Clinical Study
British Journal of Cancer (2007) 97, 1200–1205. doi:10.1038/sj.bjc.6604026 www.bjcancer.com
Published online 9 October 2007
Intensified dose of cyclophosphamide with G-CSF support versus standard dose combined with platinum in first-line treatment of advanced ovarian cancer a randomised study from the GINECO group
Presented in part at the annual meeting of ASCO, San Francisco, May 2001.
I Ray-Coquard1, D Paraiso2, J-P Guastalla1, B Leduc3, F Guichard4, C Martin5, L Chauvenet6, Z Haddad-Guichard7, D Lepillé8, H Orfeuvre9, H Gautier10, D Castera11 and É Pujade-Lauraine6 for the GINECO group
- 1Centre Léon Bérard, EA 4129 sis, 28 rue Laënnec, Lyon 69008, France
- 2Centre hospitalier de l'Agglomération Montargeoise, 658 Rue des Bourgoins, Amilly 45200, France
- 3Centre hospitalier, bd du Dr Verlhac, Brive la Gaillarde 19100, France
- 4Polyclinique Bordeaux-nord, 15 rue Claude Boucher, Bordeaux 33300, France
- 5Centre hospitalier, 1 avenue de Tresum, Annecy 74000, France
- 6Hôtel-Dieu, Place du Parvis de Notre-Dame, Paris 75004, France
- 7Centre hospitalier, 7 quai Hôpital, Chalon-sur-Saône 71100, France
- 8Clinique Pasteur, 58 bd Pasteur, Evreux 27000, France
- 9Hôpital Fleyriat, 900 route de Paris, Bourg en Bresse 01000, France
- 10CMC de Bligny, 91640 Briis sous Forges, Hôpital Privé d'Antony, 1 rue Velpeau, Antony 92160, France
- 11Clinique Saint-Pierre, rue Jean Galia, Perpignan 66000, France
Correspondence: Dr I Ray-Coquard, E-mail: ray@lyon.fnclcc.fr
Received 23 May 2007; Revised 13 August 2007; Accepted 4 September 2007; Published online 9 October 2007.
Abstract
ICON3 trial results have suggested that CAP and carboplatin–taxol regimens as first-line treatment of advanced ovarian cancer (AOC) yield similar survival. We explored the impact of increased dose of cyclophosphamide in a modified CAP regimen on the disease-free survival (DFS) and overall survival (OS) of AOC patients. From February 1994 to June 1997, 164 patients were randomised to receive six cycles every 3 weeks of either standard CEP (S) combining cyclophosphamide (C), 500 mg m-2, epirubicin (E) 50 mg m-2, and cisplatin (P) 75 mg m-2 or intensive CEP (I) with E and P at the same doses, but with (C) 1800 mg m-2 and filgrastim 5
g kg-1 per day
10 days. Response was evaluated at second-look surgery. Patient characteristics were well balanced. Except for grade 3–4 neutropaenia (S: 54%, I: 38% of cycles), Arm1 presented a significantly more important toxicity: infection requiring antibiotics, grade 3–4 thrombocytopaenia, anaemia, nausea-vomiting, diarrhoea, mucositis. Median follow-up was 84 months. DFS (15.9 vs 14.8 months) and OS (33 vs 30 months) were not significantly different between S and I (P>0.05). Increasing cyclophosphamide dose by more than 3 times with filgrastim support in the modified CAP regimen CEP induces more toxicity but not better efficacy in AOC.
Keywords:
advanced ovarian cancer, cyclophosphamide, high-dose chemotherapy, epirubicin, randomised trial
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