title: Outpatient combination chemoimmunotherapy for patients with metastatic melanoma. Results of a phase I/II trial.
abstract: BACKGROUND
  Few studies have examined the feasibility, safety, and efficacy of an outpatient biochemotherapy regimen of low dose, subcutaneously administered interleukin-2 (IL-2) for patients with metastatic (Stage IV) melanoma.
  
  
  METHODS
  Nineteen patients were treated with intravenous cisplatin and dacarbazine (DTIC), oral tamoxifen, and subcutaneous IL-2 and interferon-alpha-2b (IFN). Eligibility requirements included bidimensionally measurable metastatic melanoma, a Karnofsky performance score of 60 or higher, absence of significant cardiac or pulmonary dysfunction, no prior DTIC or cisplatin chemotherapy, and no evidence of central nervous system involvement. Patients were given a minimum of 2 6-week cycles. Treatment was continued in the absence of progressive disease, and patients were monitored for response at two-cycle intervals.
  
  
  RESULTS
  Of the 19 patients, 1 (5%) achieved a complete response; 6 (32%) a partial response; 3 (16%) stable disease; and 9 (47%) progressive disease, for an overall response proportion of 37% (95% confidence interval, 16-61%). The median survival of the treated cohort was 10.6 months. The mean time to disease progression for patients with stable disease or better was 8.4 months, with a mean response duration of 5.1 months. The most common toxicities noted were constitutional symptoms, weight loss, nausea, neutropenia, and fatigue. The 19 patients received a total of 59 cycles of treatment, and IL-2, IFN, or both were held in 14 of these cycles secondary to Grade 3 or 4 toxicities. In addition, six patients required dose reduction of IL-2 and/or IFN.
  
  
  CONCLUSIONS
  Chemoimmunotherapy consisting of cisplatin, DTIC, and tamoxifen combined with subcutaneous IL-2 and IFN can be safely administered in an outpatient setting. The described regimen yields moderate activity in metastatic melanoma, and efforts to improve its efficacy merit further examination.
authors.affiliation: Melanoma Center, University of California San Francisco Clinical Cancer Center, San Francisco, California, USA.
authors.forename: M
authors.initials: M
authors.lastname: Kashani-Sabet
authors.forename: R W
authors.initials: RW
authors.lastname: Sagebiel
authors.forename: H E
authors.initials: HE
authors.lastname: Collins
authors.forename: A B
authors.initials: AB
authors.lastname: Glassberg
authors.forename: R E
authors.initials: RE
authors.lastname: Allen
authors.forename: S P
authors.initials: SP
authors.lastname: Leong
authors.forename: E J
authors.initials: EJ
authors.lastname: Small
mesh_terms: D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D007167:Immunotherapy / Q000009:adverse effects / Q000379:methods*; D008297:Male; D008545:Melanoma / Q000556:secondary / Q000628:therapy*; D008875:Middle Aged; D012189:Retrospective Studies; D016896:Treatment Outcome