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

• Published in: European journal of cancer (1990) Vol. 50; no. 15; pp. 2592 - 2601
• Main Authors: van der Burg, M.E.L, Onstenk, W, Boere, I.A, Look, M, Ottevanger, P.B, de Gooyer, D, Kerkhofs, L.G.M, Valster, F.A.A, Ruit, J.B, van Reisen, A.G.P.M, Goey, S.H, van der Torren, A.M.E, ten Bokkel Huinink, D, Kok, T.C, Verweij, J, van Doorn, H.C
• Format: Journal Article
• Language: English
• Published: Kidlington Elsevier Ltd 01-10-2014; Elsevier
• Subjects: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Biological and medical sciences; Carboplatin; Carboplatin - administration & dosage; Carboplatin - adverse effects; Cisplatin; Cisplatin - administration & dosage; Cisplatin - adverse effects; Disease-Free Survival; Dose-dense; Drug Administration Schedule; Epithelial ovarian cancer; Europe; Fatigue - chemically induced; Female; First-line; Follow-Up Studies; Hematology, Oncology and Palliative Medicine; Humans; Induction Chemotherapy; Medical sciences; Middle Aged; Multiple tumors. Solid tumors. Tumors in childhood (general aspects); Nausea - chemically induced; Neoplasms, Glandular and Epithelial - drug therapy; Neoplasms, Glandular and Epithelial - pathology; Neutropenia - chemically induced; Ovarian Neoplasms - drug therapy; Ovarian Neoplasms - pathology; Paclitaxel; Paclitaxel - administration & dosage; Paclitaxel - adverse effects; Pharmacology. Drug treatments; Time Factors; Treatment Outcome; Tumors; Vomiting - chemically induced; Weekly; Young Adult; Europe; Epithelial ovarian cancer; Weekly; Paclitaxel; Carboplatin; First-line; Dose-dense; Cisplatin; Antineoplastic agent; Phase III trial; Ovary carcinoma; Ovary cancer; Administration schedule; Cancerology; Taxane derivatives; Clinical trial; Advanced stage; Antimitotic; Dose; Platinum II Complexes; Human; Malignant tumor; Long term; Induction treatment; Standards; Female genital diseases; First line treatment; Ovarian diseases; Alkylating agent; Chemotherapy; Treatment; Comparative study; Cancer
• ISSN: 0959-8049; 1879-0852
• DOI: 10.1016/j.ejca.2014.07.015

Abstract Background Weekly 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 methods In 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. Results Of 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). Conclusions There 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.