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

  1. 1Centre Léon Bérard, EA 4129 sis, 28 rue Laënnec, Lyon 69008, France
  2. 2Centre hospitalier de l'Agglomération Montargeoise, 658 Rue des Bourgoins, Amilly 45200, France
  3. 3Centre hospitalier, bd du Dr Verlhac, Brive la Gaillarde 19100, France
  4. 4Polyclinique Bordeaux-nord, 15 rue Claude Boucher, Bordeaux 33300, France
  5. 5Centre hospitalier, 1 avenue de Tresum, Annecy 74000, France
  6. 6Hôtel-Dieu, Place du Parvis de Notre-Dame, Paris 75004, France
  7. 7Centre hospitalier, 7 quai Hôpital, Chalon-sur-Saône 71100, France
  8. 8Clinique Pasteur, 58 bd Pasteur, Evreux 27000, France
  9. 9Hôpital Fleyriat, 900 route de Paris, Bourg en Bresse 01000, France
  10. 10CMC de Bligny, 91640 Briis sous Forges, Hôpital Privé d'Antony, 1 rue Velpeau, Antony 92160, France
  11. 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.

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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 mug kg-1 per day times 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