title: Intratumoral cisplatin/adrenaline injectable gel for the treatment of patients with cutaneous and soft tissue metastases of malignant melanoma.
abstract: Local therapies have been highly effective in the treatment of melanoma. The objective of this study was to evaluate the use of a novel intralesional chemotherapy - cisplatin/adrenaline injectable gel - for the treatment of refractory or recurrent cutaneous and soft tissue melanoma metastases. The gel is injected directly into the lesion and delivers high concentrations of cisplatin at the injection site, where it is retained for extended periods, with little systemic exposure. A total of 28 patients with refractory or recurrent melanoma were enrolled in this open-label, multicentre study. Of these, 25 patients with 244 lesions were evaluable for efficacy. Lesions were injected with 0.5 ml (2 mg cisplatin + 0.05 mg adrenaline) of gel/cm(3) of tumour. Patients received up to six weekly treatments within an 8 week period. The objective response rate (complete responses [CRs] plus partial responses [PRs]) for all the tumours treated (1-72 per patient) was 53% (130 out of 244; 114 CRs, 16 PRs). The response rate for the target tumours (i.e. each patient's single, most symptomatic, largest or most threatening tumour) was 44%. The median response duration for all tumours was 347 days (range 30-783 days) and median number of treatments per tumour was five (range one to twelve). Systemic toxicity was negligible; local adverse reactions such as erythema, necrosis or pain occurred frequently, but were easily managed in most cases. In conclusion, cisplatin/adrenaline injectable gel was well tolerated, easy to administer, and effective in treating metastatic melanoma confined to the skin or soft tissues.
authors.affiliation: Department of Medical Oncology, New York University Medical Center, New York City, New York 10016, USA. roratz@salick.com
authors.forename: Ruth
authors.initials: R
authors.lastname: Oratz
authors.forename: Axel
authors.initials: A
authors.lastname: Hauschild
authors.forename: Günther
authors.initials: G
authors.lastname: Sebastian
authors.forename: Dirk
authors.initials: D
authors.lastname: Schadendorf
authors.forename: Dan
authors.initials: D
authors.lastname: Castro
authors.forename: Eva-B
authors.initials: EB
authors.lastname: Bröcker
authors.forename: Elaine K
authors.initials: EK
authors.lastname: Orenberg
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage; D004837:Epinephrine / Q000008:administration & dosage; D005260:Female; D005782:Gels; D006801:Humans; D015552:Injections, Intralesional; D008297:Male; D008545:Melanoma / Q000188:drug therapy* / Q000556:secondary / Q000601:surgery; D008875:Middle Aged; D010865:Pilot Projects; D012449:Safety; D012878:Skin Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D012983:Soft Tissue Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery
chemical_list: D005782:Gels; D002945:Cisplatin; D004837:Epinephrine