Quality of life in randomized trials of cytotoxic or hormonal treatment of advanced breast cancer. Is there added value?

Fossati, Roldano; Confalonieri, C; Mosconi, Paola; Pistotti, Vanna; Apolone, Giovanni

doi:10.1007/s10549-004-8694-y

Cited by 12 publications

(7 citation statements)

References 66 publications

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“…Pour d'autres é tudes, les avantages en termes d'efficacité peuvent ê tre contrebalancé s par les effets toxiques des diffé rents traitements. Les mesures de QdV n'ont pas eu d'impact sur les recommandations de traitement au cours de ces diffé rentes é tudes de phase III, comme pré cé demment rapporté par Goodwin et al [30] et Fossati et al [26]. Les limites lié es à la mé thodologie de ces essais cliniques peuvent expliquer en partie ces ré sultats.…”

Section: Vers Un Meilleur Choix Thé Rapeutiqueunclassified

“…Les limites lié es à la mé thodologie de ces essais cliniques peuvent expliquer en partie ces ré sultats. La QdV n'est qu'un critè re secondaire d'efficacité et les ré sultats sont souvent peu exploité s. Les principales limites mé thodologiques fré quemment observées dans ce type d'é tudes sont l'absence de rationnel ou d'hypothè se de dé part relatifs à la QdV, l'observance (donné es manquantes aux é valuations successives) peu ou pas rapporté e, l'absence d'une gestion claire des donné es manquantes et de l'analyse des donné es, une interpré tation des donné es limité e par une pré sentation peu claire des ré sultats et l'absence de lien avec leur signification clinique [26].…”

Section: Vers Un Meilleur Choix Thé Rapeutiqueunclassified

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Chemotherapy and quality of life in metastatic breast cancer: taking stock

et al. 2008

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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 in view 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. Keywords: Chemotherapy -Quality of life (QoL) -Metastatic breast cancerRé sumé : Les é tudes de qualité de vie (QdV) pré sentent un inté rê t majeur dans l'é tude des pathologies né cessitant un arbitrage entre les effets indé sirables du traitement et le bé né fice clinique attendu. Le choix d'une monochimiothé rapie plutô t qu'une polychimiothé rapie dans le traitement du cancer du sein mé tastatique (CSM) s'inscrit parfaitement dans cette problé matique et correspond souvent à une diffé rence en termes d'objectifs avec l'obtention d'une ré ponse objective rapide pour la polychimiothé rapie et la pré servation de la QdV pour la monothé rapie. Cette repré -sentation reste toutefois discutable au vu des ré sultats des diffé rentes é tudes cliniques contrô lé es. Peu d'é tudes randomisé es ont rapporté des diffé rences majeures au niveau de la QdV entre les groupes de traitement. Les limites lié es à la mé thodologie de ces essais cliniques peuvent expliquer en partie ces ré sultats. L'é laboration de recommandations standard pour la mise en place d'é tudes de QdV dans les essais cliniques ainsi que la mise au point d'instruments de mesure de plus en plus fiables et spé cifiques devraient permettre de recentrer les objectifs et d'optimiser les ré sultats afin d'exploiter davantage les donné es de QdV.

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Section: Vers Un Meilleur Choix Thé Rapeutiqueunclassified

Chemotherapy and quality of life in metastatic breast cancer: taking stock

et al. 2008

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“…QOL in breast cancer has been reviewed previously (Bottomley & Therasse 2002;Goodwin et al 2003;Fossati et al 2004;Montazeri 2008). This study was not designed, nor intended to, evaluate individual QOL instruments, nor assess how appropriate they are to patient needs; the study was aimed at examining the consistency with which QOL instruments are (or are not) used.…”

Section: Introductionmentioning

confidence: 99%

“…This study was not designed, nor intended to, evaluate individual QOL instruments, nor assess how appropriate they are to patient needs; the study was aimed at examining the consistency with which QOL instruments are (or are not) used. QOL in breast cancer has been reviewed previously (Bottomley & Therasse 2002;Goodwin et al 2003;Fossati et al 2004;Montazeri 2008). This current review provides an up-todate summary.…”

Section: Introductionmentioning

confidence: 99%

Quality of life assessments in advanced breast cancer: should there be more consistency?

Reed

Kössler²,

Hawthorn³

2012

European Journal of Cancer Care

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Quality of life (QOL) measures have assumed increasing importance in assessing the impact of therapeutic drugs and interventions on patients and in making judgements about their cost-effectiveness. Important treatment decisions and crucial funding strategies involve QOL data and, for patients with a disease such as advanced breast cancer that impinges on their life expectancy, QOL can become a hugely important consideration. Yet, despite this, there is a lack of consensus on what defines an appropriate QOL measure, and inconsistency in the instruments that are chosen to measure it. The National Institute for Health and Clinical Excellence (NICE) is seen as a model for appraising the value of new treatments and NICE approval is required for treatments to be funded in the UK. In order to compare different disease conditions they use a generic measure, preferring the EQ-5D. We have performed a literature search of clinical trials in advanced breast cancer to establish which QOL measures have been used. Our findings show marked heterogeneity in terms of which QOL tools are used. It is suggested that there should be more consensus on which QOL instruments are used, not only between researchers, but between them and the bodies that approve funding.

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“…Despite the relatively large population of patients with advanced breast disease, there is insufficient information on the direct and indirect costs of treatments, which is crucial for understanding cost savings and cost-effectiveness of therapeutic interventions. There are limited quality-of-life data for these patients treated on randomized studies designed to estimate the cost -benefit ratios, and the available data are difficult to interpret [4]. In addition, the expenses related to caregiver burden are often ignored.…”

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confidence: 99%