A phase III randomized trial of epirubicin versus 5-fluorouracil in metastatic rectal/sigmoid adenocarcinoma.
Seventy-seven patients with previously untreated, measurable, histologically confirmed, metastatic adenocarcinoma of the rectum or sigmoid were randomized to receive either epirubicin 90 mg/m2 (75 mg/m2 if prior radiotherapy) i.v. once every 3 weeks or 5-fluorouracil 500 mg/m2 (450 mg/m2 if prior radiotherapy) i.v. once daily for 5 consecutive days every 4 weeks. None of 38 (0%) evaluable patients who received epirubicin demonstrated a response, whereas seven of 39 (18%) patients who received 5-fluorouracil had an objective response. Epirubicin is ineffective against metastatic rectal cancer at the dose and schedule used.
Molinaro
P
P
Division of Medical Oncology, Rita and Stanley Kaplan Cancer Center, New York University Medical Center, NY 10016.
Lafleur
F
F
Blum
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RH
D000230:Adenocarcinoma / Q000188:drug therapy* / Q000401:mortality; D002986:Clinical Trials as Topic; D015251:Epirubicin / Q000008:administration & dosage / Q000627:therapeutic use*; D005472:Fluorouracil / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D009362:Neoplasm Metastasis; D011897:Random Allocation; D012004:Rectal Neoplasms / Q000188:drug therapy* / Q000401:mortality; D012811:Sigmoid Neoplasms / Q000188:drug therapy* / Q000401:mortality; D013997:Time Factors
D015251:Epirubicin; D005472:Fluorouracil