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The aim of this study on shared decision-making in the doctor–patient encounter about surgical treatment for early-stage breast cancer, conducted in a regional cancer centre in France, was to further the understanding of patient perceptions on shared decision-making. The study used methodological triangulation to collect data (both quantitative and qualitative) about patient preferences in the context of a clinical consultation in which surgeons followed a shared decision-making protocol. Data were analysed from a multi-disciplinary research perspective (social psychology and health economics). The triangulated data collection methods were questionnaires (n = 132), longitudinal interviews (n = 47) and observations of consultations (n = 26). Methodological triangulation revealed levels of divergence and complementarity between qualitative and quantitative results that suggest new perspectives on the three inter-related notions of decision-making, participation and information. Patients' responses revealed important differences between shared decision-making and participation per se. The authors note that subjecting patients to a normative behavioural model of shared decision-making in an era when paradigms of medical authority are shifting may undermine the patient's quest for what he or she believes is a more important right: a guarantee of the best care available.

Prognostic signification of micrometastases ou isolated tumor cells (ITC) has not yet been clearly precised. Management of the axilla in case of micrometastases or ITC depends on the local pratices: no surgical completion or axillary lymph node dissection (ALND). Axillary lymph node status is the most important prognostic factor in patients with breast cancer; morbidity of ALND is now well known whereas its therapeutic benefit has not been demonstrated. This study is based on a retrospective database of 1375 patients who underwent sentinel node (SN) biopsy for breast cancer. In case of micrometastase or ITC in SN with completion axillary dissection, we examined if non-sentinel lymph node status has changed the indications of adjuvant treatments (chimiotherapy or radiotherapy). The results of our study show that non-sentinel lymph node status modify systemic therapy for a very few patients (less than 4% concerning chimiotherapy and less than 15% concerning radiotherapy).

International audience; PURPOSE: The risk of non sentinel node (NSN) involvement varies in function of the characteristics of sentinel nodes (SN) and primary tumor. Our aim was to determine and validate a statistical tool (a nomogram) able to predict the risk of NSN involvement in case of SN micro or sub-micrometastasis of breast cancer. We have compared this monogram with other models described in the literature. METHODS: We have collected data on 905 patients, then 484 other patients, to build and validate the nomogram and compare it with other published scores and nomograms. RESULTS: Multivariate analysis conducted on the data of the first cohort allowed us to define a nomogram based on 5 criteria: the method of SN detection (immunohistochemistry or by standard coloration with HES); the ratio of positive SN out of total removed SN; the pathologic size of the tumor; the histological type; and the presence (or not) of lympho-vascular invasion. The nomogram developed here is the only one dedicated to micrometastasis and developed on the basis of two large cohorts. The results of this statistical tool in the calculation of the risk of NSN involvement is similar to those of the MSKCC (the similarly more effective nomogram according to the literature), with a lower rate of false negatives. CONCLUSION: this nomogram is dedicated specifically to cases of SN involvement by metastasis lower or equal to 2 mm. It could be used in clinical practice in the way to omit ALND when the risk of NSN involvement is low.

Infiltrating MBC represents less than 1% of all male cancers. Our study details clinico-pathological features, treatments and prognostic factors in a large French cohort.Four hundred and eighty-nine patients were collected from 1990 to 2005. Median age was 66 years (34% over 70 years) and median follow-up 58 months.According to TN classification, we found T(1): 39%, T(2): 41%, T(3)T(4): 9%, T(x): 11% and N(1)N(2): 27%. Lumpectomy (L) and mastectomy (M) were performed in 8.6% and 91.4% of the cases. Axillary dissection (AD), sentinel node biopsy or both were performed in 90%, 2% and 5% of the cases, respectively. Ninety-five percent of tumours were ductal carcinomas; 47% were pT(1), 20% pT(2) and 33% pT(3)-T(4). Axillary nodal involvement was present in 52.8% cases. ER and PgR were positive in 92% and 89% cases. Radiotherapy (RT) was performed in 85% of the patients. Hormonal treatment (HT) was delivered in 72% of the cases. Tamoxifen and aromatase inhibitors were used in 85% and 12% of the cases; 34% of the patients received chemotherapy (CT). Local recurrence (LR), nodal recurrences (NR) and metastases occurred in 2%, 5% and 22% of the cases; 2% and 10% developed contralateral BC and second cancer. The 5- and 10-year overall survival (OS) rates were 81% and 59%; disease-specific survivals (DSS) were 89% and 72%. Death causes were BC 56%, second cancer 8%, complications 3%, intercurrent disease 15% and unknown 18%. In a univariate analysis, metastatic risk factors were T stage (T1: 19%, T(2): 26%, T(3)T(4): 40%; p=0.013), pN status (pN(0): 12% pN(1-3): 26% pN(3): 44%; p0.0001) and presence of locoregional recurrence (62% versus 18% p0.0001). In a multivariate analysis, axillary nodal involvement and high SBR remain prognostic factors.Earlier diagnosis and wide use of adjuvant treatments (RT/HT/CT) widely decreased LR and increased survival rates in MBC, reaching female ones. Prognostic factors were also very similar to female ones.

PurposeTo determine the rate of nonsentinel lymph node (NSN) involvement at axillary lymph node dissection (ALND) and predictive factors of this involvement following detection of micrometastasis in sentinel nodes (SN).MethodsWe analyzed 700 observations of SN micrometastases with additional ALND with the characteristics of the patients, tumors, and SN.ResultsInvolvement of SN was diagnosed 388 times by serial sections (55.4%) with standard hemoxylin and eosin staining (HES) and 312 times solely on immunohistochemical analysis (IHC; 44.6%). The accurate size of the micrometastases was indicated in 488 cases: 301 larger than 0.2 mm (61.7%) and 187 ≤ 0.2 mm (38.3%). Ninety-four patients (13.4%) presented an NSN involvement with only one NSN involved in 62 cases (66%). Predictive factors of NSN involvement were in univariate analysis (pT stage [P < .000], menopausal status [P = .048], T stage [P = .006], grade [P = .013], lymphovascular invasion [LVI; P = .013], histologic tumor type [P = .017], and method of micrometastasis detection, by HES or IHC [P = .015]) and in multivariate analysis (pT stage ≤ or > 20 mm [odds ratio, 2.54], micrometastases detected by HES or IHC [odds ratio,1.734], presence or absence of LVI [odds ratio, 1.706]). Micrometastasis size ≤ or greater than 0.2 mm was not predictive.ConclusionThis study confirms the value of serial sections and the vital role played by IHC in screening for small micrometastases. Omission of additional ALND may be envisaged with minimal risk for pT1a and pT1b tumors, and pT1a-b-c tumors corresponding to tubular, colloidal, or medullar cancers.

Resume Objectif Cette etude analyse les resultats de la « pratique clinique courante » chez 882 patientes traitees pour un carcinome canalaire in situ (CCIS) pur du sein dans 9 centres de lutte contre le cancer francais entre 1985 et 1995. Methode L’âge median etait de 53 ans ; 177 patientes (20 %) ont eu une mastectomie (M), 190 (22 %) une chirurgie conservatrice seule (CS) et 515 (58 %) une CS avec radiotherapie (CS + RT). Resultats Avec un recul median de 7 ans, les taux de recidive locale (RL) etaient de 2 %, 31 % et 13 % dans les groupes M, CS et CS + RT (p 60 ans (non significatif). Dans le groupe CS + RT, ces taux passent a 33 %, 13 % et 8 % (p Conclusion La mastectomie reste le traitement le plus sur des CCIS, assurant un controle local a 7 ans de 98 %. Dans notre etude, apres CS, la RT diminue tres significativement les taux de RL, avec des chiffres comparables a ceux des essais randomises NSABP B-17 et EORTC 10853. Le benefice de la RT est trouve dans tous les sous-groupes, quels que soient les facteurs cliniques ou histologiques consideres, mais son importance est variable. L’âge inferieur a 40 ans et l’exerese incomplete restent les deux facteurs majeurs de RL.

Resume Objectif Cette etude analyse les resultats de la « pratique clinique courante » chez 882 patientes traitees pour un carcinome canalaire in situ (CCIS) pur du sein dans 9 centres de lutte contre le cancer francais entre 1985 et 1995. Methode L’âge median etait de 53 ans ; 177 patientes (20 %) ont eu une mastectomie (M), 190 (22 %) une chirurgie conservatrice seule (CS) et 515 (58 %) une CS avec radiotherapie (CS + RT). Resultats Avec un recul median de 7 ans, les taux de recidive locale (RL) etaient de 2 %, 31 % et 13 % dans les groupes M, CS et CS + RT (p 60 ans (non significatif). Dans le groupe CS + RT, ces taux passent a 33 %, 13 % et 8 % (p Conclusion La mastectomie reste le traitement le plus sur des CCIS, assurant un controle local a 7 ans de 98 %. Dans notre etude, apres CS, la RT diminue tres significativement les taux de RL, avec des chiffres comparables a ceux des essais randomises NSABP B-17 et EORTC 10853. Le benefice de la RT est trouve dans tous les sous-groupes, quels que soient les facteurs cliniques ou histologiques consideres, mais son importance est variable. L’âge inferieur a 40 ans et l’exerese incomplete restent les deux facteurs majeurs de RL.

Objective To assess the significance of patients' input in the elaboration of a patient information booklet. Design Qualitative study based on focus group discussions. Setting Centre Leon Berard, a comprehensive cancer centre in the Rhone-Alpes region of France. Participants (1) A multidisciplinary working group (oncologists, health economists and one clinical psychologist) wrote up initial information documents concerning possible breast cancer treatments. (2) A focus group comprised of patients with a history of breast cancer and healthy volunteers discussed their reactions to these documents. Main outcome measure Analysis of the focus group's reactions according to key themes predetermined by the working group and related themes introduced by the focus group itself. Results The focus group proposed numerous, significant modifications to answer requests for additional information, clarification and better readability in the information booklets. Discussion/Conclusions This qualitative analysis showed a significant input of patients' perspective in the elaboration of patient information. It is also an additional support to the feasibility and appropriateness of the focus group technique. The next stage will be to test whether information documents produced here conform to the needs of patients currently undergoing treatment.

To assess the clinical and histological characteristics of breast cancer (BC) occurring after Hodgkin's disease (HD) and give possible therapies and prevention methods.In a retrospective multicentric analysis, 117 women and two men treated for HD subsequently developed 133 BCs. The median age at diagnosis of HD was 24 years. The HD stages were stage I in 25 cases (21%), stage II in 70 cases (59%), stage III in 13 cases (11%), stage IV in six cases (5%) and not specified in five cases (4%). Radiotherapy (RT) was used alone in 74 patients (63%) and combined modalities with chemotherapy (CT) was used in 43 patients (37%).BC occurred after a median interval of 16 years. TNM classification (UICC, 1978) showed 15 T0 (11.3%), 44 T1 (33.1%), 36 T2 (27.1%), nine T3 (6.7%), 15 T4 (11.3%) and 14 Tx (10.5%). Ductal infiltrating carcinoma and ductal carcinoma in situ (DCIS) represented 81.2 and 11.3% of the cases, respectively. Among the infiltrating carcinoma, the axillary involvement rate was 50%. Seventy-four tumours were treated by mastectomy without (67) or with (ten) RT. Forty-four tumours had lumpectomy without (12) or with (32) RT. Another four received RT alone, and one CT alone. Sixteen patients (12%) developed isolated local recurrence. Thirty-nine patients (31.7%) developed metastases and 34 died; 38 are in complete remission whereas five died of intercurrent disease. The 5-year disease-specific survival rate was 65.1%. The 5-year disease-specific survival rates for the pN0, pN1-3 and pN3 groups were 91, 66 and 15%, respectively (P0.0001), and 100, 88, and 64% for the TIS, T1 and T2. For the T3 and T4, the survival rates decreased sharply to 32 and 23%, respectively. These secondary BC are of two types: a large number of aggressive tumours with a very unfavourable prognosis (especially in the case of pN3 and/or T3T4), and many tumours with a 'slow spreading' such as DCIS and microinvasive lesions. These lesions developed especially in patients treated exclusively by RT.The young women and girls treated for HD should be carefully monitored in the long-term by clinical examination, mammography and ultrasonography. We suggest that a baseline mammography is performed 5-8 years after supradiaphragmatic irradiation (complete mantle or involved field) in patients who were treated before 30 years of age. Subsequent mammographies should be performed every 2 years or each year, depending on the characteristics of the breast tissue (e.g. density) and especially in the case of an association with other BC risk factors. This screening seems of importance due to excellent prognosis in our T(1S)T(1) groups, and the possibility of offering these young women a conservative treatment.

Objectives: To conduct a survey of the angiosarcomas developing after breast conservation for carcinoma in the French Cancer Centers, to study the evolution of these cases in detail, and to review literature in an attempt to propose an optimal treatment scheme. Material and Methods: Eleven of the 20 French Cancer Centers agreed to research and retrospectively analyze all angiosarcomas discovered in patients previously treated by conservative treatment. The majority of the patients were node negative, T1N0M0. The mean age of the patients at the time of primary breast cancer treatment was 62.5 years, and 69 years at the diagnosis of the angiosarcoma. Results: During the last two decades, nearly 20,000 patients have been treated conservatively in these 11 centers, and only 9 cases of angiosarcoma were found. The median latency period between the treatment of the breast carcinoma and the diagnosis of the breast angiosarcoma was approximately 74 months, with a range of 57–108 months. Mastectomy was performed as the main treatment of this angiosarcoma. All recurrences after mastectomy for the angiosarcoma appeared within 16 months after the mastectomy. A median time of recurrence was found to be 7.5 months, regardless of the treatment. The angiosarcomas appeared to be very aggressive, and chemotherapy, radiotherapy, and sometimes hyperthermia could only palliate the condition for a short time. After the diagnosis of angiosarcoma, the median survival was 15.5 months, showing a particularly poor prognosis. Only 1 patient of 9 is alive without progressive disease at 32 months after salvage mastectomy for the recurrence of the angiosarcoma. Precise data obtained from 11 centers show that, of 18115 breast carcinomas treated conservatively, only 9 breast angiosarcomas are reported, which represents a prevalence of 5 cases of angiosarcoma per 10,000, which is the same prevalence for primary breast angiosarcomas occurring in healthy breasts. Conclusion: Angiosarcoma developing after breast conserving therapy for carcinoma is a rare event, and induction of it by treatment is controversial. However, early diagnosis is essential and it appears that radical mastectomy gives the highest chance of cure and the best long-term survival.

Resume But de l'etude Ce travail portant sur le ganglion axillaire sentinelle dans le cancer du sein a pour objet d'etudier la faisabilite technique de son individualisation et la predictivite sur le statut lymphatique de l'aisselle. Patients et methodes Entre janvier 1996 et juin 1997, 128 malades atteints de cancers invasifs du sein ont beneficie, aux centres regionaux de lutte contre le cancer de Strasbourg et de Lyon, d'une individualisation du ganglion axillaire sentinelle par injection de colorant lymphotrope (bleu Patent) suivie d'une lymphadenectomie axillaire (etages I a II de Berg). Resultats Le taux d'opacification du ganglion axillaire sentinelle a ete de 76,5 % et sa predictivite du statut axillaire de 94,9 %. Le taux de faux negatifs de la procedure a ete de 5,1 %. L'envahissement histologique du ganglion axillaire sentinelle a ete de 43,9 % et son envahissement etait isole dans 30,2 %. La sensibilite de la technique a ete de 94 % (IC95 % = [88 %–98 %]) et sa specificite de 100 %. Conclusion Bien que devant etre encore consideree comme une voie de recherche en cours d'evaluation dans le cadre d'essais prospectifs controles, cette etude atteste de la faisabilite et de la reproductibilite d'une technique qui devrait, dans un proche avenir, ouvrir la voie d'une chirurgie axillaire mini-invasive de stadification dans les cancers du sein.

Since tamoxifen is widely used in breast cancer treatment and has been proposed for the prevention of breast cancer, its endometrial iatrogenic effects must be carefully examined. We have investigated the association between endometrial cancer and tamoxifen use or other treatments in women treated for breast cancer in a case-control study. Cases of endometrial cancer diagnosed after breast cancer (n = 135) and 467 controls matched for age, year of diagnosis of breast cancer and hospital and survival time with an intact uterus were included. Women who had received tamoxifen were significantly more likely to have endometrial cancer diagnosed than those who had not (crude relative risk = 4.9, p = 0.0001). Univariate and adjusted analyses showed that the risk increased with the length of treatment (p = 0.0001) or the cumulative dose of tamoxifen received (p = 0.0001), irrespective of the daily dose. Women who had undergone pelvic radiotherapy also had a higher risk (crude relative risk = 7.8, p = 0.0001). After adjusting for confounding factors, the risk was higher for tamoxifen users (p = 0.0012), treatment for more than 3 years (all p < 0.03) and pelvic radiotherapy (p = 0.012). Women who had endometrial cancer and had received tamoxifen had more advanced disease and poorer prognosis than those with endometrial cancer who had not received this treatment. Our results suggest a causal role of tamoxifen in endometrial cancer, particularly when used as currently proposed for breast cancer prevention. Pelvic radiotherapy may be an additional iatrogenic factor for women with breast cancer. Endometrial cancers diagnosed in women treated with tamoxifen have poorer prognosis. Women who receive tamoxifen for breast cancer should be offered gynaecological surveillance during and after treatment. A long-term evaluation of the risk-benefit ratio of tamoxifen as a preventive treatment for breast cancer is clearly warranted.

Resume But de l'etude L'amelioration spectaculaire de la survie des patients traites pour une maladie de Hodgkin (MH) a permis l'analyse du devenir des patients survivant a long terme. Ces derniers ont eu un certain nombre de complications, dont des neoplasies secondaires constituant le probleme le plus important. Plusieurs travaux recents font etat d'une augmentation de l'incidence des cancers du sein (CS) chez les jeunes femmes et les enfants traites pour une MH. Materiel et methodes Dans une etude retrospective realisee dans 11 centres de lutte contre le cancer, nous avons recense 63 femmes traitees pour MH et ayant ulterieurement developpe un cancer du sein. Nous avons analyse les resultats obtenus chez 13 patientes (21 %) qui ont eu un cancer du sein bilateral soit synchrone (cinq patientes), soit metachrone (huit patientes). L'âge moyen lors du traitement de la MH etait de 19 ans. Sept patientes avaient ete traitees par irradiation exclusive (comprenant une irradiation sus-diaphragmatiquedetype ≪ mantelet ≫ et six par association chimiotherapie-radiotherapie. Resultats Le delai moyen d'apparition du premier cancer du sein a ete de 16 ans. Selon la classification TNM, on notait: neuf tumeurs de stade T0, quatre tumeurs de stade T1, cinq tumeurs de stade T2, une tumeur de stade T3, deux tumeurs de stade T4 et cinq tumeurs de stade Tx; il y avait 17 carcinomes infiltrants, deux fibrosarcomes et sept carcinomes canalaires in situ. Un envahissement ganglionnaire a ete retrouve dans dix des 15 curages realises pour des cancers infiltrants. Globalement, 17 tumeurs ont ete traitees par chirurgie radicale et neuf par association radiochirurgicale conservatrice. Avec un suivi moyen de 70 mois (extremes: 15–125), trois patientes ont eu une recidive locale et/ou regionale et quatre des metastases. Huit patientes etaient en vie sans signe de maladie et une est decedee d'affection intercurrente. Conclusion Dans la litterature, les cancers du sein representent de 6,3 a 9 % des neoplasies secondaires apres traitement pour MH, mais le risque est beaucoup plus eleve chez les jeunes filles traitees avant 20 ans, et plus particulierement avant 15 ans. Les facteurs favorisants sont: l'irradiation, la jeunesse lors du traitement, la chimiotherapie par agents alkylants, et peut-etre des facteurs genetiques. Ces femmes doivent beneficier d'une surveillance senologique tres reguliere et prolongee, cela au minimum des la fin de la 10e annee apres la fin du traitement de la MH. Un traitement conservateur pour ces cancers du sein secondaires est parfois possible.

Purpose Ductal carcinoma in situ overall prognosis is excellent, but after breast conserving surgery, with or without radiotherapy, local recurrences can lead to locoregional or distant evolution and death. However, there are few data on optimal local recurrences treatment and long-term impact on survival. Patients and methods This study included 195 women treated from 1985 to 1996 by conservative surgery (CS) or conservative surgery followed by radiotherapy (CS + RT), presenting local recurrences, with a 156-month median follow-up. Results Eighty-two out of 195 (42%) local recurrences were non-invasive (in situ) and 113 (58%) invasive. In situ local recurrence was discovered by mammography in 80.5% of the cases versus 47.5% for invasive local recurrence (P = 0.0001). Salvage mastectomy was used in 53% of the cases after conservative surgery and 75% after conservative surgery followed by radiotherapy. The axillary nodal involvement rates were 11.8% and 25.8% among 17 and 62 patients with in situ and invasive local recurrences. Among 113 patients with invasive local recurrences and 82 with in situ local recurrences, 19 (16.8%) and three (3.6%) developed metastases, respectively. Among invasive local recurrences, comedocarcinoma subtype was highly predictive of subsequent metastases (32% versus 4.4%, P Conclusion Invasive local recurrence after ductal carcinoma in situ treatment could be a dramatic event, fully changing long-term prognosis. Early mammographic local recurrence diagnosis (if possible still at non-invasive stage) seems essential to avoid or minimize metastatic risk. Mastectomy remains the safest option but, in some cases, a new conservative approach could be discussed.

Purpose Medical practices in oncology are expected to be multidisciplinary, yet few articles studied how this may be concretely applied. In the present study, we evaluated the organization of two multidisciplinary committees, one for breast cancer and one for sarcoma, in a French Comprehensive Cancer Centre. Methods Both tumours were specifically chosen so as to emphasise substantial differences in relation with incidence, histological subtypes, management strategy, and scientific evidence. Between 2003 and 2004, 404 decision processes were observed, 210 for sarcoma (26 meetings) and 194 for breast cancer (10 meetings). The number of physicians who took part in the discussions and their medical specialties were systematically noted as well as the number of contradictory discussions, medical specialties represented in these contradictory discussions and the topics of contradiction. The last measured data was whether the final committee's decision was in conformity with the referent preferences or not. All these measures were related to the referent's medical speciality and working place, to the stage of the disease and to the disease management stage. Results Committees’ specificities concerned their organization, referent's medical specialties, the number of participants in discussions and their medical specialties. Discussions in the sarcoma committee tended to be more multidisciplinary, involving more specialties. Initial strategy proposal for one patient was modified during the discussions for 86 patients out of 210 (41%) and for 62 out of 194 (32%) respectively for sarcoma and breast cancer. However, there was no significant difference in the rate of contradictory discussions between breast cancer and sarcoma committees (32% versus 41% respectively; P = 0.08). The rates of contradictory discussions were similar for localized cancers, local relapse and metastasis disease (37%, 41% and 34% respectively; P = 0.86). Conclusions The present study reports more than 30% of changes concerning strategy for patient with cancer due to multidisciplinary discussions. This indicates that, providing tumour committees are adapted to the pathologies’ characteristics, they can promote a collective and multidisciplinary approach to oncology.

Our objective was to assess the global cost of the sentinel lymph node detection [axillary sentinel lymph node detection (ASLND)] compared with standard axillary lymphadenectomy [axillary lymph node dissection (ALND)] for early breast cancer patients.We conducted a prospective, multi-institutional, observational, cost comparative analysis. Cost calculations were realized with the micro-costing method from the diagnosis until 1 month after the last surgery.Eight hundred and thirty nine patients were included in the ASLND group and 146 in the ALND group. The cost generated for a patient with an ASLND, with one preoperative scintigraphy, a combined method for sentinel node detection, an intraoperative pathological analysis without lymphadenectomy, was lower than the cost generated for a patient with lymphadenectomy [€ 2947 (σ = 580) versus € 3331 (σ = 902); P = 0.0001].ASLND, involving expensive techniques, was finally less expensive than ALND. The length of hospital stay was the cost driver of these procedures. The current observational study points the heterogeneous practices for this validated and largely diffused technique. Several technical choices have an impact on the cost of ASLND, as intraoperative analysis allowing to reduce rehospitalization rate for secondary lymphadenectomy or preoperative scintigraphy, suggesting possible savings on hospital resources.

Background After breast conservative treatment (BCT), young age is a predictive factor for recurrence in patients with Ductal Carcinoma In Situ (DCIS) of the breast. The purpose of this study was to evaluate predictive factors for recurrence and outcomes in these younger women (under 40 years) treated for pure DCIS. Methods From 1974 to 2003, 207 cases were collected in 12 French Cancer Centers. Median age was 36.3 years and median follow-up 160 months. Seventy four (35.8%) underwent mastectomy, 67 (32.4%) lumpectomy alone and 66 (31.9%) lumpectomy plus radiotherapy. Results 37 recurrences occurred (17.8%): 14 (38%) were in situ and 23 (62%) invasive. After BCT, the overall rate of recurrence was 27% (33% in the lumpectomy plus radiotherapy group vs. 21% in the lumpectomy alone group). Comedocarcinoma subtype ( p = 0.004), histological size more than 10 mm ( p = 0.011), necrosis ( p = 0.022) and positive margin status ( p = 0.019) were statistically significant predictive factors for recurrence. The actuarial 15-year rates of local recurrence were 29%, 42% and 37% in the lumpectomy alone, lumpectomy and whole breast radiotherapy and lumpectomy + whole breast radiotherapy with additional boost groups respectively. After recurrence, the 10-year overall survival rate was 67.2%. Conclusion High recurrence rates (mainly invasive) after BCT in young women with DCIS are confirmed. BCT in this subgroup of patients is possible if clear and large margins are obtained, tumor size is under 11 mm and necrosis- and/or comedocarcinoma-free.

Background To prospectively determine the feasibility of sentinel lymph node biopsy (SLNB) in preoperatively diagnosed multiple unilateral synchronous invasive breast cancers. Patients and methods The Interest of Axillary Sentinel Lymph Node Biopsy in Multiple Invasive Breast Cancer (IGASSU) study was a prospective multi-institutional study with initial breast surgery, SLNB, and systematic axillary lymph node dissection (ALND). Patients eligible for the IGASSU study had an operable invasive multiple synchronous tumor (MST), defined as two or more physically separate invasive tumors in the same or different quadrant. Results From 1 March 2006 to 31 August 2007, 216 patients were prospectively included from 16 institutions. Of these patients, 211 were assessable. The SLNB-identified rate was 93.4% (197 of 211). The false-negative rate (FNR) was 13.6% (14 of 103) [95% confidence interval (CI) 7% to 20%], and the accuracy was 92.9% (183 of 197) (95% CI 89% to 96%). In a univariate analysis, tumor location (only external location versus other location) was the only clinicopathological factor influencing the FNR [22% (11%–33%) versus 7% (4%–10%)], even then median aggregate histological tumor size was smaller in external tumors [17 mm (range 12–80 mm) versus 34 mm (range 8–90 mm), P = 0.016]. Conclusion With a FNR of 13.6%, we do not recommend SLNB as a routine procedure for MST, even for small tumor.

Purpose Predictive factors of non-sentinel lymph node (NSN) involvement at axillary lymph node dissection (ALND) have been studied in the case of sentinel node (SN) involvement, with validation of a nomogram. This nomogram is not accurate for SN micrometastasis. The purpose of our study was to determine a nomogram for predicting the likelihood of NSN involvement in breast cancer patients with a SN micrometastasis. Methods We collated 909 observations of SN micrometastases with additional ALND. Characteristics of the patients, tumours and SN were analysed. Results Involvement of SN was diagnosed 490 times (53.9%) with standard staining (HES) and 419 times solely on immunohistochemical analysis (IHC) (46.1%). NSN invasion was observed in 114 patients (12.5%), whereas 62.3% (71) had only one NSN involved and 37.7% (43) two or more NSN involved. In multivariate analysis, significant predictive factors were: tumour size (pT stage ≤10 mm or >11 and ≤20 or >20 mm [odds ratio (OR) 2.1 and 3.43], micrometastases detected by HES or IHC [OR 1.64], presence or absence of lymphovascular invasion (LVI) [OR 1.76], tumour histological type mixed or not [OR 2.64]. The rate and probability of NSN involvement with the model are given for 24 groups, with a representation by a nomogram. Conclusion One group, corresponding to 10.1% of the patients, was associated with a risk of NSN involvement of less than 5%, and five groups, corresponding to 29.8% of the patients, were associated with a risk ≤10%. Omission of ALND could be proposed with minimal risk for a low probability of NSN involvement.

In France, patients’ claim for information and participation to medical decision-making was initiated in the eighties by AIDS associations, then reinforced by the tainted blood scandal and more recently by demands from cancer patients. The right to patient information was recognised on March 4th 2002 by the law pertaining to patients’ rights and the quality of the healthcare system. The present article will explore this background by examining the bases, the current status and the development of shared decision-making in the physician-patient encounter in France. We will describe the evolution of the physician-patient relationship on the basis of legal and administrative documents, then show that patients’ information, and more generally healthcare users’ information, is a central concern for some national health institutions. Finally, we will demonstrate that even if the literature on shared decision-making is little developed in France as compared to other European countries, Northern America and Australia, some studies have nonetheless been conducted. Their results, combined with a legal context and national health institutions encouraging shared decision-making, should prompt otherwise reluctant healthcare professionals to implement this approach in everyday medical practice.

Purpose To determine the optimal injection path for blue dye and radiocolloid for sentinel lymph node (SLN) biopsy in early breast cancer. Patients and Methods A prospective randomized multicentric study was initiated to compare the peritumoral (PT) injection site to the periareolar (PA) site in 449 patients. Results The detection rate of axillary SLN by lymphoscintigraphy was significantly higher (P = .03) in the PA group (85.2%) than in the PT group (73.2%). Intraoperative detection rate by blue dye and/or gamma probe was similar (99.11%) in both groups. The rate of SLN detection was somewhat higher in the PA group than in the PT group: 95.6% versus 93.8% with blue dye (P = .24) and 98.2% versus 96.0% by probe (P = .16), respectively. The number of SLNs detected by lymphoscintigraphy and by probe was significantly higher in the PA group than in the PT group, 1.5 versus 1.2 (P = .001) and 1.9 versus 1.7 (P = .02). The blue and hot concordance was 95.6% in the PA group and 91.5% in the PT group (P = .08). The mean ex vivo count of the SLN was significantly higher in the PA group than in the PT group (P < .0001). Conclusion This study strongly validates the PA injection technique given the high detection rate (99.1%) of SLN and the high concordance (95.6%) between blue dye and the radiotracer, as well as higher significant ex and in vivo counts, improving SLN probe detection.

Objectives: The feasibility and accuracy of sentinel lymph node biopsy (SLNB) in the treatment of breast cancer is widely acknowledged today. The aim of our study was to compare the hospital-related costs of this strategy with those of conventional axillary lymph node dissection (ALND).Methods: A retrospective study was carried out to determine the total direct medical costs for each of the two medical strategies. Two patient samples (n=43 for ALND; n=48 for SLNB) were selected at random among breast cancer patients at the Centre Léon Bérard, a comprehensive cancer treatment center in Lyon, France. Costs related to ALND carried out after SLNB (either immediately or at a later date) were included in SLNB costs (n=18 of 48 patients).Results: Total direct medical costs were significantly different in the two groups (median 1,965.86€ versus 1,429.93€, p=0.0076, Mann-Whitney U-test). The total cost for SLNB decreased even further for patients who underwent SLNB alone (median, 1,301€). Despite the high cost of anatomic pathology examinations and nuclear medicine (both favorable to ALND), the difference in direct medical costs for the two strategies was primarily due to the length of hospitalization, which differs significantly depending on the technique used (9-day median for ALND versus 3 days for SLNB, pConclusions: A lower morbidity rate is favorable to the generalization of SLNB, when the patient's clinical state allows for it. From an economic point of view, SLNB also seems to be preferred, particularly because our results confirm those found in two published studies concerning the cost of SLNB.

Tamoxifen has been used for two decades as adjuvant therapy for breast cancer. It is also now being used to try and prevent this disease in women at high risk. A series of 89 patients who developed endometrial cancer on adjuvant has been identified from nine French cancer institutes. Although there was a high frequency of superficial, generally well-differentiated forms, some patients did have aggressive disease with a relatively poor outcome and there were 10 deaths from endometrial carcinoma. These data support gynaecological surveillance of women receiving tamoxifen therapy.

To assess the long-term outcome for women with ductal carcinoma in situ of the breast treated in current clinical practice by conservative surgery with or without definitive breast irradiation.We analyzed 705 cases of ductal carcinoma in situ treated between 1985 and 1995 in nine French regional cancer centers; 515 underwent conservative surgery and radiotherapy (CS+RT) and 190 CS alone. The median follow-up was 7 years.The 7-year crude local recurrence (LR) rate was 12.6% (95% confidence interval [CI] 9.4-15.8) and 32.4% (95% CI 25-39.7) for the CS+RT and CS groups, respectively (p0.0001). The respective 10-year results were 18.2% (95% CI 13.3-23) and 43.8% (95% CI 30-57.7). A total of 125 LRs occurred, 66 and 59 in the CS+RT and CS groups, respectively. Invasive or microinvasive LRs occurred in 60.6% and 52% of the cases in the same respective groups. The median time to LR development was 55 and 41 months. Nine (1.7%) and 6 (3.1%) nodal recurrences occurred in the CS+RT and CS groups, respectively. Distant metastases occurred in 1.4% and 3% of the respective groups. Patient age and excision quality (final margin status) were both significantly associated with LR risk in the CS+RT group: the LR rate was 29%, 13%, and 8% among women agedor =40, 41-60, andor =61 years (p0.001). Even in the case of complete excision, we observed a 24% rate of LR (6 of 25) in women40 years. Patients with negative, positive, or uncertain margins had a 7-year crude LR rate of 9.7%, 25.2%, and 12.2%, respectively (p = 0.008). RT reduced the LR rate in all subgroups, especially in those with comedocarcinoma (17% vs. 59% in the CS+RT and CS groups, respectively, p0.0001) and mixed cribriform/papillary tumors (9% vs. 31%, p0.0001). In the multivariate Cox regression model, young age and positive margins remained significant in the CS+RT group (p = 0.00012 and p = 0.016). Finally, the relative LR risk in the CS+RT group compared with the CS group was 0.35 (95% CI 0.25-0.51, p = 0.0001). Subsequent contralateral breast cancer occurred in 7.1% and 7.5% of the patients in the CS+RT and CS groups, respectively.Despite the absence of randomization, our results are extremely consistent with the updated National Surgical Adjuvant Breast Project B17 and European Organization for Research and Treatment of Cancer 10853 trials. We also noted that the LR risk was very high in women40 years and/or in the case of incomplete excision.

Until now, less than 5% of the patients with breast ductal carcinoma in situ (DCIS) have been enrolled in clinical trials. Consequently, we have analysed the results of ‘current practice’ among 716 women treated in eight French Cancer Centres from 1985 to 1992: 441 cases (61.6%) corresponded to impalpable lesions, 92 had a clinical size of less than or equal to 2 cm and 70 from 2 to 5 cm; in 113 cases, the size was unspecified. Median age was 53.2 years (range: 21–87 years). 145 patients underwent mastectomy (RS) and 571 conservative surgery (CS) without (136) or with (435) radiotherapy (CS+RT). The mean histological tumour sizes in these three groups were 25.6, 8.2, 14.8 mm, respectively (P

The aim of this study was to evaluate the reliability and accuracy of sentinel node biopsy for invasive breast cancer and the predictability of axillary node status. Between January 1996 and June 1997 a total of 73 patients underwent patent blue dye lymphatic mapping and sentinel node biopsy followed by standard (level I and II) axillary node dissection (one bilateral procedure). The sentinel node was identified in 82.4% (61/74) of the cases and was predictive of axillary status in 96.7% (59/61). The false-negative rate of the procedure was 8.0% (2/25). The sentinel node was involved in 37.7% (23/61) and was the only one invaded in 30.4% (7/23). The sensitivity of the procedure was 92% (CI95% 74–99%) and its specificity 100%. It is currently considered to be an attractive new procedure undergoing evaluation in prospective controlled trials. This study confirmed the reliability and reproducibility of intraoperative lymphatic mapping and sentinel node biopsy. This is the first step toward a new era of minimally invasive axillary surgery for breast cancer.

In a retrospective multicentric analysis, 63 women treated between 1941 to 1988 for Hodgkin's disease (HD) subsequently developed 76 breast cancers (BC). The median age at diagnosis of HD was 26 years (range 7-67), and 22 women (35%) were 20 years old or less. Exclusive radiotherapy (RT) was used in 36 women (57%) and combined modalities with chemotherapy (CT) in 25 (39%). Breast cancer occurred after a median interval of 16 years (range 2-40) and the median age at diagnosis of the first BC was 42 years (range 25-73). TNM classification (UICC, 1978) showed 10 T0 (non-palpable lesions) (13%), 20 T1 (26%), 22 T2 (29%), 8 T3 (11%), 7 T4 (9%) and 9 Tx (12%), giving altogether a total of 76 tumours, including, respectively, 5 and 8 bilateral synchronous and metachronous lesions. Among the 68 tumours initially discovered, 53 ductal infiltrating, one lobular infiltrating and two medullary carcinomas were found. Moreover, two fibrosarcomas and 10 ductal carcinoma in situ (DCIS) were also found. Among 50 axillary dissections for invasive carcinomas, histological involvement was found in 31 cases (62%). 45 tumours were treated by mastectomy, without (n = 35) or with (n = 10) RT. 27 tumours had lumpectomy, without (n = 7) or with RT (n = 20). 2 others received RT only, and one only CT. 7 patients (11%) developed isolated local recurrence. 20 patients (32%) developed metastases and all died; 38 are in complete remission, whereas 5 died of intercurrent disease. The 5-year disease-specific survival rate by the Kaplan-Meier method was 61%. The 5-year disease-specific survival rate for pN0, pN1-3 and pNor = 3 groups were 91%, 66% and 0%, respectively (P0.0001) and 100%, 88%, 64% and 23% for the T0, T1, T2 and T3T4 groups, respectively. These secondary BCs seem to be of two types: a large number of aggressive tumours with a very unfavourable prognosis (especially in the case of pN3 and/or T3T4); and many tumours with a 'slow development' such as DCIS and microinvasive lesions, especially in patients treated exclusively by RT. Moreover, a very unusual rate of bilateral tumours (21%) was observed. These secondary BC could be 'in field', in 'border of field' or 'out of field'. However, a complete analysis of doses delivered by supradiaphragmatic irradiation was often very difficult, due to large variations in several parameters. We conclude that young women and girls treated for HD should be carefully monitored by clinical examination, mammography and ultrasonography.

Background Chemokines and chemokine receptors are major actors of leukocytes trafficking and some have been shown to play an important role in cancer metastasis. Chemokines CCL19, CCL20 and CCL21 and their receptors CCR6 and CCR7, were assessed as potential biomarkers of metastatic dissemination in primary breast cancer. Methods Biomarker expression levels were evaluated using immunohistochemistry on paraffin-embedded tissue sections of breast cancer (n = 207). Results CCR6 was expressed by tumor cells in 35% of cases. CCR7 was expressed by spindle shaped stromal cells in 43% of cases but not by tumor cells in this series. CCL19 was the only chemokine found expressed in a significant number of breast cancers and was expressed by both tumor cells and dendritic cells (DC). CCR6, CCL19 and CCR7 expression correlated with histologic features of aggressive disease. CCR6 expression was associated with shorter relapse-free survival (RFS) in univariate and but not in multivariate analysis (p = 0.0316 and 0.055 respectively), and was not associated with shorter overall survival (OS). Expression of CCR7 was not significantly associated with shorter RFS or OS. The presence of CCL19-expressing DC was associated with shorter RFS in univariate and multivariate analysis (p = 0.042 and 0.020 respectively) but not with shorter OS. Conclusion These results suggest a contribution of CCR6 expression on tumor cells and CCL19-expressing DC in breast cancer dissemination. In our series, unlike what was previously published, CCR7 was exclusively expressed on stromal cells and was not associated with survival.

Introduction: Controversy remains over whether to perform sentinel lymph node biopsy (SLNB) in multiple (multicentric or multifocal) unilateral synchronous breast cancer. Several small retro- or prospective studies, included pre- or post-operative (or both) multiple synchronous tumours (MST) have suggested that the test performance of SLNB is similar to that seen in unifocal disease. The purpose of this study was to evaluate the feasibility and accuracy of SLNB in preoperatively diagnosed invasive MST.Patients and Methods: The Interest of Axillary SLNB in Multiple Invasive Breast Cancer (IGASSU) study was a prospective multi-institutional study with initial breast surgery, SLNB, and systematic level I to II axillary lymph node dissection (ALND). Patients eligible for the IGASSU study had an operable invasive MST, defined as two or more physically separate invasive tumours in the same or different breast quadrant. The diagnosis of invasive MST was confirmed histologically in all patients by core needle biopsy before surgery. Detection of sentinel node was performed by using either blue patent or radiocolloide injection or both. Injection sites were subareolar.Statistical Analysis: Sensitivity (Se), negative predictive value (NPV), accuracy (A), false negative rate (FNR) and their 95%-confidence intervals (95%CI) were calculated with a classical 2x2 contingency table. A univariate analysis using odds ratio calculation was performed to identify the risk factors for false negative results.Results: Between March 1, 2006, and August 31, 2007, 216 patients were prospectively included from 16 institutions. Of these patients, 211 were evaluable. The SLNB identified rate were 93.4% (197/211). A mean number of 2.2 SLN (range, 1 to 8, ± 1.4) was successfully excised. The mean number of resected nodes in ALND was 12 (range, 1 to 39, ± 5.7). The FNR was 13.6% (14/103) [95%CI: 7- 20%], Se was 86 .4% (89/103) [95%CI: 79- 93%], NPV was 87% (94/108) [95%CI: 80-93%], A was 92.9% (183/197) [95%CI: 89- 96%]. For the 14 false-negative SN, all had ≤ 3 involved nodes in ALND. Table 1 shows patterns of management of the axilla.Table 1 ALND+ALND-Non-identified SLNB113Identified SLNB+4544Identified SLNB-1494 In a univariate analysis, tumour location (only external location vs other location) was the only clinico-pathological factor influencing the FNR (22% [11-33%] vs 7% [4-10%]), even then median aggregate histological tumour size was smaller in external tumours (17mm [range, 12-80] vs 34mm [range, 8- 90], p=0.016).Conclusion: With a FNR of 13.6% (95%CI: 7-20%), we do not recommend SLNB as a routine procedure for multiple unilateral synchronous breast cancer, even for small tumour foci. Citation Information: Cancer Res 2009;69(24 Suppl):Abstract nr 305.

Abstract #207 BACKGROUND. Pure tubular carcinoma (PTC) is a favourable histologic subtype of breast cancer with a low rate of lymph node involvement. This study was initiated to assess the sentinel lymph node (SLN) detection rate and the rate of axillary involvement. METHODS. Inclusion criteria were a PTC (tubular component >90%) core biopsy diagnosed breast cancer smaller than 20 mm, and a homolateral clinically axilla free of nodal involvement. Patients underwent a SLND alone or with an Axillary level I-II Lymphadenectomy (AL). An AL was performed in the case of the learning curve, or in the case of SLN involvement – macrometastases, micrometastases or isolated cells - or in the case of mapping failure. RESULTS. From January 1999 to December 2006, 234 patients were selected from 9 French Comprehensive Cancer Centers. Median tumour size was 9.59 mm (1-22) . The SLN detection rate was 97.9% (229/234). The median number of SLN harvested was 2.15 (range 0-8). Respectively the frequency of macrometastasis - >2mm - was 2.6% (6/229), micrometastasis was 6.5% (15/229) and isolated cells was 0.8% (2/229). There were no false negative cases among the 24 patients with a systematic complementary axillary lymphadenectomy performed in the case of a learning curve. Axillary macrometastasis were found in non sentinel lymph nodes after completed axillary lymphadenectomy in 3 / 6 patients with macrometastasis, in 1/15 patients with micrometastasis and in 0/2 patients with isolated cells. There was no lymph node involvement for tumour size < 10mm. Pathological tumor size >10 mm was statistically correlated to the risk of axillary involvement (p=0.0223). CONCLUSIONS. This study confirms that in the case of PTC ≤ 20mm SLN detection is feasible and the risk of lymph node involvement very low. In the case of PTC Citation Information: Cancer Res 2009;69(2 Suppl):Abstract nr 207.

In a case-control study, including 135 cases of endometrial carcinoma diagnosed after breast cancer and 467 controls, the relative risks for endometrial carcinoma were higher for women treated with tamoxifen (4.9; P = 0.0001) and those who undergone pelvic radiotherapy (7; 8; P = 0.0001). After adjusting for confounding factors, a multivariate analysis has shown an increased risk of endometrial carcinoma for tamoxifen users, especially for treatment longer than 3 years and for pelvic radiotherapy. Patients treated with tamoxifen had more advanced tumours and lower survival rates than those who had not received tamoxifen.

591 Background: The debate concerning poorer survival for patients with breast cancer (BC) carrying a BRCA1 germline mutation is unresolved, and requires additional data from population-based studies. Methods: We followed 232 women with invasive BC under age 46, ascertained prospectively through a French population-based BC registry, and tested for BRCA1/2 mutations (median follow-up: 82 months). We compared tumour characteristics and survival rates between 21 BRCA1/2 deleterious mutation carriers and 211 non-carriers. Results: As compared to sporadic tumours, BRCA1/2 tumours showed higher grade (p = 0.02), fewer ductal carcinoma in situ (p = 0.02), more frequent medullary histology (p = 0.02), more frequent negative oestrogen and progesterone receptors (p = 0.001 each). At five years, BC-specific survival, metastasis-free survival, ipsilateral recurrence-free survival and contralateral BC-free survival rates for BRCA1/2 mutation carriers were 95.0%, 94.7%, 100% and 90.0% respectively, compared with 89.6%, 78.2%, 88.8% and 94.4% respectively, for non-carriers (not significant). Rates for women carrying only a BRCA1 mutation were 93.3%, 93.3%, 100%, 86.7%, respectively. 76% of BRCA1/2 carriers received chemotherapy. Conclusions: Despite unfavourable tumour features, we found no evidence for poorer short-term survival in BRCA1 mutation carriers compared to non-carriers in this prospective population-based cohort. The high rate of BRCA1 carriers who received chemotherapy for their BC should question the positive impact of this treatment, as suggested by preclinical studies showing increased chemosensitivity of BRCA1-associated tumours. No significant financial relationships to disclose.

1016 Background: Tamoxifen-associated endometrial cancers may have poor prognosis but few data are available. We examined whether exposure to tamoxifen at defined steps of endometrial carcinogenesis could be associated with poor-prognosis tumours Methods: From a hospital-based case-control study*, 115 women with endometrial cancer after breast cancer were selected for pathological review. The delay between tamoxifen initiation and diagnosis of endometrial cancer was define as early- (delay 5 years) onset tumours. Results: The 5-year endometrial cancer-specific (ECS)-survival rate was worse in tamoxifen users for >5 years (55% vs 84% for 2–5 years, 86% for 5 years was independently linked to a lower survival rate (Cox model relative risk 7.9, p=0.03) and was associated with a high frequency of grade >=2 tumours (75.0% vs 44.8% for 2–5 years, 33.3% for

Aims Cervical cancer frequency in France is from 12 to 16 per 100.00 per year, despite an efficient screening test: the Cervical Smear (CS). This campaign aims to increase women participation, specially for high risk groups, helped by an intensive collaboration of local practitioners and social workers. Melhodology From November 93 to October 94, a free CS was proposed to 30846 women, from 25 to 65 year-old, living in one of the three target districts (Saint Fons, Saint Priest, Venissieux). Women information was performed by sending a personalized letter and using local audio visual possibilities, provided by the town council. Direct information was also given by all family practitioners and/or gynaecologists. During medical consultation, epidemiologie information were collected for each woman, and according to French recommenda-tion of “Consensus de Lille”, a CS was eventually done. AU the action is free of charge for the women, due to the French Insurance System and personal complementary insurance. Results From November 93 to October 94, 2934 women were in-cluded in the study. 33% were over 50 and participation rate was higher for women over 50. 43% of CS were done by the family practitioner. In this series, 58.3% of women had an insufficient screening, with a 70% rate for women over 50. For 8.2% of them, no previous CS were performed. High quality of technic may be underlined, with 98% of interpretable CS. Only 33 abnormalities were found (2%). Conclusions After one year, a low women participation is observed. Nevertheless, a fraction of high risk group was screened: 3 out of 4 women over 50 had an insufficient or no screening and we noted a good participation for menopaused women. Furthermore, this action will continue for 3 years and new advertisements will be done.