Advanced ovarian adenocarcinoma. A prospective clinical trial of melphalan (L-PAM) versus combination chemotherapy

N Engl J Med. 1978 Dec 7;299(23):1261-6. doi: 10.1056/NEJM197812072992301.

Abstract

Eighty patients with advanced ovarian adenocarcinoma were treated in a prospective, randomized trial comparing a four-drug combination--hexamethylmelamine, cyclophosphamide, methotrexate and 5-fluorouracil--with the oral alkylating agent, melphalan. Treatment with the four-drug combination was associated with a significantly increased overall response rate (75 vs. 54 per cent) (P less than 0.05), more complete remissions (33 vs. 16 per cent) and longer median survival (29 vs. 17 months) (P less than 0.02) but more severe toxicity than occurred with melphalan. Patients with minimal residual disease had a significantly higher overall response rate than patients with extensive residual disease (84 vs. 53 per cent) (P less than 0.05). Patients with advanced disease who achieved a complete remission documented by peritoneoscopy or laparotomy (or both) have a median survival that will exceed three years. The four-drug regimen is more effective than melphalan in the management of advanced ovarian adenocarcinoma.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Adenocarcinoma / drug therapy*
  • Adenocarcinoma / mortality
  • Adult
  • Aged
  • Altretamine / administration & dosage
  • Antineoplastic Agents / administration & dosage*
  • Antineoplastic Agents / adverse effects
  • Cyclophosphamide / administration & dosage
  • Drug Administration Schedule
  • Drug Therapy, Combination
  • Female
  • Fluorouracil / administration & dosage
  • Humans
  • Melphalan / administration & dosage
  • Melphalan / adverse effects
  • Melphalan / therapeutic use*
  • Methotrexate / administration & dosage
  • Middle Aged
  • Ovarian Neoplasms / drug therapy*
  • Ovarian Neoplasms / mortality
  • Prospective Studies

Substances

  • Antineoplastic Agents
  • Cyclophosphamide
  • Melphalan
  • Altretamine
  • Fluorouracil
  • Methotrexate