Phase III randomized trial of sunitinib versus capecitabine in patients with previously treated HER2-negative advanced breast cancer

This multicenter, randomized, open-label phase III trial (planned enrollment: 700 patients) was conducted to test the hypothesis that single-agent sunitinib improves progression-free survival (PFS) compared with capecitabine as treatment for advanced breast cancer (ABC). Patients with HER2-negative ABC that recurred after anthracycline and taxane therapy were randomized (1:1) to sunitinib 37.5 mg/day or capecitabine 1,250 mg/m2 (1,000 mg/m2 in patients >65 years) BID on days 1–14 q3w. The independent data-monitoring committee (DMC) determined during the first interim analysis (238 patients randomized to sunitinib, 244 to capecitabine) that the trial be terminated due to futility in reaching the primary endpoint. No statistical evidence supported the hypothesis that sunitinib improved PFS compared with capecitabine (one-sided P = 0.999). The data indicated that PFS was shorter with sunitinib than capecitabine (median 2.8 vs. 4.2 months, respectively; HR, 1.47; 95% CI, 1.16–1.87; two-sided P = 0.002). Median overall survival (15.3 vs. 24.6 months; HR, 1.17; two-sided P = 0.350) and objective response rates (11 vs. 16%; odds ratio, 0.65; P = 0.109) were numerically inferior with sunitinib versus capecitabine. While no new or unexpected safety findings were reported, sunitinib treatment was associated with higher frequencies and greater severities of many common adverse events (AEs) compared with capecitabine, resulting in more temporary discontinuations due to AEs with sunitinib (66 vs. 51%). The relative dose intensity was lower with sunitinib than capecitabine (73 vs. 95%). Based on these efficacy and safety results, sunitinib should not be used as monotherapy for patients with ABC

CANCER DU SEIN CONTROLATERAL (ETUDE RETROSPECTIVE CHEZ 178 PATIENTES)

LILLE2-BU Santé-Recherche (593502101) / SudocPARIS-BIUM (751062103) / SudocSudocFranceF

Activité d'un service de médecine dans un centre régional de lutte contre le cancer

LILLE2-BU Santé-Recherche (593502101) / SudocPARIS-BIUM (751062103) / SudocSudocFranceF

Répercussions du cancer du sein sur la qualité de vie des femmes jeunes sous surveillance

Afficheno abstrac

[Assessing the quality of life of young women and their partners: a pertinent approach to the study of breast cancer]

National audienc

Répercussions du cancer du sein sur la qualité de vie des partenaires de femmes atteintes d'un cancer du sein

Afficheno abstrac

Young Couples' Experiences of Breast Cancer During Hormone Therapy: A Interpretative Phenomenological Dyadic Analysis

PMID: 22964867International audienceBACKGROUND:: Young women are confronted with the same consequences of cancer as older women are. In addition, they face problems specifically related to their age, such as their children's education and their family responsibilities, marital relationships, and career issues. OBJECTIVE:: The objective was to identify the functioning profiles of young couples confronted with hormone therapy. METHODS:: This study was both qualitative and dyadic. Interviews with 11 couples revealed 5 themes. RESULTS:: Initially, the partners reported increased intimacy and mutual support; however, during hormone therapy, a divergence developed between the patients and their partners. The partners wished for the couple to resume a normal life. The patients' loved ones, also helpful in the beginning, were tempted to promote this resumption of normalcy, with the risk that the patients' suffering would no longer be acknowledged. The risk of cancer recurrence appeared to immobilize the patients, who were unable to adopt a long-term perspective. Finally, the experience of the disease led the participants to reorganize their priorities and promoted self-centering. CONCLUSIONS:: Breast cancer affects both the patient and her loved ones. Future research should focus on qualitative extensions to other stages of cancer treatment and quantitative studies to measure the phenomena revealed in the current work. IMPLICATIONS FOR PRACTICE:: Cancer and its treatment have impacts on the patient and her marriage; therefore, the focus for the clinical care should be on the couple rather than just the patient. Additionally, our findings suggest new areas of psychological dyadic counseling for cancer patients and their partners

Quality of life of young women with early breast cancer and their partners: specific needs result in the necessity of development of specific questionnaires for the patient and the partner

PMID: 22640925International audiencePurpose. To determine the feelings of young women with early breast cancer concomitantly with their partners at different treatment periods in order to create a specific quality of life (QOL) scale for this population. Materiel and methods. It was a prospective, multicentre, qualitative study, in patients younger than 45 years old at diagnosis and living with a partner for at least six months. Patients and partners were interviewed by a psychologist, from the diagnosis disclosure until follow up, using non-directing individual talks. Results. Sixty-nine couples were interviewed. Analyses of the interviews have highlighted the impact of disease on eight dimensions: psychological, physical, family, social, couple, sexuality, domestic, professional and economic dimensions. These impacts are mostly negative and are present in all periods and even after treatment for follow up. Discussion. A multidimensional profile of this specific population was established. A QOL scale dedicated to this population is being validated

Profiles of caregivers most at risk of having unmet supportive care needs: Recommendations for healthcare professionals in oncology

International audiencePurpose: This study aimed to identify profiles of caregivers to cancer patients at higher risk of having at least one moderately or highly unmet supportive care need based on 1) relevant socio-demographic (e.g. age, gender) and clinical (e.g. type of cancer, phase of the cancer pathway) variables highlighted in the literature and easily identifiable in routine, and 2) caregivers' anxiety and depression symptoms.Method: Three hundred and sixty-four main caregivers completed a questionnaire assessing their supportive care needs (SCNS-P&C-F) and anxiety and depression symptoms (HADS) during the treatment or follow-up stage of patients with digestive, breast, or lung cancer. Decision trees were used to identify profiles of caregivers with the Conditional inference Tree (CTree) technique.Results: In our study, only the combination of three main variables was important to predict the risk of unmet supportive care needs of caregivers: anxiety and/or depression symptoms, the age of caregivers or patients, and the presence/absence of metastases. Emotional distress has the greatest impact, exceeding that of the socio-demographic and clinical variables considered in this study.Conclusions: This study shows the importance of considering a set of variables and their combinations rather than evaluating their effects separately. Routinely assessing the anxiety and depression symptoms of caregivers using the HADS could improve the screening of caregivers at higher risk of unmet supportive care needs based on socio-demographic and clinical variables only. This study provides recommendations on how to identify caregivers at risk of unmet needs, in the context of an inability to support all caregivers

Index de compréhension des essais cliniques randomisés en oncologie

International audienceL’objectif principal de cette étude est d’élaborer un outil de mesure (ICEC-R) validé en français de la compréhension objective des modalités etfinalités de la participation à une étude clinique randomisée (phase II ou III). Il s’agit également de comparer les scores obtenus à l’ICEC-R par différents groupes de participants selon leur niveau d’expertise dans le domaine (médecins vs patients inclus dans un essai clinique vs patients recevant un traitement standard vs profanes), et de vérifier si l’état d’anxiété et la satisfaction générale par rapport aux soins des patients ont un impact sur le score global de compréhension objective.L’échantillon comprend 474 participants : 73 « patients cibles » atteints d’une pathologie cancéreuse et inclus dans un essai clinique randomisé, 97 « patients standard » atteints d’une pathologie cancéreuse mais non inclus dans un essai clinique, 25 « médecins » procédant aux inclusions de patients dans des essais cliniques, 18 « soignants » ne procédant pas aux inclusions dans les essais cliniques, 261 « profanes » (étudiants en psychologie). Les patients « cibles » ou « standard » ont reçu un questionnaire composé d’un inventaire de compréhension des essais cliniques randomisés (ICEC-R), d’une mesure de l’anxiété état et trait STAI-Y, et d’une échelle de satisfaction par rapport aux soins prodigués (SAT). Outre des informations générales, les médecins, les soignants et les profanes ne complétaient que l’ICEC-R. Les analyses ont permis de retenir un inventaire unidimensionnel de compréhension composé de dix items suffisamment discriminants auprès des patients et dont les réponses sont consensuelles au sein d’une population de médecins experts. En outre, les réponses des participants à cet inventaire ne semblent être affectées ni par l’anxiété, ni par la satisfaction à l’égard des soins prodigués. Mieux appréhender les connaissances des patients inclus dans un essai clinique randomisé nous semble un atout indéniable pour l’amélioration de leur prise en charge globale