy; D003606:Dacarbazine / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007022:Hypotension / Q000139:chemically induced; D007155:Immunologic Factors / Q000627:therapeutic use*; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000009:adverse effects / Q000627:therapeutic use*; D007376:Interleukin-2 / Q000009:adverse effects / Q000627:therapeutic use*; D015993:Life Tables; D008113:Liver Neoplasms / Q000188:drug therapy / Q000401:mortality / Q000556:secondary*; D008175:Lung Neoplasms / Q000188:drug therapy / Q000401:mortality / Q000556:secondary*; D008297:Male; D008545:Melanoma / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary*; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D012074:Remission Induction; D016019:Survival Analysis; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D007155:Immunologic Factors; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D007376:Interleukin-2; D011994:Recombinant Proteins; D014747:Vinblastine; D003606:Dacarbazine; D002945:Cisplatin