5-Fluorouracil, methyl-CCNU, and radiotherapy with or without testolactone for localized adenocarcinoma of the exocrine pancreas: a Southwest Oncology Group Study.
Since August 1975, 69 patients with localized pancreatic carcinoma (extent of tumor confined to a 15 cm x 15 cm radiotherapy port) have received either Regimen A, comprising radiotherapy (6,000 rad) to the tumor area with simultaneous combination chemotherapy utilizing methyl-CCNU, 125 mg/m2 orally, every six weeks, and 5-fluorouracil, 400 mg/m2 intravenously, weekly; or Regimen B, comprising Regimen A with the addition of testolactone, 200 mg, orally every day. Thirty-eight patients on Regimen A and 30 patients on Regimen B are currently evaluable. Median survival, which appeared not to be affected by the addition of testolactone, was 38 weeks for those on Regimen A and 30 weeks for those on Regimen B (P = 0.677). The median survival time for all patients was 38 weeks. Good performance status did correlate with improved survival vs. poor performance status (46 weeks vs. 20 weeks, P = .008). Fifteen patients have survived for more than 52 weeks, with the longest survival time being 160 + weeks, and in 3 cases all therapy has been discontinued. However, most patients experienced moderate to severe hematologic toxic reactions. There was one treatment-related death and significant gastrointestinal bleeding developed in 6. Because of the toxic reactions of this program, it should not be considered in favor of similar less aggressive programs.
D000230:Adenocarcinoma / Q000628:therapy*; D000368:Aged; D000380:Agranulocytosis / Q000139:chemically induced; D000855:Anorexia / Q000139:chemically induced; D000970:Antineoplastic Agents / Q000009:adverse effects; D002986:Clinical Trials as Topic; D004307:Dose-Response Relationship, Radiation; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005472:Fluorouracil / Q000008:administration & dosage*; D006471:Gastrointestinal Hemorrhage / Q000139:chemically induced; D006801:Humans; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D009607:Nitrosourea Compounds / Q000008:administration & dosage*; D010190:Pancreatic Neoplasms / Q000628:therapy*; D011379:Prognosis; D012673:Semustine / Q000008:administration & dosage*; D013738:Testolactone / Q000008:administration & dosage*; D013921:Thrombocytopenia / Q000139:chemically induced; D014839:Vomiting / Q000139:chemically induced
D000970:Antineoplastic Agents; D009607:Nitrosourea Compounds; D012673:Semustine; D013738:Testolactone; D005472:Fluorouracil