La thrombose associée au cancer est une complication fréquente résultant de divers mécanismes vasculaires liés au cancer, au traitement antitumoral et au patient, et qui est associée à un mauvais pronostic. L’anticoagulation recommandée, en prévention ou en traitement curatif, repose essentiellement sur les héparines de bas poids moléculaire (HBPM) ou les anticoagulants oraux directs. L’enjeu de la thromboprophylaxie, pour laquelle les HBPM sont privilégiées en raison d’un moindre risque hémorragique notamment en cas de tumeur digestive endoluminale ou urothéliale en place, demeure l’identification des patients à risque. La question majeure concernant la prise en charge des thromboses avérées est le choix de l’anticoagulant. Du fait de la simplicité de leur administration, les anticoagulants oraux directs apparaissent comme attractifs, et les études randomisées les ayant évalués ont montré leur efficacité. Cependant, ces études sont limitées par le profil des patients inclus qui ne sont pas toujours représentatifs des situations en vraie vie, notamment concernant les cancers à risque hémorragique et certains traitements antitumoraux, inhibiteurs de tyrosine kinase notamment, qui peuvent interagir avec les anticoagulants oraux directs et en modifier potentiellement la biodisponibilité. Les recommandations disponibles soulignent ces précautions et renvoient in fine à des décisions au cas par cas. Cet article a pour but de guider l’oncologue dans son choix d’anticoagulation à travers une série de réponses documentées et pragmatiques aux questions qui se posent face à un patient pris en charge pour une tumeur solide et potentiellement à risque de thrombose ou avec une thrombose établie.

Cancer-associated thrombosis (CAT) is a common complication resulting from various vascular mechanisms related to cancer, antitumoral therapy and patient status, and is associated with a poor prognosis. Anticoagulants recommended for CAT treatment or prevention mainly include low molecular weight heparin (LMWH) and direct oral anticoagulants (DOACs). Regarding thromboprophylaxis, a situation for which LMWH is a preferred option due to a lower risk of hemorrhage especially in patients with unresected gastro-intestinal and genito-urinary malignancies, the identification of patients at risk is a major issue. For patients with established CAT, the main issue is the choice of the most appropriate anticoagulant therapy. Because of the convenience of oral formulation, DOACs are an attractive option, and their efficacy has been shown in randomized trials. However, such studies are limited by selection biases, which make the analyzed population not representative of the real-life setting, as for instance cancers associated with a high risk of hemorrhage, or antitumoral therapies (e.g., tyrosine kinase inhibitors) known to interact with DOACs and then modifying their bioavailability. Caution associated with DOAC use is highlighted by most updated guidelines that recommend a case-by-case-based approach. The aim of the present paper is to help the oncologists make the most appropriate decision regarding the choice of anticoagulant therapy in a context of thromboprophylaxis or established CAT management in a patient with a solid tumor. The main issues are addressed through key practical questions, the answers of which are based on the current guidelines and additional published data or expert opinions.

The French National Cancer Institute has developed breast cancer Care Quality and Safety Indicators (QIs) based on good clinical practices. The objective is to support quality initiatives, improve pathways and outcomes, and reduce regional inequities. QIs computation is automatable and published annually to all French hospitals. In France, BC care was found to be close to compliance with most QIs. Purpose: The French National Cancer Institute has developed, in partnership with the French National Authority for Health, breast cancer-specific Care Quality, and Safety Indicators (BC QIs). With regard to the most common form of cancer, our aim is to support local and national quality initiatives, to improve BC pathways and outcomes, reduce heterogeneity of practice and regional inequities. In this study, we measure the BC QIs available in the French National medico-administrative cancer database, the French Cancer Cohort, for 2018. Materials and Methods: BC QIs are developed according to the RAND method. QIs are based on good clinical practice and care pathway recommendations. QI computation should be automatable without any additional workload for data collection. They will be published annually for all stakeholders, and especially hospitals. Results: Finally, ten feasible and pertinent QIs were selected. In France, BC care was found to be close to compliance with most QIs: proportion of patients undergoing biopsy prior to first treatment (94.5%), proportion of patients undergoing adjuvant radiotherapy after breast-conserving surgery for BC (94.5%), proportion of women undergoing radiotherapy within 12 weeks after surgery and without chemotherapy (86.2%), proportion of DCIS patients undergoing immediate breast reconstruction (54.3%) and proportion of women with NMIBC undergoing breast reintervention (14.4%). However, some are still far from their recommended rate. In particular, some QIs vary considerably from one region, or one patient, to another. Conclusion: Each result needs to be analyzed locally to find care quality leverage. This will strengthen transparency actions aimed at the public.

Regular physical activity is associated with improved symptom control in patients with breast cancer but its association with chemotherapy completion or response is unclear. Using a prospective design, 1075 breast cancer patients receiving neoadjuvant chemotherapy between March 2012 and February 2017 were studied. Physical activity was assessed using the Global Physical Activity Questionnaire [GPAQ-16], quantified in standardised MET-h/wk. Chemotherapy completion was defined as the proportion of patients completing planned treatment course, requiring dose reduction, or requiring dose delay. Response was evaluated by pathologic complete response (pCR). Associations between physical activity and primary outcomes were assessed using multivariable logistic regression models. There was no differences between any chemotherapy completion outcome on the basis of physical activity classification. The percent of patients not completing planned treatment was 5.7% for ≦0.33 MET-h/wk, compared with 6.8% for 0.34–16.65 MET-h/wk, and 4.6% for ≥16.6 MET-h/wk (p = 0.52). No significant relationships were observed between physical activity dose classification and pCR for the overall cohort or upon stratification by clinical subtype. Future studies are required to further investigate the relationship between pre-treatment levels of physical activity and function on treatment completion and response in breast and other cancer populations. NCT01993498.

PURPOSE We aimed to characterize long-term quality of life (QOL) trajectories among patients with breast cancer treated with adjuvant chemotherapy and to identify related patterns of health behaviors. METHODS Female stage I-III breast cancer patients receiving chemotherapy in CANTO (CANcer TOxicity; ClinicalTrials.gov identifier: NCT01993498 ) were included. Trajectories of QOL (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire–C30 Summary Score) and associations with trajectory group membership were identified by iterative estimations of group-based trajectory models and multivariable multinomial logistic regression, respectively. RESULTS Four trajectory groups were identified (N = 4,131): excellent (51.7%), very good (31.7%), deteriorating (10.0%), and poor (6.6%) QOL. The deteriorating trajectory group reported fairly good baseline QOL (mean [95% CI], 78.3/100 [76.2 to 80.5]), which significantly worsened at year-1 (58.1/100 [56.4 to 59.9]) and never recovered to pretreatment values through year-4 (61.1/100 [59.0 to 63.3]) postdiagnosis. Healthy behaviors were associated with better performing trajectory groups. Obesity (adjusted odds ratio [aOR] v lean, 1.51 [95% CI, 1.28 to 1.79]; P < .0001) and current smoking (aOR v never, 1.52 [95% CI, 1.27 to 1.82]; P < .0001) at diagnosis were associated with membership to the deteriorating group, which was also characterized by a higher prevalence of patients with excess body weight and insufficient physical activity through year-4 and by frequent exposure to tobacco smoking during chemotherapy. Additional factors associated with membership to the deteriorating group included younger age (aOR, 1-year decrement 1.01 [95% CI, 1.01 to 1.02]; P = .043), comorbidities (aOR v no, 1.22 [95% CI, 1.06 to 1.40]; P = .005), lower income (aOR v wealthier households, 1.21 [95% CI, 1.07 to 1.37]; P = .002), and endocrine therapy (aOR v no, 1.14 [95% CI, 1.01 to 1.30]; P = .047). CONCLUSION This latent-class analysis identified some patients with upfront poor QOL and a high-risk cluster with severe, persistent postchemotherapy QOL deterioration. Screening relevant patient-level characteristics may inform tailored interventions to mitigate the detrimental impact of chemotherapy and preserve QOL, including early addressal of behavioral concerns and provision of healthy lifestyle support programs.

Background Elevated body mass index (BMI) represents a risk factor for cancer-related fatigue (CRF). Weight loss interventions are feasible and safe in cancer survivors, leading to improved cardio-metabolic and quality of life (QOL) outcomes and modulating inflammatory biomarkers. Randomized data are lacking showing that a lifestyle intervention aimed at weight loss, combining improved diet, exercise, and motivational counseling, reduces CRF. Motivating to Exercise and Diet, and Educating to healthy behaviors After breast cancer (MEDEA) is a multi-center, randomized controlled trial evaluating the impact of weight loss on CRF in overweight or obese survivors of breast cancer. Herein, we described the MEDEA methodology. Methods Patients ( N = 220) with stage I–III breast cancer and BMI ≥ 25 kg/m 2 , within 12 months of primary treatment, and able to walk ≥ 400 m are eligible to enroll. Participants are randomized 1:1 to health education alone vs. a personalized telephone-based weight loss intervention plus health education. Both arms receive a health education program focusing on healthy living. Patients in the intervention arm are paired with an individual lifestyle coach, who delivers the intervention through 24 semi-structured telephone calls over 1 year. Intervention goals include weight loss ≥ 10% of baseline, caloric restriction of 500–1000 Kcal/day, and increased physical activity (PA) to 150 (initial phase) and 225–300 min/week (maintenance phase). The intervention is based on the social cognitive theory and is adapted from the Breast Cancer Weight Loss trial (BWEL, A011401). The primary endpoint is the difference in self-reported CRF (EORTC QLQ-C30) between arms. Secondary endpoints include the following: QOL (EORTC QLQ-C30, -BR45, -FA12), anxiety, and depression (HADS); weight and BMI, dietary habits and quality, PA, and sleep; health care costs (hospital-admissions, all-drug consumption, sick leaves) and cost-effectiveness (cost per quality-adjusted life-year); and patient motivation and satisfaction. The primary analysis of MEDEA will compare self-reported CRF at 12 months post-randomization between arms, with 80.0% power (two-sided α = 0.05) to detect a standardized effect size of 0.40. Discussion MEDEA will test the impact of a weight loss intervention on CRF among overweight or obese BC survivors, potentially providing additional management strategies and contributing to establish weight loss support as a new standard of clinical care. Trial registration ClinicalTrials.gov NCT04304924

Rationale: Overweight and obesity are highly prevalent among BC patients and are linked to poorer prognosis and worse patient-reported outcomes (PROs). Weight loss interventions, based on caloric restriction, increased physical activity (PA) and behavioral counselling, are safe and feasible among BC survivors and hold the promise to improve BC-specific outcomes. MEDEA: Motivating to Exercise and Diet, and Educating to healthy behaviors After breast cancer (ClinicalTrials.gov NCT04304924) will evaluate the impact of weight loss on CRF. Trial design: French multi-center 1:1 randomized controlled trial comparing a 12-month personalized, telephone-based weight loss program + health education intervention vs health education alone in overweight or obese BC patients. Endpoints and measures: Primary endpoint: difference in self-reported CRF 12 months post-randomization between arms, measured using the EORTC QLQ-C30 CRF subscale. Secondary endpoints: 1) PROs (EORTC QLQ-C30, -B45, -FA12), anxiety and depression (Hospital Anxiety and Depression Scale); 2) weight and body mass index (BMI), diet habits and quality, PA, sleep; 3) cost-effectiveness (number and length of hospital-admissions, all-drug consumption, number and duration of sick leaves). Accelerometer data will be collected to track PA and sleep measures. Qualitative analyses will evaluate patient motivation and satisfaction. Main eligibility criteria: stage I-II-III BC, primary BC treatment completed within the prior 12 months (definitive surgery, adjuvant chemo-, and/or radio-therapy, if administered), BMI ≥25 kg/m2, ability to walk at least 400 meters at any pace, ECOG PS 0-1, not participating in another weight loss, dietary or PA intervention clinical trial. Intervention and Control arms: The intervention and health education program are adapted from the BWEL: Breast Cancer WEight Loss study (ClinicalTrials.gov NCT02750826; PI Ligibel JA). The behavior change program is based on the Social Cognitive Theory. Patients in the intervention arm are paired with an individual lifestyle coach, who delivers the intervention through 24 semi-structured telephone calls of 30-60 minutes, supplemented by a detailed participant workbook and scheduled as follows: 1) intensive phase (weeks 1-12), 12 weekly calls; 2) consolidation phase (weeks 13-24), 6 bi-weekly calls; 3) maintenance phase (weeks 25-52), 1 monthly call. Coaches were hired and trained specifically for MEDEA, they are located at a centralized call center and receive support from coordinating nutrition, PA, and behavioral experts. Regular meetings with study team and investigators assure standardized delivery of the intervention and troubleshooting. Intervention goals include weight loss ≥10% of baseline weight, caloric restriction of 500-1000 Kcal/day, increased PA to 150 minutes/week in the initial phase and 225-300 minutes/week in the maintenance phase. Toolbox solutions are offered to tailor the intervention and meet the needs of specific ethnic, socioeconomic or other patient populations with difficulties in achieving intervention goals. All participants in both arms receive a health education program focusing on healthy living. Accrual: MEDEA will enroll 220 patients overall. Recruitment started in June 2020. Statistical considerations: The primary analysis of MEDEA will compare the primary endpoint of CRF scores at the 12-month post-randomization time point between arms. The study has 90.0% power at two-sided α=0.05 to detect a standardized effect size of 0.40 (sample size inflated for drop outs). For interpreting the clinical significance of effects, 0.2, 0.5 and 0.8 standard deviation effects will be considered as small, moderate, and large (Cohen, 1988). All other measures, time points and analyses will be considered secondary or exploratory. Citation Format: Antonio Di Meglio, Elise Martin, Stefan Michiels, Cecile Charles, Tracy E. Crane, Aude Barbier, Bruno Raynard, Anthony Mangin, Olivier Tredan, Paul H. Cottu, Laurence Vanlemmens, Carine Segura-Djezzar, Anne Lesur, Barbara Pistilli, Florence Joly, Thomas Ginsbourger, Bernadette Coquet, Guillemette Jacob, Aude Sirven, Julia Bonastre, Jennifer A. Ligibel, Ines Vaz-Luis. MEDEA: A randomized trial of weight loss to reduce cancer-related fatigue (CRF) among overweight and obese breast cancer (BC) patients [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr OT-38-01.

Background. - The French National Cancer Institute recommends the use of survivorship care plans (SCP) for all cancer survivors. Developing useful SCP's requires understanding of what survivors and their providers need and how SCP's can be implemented in practice. We conducted a study to assess the delivery of SCP comprehensive binders for breast cancer women (BCW) and their general practitioners (GP) in a Cancer center from January 2019. Methods. - SCP binders, containing a full range of information on topics related to post-cancer care to survivor-specific information and referrals, were given to BCW during a post-treatment dedicated consultation. Then a letter, containing the treatment summary and 5-year follow-up schedule, was sent to their GPs. Comprehensive binder delivery assessment was carried out using item checkbox, and anonymous open-answered, self-reported questionnaires were sent by email to BCW and their GPs. Results. - The questionnaire response rates were 81.3% for BCW (n = 109/134) and 48.6% for their GPs (n = 52/107). Most BCW (85%) reported that SCP binders provided useful and comprehensive information. However, some of them (18%) felt abandoned and anonymous during the post-treatment follow-up. Most GPs found SCP letters from our anti-cancer center physicians to be useful for their patients, 38% of them had used this information to assure transition of care with other care providers. In addition, GPs were unanimous to express their feeling that this SCP could improve the long-term surveillance of BCW. There was a high concordance between BCW survivors' and PCP' answers, especially regarding SCPs as a communication bridge between GPs and BCW survivors. Response results concerning use of the binders: to talk about them: 59% for BCW vs. 51% for GPs, and to show them: 35% for BCW vs. 31% for GPs. Conclusion. - The opinions of BCW survivors' and PCP' opinions about the use of SCP's by our Cancer Center seems to be favourable. It is essential to implement and develop SCP's as a key tool in long-term surveillance and support for cancer patient survivors and they are a useful instrument for care providers in communication and transition. (C) 2021 ElsevierMasson SAS. All rights reserved.

PURPOSE MINDACT demonstrated that 46% of patients with early breast cancer at high clinical but low genomic risk on the basis of MammaPrint may safely avoid adjuvant chemotherapy. A second random assignment (R-C) compared docetaxel-capecitabine with an anthracycline-based regimen. PATIENTS AND METHODS R-C randomly assigned patients 1:1 between standard anthracycline-based regimens, with or without taxanes (control) and experimental docetaxel 75 mg/m2 intravenously plus oral capecitabine 825 mg/m2 two times per day for 14 days (DC) every 3 weeks for 6 cycles. The primary end point was disease-free survival (DFS). Secondary end points included overall survival and safety. RESULTS Of 2,832 patients, 1,301 (45%) were randomly assigned, and 97% complied with R-C assignment. In the control arm, 29.6% only received taxanes (0.5% of N0 patients). DFS events (n = 148) were much less than required (n = 422) as a result of a lower-than-expected accrual and event rate. At 5 years of median follow-up, DFS was not different between DC (n = 652) and control (n = 649; 90.7% [95% CI, 88% to 92.8%] v 88.8% [95% CI, 85.9% to 91.1%]; hazard ratio [HR], 0.83 [95% CI, 0.60 to 1.15]; P = .26). Overall survival (HR, 0.91 [95% CI, 0.54 to 1.53]) and DFS in the clinical high and genomic high-risk subgroup (86.1% v 88.1%; HR, 0.83 [95% CI, 0.58 to 1.21]) were similar in both arms. DC led to more grade 1 neuropathy (27.1% v 11.2%) and more grade 2 hand/foot syndrome (28.5% v 3.3%) and diarrhea (13.7% v 5.8%). Serious cardiac events occurred in 9 patients (control, n = 4; DC, n = 5). Fifty-three patients developed second cancers (control, n = 32; DC, n = 21; leukemia: 2 v 1). Five treatment-related deaths occurred (control, 2 [0.3%]; DC, 3 [0.5%]). CONCLUSION Although underpowered, this second randomization in MINDACT did not show any improvement in outcome or safety with the use of DC compared with anthracycline-based chemotherapy.

Background: Use of OCAM varies widely among cancer pts, ranging 20– 80%. Efficacy of OCAM for cancer-related symptoms including fatigue is controversial, while some interactions with standard anticancer therapy were reported. We aimed to describe factors associated with use of OCAM, particularly its relationship with self-reported fatigue in BC pts.

Abstract Background: Nowadays, the assessment of health related quality of life (HRQOL) in women with breast cancer (BC) has become very important, with the improvement of their prognosis and the growing number of BC survivors. HRQOL is therefore a main endpoint in cancer therapeutic care and its improvement should be an important goal of BC treatment. The aim of this study was to assess HRQOL at the end of acute treatment in BC patients using data of the multicenter prospective French CANTO cohort. Methods: CANTO (NCT 01993498) is a multicenter prospective observational study (26 centers in France) whose main objective is to study the chronic toxicities of anticancer treatments in 12,000 women with localized stages I to III BC. HRQOL was assessed at baseline and at the end of acute treatments (surgery +/- radiotherapy +/- chemotherapy) using the EORTC-QLQ-C30 questionnaire and its BC specific module, the EORTC-QLQ-BR23 questionnaire. The EORTC-QLQ-C30 is composed of 30 items which allow generating 15 scales which are: 5 functional scales, 8 symptom scales, a global health status and a financial difficulties scale. The EORTC-QLQ-BR23 comprises 23 items and contains 4 functional scales and 4 symptoms scales. The minimal clinically important change score (MCID) was defined as a mean difference of at least 10 points in HRQOL scores between the baseline and the end of acute treatments (M0). Mixed linear model was used to assess the determinants of HRQOL For the dimensions with MCID. Results: from March 2012 to December 2014, 5801 BC patients were included in the CANTO cohort. The mean age at diagnostic was 57 years (SD=11.5) and 22.1 % of patients was single. Ninety percent of women had a good performance status and 79 % did not have comorbidities. Most of patients underwent surgery (99.7%), among which 77% by conservative surgery, and respectively 90.3 % were treated with radiotherapy, 80.2 % with hormone therapy and 53.3 with chemotherapy. Out of 23 dimensions, treatments for the disease did not impact the HRQOL of patients for global health status and 17 others dimensions of the QLQ-C30 and QLQ-BR23. However, with the means change score (MD) over 10 points, body image functional scale (MD= -14, p<0.0001) and 4 symptoms scales: pain (MD= +11, p<0.0001), breast symptoms (MD=+12, p<0.0001), arm symptoms (MD=11, p<0.0001) and upset by hair loss (MD=+12, p<0.0001) were negatively impacted. In multivariate analysis, overweight, anxiety, depression and chemotherapy, were the main determinants which negatively impacted HRQOL for the body image dimension, pain symptoms, breast symptoms, arm symptoms and upset by hair loss. Hormonal status and education level were independent predictors of an improvement in HRQOL for the body image dimension and arm symptoms. Conclusion: Results of this study did not show an impact of acute treatments for early stage BC on global health status of patients. The most affected dimensions, by the treatments, were body image, pain, breast symptoms, arm symptoms and upset by hair loss. Overweight, anxiety, depression, education level, hormonal status and chemotherapy were the main determinant of HRQOL. Citation Format: Oumar Billa, Olivia Dialla, Sarah Dauchy, Barbara Pistilli, Paul-Henri Cottu, Anne Lesur, Florence Lerebour, Olivier Tredan, Laurence Vanlemmens, Christelle Jouannaud, Christelle Levy, Charles Cecile, Anne Laure Martin, Sibille Everhard, Florence Joly, Charles Coutant, Fabrice Andre, Patrick Arveux, Sandrine Dabakuyo-Yonli. Health related quality of life at the end of acute treatments for early stage breast cancer patients [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P1-17-04.

PURPOSE:Nonadherence to long-term treatments is often under-recognized by physicians and there is no gold standard for its assessment. In breast cancer, nonadherence to tamoxifen therapy after surgery constitutes a major obstacle to optimal outcomes. We sought to evaluate the rate of biochemical nonadherence to adjuvant tamoxifen using serum assessment and to examine its effects on short-term, distant disease-free survival (DDFS).PATIENTS AND METHODS:We studied 1,177 premenopausal women enrolled in a large prospective study (CANTO/NCT01993498). Definition of biochemical nonadherence was based on a tamoxifen serum level < 60 ng/mL, assessed 1 year after prescription. Self-reported nonadherence to tamoxifen therapy was collected at the same time through semistructured interviews. Survival analyses were conducted using an inverse probability weighted Cox proportional hazards model, using a propensity score based on age, staging, surgery, chemotherapy, and center size.RESULTS:Serum assessment of tamoxifen identified 16.0% of patients (n = 188) below the set adherence threshold. Patient-reported rate of nonadherence was lower (12.3%). Of 188 patients who did not adhere to the tamoxifen prescription, 55% self-reported adherence to tamoxifen. After a median follow-up of 24.2 months since tamoxifen serum assessment, patients who were biochemically nonadherent had significantly shorter DDFS (for distant recurrence or death, adjusted hazard ratio, 2.31; 95% CI, 1.05 to 5.06; P = .036), with 89.5% of patients alive without distant recurrence at 3 years in the nonadherent cohort versus 95.4% in the adherent cohort.CONCLUSION:Therapeutic drug monitoring may be a useful method to promptly identify patients who do not take adjuvant tamoxifen as prescribed and are at risk for poorer outcomes. Targeted interventions facilitating patient adherence are needed and have the potential to improve short-term breast cancer outcomes.

PURPOSEAdverse effects of breast cancer treatment can negatively affect survivors’ work ability. Previous reports lacked detailed clinical data or health-related patient-reported outcomes (PROs) and did not prospectively assess the combined impact of treatment and related sequelae on employment.METHODSWe used a French prospective clinical cohort of patients with stage I-III breast cancer including 1,874 women who were working and ≥ 5 years younger than legal retirement age (≤ 57 years) at breast cancer diagnosis. Our outcome was nonreturn to work (non-RTW) 2 years after diagnosis. Independent variables included treatment characteristics as well as toxicities (Common Toxicity Criteria Adverse Events [CTCAE] v4) and PROs (European Organization for Research and Treatment of Cancer [EORTC] Quality of life Questionnaires, Breast cancer module [QLQ-BR23] and Fatigue module [QLQ-FA12], Hospital Anxiety and Depression Scale) collected 1 year after diagnosis. Logistic regression models assessed correlates of non-RTW, adjusting for age, stage, comorbidities, and socioeconomic covariates.RESULTSTwo years after diagnosis, 21% of patients had not returned to work. Odds of non-RTW were significantly increased among patients treated with combinations of chemotherapy and trastuzumab (odds ratio [OR] v chemotherapy-hormonotherapy: for chemotherapy-trastuzumab, 2.01; 95% CI, 1.18 to 3.44; for chemotherapy-trastuzumab-hormonotherapy, 1.62; 95% CI, 1.10 to 2.41). Other significant associations with non-RTW included grade ≥ 3 CTCAE toxicities (OR v no, 1.59; 95% CI, 1.15 to 2.18), arm morbidity (OR v no, 1.59; 95% CI, 1.19 to 2.13), anxiety (OR v no, 1.47; 95% CI, 1.02 to 2.11), and depression (OR v no, 2.29; 95% CI, 1.34 to 3.91).CONCLUSIONReceipt of systemic therapy combinations including trastuzumab was associated with increased odds of non-RTW. Likelihood of unemployment was also higher among patients who reported severe physical and psychological symptoms. This comprehensive study identifies potentially vulnerable patients and warrants supportive interventional strategies to facilitate their RTW.

Using TAM serum assessment, we demonstrated that 1 in 6 premenopausal pts with early breast cancer (EBC) are non-adherent to TAM at 1 year (Y1) from treatment initiation. Most of them did not overtly declare non-adherence. We now evaluate the longitudinal evolution of non-adherence to TAM by using serum assessment and pts' self-declarations at year 3 (Y3). CANTO COMPLETE, a sub-study of CANTO cohort (NCT01993498), evaluates prevalence and predictors of non-adherence to adjuvant endocrine therapy in premenopausal pts at several time points from treatment initiation by drug serum levels and pts' self-declarations. TAM was measured by liquid chromatography-tandem mass spectrometry on 50 μL of serum (lower limit of quantification [LLOQ]= 10 ng/mL). Pts were considered as biochemically non-adherent if TAM <60 ng/mL. Pts' declarations were collected at the same time points. We used multivariable logistic regression and longitudinal multivariable mixed models to evaluate non-adherence at Y3. 718 pts were evaluable at Y3. Median age 46 (IQR 42–49), partnered 536 (78.7%), post-graduation education 362 (52.6%), stage I BC 333 (46.4%) and received chemotherapy 444 (61.8%). At Y3, serum assessment showed that 260 (36.2%) pts were non-adherent, of whom 226 (31.5%) with TAM

We assessed long-term associations of Granulocyte-Colony Stimulating Factors (G-CSF) use with patient-reported outcomes (PROs) and hematologic toxicity among chemotherapy-treated, early-stage breast cancer patients in CANTO (NCT01993498).Among 2920 patients longitudinally followed-up until year-4 after diagnosis, 49% used G-CSF. In multivariable-adjusted mixed-models, EORTC QLQ-C30 pain and summary score were not substantially different between groups (overall adjusted mean difference, use vs no-use [95%CI]: +1.27 [-0.33 to +2.87] and −1.01 [-1.98 to −0.04], respectively). PROs were slightly worse at year-4 among patients receiving G-CSF, although differences were of trivial clinical significance. No major differences were observed in leukocyte or platelet count over time.

Quoi que l’on fasse, le cancer du sein reste à travers le temps le premier cancer en incidence chez la femme, lentement mais inexorablement toujours en augmentation (chiffres INCa : 58 968 nouveaux cas de cancer du sein en France métropolitaine en 2017, 11 883 décès estimés en 2017). Hormis le pourcentage élevé de population que cela touche, cette maladie pose sans cesse de nouvelles questions, non pas tant en organisation de traitements (cette localisation est le meilleur exemple d’illustration de la notion de parcours mais surtout en choix thérapeutiques). Si bien qu’en ce début de 2019, nous avons choisi de façon éclectique quelques thèmes actuels qui, à la fois, questionnent et préoccupent. Il est fini et bien fini le temps d’avant les Plans cancers où une boule dans le sein se voyait opérée pour débarrasser la patiente— qui n’attendait que cela, croyant résoudre le problème — et faire un diagnostic souvent déconcertant, imposant des lendemains complexes car non anticipés. Plus personne n’imaginerait traiter une patiente d’un probable cancer du sein sans connaître ses caractéristiques anatomopathologiques et immunohistochimiques. Cela conditionne tout le temps diagnostique parfois trop long pour la patiente, mais qui optimise la prise en charge ultérieure en pertinence. À travers les décennies, la désescalade dans la morbidité des traitements n’a cessé d’être une règle d’or. Ainsi, les chirurgiens n’ont pas attendu E. Winer à San Antonio en décembre dernier : « the challenge of doing less » pour appliquer la devise du Bachaus less is more passés du Halstedt au Patey pour arriver à la mastectomie partielle associée à la radiothérapie mammaire, les chirurgiens ont peu à peu, avec prudence néanmoins, laissé au ganglion sentinelle (GS) une place grandissante, réservant les curages axillaires aux situations incontournables (Il n’y a pas si longtemps, un numéro entier de cette revue était consacré au sujet (Le creux axillaire Oncologie (2013) Volume 15 (6) : 275-339). Ces notions posent la question du bilan initial qui bien qu’indispensable est souvent mal vécu, car retardant le début du traitement tant attendu une fois le diagnostic de malignité établi. Faut-il privilégier un bilan iconographique locorégional pointu dans les mains de radiologues experts pour se donner toutes les chances d’opérer au bon endroit et de la meilleure façon ? Tant que tout GS atteint (microou macrométastase) faisait l’objet d’une reprise chirurgicale par curage, il n’y avait aucun doute pour considérer que cela représentait un avantage certain (la pratique de la technique OSNA nous en avait persuadés). Mais voici que se posent deux questions incontournables :

Lors de la découverte d’un cancer du sein, la qualité du bilan préthérapeutique est essentielle afin d’orienter la décision thérapeutique. L’exploration axillaire est primordiale, car elle évalue l’extension régionale de la maladie, ce qui en fait un des facteurs pronostiques majeurs. Différents examens d’imagerie préopératoires peuvent révéler une atteinte de ces ganglions axillaires. Cependant, l’imagerie de référence reste l’échographie axillaire, qui permet également de guider des prélèvements. Depuis l’étude ACOSOGZ0011, nous sommes face à une désescalade thérapeutique de la chirurgie axillaire. Selon des résultats récents, on constate que la place de l’imagerie axillaire est encore plus importante. Le but de l’échographie est d’éviter un curage en deux temps après un ganglion sentinelle positif lorsque les critères de l’ACOSOG-Z0011 ne sont pas remplis.