Phase II Evaluation of 5-Fluorouracil and Low-Dose Leucovorin in Cisplatin-Refractory Advanced Ovarian Carcinoma

• Published in: Gynecologic oncology Vol. 54; no. 2; pp. 180 - 183
• Main Authors: Long, Harry J., Nelimark, Robert A., Su, John Q., Garneau, Stewart C., Levitt, Ralph, Goldberg, Richard M., Poon, Michael A., Kugler, John W.
• Format: Journal Article
• Language: English
• Published: San Diego, CA Elsevier Inc 01.08.1994; Elsevier
• Subjects: Adenocarcinoma - drug therapy; Adult; Aged; Antineoplastic agents; Antineoplastic Combined Chemotherapy Protocols - administration & dosage; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Biological and medical sciences; Chemotherapy; Cisplatin - administration & dosage; Cisplatin - adverse effects; Cisplatin - therapeutic use; Dose-Response Relationship, Drug; Drug Resistance; Drug Therapy, Combination; Female; Fluorouracil - administration & dosage; Fluorouracil - adverse effects; Fluorouracil - therapeutic use; Humans; Injections, Intravenous; Leucovorin - administration & dosage; Leucovorin - adverse effects; Leucovorin - therapeutic use; Medical sciences; Middle Aged; Ovarian Neoplasms - drug therapy; Pharmacology. Drug treatments; Antineoplastic agent; Human; Ovarian diseases; Ovary; Chemotherapy; Carcinoma; Treatment; Phase II trial; Malignant tumor; Negative therapeutic reaction; Female genital diseases
• ISSN: 0090-8258; 1095-6859
• DOI: 10.1006/gyno.1994.1190

Thirty-nine women with advanced, recurrent epithelial ovarian carcinoma who failed prior treatment with a platinum-based regimen were treated with leucovorin, 20 mg/m2 intravenously followed by 5-fluorouracil, 425 mg/m2 intravenously, daily for 5 consecutive days every 5 weeks in a phase II trial. Partial regressions were seen in 3 of 15 (20%) measurable disease patients, and objective regressions were seen in 3 of 14 (21%) evaluable/nonmeasurable disease patients. A 50% or greater decrease in CA-125 level was observed in 3 of 10 (30%) patients with no objectively evaluable or measurable disease. Overall objective response rate was 23% (95% confidence interval: 11 to 39%) in all 39 patients evaluated, with a median time to progression of 3 months and overall median survival of 7 months. Toxicities were acceptable and consisted of neutropenia, thrombocytopenia, stomatitis, and mild diarrhea. 5-Fluorouracil, as administered in this protocol, had modest antitumor activity in cisplatin-refractory ovarian carcinoma of short duration and minimal toxicity.