William P. McGuire, MD; Eric K. Rowinsky, MD; Neil B. Rosenshein, MD; Francis C. Grumbine, MD; David S. Ettinger, MD; Deborah K. Armstrong, MD; Ross C. Donehower, MD
Study Objective: To assess the activity of taxol in patients with advanced, progressive, and drug-refractory ovarian cancer and to delineate more clearly the toxicity of taxol in this patient population.
Design: Nonrandomized, prospective phase II trial.
Patients: Forty-seven patients with drug-refractory epithelial ovarian cancer who had one or more lesions measurable in perpendicular diameters. Of these patients, 45 were evaluable for toxicity and 40 were evaluable for response.
Interventions: Patients were treated every 22 days with varying doses of taxol (110 to 250 mg/m2 body surface) given as a 24-hour infusion with subsequent doses based on adverse effects. A premedication regimen was used to avoid acute hypersensitivity reactions.
Measurements and Main Results: Twelve patients (30%; CI, 16% to 44%) responded to taxol for periods lasting from 3 to 15 months. The dose-limiting toxicity was myelosuppression with leukocytes affected more severely and commonly than thrombocytes or reticulocytes. Leukopenia was usually brief in duration but was associated with sepsis in 3 cases (2 fatal). Other adverse effects included myalgias, arthralgias, alopecia, diarrhea, nausea, vomiting, mucositis, and peripheral neuropathy. Rare cases of cardiac and central neurotoxicity were also noted.
Conclusions: Taxol is an active agent in drug-refractory ovarian cancer and deserves further study in combination with other active drugs in previously untreated patients with advanced ovarian cancer.
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McGuire WP, Rowinsky EK, Rosenshein NB, Grumbine FC, Ettinger DS, Armstrong DK, et al. Taxol: A Unique Antineoplastic Agent with Significant Activity in Advanced Ovarian Epithelial Neoplasms. Ann Intern Med. 1989;111:273-279. doi: 10.7326/0003-4819-111-4-273
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Published: Ann Intern Med. 1989;111(4):273-279.
Diarrhea, Emergency Medicine, Gastroenterology/Hepatology, Hematology/Oncology, Infectious Disease.
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Print ISSN: 0003-4819 | Online ISSN: 1539-3704
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