Randomized, controlled trial investigating short-term health-related quality of life with doxorubicin and paclitaxel versus doxorubicin and cyclophosphamide as first-line chemotherapy in patients with metastatic breast cancer: European Organization for Research and Treatment of Cancer Breast Cancer Group, Investigational Drug Branch for Breast Cancer and the New Drug Development Group Study.

Centre Georges-François Leclerc, Dijon, Bourgogne, France
Journal of Clinical Oncology (Impact Factor: 18.43). 08/2004; 22(13):2576-86. DOI: 10.1200/JCO.2004.02.037
Source: PubMed


To compare health-related quality of life (HRQOL) in patients with metastatic breast cancer receiving the combination of doxorubicin and paclitaxel (AT) or doxorubicin and cyclophosphamide (AC) as first-line chemotherapy treatment.
Eligible patients (n = 275) with anthracycline-naive measurable metastatic breast cancer were randomly assigned to AT (doxorubicin 60 mg/m(2) as an intravenous bolus plus paclitaxel 175 mg/m(2) as a 3-hour infusion) or AC (doxorubicin 60 mg/m(2) plus cyclophosphamide 600 mg/m(2)) every 3 weeks for a maximum of six cycles. Dose escalation of paclitaxel (200 mg/m(2)) and cyclophosphamide (750 mg/m(2)) was planned at cycle 2 to reach equivalent myelosuppression in the two groups. HRQOL was assessed with the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 and the EORTC Breast Module at baseline and the start of cycles 2, 4, and 6, and 3 months after the last cycle.
Seventy-nine percent of the patients (n = 219) completed a baseline measure. However, there were no statistically significant differences in HRQOL between the two treatment groups. In both groups, selected aspects of HRQOL were impaired over time, with increased fatigue, although some clinically significant improvements in emotional functioning were seen, as well as a reduction in pain over time. Overall, global quality of life was maintained in both treatment groups.
This information is important when advising women patients of the expected HRQOL consequences of treatment regimens and should help clinicians and their patients make informed treatment decisions.

Download full-text


Available from: Robert E Coleman,
  • [Show abstract] [Hide abstract]
    ABSTRACT: Les études de qualité de vie (QdV) présentent un intérêt majeur dans l’étude des pathologies nécessitant un arbitrage entre les effets indésirables du traitement et le bénéfice clinique attendu. Le choix d’une monochimiothérapie plutôt qu’une polychimiothérapie dans le traitement du cancer du sein métastatique (CSM) s’inscrit parfaitement dans cette problématique et correspond souvent à une différence en termes d’objectifs avec l’obtention d’une réponse objective rapide pour la polychimiothérapie et la préservation de la QdV pour la monothérapie. Cette représentation reste toutefois discutable au vu des résultats des différentes études cliniques contrôlées. Peu d’études randomisées ont rapporté des différences majeures au niveau de la QdV entre les groupes de traitement. Les limites liées à la méthodologie de ces essais cliniques peuvent expliquer en partie ces résultats. L’élaboration de recommandations standard pour la mise en place d’études de QdV dans les essais cliniques ainsi que la mise au point d’instruments de mesure de plus en plus fiables et spécifiques devraient permettre de recentrer les objectifs et d’optimiser les résultats afin d’exploiter davantage les données de QdV. Quality of life (QoL) is of particular importance in the study of pathologies requiring arbitration between the side effects and the expected clinical benefit of a treatment. The choice of a monotherapy over polychemotherapy in the treatment of metastatic breast cancer is a good example of this problem and often corresponds with a difference in terms of expected end result, i.e. a rapid objective response for polychemotherapy and the preservation of QoL for monotherapy. This way of looking at things remains debatable inview of the results of various controlled trials. Few randomised studies reported major differences in terms of QoL between the treatment groups. The limits concerning the methodology of these clinical trials could partially explain these results. The development of standard guidelines for implementing QoL studies in clinical trials as well as the development of increasingly reliable and specific measuring instruments should allow the regrouping of objectives and the optimization of results in order to improve exploitation of QoL data.
    Oncologie 10/2008; 10(10):580-590. DOI:10.1007/s10269-008-0932-1 · 0.06 Impact Factor
  • Source

    Oncology nursing forum 01/2005; 32(2):237-240. DOI:10.1188/05.ONF.237-240 · 2.79 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: Chemotherapy including taxane could improve survival and disease progression in women with advanced breast cancer, but more research is needed on which regimens help most. Advanced (metastatic) breast cancer is cancer that has spread beyond the breast. Treatment usually involves chemotherapy (anti-cancer drugs) to try to reduce the cancer. Drugs can be used alone or in combination. Paclitaxel and docitaxel are chemotherapy drugs known as taxanes. Taxanes can inhibit cancer cells from dividing and reproducing. Adverse effects can include nausea, vomiting and hair loss, as well as allergic reactions which can be reduced by premedication. The review found that chemotherapy including taxanes improved survival and decreased the progression of advanced breast cancer. Further trials are needed to determine which chemotherapy regimens are most effective.
    Cochrane database of systematic reviews (Online) 04/2005; 6(2):CD003366. DOI:10.1002/14651858.CD003366.pub2 · 6.03 Impact Factor
Show more