Breast Cancer Research and Treatment

, Volume 131, Issue 1, pp 127–135 | Cite as

A GINECO randomized phase II trial of two capecitabine and weekly paclitaxel schedules in metastatic breast cancer

  • Alain LortholaryEmail author
  • Anne-Claire Hardy-Bessard
  • Thomas Bachelot
  • Gaëtan de Rauglaudre
  • Jérôme Alexandre
  • Hugues Bourgeois
  • Dominique Jaubert
  • Désiré Paraiso
  • Rémy Largillier
Clinical trial


To determine whether capecitabine schedule adaptation improves the tolerability of capecitabine–paclitaxel combination therapy for metastatic breast cancer (MBC), patients with anthracycline-pretreated HER2-negative MBC were randomized to either arm A (21-day cycles: capecitabine 1,000 mg/m2 twice daily, days 1–14; paclitaxel 60 mg/m2, days 1, 8, and 15) or arm B (28-day cycles: capecitabine 1,000 mg/m2 twice daily, days 1–5, 8–12, and 15–19; paclitaxel 80 mg/m2, days 1, 8, and 15). The primary endpoint was the incidence of dose reductions or delays >1 week for grade 3/4 toxicity. Secondary endpoints were efficacy and safety. All 130 randomized patients were evaluable for safety. Dose reduction or delay for grade 3/4 toxicity occurred in 39% of patients in arm A and 34% in arm B during cycles 1–6. In arm A, there were significantly more toxicity-related dose reductions (cycles 1–6: 82 vs. 67%, respectively; P = 0.05) and discontinuations (29 vs. 8%, respectively). Grade 3 diarrhea occurred in 12 and 0%, respectively, and grade 3 hand-foot syndrome in 12 versus 9%, respectively (grade 4 not applicable). There were no detectable differences in efficacy. Weekday capecitabine dosing with weekly paclitaxel may improve tolerability without a detrimental effect on efficacy, and merits further evaluation in patients suited to combination chemotherapy.


Capecitabine Combination therapy Metastatic breast cancer Weekly paclitaxel 



The authors would like to thank Nicolas Gane, Data Management at the study office of ARCAGY-GINECO (the sponsor of the study), Paris. We also thank the following investigators who participated in the trial: Dr P.L. Etienne (Clinique Armoricaine de Radiologie, Saint Brieuc); Dr P. Dalivoust (Hôpital Saint-Joseph, Marseille); Dr C. El Kouri and Dr J.F. Ramee (Centre Catherine de Sienne, Nantes); Dr J.M. Ferrero and Dr W. Lescaut (Centre Antoine Lacassagne, Nice); Dr J.P. Guastalla and Dr I. Ray-Coquard (Centre Léon Bérard, Lyon); Dr S. Kirscher (Institut Sainte Catherine, Avignon); Dr L. Chauvenet (Hôpital Hôtel-Dieu, Paris); and Dr G. Sadki-Benaoudia (Centre Hospitalier Robert Ballanger, Aulnay sous Bois). This work and third-party medical writing assistance for this article were supported by Roche France.

Conflict of interest

The authors declared no conflict of interest.


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Copyright information

© Springer Science+Business Media, LLC. 2011

Authors and Affiliations

  • Alain Lortholary
    • 1
    Email author
  • Anne-Claire Hardy-Bessard
    • 2
  • Thomas Bachelot
    • 3
  • Gaëtan de Rauglaudre
    • 4
  • Jérôme Alexandre
    • 5
  • Hugues Bourgeois
    • 6
  • Dominique Jaubert
    • 7
  • Désiré Paraiso
    • 8
  • Rémy Largillier
    • 9
  1. 1.Centre Catherine de SienneNantes Cedex 2France
  2. 2.Clinique Armoricaine de RadiologieSaint BrieucFrance
  3. 3.Centre Léon BérardLyonFrance
  4. 4.Clinique Sainte CatherineAvignonFrance
  5. 5.Université Paris Descartes, AP-HP, Hôpitaux Universitaire Paris Centre, Site Hôpital Hôtel-DieuParisFrance
  6. 6.Centre Jean BernardLe MansFrance
  7. 7.Clinique TivoliBordeauxFrance
  8. 8.Centre Hospitalier de L’Agglomération MontargoiseAmillyFrance
  9. 9.Centre Antoine LacassagneNiceFrance

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