Long-term results of a randomised phase III trial of weekly versus three-weekly paclitaxel/platinum induction therapy followed by standard or extended three-weekly paclitaxel/platinum in European patients with advanced epithelial ovarian cancer |
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| Institution: | 1. St. James University Hospital, Beckett Street, Leeds LS9 7TF, UK;2. Leeds Institute of Medical Education, Level 7, Worsley Building, University of Leeds, Leeds LS2 9JT, UK;1. Department of Obstetrics and Gynecology, University of Washington, 1959 NE Pacific Street, Seattle, WA 98195-6460, USA;2. Memorial Sloan Kettering Cancer Center, 300 East 66th Street, New York, NY 10065, USA;3. The Ohio State University and James CCC, 460 W. 10th Avenue, Columbus, OH 43210, USA;4. The University of Chicago Medicine, 5841 S. Maryland Avenue, Chicago, IL, USA;5. Division of Oncology Research, Mayo Clinic, 200 First Street SW, Rochester, MN 55905, USA;6. NYU Langone Health, 240 East 38th Street, NY 10016, USA;7. Winthrop P Rockefeller Cancer Institute, 4301 W. Markham Street, Little Rock, AR 72205-7199, USA;8. Stephenson Cancer Center at the University of Oklahoma Health Sciences Center, 800 N.E. 10th Street, Oklahoma City, OK 73104, USA;9. Women''s Cancer Center of Nevada, 2460 Augusta, Las Vegas NV89109, USA;10. Abington Jefferson Hospital, Asplundh Cancer Center of Sidney Kimmel Cancer Center, 3941 Commerce Ave, Willow Grove, PA 19090, USA;11. University of Cincinnati College of Medicine, 3230 Eden Avenue, Cincinnati, OH 45267, USA;12. Prince of Wales Clinical School UNSW and Prince of Wales Hospital and ANZGOG, Corner High Street and Avoca Street, Randwick, NSW 2031, Australia;13. Lillebaelt University Hospital of Southern Denmark, Winsløwparken 19, 3, DK-5000 Odense C, Vejle, Denmark;14. The Jikei University School of Medicine, 3-25-8 Nishi-Shimbashi, Minato-ku, Tokyo 105-8461, Japan;15. AbbVie Inc., 1 North Waukegan Road, North Chicago, IL 60064-6124, USA;p. Kaiser Permanente Northern California, 2238 Geary Blvd, San Francisco, CA 94115, USA;q. US Oncology Research, 9180 Pinecroft, The Woodlands, TX 77380, USA |
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| Abstract: | BackgroundWeekly paclitaxel/carboplatin might improve survival in platinum-resistant epithelial ovarian cancer (EOC). We compared efficacy of first-line weekly to three-weekly paclitaxel/cis- or carboplatin (PCw and PC3w) induction therapy, followed by either three or six PC3w cycles.Patients and methodsIn this multicentre, randomised phase III trial with 2×2 design, patients with FIGO stage IIb–IV EOC were randomised to six cycles PCw (paclitaxel 90 mg/m2, cisplatin 70 mg/m2 or carboplatin AUC 4) or three cycles PC3w (paclitaxel 175 mg/m2, cisplatin 75 mg/m2 or carboplatin AUC 6), followed by either three or six cycles PC3w. Primary endpoints were progression free survival (PFS) and overall survival (OS). Secondary endpoints were response rate (RR) and toxicity.ResultsOf 267 eligible patients, 133 received PCw and 134 PC3w. The first 105 patients received cisplatin, after protocol amendment the subsequent 162 patients received carboplatin. Weekly cisplatin was less well tolerated than weekly carboplatin. All PC3w cycles were well tolerated. At the end of all treatments, RR was 90.8% with no differences between the treatment arms. After a follow-up of median 10.3 years (range 7.1–14.8), median PFS was 18.5 (95% confidence interval (CI) 15.9–21.0) months for PCw and 16.4 (95% CI 13.5–19.2) months for PC3w (p = 0.78). Median OS was 44.8 (95% CI 33.1–56.5) months for PCw and 41.1 (95% CI 34.4–47.7) months for PC3w (p = 0.98).ConclusionsThere was no benefit in terms of OS, PFS or RR for a weekly regimen nor for extended chemotherapy as first-line treatment for EOC in European patients. |
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| Keywords: | Epithelial ovarian cancer First-line Dose-dense Weekly Carboplatin Cisplatin Paclitaxel |
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