Dataset Information

UNICANCER: French prospective cohort study of treatment-related chronic toxicity in women with localised breast cancer (CANTO).

ABSTRACT: Background:Corresponding with improved survival among patients with breast cancer, the awareness of the long-term effects of cancer treatments has increased. CANcer TOxicities (CANTO) aims to identify predictors of development and persistence of long-term toxicities in patients treated for stages I-III breast cancer and to characterise their incidence, as well their impact. In this paper, we describe the methodology used in this study and provide a first characterisation of the study population. Methods:CANTO (NCT01993498) is a French prospective, longitudinal cohort study enrolling patients with invasive cT0-cT3cN0-3M0 breast cancer of 26 French cancer centres. Patients are assessed at diagnosis, 3-6 (M0), 12 (M12), 36 (M36) and 60 (M60) months after completion of primary surgery, chemotherapy or radiotherapy whichever comes last. CANTO collects clinical, treatment, toxicity data, an extensive list of validated patient-reported outcomes (focusing on quality of life, psychological and behavioural questionnaires) and ad hoc socioeconomic questionnaires. Blood collection is performed at diagnosis, M0, M12, M36 and M60. Biologic sub-studies are ongoing (eg, microbiotic and cognitive sub-study). Results:Enrolment started in 2012; by October 2018, 12 012 patients had been enrolled. Data collected have a low missing completion rate (<5% for key clinical variables, <20% for patient-reported outcomes). Blood, serum and plasma samples are stored in over 96% of patients. Among the first 5801 patients enrolled in CANTO, 76.7% of patients had hormone receptor positive and human epidermal growth factor 2 negative tumours; 73.1% of patients had breast conserving surgery; 90.4% received adjuvant radiotherapy, 53.4% (neo) adjuvant chemotherapy, 11.3% adjuvant trastuzumab and 80.3% adjuvant hormonotherapy. Conclusions:CANTO represents a unique opportunity to explore important medical, biological and psychosocial outcomes on breast cancer survivor population.

SUBMITTER: Vaz-Luis I

PROVIDER: S-EPMC6735667 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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UNICANCER: French prospective cohort study of treatment-related chronic toxicity in women with localised breast cancer (CANTO).

Vaz-Luis Ines I Cottu Paul P Mesleard Christel C Martin Anne Laure AL Dumas Agnes A Dauchy Sarah S Tredan Olivier O Levy Christelle C Adnet Johan J Rousseau Tsangaris Marina M Andre Fabrice F Arveux Patrick P

ESMO open 20190908 5

<h4>Background</h4>Corresponding with improved survival among patients with breast cancer, the awareness of the long-term effects of cancer treatments has increased. CANcer TOxicities (CANTO) aims to identify predictors of development and persistence of long-term toxicities in patients treated for stages I-III breast cancer and to characterise their incidence, as well their impact. In this paper, we describe the methodology used in this study and provide a first characterisation of the study pop ...[more]

PMID: 31555487

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Project description:Young women with breast cancer experience unique treatment and survivorship issues centering on treatment-related amenorrhea (TRA), including fertility preservation and management of ovarian function as endocrine therapy. The Young Women's Breast Cancer Study (YWS) is a multi-center, prospective cohort study of women diagnosed at age ≤40, enrolled from 2006 to 2016. Menstrual outcomes were self-reported on serial surveys. We evaluated factors associated with TRA using logistic regression. One year post-diagnosis, 286/789 (36.2%) experienced TRA, yet most resumed menses (2-year TRA: 120/699; 17.2%). Features associated with 1-year TRA included older age (OR≤30vs36-40 = 0.29 (0.17-0.48), OR31-35vs36-40 = 0.67 (0.46-0.94), p = 0.02); normal body mass index (BMI) (OR≥25vs18.5-24. =0.59 (0.41-0.83), p < 0.01); chemotherapy (ORchemo vs no chemo = 5.55 (3.60-8.82), p < 0.01); and tamoxifen (OR = 1.55 (1.11-2.16), p = 0.01). TRA rates were similar across most standard regimens (docetaxel/carboplatin/trastuzumab +/- pertuzumab: 55.6%; docetaxel/cyclophosphamide +/- trastuzumab/pertuzumab: 41.8%; doxorubicin/cyclophosphamide/paclitaxel +/- trastuzumab/pertuzumab: 44.1%; but numerically lower with AC alone (25%) or paclitaxel/trastuzumab (11.1%). Among young women with breast cancer, lower BMI appears to be an independent predictor of TRA. This finding has important implications for interpretation of prior studies, future research, and patient care in our increasingly obese population. Additionally, these data describe TRA associated with use of docetaxel/cyclophosphamide, which is increasingly being used in lieu of anthracycline-containing regimens. Collectively, these data can be used to inform use of fertility preservation strategies for women who need to undergo treatment as well as the potential need for ovarian suppression following modern chemotherapy for young women with estrogen-receptor-positive breast cancer.Clinical trial registration: www.clinicaltrials.gov, NCT01468246.

Project description:BACKGROUND: While melanocytic nevi have been associated with genetic factors and childhood sun exposure, several observations also suggest a potential hormonal influence on nevi. To test the hypothesis that nevi are associated with breast tumor risk, we explored the relationships between number of nevi and benign and malignant breast disease risk. METHODS AND FINDINGS: We prospectively analyzed data from E3N, a cohort of French women aged 40-65 y at inclusion in 1990. Number of nevi was collected at inclusion. Hazard ratios (HRs) for breast cancer and 95% confidence intervals (CIs) were calculated using Cox proportional hazards regression models. Associations of number of nevi with personal history of benign breast disease (BBD) and family history of breast cancer were estimated using logistic regression. Over the period 15 June 1990-15 June 2008, 5,956 incident breast cancer cases (including 5,245 invasive tumors) were ascertained among 89,902 women. In models adjusted for age, education, and known breast cancer risk factors, women with "very many" nevi had a significantly higher breast cancer risk (HR = 1.13, 95% CI = 1.01-1.27 versus "none"; ptrend = 0.04), although significance was lost after adjustment for personal history of BBD or family history of breast cancer. The 10-y absolute risk of invasive breast cancer increased from 3,749 per 100,000 women without nevi to 4,124 (95% CI = 3,674-4,649) per 100,000 women with "very many" nevi. The association was restricted to premenopausal women (HR = 1.40, ptrend = 0.01), even after full adjustment (HR = 1.34, ptrend = 0.03; phomogeneity = 0.04), but did not differ according to breast cancer type or hormone receptor status. In addition, we observed significantly positive dose-response relationships between number of nevi and history of biopsy-confirmed BBD (n = 5,169; ptrend<0.0001) and family history of breast cancer in first-degree relatives (n = 7,472; ptrend = 0.0003). The main limitations of our study include self-report of number of nevi using a qualitative scale, and self-reported history of biopsied BBD. CONCLUSIONS: Our findings suggest associations between number of nevi and the risk of premenopausal breast cancer, BBD, and family history of breast cancer. More research is warranted to elucidate these relationships and to understand their underlying mechanisms.

Project description:OBJECTIVES:To assess the health burden of breast hypertrophy and the comparative effectiveness of breast reduction surgery in improving health-related quality of life. DESIGN:Prospective cohort study. SETTING:A major public tertiary care hospital in Australia. PARTICIPANTS:Women with symptomatic breast hypertrophy who underwent breast reduction surgery were followed for 12 months. A comparison control cohort comprised women with breast hypertrophy who did not undergo surgery. INTERVENTIONS:Bilateral breast reduction surgery for women in the surgical cohort. MAIN OUTCOME MEASURES:The primary outcome measure was health-related quality of life measured preoperatively and at 3, 6 and 12 months postoperatively using the Short Form-36 (SF-36) questionnaire. Secondary outcome measures included post-surgical complications. RESULTS:209 patients in the surgical cohort completed questionnaires before and after surgery. 124 patients in the control hypertrophy cohort completed baseline and 12-month follow-up questionnaires. At baseline, both groups had significantly lower scores compared with population norms across all scales (p<0.001). In the surgical cohort significant improvements were seen across all eight SF-36 scales (p<0.001) following surgery. Within 3 months of surgery scores were equivalent to those of the normal population and this improvement was sustained at 12 months. SF-36 physical and mental component scores both significantly improved following surgery, with a mean change of 10.2 and 9.2 points, respectively (p<0.001). In contrast, SF-36 scores for breast hypertrophy controls remained at baseline across 12 months. The improvement in quality of life was independent of breast resection weight and body mass index. CONCLUSION:Breast reduction significantly improved quality of life in women with breast hypertrophy. This increase was most pronounced within 3?months of surgery and sustained at 12-month follow-up. This improvement in quality of life is comparable to other widely accepted surgical procedures. Furthermore, women benefit from surgery regardless of factors including body mass index and resection weight.

Dataset Information

UNICANCER: French prospective cohort study of treatment-related chronic toxicity in women with localised breast cancer (CANTO).

Publications

UNICANCER: French prospective cohort study of treatment-related chronic toxicity in women with localised breast cancer (CANTO).

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