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| PHASE-II TRIAL OF PACLITAXEL IN PATIENTS WITH PROGRESSIVE OVARIAN-CARCINOMA AFTER PLATINUM-BASED CHEMOTHERAPY - A GYNECOLOGIC-ONCOLOGY-GROUP STUDY |
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| Author(s): THIGPEN JT, BLESSING JA, BALL H, HUMMEL SJ, BARRETT RJ |
| Source: JOURNAL OF CLINICAL ONCOLOGY Volume: 12 Issue: 9 Pages: 1748-1753 Published: SEP 1994 |
| Times Cited: 246 References: 15 |
| Abstract: Purpose: This Gynecologic Oncology Group (GOG) trial of paclitaxel (Taxol; Bristol-Myers Squibb Co, princeton, NJ) as salvage therapy for recurrent epithelial carcinoma of the ovary sought to confirm activity reported previously. If positive, the trial wets to serve as a basis for phase III trials of Taxol in combination with platinum compounds in first-line therapy. Patients and Methods: Patients with recurrent, persistent, or progressive ovarian carcinoma during or after platinum-based chemotherapy received Taxol 170 mg/m(2) intravenously once over 24 hours every 3 weeks. All patients had measurable disease and received premedication (dexamethasone, diphenhydramine, and ranitidine) followed by Taxol.
Results: Of 49 patients, 45 were eligible and assessable. Among 43 patients who were assessable for response, there were eight complete and eight partial responses (37%). The median progression-free interval was 4.2 months, and median survival 16 months. Among 27 resistant patients who progressed during or within 6 months of prior platinum-based therapy or had stable disease as the best response, five complete (18%) and four partial (15%) responses were observed (33%). The median progression-free interval was 4 months. Among 16 sensitive patients who responded and progressed more than 6 months after prior platinum-based treatment, three complete (19%) and four partial (25%) responses were observed (44%). The median progression-free interval was 4.9 months. Grade 4 neutropenia (< 500/mu L), the most frequent and severe toxicity, occurred in 73% of patients. Other hematologic effects were less frequent and less severe. Cardiac problems and hypersensitivity reactions were observed in one patient each.
Conclusion: Taxol is a highly active agent in ovarian carcinoma, even in patients who are clinically resistant to platinum-based chemotherapy, and produces frequent and severe, albeit manageable, myelosuppression. It is clearly active as salvage therapy for ovarian carcinoma. (C) 1994 by American Society of Clinical Oncology.
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| Document Type: Article |
| Language: English |
Addresses:
1. UNIV MISSISSIPPI, SCH MED, DEPT MED, JACKSON, MS USA 2. UNIV MISSISSIPPI, SCH MED, DEPT OBSTET & GYNECOL, DIV MED ONCOL, JACKSON, MS USA 3. ROSWELL PK CANC INST, DEPT STAT, GYNECOL ONCOL GRP, BUFFALO, NY USA 4. TUFTS UNIV NEW ENGLAND MED CTR, DEPT OBSTET & GYNECOL, DIV GYNECOL ONCOL, BOSTON, MA USA 5. TUFTS UNIV, SCH MED, BOSTON, MA 02111 USA 6. WASHINGTON HOSP CTR, DEPT GYNECOL ONCOL, WASHINGTON, DC USA 7. WAKE FOREST UNIV, BOWMAN GRAY SCH MED, DEPT OBSTET & GYNECOL, GYNECOL ONCOL SECT, WINSTON SALEM, NC 27103 USA |
| Publisher: W B SAUNDERS CO, INDEPENDENCE SQUARE WEST CURTIS CENTER, STE 300, PHILADELPHIA, PA 19106-3399 |
| Subject Category: Oncology |
| IDS Number: PG300 |
| ISSN: 0732-183X |
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