Low-dose continuous chemotherapy for metastatic melanoma: a phase II trial

Melanoma Res. 2003 Apr;13(2):197-9. doi: 10.1097/00008390-200304000-00014.

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.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II

MeSH terms

  • Administration, Oral
  • Adult
  • Aged
  • Antimetabolites, Antineoplastic / therapeutic use*
  • Antineoplastic Agents, Alkylating / administration & dosage
  • Antineoplastic Agents, Hormonal / administration & dosage
  • Antineoplastic Agents, Phytogenic / administration & dosage
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Bleomycin / administration & dosage*
  • Chlorambucil / administration & dosage
  • Dacarbazine / administration & dosage
  • Disease Progression
  • Disease-Free Survival
  • Female
  • Follow-Up Studies
  • Humans
  • Infusions, Intravenous
  • Injections, Subcutaneous
  • Lomustine / administration & dosage
  • Male
  • Melanoma / drug therapy*
  • Methotrexate / administration & dosage
  • Middle Aged
  • Neoplasm Metastasis / drug therapy*
  • Prognosis
  • Tamoxifen / administration & dosage
  • Time Factors
  • Treatment Outcome
  • Vinblastine / administration & dosage

Substances

  • Antimetabolites, Antineoplastic
  • Antineoplastic Agents, Alkylating
  • Antineoplastic Agents, Hormonal
  • Antineoplastic Agents, Phytogenic
  • Tamoxifen
  • Bleomycin
  • Chlorambucil
  • Vinblastine
  • Lomustine
  • Dacarbazine
  • Methotrexate