Phase III randomized trial of intravenous cisplatin plus a 24- or 96-hour infusion of paclitaxel in epithelial ovarian cancer: A gynecologic oncology group study Journal Article
| Authors: | Spriggs, D. R.; Brady, M. F.; Vaccarello, L.; Clarke-Pearson, D. L.; Burger, R. A.; Mannel, R.; Boggess, J. F.; Lee, R. B.; Hanly, M. |
| Article Title: | Phase III randomized trial of intravenous cisplatin plus a 24- or 96-hour infusion of paclitaxel in epithelial ovarian cancer: A gynecologic oncology group study |
| Abstract: | Purpose: This study was undertaken to assess if prolonged paclitaxel administration in combination with cisplatin improves overall survival (OS) in epithelial ovarian cancer (EOC). Patients and Methods: Eligible patients with suboptimal stage III or IV EOC, fallopian tube, or primary peritoneal cancer were randomly allocated to receive six cycles of cisplatin 75 mg/m2 and either paclitaxel 135 mg/m2 during 24 hours (arm 1) or paclitaxel 120 mg/m2 during 96 hours (arm 2). Results: Planned accrual was 324 patients; 293 were enrolled before the study was closed as a result of a scheduled interim futility analysis. There were 13 ineligible patients; thus, 140 patients in each arm were assessable. In arm 1, 80% of patients completed all six cycles compared with 83% of patients in arm 2. Grade 4 granulocytopenia was more common in arm 1 (79% v 54%; P < .001) whereas grade 3 or worse anemia was more severe in arm 2 (6% v 18%; P < .003). The median progression-free survival was 1.03 years for arm 1 versus 1.05 years for arm 2. The median OS was 2.49 and 2.54 years for arms 1 and 2, respectively. There have been 237 reported deaths. The relative death rate was approximately 12% greater in arm 2 (hazard ratio, 1.12; 95% CI, 0.860 to 1.45). Conclusion: Patients with advanced EOC have a relatively poor prognosis. The results of treatment with cisplatin and paclitaxel are not significantly improved by prolonging the paclitaxel infusion from 24 to 96 hours. © 2007 by American Society of Clinical Oncology. |
| Keywords: | survival; adult; controlled study; treatment response; aged; middle aged; survival analysis; major clinical study; overall survival; clinical trial; fatigue; mortality; cisplatin; side effect; paclitaxel; cancer staging; antineoplastic agent; ovarian neoplasms; controlled clinical trial; infection; liver toxicity; multiple cycle treatment; nephrotoxicity; ovary cancer; pain; peritoneum cancer; peritoneal neoplasms; anemia; leukopenia; lung disease; randomized controlled trial; thrombocytopenia; antineoplastic combined chemotherapy protocols; peripheral neuropathy; drug administration schedule; weight reduction; continuous infusion; pathology; drug hypersensitivity; fever; confidence interval; gastrointestinal toxicity; multicenter study; cardiotoxicity; ovary tumor; skin disease; drug toxicity; hazard ratio; phase 3 clinical trial; ca 125 antigen; fallopian tube neoplasms; drug administration; urogenital tract disease; alopecia; infusions, intravenous; metabolic disorder; hearing disorder; peritoneum tumor; granulocytopenia; intravenous drug administration; uterine tube tumor; perception deafness; zygote |
| Journal Title: | Journal of Clinical Oncology |
| Volume: | 25 |
| Issue: | 28 |
| ISSN: | 0732-183X |
| Publisher: | American Society of Clinical Oncology |
| Date Published: | 2007-10-01 |
| Start Page: | 4466 |
| End Page: | 4471 |
| Language: | English |
| DOI: | 10.1200/jco.2006.10.3846 |
| PUBMED: | 17906207 |
| PROVIDER: | scopus |
| DOI/URL: | |
| Notes: | --- - "Cited By (since 1996): 18" - "Export Date: 17 November 2011" - "CODEN: JCOND" - "Source: Scopus" |
