title: Intratumoral cisplatin/epinephrine gel in advanced head and neck cancer: a multicenter, randomized, double-blind, phase III study in North America.
abstract: BACKGROUND
  The objective was to evaluate the efficacy and safety of a novel intratumoral cisplatin/epinephrine injectable gel (CDDP/epi gel) for local control and palliation of tumor-related symptoms in patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).
  
  
  METHODS
  Eighty-seven patients were randomly assigned to either CDDP/epi or placebo gel in this phase III, double-blind study. Tumors were < or =20 cm(3); most recurrences (88%) were in a previously irradiated field. The most symptomatic or threatening tumor was designated as the target tumor. DOSE: 0.25 mL CDDP/epi gel/cm(3) tumor volume.
  
  
  METHODS
  < or =6 weekly intratumoral injections in an 8-week period.
  
  
  METHODS
  target tumor response and symptom relief.
  
  
  RESULTS
  During the blinded phase, 34% (21 of 62) of patients achieved an objective response (CR or PR) in the target tumor treated with CDDP/epi gel vs 0% (0 of 24) treated with placebo gel (p <.001). Responses occurred within a median of four treatments (range, 2-6) and were durable (median, 95 days; range, 34-168+ days). More patients treated with CDDP/epi gel achieved palliative benefit than did those treated with placebo gel (37% vs 12%, p =.036). Most frequent side effects were local pain and local cutaneous reactions, which resolved over 3-12 weeks. Renal and hematologic toxicities were rare.
  
  
  CONCLUSIONS
  This phase III trial showed that CDDP/epi gel significantly reduces tumor burden, palliates tumor-related symptoms, and is an effective local treatment for recurrent tumors.
authors.affiliation: Division of Head and Neck Surgery, UCLA School of Medicine, 10833 LeConte Ave., 62-132 CHS, Los Angeles, California 90024, USA.
authors.forename: Dan J
authors.initials: DJ
authors.lastname: Castro
authors.forename: Kasi S
authors.initials: KS
authors.lastname: Sridhar
authors.forename: Harinder S
authors.initials: HS
authors.lastname: Garewal
authors.forename: Glenn M
authors.initials: GM
authors.lastname: Mills
authors.forename: Barry L
authors.initials: BL
authors.lastname: Wenig
authors.forename: Frank R
authors.initials: FR
authors.lastname: Dunphy
authors.forename: Peter D
authors.initials: PD
authors.lastname: Costantino
authors.forename: Richard D
authors.initials: RD
authors.lastname: Leavitt
authors.forename: Morgan E
authors.initials: ME
authors.lastname: Stewart
authors.forename: Elaine K
authors.initials: EK
authors.lastname: Orenberg
mesh_terms: D000322:Adrenergic Agonists / Q000008:administration & dosage* / Q000009:adverse effects; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000556:secondary; D002945:Cisplatin / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D004837:Epinephrine / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D005782:Gels; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D015552:Injections, Intralesional; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D009656:North America; D010166:Palliative Care; D011788:Quality of Life; D016896:Treatment Outcome
chemical_list: D000322:Adrenergic Agonists; D000970:Antineoplastic Agents; D005782:Gels; D002945:Cisplatin; D004837:Epinephrine