A Phase II Study of Doxorubicin, Cisplatin, and 5-Fluorouracil in Patients with Advanced Adenocarcinoma of the Stomach or Esophagus

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Abstract
Background: The combination of epirubicin, cisplatin, and infusional 5-fluorouracil (ECF) currently represents a standard and effective regimen for the treatment of advanced gastroesophageal cancer. The use of doxorubicin as an alternative to epirubicin in the ECF regimen has not been evaluated. Methods: Thirty-two patients with metastatic adenocarcinoma of the stomach, gastroesophageal junction, or esophagus were treated with cisplatin 60 mg/m2 and doxorubicin 30 mg/m2 repeated every 21 days, in combination with infusional 5-fluorouracil 200 mg/m2/day (ACF). Results: Major objective responses were observed in 28 percent of patients (46 percent previously untreated; 13 percent previously treated), with one complete response. The median progression-free survival was 4.0 months, and the median overall survival was 5.8 months (9.3 months previously untreated; 4.5 months previously treated). The major (Grade 3–4) toxicities were neutropenia (34 percent), anorexia (31 percent), nausea (28 percent), diarrhea (19 percent), and stomatitis (16 percent). Conclusion: In comparison with historical data taken from published trials of ECF, the ACF regimen appears similar in efficacy when differences in prior treatment status are taken into account. However, ACF appears to be associated with a higher incidence of major toxicities. Our findings therefore support the continued use of epirubicin rather than doxorubicin in combination chemotherapy regimens for advanced gastroesophageal cancer.