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Routine Electronic Monitoring of Health-Related Quality of Life (HRQoL) (REMOQOL) in clinical care with real-time feedback to physicians could help to enhance patient-centered care. We evaluated the feasibility of REMOQOL in the French context in the QOLIBRY study. The primary objective was to assess the patients’ compliance with REMOQOL. The QOLIBRY study was a single-center, prospective study conducted in the University Hospital of Besancon (France). Eligible patients were those treated with systemic therapies for breast, lung or colorectal cancer at any stage. Patients were invited to complete the EORTC QLQ-C30 questionnaire and cancer-site-specific modules before each visit on tablets and/or computers in the hospital or at home. During the consultation, physicians had real-time access to visual summaries of HRQoL scores. Compliance was assessed as adequate if at least 66% of HRQoL assessments were completed during the 4 months of follow-up. Between March 2016 and October 2018, 177 patients were included in the QOLIBRY study. Median age was 64 years (IQR 54–71). The proportion of patients with an adequate compliance rate was 95.5% (n = 63) in the breast cancer cohort, 98.2% (n = 55) in the colorectal cancer cohort, and 90.9% (n = 50) in the lung cancer cohort. The physicians checked the HRQoL results in 73.1% of visits and prescribed supportive care and adapted patient management in 8.3% and 5.2% of visits, respectively. The results of QOLIBRY study suggest that REMOQOL is feasible in the French context. However, information about HRQoL monitoring, training of the physicians in the use of the software, and recommendations for using HRQoL results to guide care are essential and must be improved.

Breast cancers expressing high levels of Ki67 are associated with poor outcomes. Oncotype DX® test was designed for ER+/HER2- early-stage breast cancers to help adjuvant chemotherapy decision by providing a Recurrent Score® (RS®). RS® measures the expression of 21 specific genes from tumor tissue, including Ki67. The primary aim of this study was to assess the agreement between Ki67RNA obtained with Oncotype DX® RS® and Ki67IHC. Other objectives were to analyze the association between the event free survival (EFS) and the expression level of Ki67RNA; and association between RS® and Ki67RNA.Herein, we report a low agreement of 0.24 by Cohen’s kappa test between Ki67IHC and Ki67RNA in a cohort of 98 patients with early ER+/HER2- breast cancers. Moreover, Ki67RNAhigh tumors were significantly associated with the occurrence of events (p=0.02). On the other hand, we did not find any association between Ki67IHC and EFS (p=0.25).We observed of low agreement between expression level of Ki67RNA and Ki67 protein labelling by IHC. Unlike Ki67IHC and independently of the RS®, Ki67RNA could have a prognostic value. It would be interesting to better assess the prognosis and predictive value of Ki67RNA measured by qRT-PCR. The Ki67RNA in medical routine could be a good support in countries where Oncotype DX® is not accessible.

Breast cancers expressing high levels of Ki67 are associated with poor outcomes. Oncotype DX test was designed for ER+/HER2− early-stage breast cancers to help adjuvant chemotherapy decision by providing a Recurrent Score (RS). RS measures the expression of 21 specific genes from tumor tissue, including Ki67. The primary aim of this study was to assess the agreement between Ki67RNA obtained with Oncotype DX RS and Ki67IHC. Other objectives were to analyze the association between the event free survival (EFS) and the expression level of Ki67RNA; and association between RS and Ki67RNA. Herein, we report a low agreement of 0.288 by Pearson correlation coefficient test between Ki67IHC and Ki67RNA in a cohort of 98 patients with early ER+/HER2− breast cancers. Moreover, Ki67RNAhigh tumors were significantly associated with the occurrence of events (p = 0.03). On the other hand, we did not find any association between Ki67IHC and EFS (p = 0.26). We observed a low agreement between expression level of Ki67RNA and Ki67 protein labelling by IHC. Unlike Ki67IHC and independently of the RS, Ki67RNA could have a prognostic value. It would be interesting to better assess the prognosis and predictive value of Ki67RNA measured by qRT-PCR. The Ki67RNA in medical routine could be a good support in countries where Oncotype DX is not accessible.

Background: Breast cancers expressing high levels of Ki67 are associated with poor outcomes. To provide individualized patient care, reliability of prognostic and predictive information deriving from Ki67 assessment is essential. Oncotype DX® test was designed for ER+/HER2- early-stage breast cancers to help adjuvant chemotherapy decision by providing a Recurrent Score® (RS®). RS® measures the expression of 21 specific genes from tumor tissue, including Ki67, and aim to predict the benefit of chemotherapy and the risk of distant recurrence. The primary aim of this study was to assess the agreement between Ki67RNA obtained with Oncotype DX® RS® and Ki67IHC. Other objectives were to analyze the association between the event free survival (EFS) and the expression level of Ki67RNA; and association between RS® and Ki67RNA.Methods: In a cohort of 98 patients with early ER+/HER2- breast cancers, we obtained: Recurrence score®, RNA level of Ki67 expression measured when assessing RS® and Ki67 tumor labelling by immunohistochemistry (Ki67IHC). The Ki67RNA was compared to the Ki67IHC by Kappa Cohen test. With a mean follow-up of 57 months, the association between the event free survival (EFS) and Ki67 status was measured using R package survival. Results: This population was essentially composed of no special type tumor (91%), N0 or Nmic (71%), grade 1 (62%), and tumor size pT1c (1-2 cm) (58%). The RS® values were 30 in 11% (n=11) of the patients. A low agreement of 0.24 was found by Cohen’s kappa test between Ki67IHC and Ki67RNA. Moreover, Ki67RNAhigh tumors were significantly associated with the occurrence of events (p=0.02). On the other hand, we did not find any association between Ki67IHC and EFS (p=0.25).Conclusion: We observed of low agreement between expression level of Ki67RNA and Ki67 protein labelling by IHC. Unlike Ki67IHC and independently of the RS®, Ki67RNA could have a prognostic value. It would be interesting to better assess the prognosis and predictive value of Ki67RNA measured by qRT-PCR. The Ki67RNA in medical routine could be a good support in countries where Oncotype DX® is not accessible.

e13020 Background: Until 2020, in human epidermal growth factor receptor 2 (HER2)-positive advanced breast cancer (ABC), the two first lines of metastatic treatment were well defined but after, many options were possible, most often combining targeted therapy plus chemotherapy. Eribulin mesylate is indicated for the treatment of patients with ABC previously treated by anthracycline and taxane regimens in the advanced setting. Here, we present the results of eribuline and trastuzumab (E/T) combination in HER2-positive ABC previously treated. Methods: Patients with HER2-positive ABC treated with the E/T combination from our region cancer institute were included in this retrospective study. The primary endpoint was progression-free survival (PFS). Secondary endpoints included overall survival (OS), overall response rate (ORR), clinical benefit rate (CBR) and safety. Results: Between November 2013 and July 2019, a total of 34 consecutive patients with HER2-positive ABC were included. The median number of previous lines for advanced setting was 4 (range 2-7). Patients treated by taxanes and anthracyclines represented 91% and 47% respectively; 50%, 79% and 62% were previously treated with pertuzumab, trastuzumab emtansine and lapatinib respectively. After a median follow up of 24.8 months, median PFS was 6.2 months (95% CI [3.35-7.13]) and median OS was 12.6 months (95% CI [7.13-18.56]). The ORR and CBR were 38% and 53%, respectively. No unexpected adverse event was observed. The most frequent grade 3-4 toxicity was hematologic (44.1%). Conclusions: Recently, new therapies have revolutionized the management of HER2-positive ABC and patients benefit from a prolonged overall survival associated with a maintained performance status. However, in pretreated and advanced metastatic setting, there are few scientific evidence to guide the choice of treatments. A combination of E/T could be an effective option in patients with good performance status and willing to receive treatment.

Breast cancer, the most common in women, is a cancer of good prognosis. During this last decade, the improvement of cancer screening and treatment has significantly increased disease-free and overall survival. However, the chemotherapy, especially based on anthracyclines, and targeted therapies like trastuzumab have a toxicity to the cardiovascular system. If physical exercise is recognized as beneficial in tertiary prevention, especially by reducing fatigue, improving the physiological capacities of exercise, muscle strength and ultimately quality of life, conversely, few data are available on the effects of exercise on treatment-induced cardiotoxicity. This review, based on the PubMed database, presents the results of preclinical and clinical studies showing that physical exercise, by its cardioprotective role, increases the antioxidant capacity, reduces oxidative stress, maintains the left ventricular ejection fraction at a normal value and improves diastolic functions during and after treatment. Regular physical exercise should be an integral part of supportive care in oncology but it is necessary, in future studies, to determine its modalities for a better prevention of the cardiotoxicity of the treatments.

Resume Introduction La prise en charge de la douleur est un enjeu de sante publique important, particulierement en cancerologie. Dans une demarche d’evaluation des pratiques professionnelles, l’IRFC-FC a realise une enquete chez des patients presentant une tumeur solide metastatique osteophile en Franche-Comte. Les objectifs etaient d’evaluer la prevalence de la douleur, ses caracteristiques, sa prise en charge et son impact sur la qualite de vie. Methode Une enquete observationnelle, prospective et multicentrique a ete realisee via un questionnaire d’autoevaluation. Ont ete inclus les patients presentant un cancer metastatique du sein ou de la prostate pris en charge dans 5 hopitaux de jour de l’IRFC-FC sur une periode de 3 mois. Resultats Deux cent trente-trois questionnaires ont ete analyses. La prevalence de la douleur etait de 48,5 %. Trois-quarts des patients algiques avaient une douleur chronique de fond, d’intensite moderee a severe, associee ou non a des acces douloureux. Eu egard a l’intensite de leur douleur et a leur traitement antalgique, 42,0 % des patients semblaient sous-traites. Quatre-vingt-cinq pour cent des patients traites declaraient etre observants et estimaient que leur douleur etait bien prise en charge malgre un impact negatif sur la qualite de vie. Conclusion La mise en œuvre d’un chemin clinique est essentielle pour garantir une prise en charge standardisee, optimale et efficiente des patients algiques. L’evaluation de la satisfaction des soins et de la qualite de vie doit etre integree a la pratique clinique pour mieux identifier les patients algiques dont le traitement est inadapte.

Resume L’eribuline a obtenu son autorisation de mise sur le marche (AMM) en mars 2011 pour le traitement des patientes atteintes de cancer du sein localement avance ou metastatique ayant progresse apres anthracycline et taxane. L’objectif de cette etude etait d’evaluer retrospectivement l’efficacite, la tolerance et le cout de ce traitement chez les patientes traitees en Franche-Comte pour un cancer du sein metastatique (CSM) ayant recu l’eribuline. Quatre-vingt-dix patientes ont ete traitees par eribuline entre juillet 2006 et octobre 2013. L’âge median etait de 62 ans (35–83). La survie globale etait de 10,3 mois [IC 95 % : 7,6–17,9], la survie sans progression mediane de 3,8 mois [IC 95 % : 2,9–5,0]. Un benefice clinique a ete obtenu chez 55 % des patientes [IC 95 % : 43,1–66,9] evaluable selon les criteres RECIST. Les effets indesirables de grade 3 et 4 les plus frequents etaient la neutropenie (38 %), l’asthenie (10 %) et la neuropathie peripherique (7 %). Le cout median du traitement etait de 9767 € par patiente (6344–17 517). Cette analyse a retrouve des resultats comparables a l’etude EMBRACE malgre une population moins selectionnee. Une evaluation medico-economique de type cout–utilite permettrait d’evaluer l’efficacite de cette strategie therapeutique comparativement aux traitements standard.

Resume La signature genomique Oncotype DX ® est capable d’estimer le risque de recidive et de predire le benefice potentiel d’une chimiotherapie adjuvante pour un cancer du sein localise RE+ et HER-2 negatif. En 2012, grâce a l’Agence Regionale de Sante de Franche-Comte, ce test a ete disponible en routine dans la region. Les patientes pouvant en beneficier devaient presenter un cancer du sein localise RE+, HER-2-, avec un envahissement ganglionnaire absent ou limite a un ganglion sans rupture capsulaire et etre candidates a une chimiotherapie adjuvante sur les criteres histopathologiques et/ou cliniques classiques. En situation de limitations des ressources et de contraintes budgetaires, l’objectif de cette etude est d’evaluer l’impact economique de l’utilisation du test Oncotype DX ® en Franche-Comte. Pour y repondre, une evaluation de type minimisation de cout a ete realisee. Propose a 48 patientes, le test Oncotype DX ® a permis d’eviter une chimiotherapie adjuvante dans 73 % des cas. Cela se traduit par une absence de surcout lie a sa realisation, voire une economie potentielle pour l’Assurance-Maladie. Devant le succes de cette strategie pilote, la generalisation de l’utilisation du test Oncotype DX ® sur l’ensemble du territoire sous reserve d’une organisation stricte est a considerer rapidement par les autorites de sante.

Trastuzumab in Human Epidermal growth Receptor 2-positive (HER2+) metastatic breast cancer (MBC) was established as standard therapy since 2001. The objective of this study was to search for significant prognostic factors in patients with HER2+ MBC treated by trastuzumab taking into account the institution where the treatment was given.All patients with HER2+ MBC treated by trastuzumab between 2001 and 2010 in the 8 hospitals of Franche Comte region were analysed. Univariate and multivariate analysis were conducted to search for factors related to overall survival (OS).Among 1234 patients with MBC treated by chemotherapy between 2001 and 2010, 217 patients received trastuzumab. In this subset, the median age was 60 years, 8% and 38% had brain and liver metastases at first occurrence of MBC, 36% of, tumours were hormonal receptors positive. Patients were treated in 48% and 52% of cases in specialized and in general hospitals, respectively. The median OS length was 45.2 months (IQR 23.2-89.3 months). In univariate analysis the following factors were significantly related to favourable OS: inclusion in clinical trials, treatment in a specialized hospital, positive hormonal receptors status, age50. In multivariate analysis remained significant: treatment in specialized hospital (aHR 0.78; 95%CI 0.64-0.94; p = 0.03) and age50 (aHR 0.76; 95%CI 0.59-0.95; p = 0.02).Exposure to trastuzumab erases all established prognostic factors at the metastatic setting. The fact that patients treated in specialized hospitals presented a longer survival emphasizes the dramatic impact of this therapy and the relevance to optimize its use.

Introduction Un tiers des cancers du sein surexprime la proteine HER2 [1] . Les traitements radio-chimiotherapique et par trastuzumab s’accompagnent de douleurs, d’une fatigue, d’une diminution de la capacite aerobie alterant la qualite de vie (QdV) [2] , [3] . La pratique d’une activite physique reguliere d’intensite moderee pendant et apres le traitement par radio-chimiotherapie diminue ces effets indesirables. Cependant, c’est la premiere etude qui evalue les effets d’un reentrainement a l’effort aerobie, individualise, intermittent, sur les aptitudes physiologiques a l’exercice et la QdV chez des patientes ayant un cancer du sein HER2+, traitees exclusivement par trastuzumab. Materiel et methodes Quarante patientes (49,3 ± 9,4 ans ; IMC : 26,5 ± 5,9 kg.m−2) ont ete randomisees en 2 groupes (entraine : GE ou controle : GC). Une epreuve d’effort avec determination des seuils ventilatoires (SV1 et SV2) a ete realisee en pre- et post-reentrainement (cycloergometre, 3 fois/semaine, 12 semaines). Avant chaque epreuve, la QdV a ete evaluee par le QLQ-C30. Resultats Apres entrainement, la puissance maximale et le VO2 pic sont augmentes dans le GE (147,5 ± 6,8 W vs 123 ± 6,5 et 27,5 ± 1,4 vs 25,4 ± 1,5 mL.min−1.kg−1). Les SV1 et SV2 sont retardes, temoin d’une amelioration de la capacite aerobie. Les scores des domaines fonctionnels sont ameliores et ceux des symptomes de la douleur et de la fatigue sont diminues. Le VO2 pic est correle positivement au domaine « fonctionnement social » (r = 0,46) et negativement a la douleur (r = −0,45). Conclusion Une amelioration des parametres d’adaptation a l’exercice sous maximal et maximal est associee a une meilleure qualite de vie des patientes. Ces resultats montrent l’interet du reentrainement a l’effort dans les soins de support en cancerologie.

Background. The primary aim of this retrospective study was to investigate intraindividual correlation of estrogen receptor (ER) status, progesterone receptor (PR) status, and HER2 status between primary breast cancer and metastatic breast cancer (mBC). Secondary aims included patients' characteristics, overall survival, feasibility of histopathological evaluation in the metastatic setting, and predictive factors associated with receptors status discordance. Methods. Patients with either biopsy of metastatic relapse or surgery of metastasis were identified. Demographics, tumor characteristics, treatment characteristics, and ER, PR, and HER2 statuses were retrospectively obtained in patients' reports. Receptors statuses were assessed by immunohistochemistry with a positivity cutoff of more than 10% for ER and PR. HER2 was considered as positive if overexpression was scored at 3+ in immunohistochemistry or if amplification ratio was >2 in fluorescent in situ hybridization. Results. From a cohort of 489 patients with mBC, 269 patients had histopathological samples of metastatic relapse. Histopathological analysis of the specimen confirmed the diagnosis of mBC in 235 patients. Discordance in one or more receptors between primary breast cancer and mBC was found in 99 patients (42%). A switch in receptor status was identified for ER in 17% of tumors (p = 4 × 10−3), PR in 29% of cancers (p < 4 × 10−4), and HER2 in 4% of lesions (p = .16). Exposure to chemotherapy and to anthracycline-based chemotherapy was statistically associated with switches in ER status. Seven (2%) second malignancies and three benign diseases (1%) were diagnosed. Conclusions. This study confirms that discordance in ER and PR receptor expression between the primary breast tumor and the corresponding metastatic lesions is high, whereas HER2 status remains relatively constant. Chemotherapy, and specifically anthracycline-based chemotherapy, was associated with switch in ER status. These results were obtained in a selected population of patients; further studies are warranted to confirm these data and to determine the interest of systematic rebiopsy in the metastatic setting.

Pain management is a major public health problem, especially in oncology. In order to assess professional practice, the IRFC-FC conducted a survey amongst patients with metastatic osteophilic solid tumor in Franche-Comté. The aims were to assess the pain prevalence, and its characteristics, its management and its impact on patients' quality of life in patients in pain.An observational, prospective and multicenter survey was conducted using a self-report questionnaire. Patients with metastatic breast or prostate cancer managed in 5 day-hospitals of the IRFC-FC over a period of three months were included.Two hundred thirty-three questionnaires were analyzed. Pain prevalence rate was 48.5%. Three quarters of patients in pain had chronic background pain, moderate to severe, with or without breakthrough pain. Considering their pain intensity and their analgesic therapy, 42.0% of patients seem to have an inadequate treatment. Eighty-five percent of treated patients reported to be compliant and felt that their pain was well managed despite a strong impact on their quality of life.The setting of a specific clinical pathway is essential to secure the standardized, optimal and efficient management of patients in pain. The assessment of patient satisfaction and quality of life must be integrated in clinical practice to identify patients in pain for which the treatment is inappropriate.

TPS10126 Background: Fatigue is a frequent side effect with oral targeted therapies (OTT). Physical activity has been reported to improve fatigue and quality of life (QoL). However, few studies focused on metastatic cancer patients and mainly among patients treated with chemotherapy. Furthermore, recent guidelines recommend evaluation and optimization of standardized exercise programs. The aim of our study is to evaluate home-based standard physical exercise program (SPEP) for metastatic cancer patients treated with OTT. Methods: This phase II-III study will randomize (2:1) patients starting first-line OTT for metastatic cancer between an individualized SPEP supervised by a personal coach, and recommended physical exercises via a booklet. Eligible patients will have received ≤2 lines of metastatic chemotherapy, ECOG PS ≤2, controlled pain (VAS < 3/10), and life expectancy ≥3 months. The phase II part (120 patients) will evaluate the feasibility of a 3-month SPEP using the rate of patients performing ≥50% of SPEP (2-stage Fleming: one-sided α = 5%; β = 85%). An interim analysis is planned after the phase II. The phase III will compare the efficacy of an SPEP as opposed to recommendations to reduce fatigue and/or improve physical well-being (PWB) dimensions of QoL (evaluated with FACT-G and FACT-F questionnaires). To show a difference of ≥5 points in PWB and 2.5 for fatigue (α = 2.5%; β = 80%), 312 patients are required in the phase III trial. . Secondary objectives include: PFS, OS, other dimensions of QoL, tolerability and observance of OTT, change in body composition, physical benefits, and a medico-economic study. The SPEP was developed by specialized coaches involved in physical activity and cancer. The study has Ethic committee approval and accrual is planned in 18 French centers in April 2017, for 30 months. This is the first randomized trial dedicated to patients with metastatic cancer treated with OTT evaluating the feasibility and the efficacy of a well design home based SPEP on fatigue and physical well-being.

Eribulin gained its approval in March 2011 for the treatment of patients with locally advanced or metastatic breast cancer (MBC) whose disease has progressed despite anthracycline and taxane-containing regimens. This study retrospectively assessed the efficacy, safety and cost of this treatment for all patients with MBC treated by eribulin in Franche-Comté. Ninety-four patients received eribulin between July 2006 and October 2013. The median age was 62 years (35-83). Median overall survival was 10.3 months [95% CI: 7.6 to 17.9]. Median progression-free-survival was 3.8 months [95% CI: 2.9 to 5.0]. Clinical benefit was obtained in 55% evaluable patients [95% CI: 43.1 to 66.9] by RECIST criteria. Most common grade 3-4 adverse events (AEs) were neutropenia (38%), asthenia (10%) and peripheral neuropathy (7%). Median cost of the treatment was 9767 € per patient (6344-17,517). This analysis found similar results to the EMBRACE study despite less selected population. A medico-economic evaluation cost-utility type would assess the effectiveness of this strategy compared to standard treatments.

Aim To carry out a cost-minimization analysis including a comparison of the costs arising from first-line treatment by trastuzumab plus docetaxel versus trastuzumab plus paclitaxel in patients with metastatic breast cancer. Methods All consecutive patients with human epidermal growth receptor 2-postive metastatic breast cancer who were treated at Besançon University Hospital and Saint Vincent private hospital between 2001 and 2010 by first-line therapy containing trastuzumab plus taxane were retrospectively studied. Economic analysis took into account costs related to drugs, hospitalization, and healthcare travel. Results Progression-free survival difference between the two treatments was not significant ( p = 0.65). First-line treatment by trastuzumab plus taxane was estimated at approximately €68,000 ( p = 0.74). The drug costs represented around 70–75% of the total cost, mainly related to the use of trastuzumab. Conclusion Our economic analysis shows that although the costs of the two trastuzumab plus taxane regimens are similar, they may contribute to the on-going debate about the availability and use of innovative chemotherapy drugs, in particular in human epidermal growth factor receptor 2-positive metastatic breast cancer with new therapies such as trastuzumab-DM1 and pertuzumab.

e11531 Background: There is a need to perform cost-effectiveness analysis for all new treatements approved for routine use based on national economical model. Eribuline, a new anti-microtubule inhibitor got approval for the treatment of patients with locally advanced or metastatic breast cancer who have progressed after an anthracycline, a taxane and a capecitabine containing regimens. Methods: All patients treated by eribulin in the Franche Comte region were prospectively monitored to assess efficacy, safety and cost-effectiveness of this new treatment based on a cost minimization strategy. The following costs were taken into account: drug, consultation with a medical oncologist, eventual supportive treatments, hospitalizations for treatment administration or for management of serious adverse events and the healthcare travels. Results: Ninety patients were treated by eribulin between July 2006 and October 2013. The median age was 58 (ranges: 32-79). A median number of 8 cycles (ranges 1 – 48) of eribulin...

1122 Background: It is debatable whether sentinal lymph node (SLN), before chemotherapy in locally breast cancer (LBC) is feasible. Impact on survival and locoregionally recurrence are unknown. Methods: 256 consecutive patients with LBC treated in Franche Comté (France) between 2004 and 2010 by standard neoadjuvant chemotherapy were retrospectively studied. 177 patients underwent axillary lymph node (ALN) dissection after chemotherapy (cohort A) and 79 patients underwent SLN before chemotherapy (cohort B). The aim of this study was designed to confirm the feasible of SLN before neoadjuvant chemotherapy without negative impact of recurrence and survival. Disease-free survival (DFS) and overall survival (OS) were calculated using Kaplan-Meier method. Differences in OS and DFS according ALN exploration were tested for significance using the Log-Rank test. Results: No statistically significant differences were observed in terms of median age (respectively 59 and 48 years in cohort A and B), tumor size, histological type, grading score, estrogen receptor, progesteron receptor and human epidermal receptor-2 status. No difference of breast conserving surgery was observed between cohort A and B (56.25 vs. 64.56%, p = 0.21). In cohort B, 38 patients (48.10%) of patients underwent SLN alone. For others patients (n = 41, 51.90%), secondary complete axillary lymphadenectomy was performed in the same time of breast surgery. After a median follow up of 57 months (range: 38-105), there was no significant difference in termsof local and axillary recurrences (1.13 vs. 1.27%), metastatic recurrence (11.30 vs. 11.40%). Five-year DFS (76 vs 81%, p = 0.55) and 5-year OS (91 vs. 97%, p = 0.76) did not differ between patients in cohort A and B. Conclusions: SLN before neoadjuvant chemotherapy is feasible and allows to avoid ALN dissection in nearly 50% of patients without impact on recurrence and survival.

e11579 Background: Clusterin (CLU) is a glycoprotein expressed constitutively in many tissues and involved in various physiopathological processes. Despite CLU expression is dysregulated in many types of cancer, the specific role of CLU in tumorigenesis remains unclear. The identification of several forms of the protein, with multiple roles is an explanation for these conflicting results. Cytoplasmic CLU (cCLU) has a role in breast tumorigenesis, cancer progression and is associated with breast cancer cell lines death in vitro. However contradictory data are reported about prognostic value of cCLU on survival and clinical progression. Our objective was to estimate patient’s overall survival (OS) according to the expression of cCLU. Methods: Histological and clinical data of 158 patients diagnosed with breast cancer were retrospectively recorded. Every patients were treated in a single French university hospital between 1993 and 2001. Histological samples had been reviewed to determine hormonal status, HER2 and clusterin expression. Immunohistochemical techniques were based on standards and recommendations applied at the time of analysis. Tumors were defined as cCLU positive (cCLU +) if its expression was superior to 10%. Overall Survival rates along with standard deviations were estimated using the Kaplan-Meier method. Differences in OS according to cCLU expression were tested for significance using the log-rank test. Results: Patients had a median age of 56 years (31 – 82 years). Among the 158 patients analyzed, cCLU was overexpressed in 31 patients (19.62%). The histopathologic and clinical characteristics were not statistically different according to clusterin expression even if a trend favouring less favourable tumoural characteristics were observed in cCLU positive tumour. The median follow-up was 14.1 years (11.3 - 19.3). In univariate analysis, cCLU overexpession were not related to OS (HR = 0.86; CI95%: 0.43 - 1.70). Ten-year OS was 76% (± 4) among patients with cCLU - tumors vs 77% (± 7) in patients with cCLU + tumor (p = 0.66). Conclusions: cCLU expression does not seem to be a pronostic factor of overall survival.