title: Low-dose continuous chemotherapy for metastatic melanoma: a phase II trial.
abstract: The prognosis of patients with metastatic melanoma remains poor and there is a need to develop new regimens with low toxicity. We investigated a novel outpatient regimen combining oral and intravenous chemotherapy with daily subcutaneous bleomycin. Twenty-nine chemotherapy-naive patients with metastatic melanoma were treated with a novel regimen consisting of low dose lomustine, daily subcutaneous bleomycin, chlorambucil, methotrexate and vinblastine with tamoxifen for an 8 week cycle (LBCMVT-56). A median of two cycles were given until disease progression or grade 3/4 toxicity. Five out of 29 (17%) patients had an objective response, of whom two (7%) had a complete response and remain progression-free after 2 years of follow-up. The median overall survival was 7.3 months. A symptomatic response was seen in 11 out of 29 patients (38%). Toxicity was acceptable, with grade 3/4 haematological toxicity seen in 25% of cycles, infection requiring intravenous antibiotics in 11% of cycles, and pulmonary toxicity seen in 4% of cycles. Hospitalization was required in 21% of the patients at some point during the treatment, most commonly for neutropenic sepsis. LBCMVT-56 chemotherapy is a novel outpatient regimen producing occasional durable complete responses in a patient group with a poor prognosis. The median survival is similar to that obtained with dacarbazine, though the toxicity is greater.
authors.affiliation: Department of Medical Oncology, St Bartholomew's Hospital, London, UK.
authors.forename: Maria L
authors.initials: ML
authors.lastname: Nystrom
authors.forename: Jeremy P
authors.initials: JP
authors.lastname: Steele
authors.forename: Jonathan
authors.initials: J
authors.lastname: Shamash
authors.forename: Frances
authors.initials: F
authors.lastname: Neville
authors.forename: R Timothy
authors.initials: RT
authors.lastname: Oliver
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000627:therapeutic use*; D018906:Antineoplastic Agents, Alkylating / Q000008:administration & dosage; D018931:Antineoplastic Agents, Hormonal / Q000008:administration & dosage; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001761:Bleomycin / Q000008:administration & dosage*; D002699:Chlorambucil / Q000008:administration & dosage; D003606:Dacarbazine / Q000008:administration & dosage; D018450:Disease Progression; D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007262:Infusions, Intravenous; D007279:Injections, Subcutaneous; D008130:Lomustine / Q000008:administration & dosage; D008297:Male; D008545:Melanoma / Q000188:drug therapy*; D008727:Methotrexate / Q000008:administration & dosage; D008875:Middle Aged; D009362:Neoplasm Metastasis / Q000188:drug therapy*; D011379:Prognosis; D013629:Tamoxifen / Q000008:administration & dosage; D013997:Time Factors; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage
chemical_list: D000964:Antimetabolites, Antineoplastic; D018906:Antineoplastic Agents, Alkylating; D018931:Antineoplastic Agents, Hormonal; D000972:Antineoplastic Agents, Phytogenic; D013629:Tamoxifen; D001761:Bleomycin; D002699:Chlorambucil; D014747:Vinblastine; D008130:Lomustine; D003606:Dacarbazine; D008727:Methotrexate