title: A phase II study of interferon-alpha 2b with dacarbazine, carmustine, cisplatin and tamoxifen in metastatic melanoma.
abstract: A phase II trial was conducted to determine the efficacy and toxicity of the addition of interferon-alpha 2b (IFN-alpha) to the chemotherapy combination of dacarbazine (DTIC), carmustine (BCNU), cisplatin and tamoxifen (DBCT), in patients with stage III or IV melanoma. Treatment consisted of DTIC 220 mg/m2 and cisplatin 25 mg/m2 intravenously on days 1-3, BCNU 100 mg/m2 IV on day 1 only, tamoxifen 20 mg orally twice daily and IFN-alpha 5 x 10(6) units/m2 subcutaneously on days 1-5. Cycles were repeated every 4 weeks. All patients received a loading dose of tamoxifen 100 mg orally twice daily for 5 days before the first course of therapy. Of the 24 patients treated, three (13%) achieved a complete response (CR) and six (25%) a partial response (PR), for an overall response rate of 38% (95% confidence interval, 17-58%). Two patients, one who achieved a clinical CR and one a PR, had pathologically confirmed complete responses. Severe myelosuppression occurred in 47% of cycles and constitutional symptoms were common. Overall, the addition of IFN-alpha to the DBCT regimen did not appear to enhance the response rate and may have increased toxicity.
authors.affiliation: Yale Comprehensive Cancer Center, New Haven, CT, USA.
authors.forename: M Z
authors.initials: MZ
authors.lastname: Schultz
authors.forename: A C
authors.initials: AC
authors.lastname: Buzaid
authors.forename: W J
authors.initials: WJ
authors.lastname: Poo
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002330:Carmustine / Q000008:administration & dosage; D002945:Cisplatin / Q000008:administration & dosage; D003131:Combined Modality Therapy / Q000009:adverse effects; D016001:Confidence Intervals; D003606:Dacarbazine / Q000008:administration & dosage; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000009:adverse effects / Q000627:therapeutic use*; D008545:Melanoma / Q000473:pathology / Q000628:therapy*; D008875:Middle Aged; D009362:Neoplasm Metastasis; D011994:Recombinant Proteins; D013629:Tamoxifen / Q000008:administration & dosage
chemical_list: D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D013629:Tamoxifen; D003606:Dacarbazine; D002945:Cisplatin; D002330:Carmustine