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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 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.

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.

Breast cancer incidence remains the highest among gynaecologic neoplasms. Once they have achieved their treatments, patients should undergo careful follow-up. It aims at detecting early local recurrence or controlateral breast cancer. Based on large cohorts, clinical and radiological follow-up procedures come from guidelines realised by scientific organisations. We evaluated our regional practices in Franche-Comte and compared them to current guidelines. Patients with early breast cancer positive for hormonal receptors filled a questionnaire concerning their follow-up. It included patients treated from 1999 to 2005. When frequency of consultation is evaluated, only half of the patients undergo what is recommended. Whereas mammography and non-validated complementary exams are more regularly realised. Patients consulting more one practician have a better compliance. Our study underlines significant disparities among patients follow-up. Better interactions between physicians and a greater implication of patients in their follow-up would increase its quality.

The development of drug resistance is a major obstacle to effective cancer therapy. Several agents are in clinical development with the goal of overcoming resistance. Among them is cabazitaxel, a semisynthetic taxoid that is able to overcome a common mechanism of resistance that limits the efficacy of other chemotherapeutic agents, including the older taxanes. The promise of cabazitaxel as a second-line chemotherapy option for advanced prostate cancer has been confirmed clinically in the phase III TROPIC (Treatment of Hormone-Refractory Metastatic Prostate Cancer Previously Treated with a Taxotere-Containing Regimen) trial. This trial showed that cabazitaxel is the first chemotherapeutic agent to demonstrate a survival benefit in metastatic castration-resistant prostate cancer (mCRPC) since the approval of docetaxel. On this basis, the US FDA and the European Medicines Agency approved cabazitaxel in June 2010 and January 2011, respectively, for the treatment of patients with mCRPC who have previously been treated with docetaxel. The most prevalent toxicity was neutropenia and the use of primary prophylaxis with granulocyte-colony stimulating factor is recommended in high risk patients. This article presents the preliminary antitumour activity, safety, tolerability and pharmacokinetic data of cabazitaxel, and an overview of the current status of clinical development.

Introduction Temozolomide and concomitant radiotherapy followed by temozolomide has been used as a standard therapy for the treatment of newly diagnosed glioblastoma multiform since 2005. A search for prognostic factors was conducted in patients with glioblastoma routinely treated by this strategy in our institution. Methods This retrospective study included all patients with histologically proven glioblastoma diagnosed between June 1, 2005, and January 1, 2012, in the Franche-Comté region and treated by radiotherapy (daily fractions of 2 Gy for a total of 60 Gy) combined with temozolomide at a dose of 75 mg/m2 per day, followed by six cycles of maintenance temozolomide (150–200 mg/m2, five consecutive days per month). The primary aim was to identify prognostic factors associated with overall survival (OS) in this cohort of patients. Results One hundred three patients were included in this study. The median age was 64 years. The median OS was 13.7 months (95% confidence interval, 12.5–15.9 months). In multivariate analysis, age over 65 years (hazard ratio [HR] = 1.88; P = 0.01), Medical Research Council (MRC) scale 3–4 (HR = 1.62; P = 0.038), and occurrence of postoperative complications (HR = 2.15; P = 0.028) were associated with unfavorable OS. Conclusions This study identified three prognostic factors in patients with glioblastoma eligible to the standard chemotherapy and radiotherapy treatment. Age over 65 years, MRC scale 3–4, and occurrence of postoperative complications were associated with unfavorable OS. A simple clinical evaluation including these three factors enables to estimate the patient prognosis. MRC neurological scale could be a useful, quick, and simple measure to assess neurological status in glioblastoma patients.

Background Nivestim™ (filgrastim) is a follow-on biologic agent licensed in the EU for the treatment of neutropenia and febrile neutropenia induced by myelosuppressive chemotherapy. Nivestim™ has been studied in phase 2 and 3 clinical trials where its efficacy and safety was found to be similar to its reference product, Neupogen®. Follow-on biologics continue to be scrutinised for safety. We present a design for two observational phase IV studies that are evaluating the safety profile of Nivestim™ for the prevention and treatment of febrile neutropenia (FN) in patients treated with cytotoxic chemotherapy in general clinical practice. Methods/Design The NEXT (Tolérance de Nivestim chez les patiEnts traités par une chimiothérapie anticancéreuse cytotoXique en praTique courante) and VENICE (VErträglichkeit von NIvestim unter zytotoxischer Chemotherapie in der Behandlung malinger Erkrankungen) trials are multicentre, prospective, longitudinal, observational studies evaluating the safety profile of Nivestim™ in 'real-world’ clinical practice. Inclusion criteria include patients undergoing cytotoxic chemotherapy for malignancy and receiving Nivestim as primary or secondary prophylaxis (NEXT and VENICE), or as treatment for ongoing FN (NEXT only). In accordance with European Union pharmacovigilance guidelines, the primary objective is to evaluate the safety of Nivestim™ by gathering data on adverse events in all system organ classes. Secondary objectives include obtaining information on patient characteristics, efficacy of Nivestim™ therapy (including chemotherapy dose intensity), patterns of use of Nivestim™, and physician knowledge regarding filgrastim prescription and the reasons for choosing Nivestim™. Data will be gathered at three visits: 1. At the initial inclusion visit, 2. At a 1-month follow-up visit, and 3. At the end of chemotherapy. Recruitment for VENICE commenced in July 2011 and in November 2011 for NEXT. VENICE completed recruitment in July 2013 with 407 patients, and NEXT in September 2013 with 2123 patients. Last patient, last visit for each study will be December 2013 and March 2014 respectively. Discussion The NEXT and VENICE studies will provide long-term safety, efficacy and practice pattern data in patients receiving Nivestim™ to support myelosuppressive chemotherapy in real world clinical practice. These data will improve our understanding of the performance of Nivestim™ in patients encountered in the general patient population. Trial registration NEXT NCT01574235, VENICE NCT01627990

International audience; BACKGROUND: This study searched for extra capsular tumour spread (ECS) as a prognostic factor for recurrence in terms of Disease Free Survival (DFS) and Overall Survival (OS). PATIENTS AND METHODS: For this study, from a retrospective database of the Doubs cancer registry, 823 eligible women with node positive breast cancer treated from February 1984 to November 2000 were identified. The following factors were evaluated: ECS, numbers of involved nodes, histological tumour grade, tumour size, status of estrogen and progesterone receptors, and age of patient. A Cox proportional hazards method was used to search for significant factors related to OS and DFS length. RESULTS: In the multivariate analysis, factors related to DFS length were found to be: tumour grade (aHR 0.76, 95 % CI 0.61-0.96, p = 0.02), ECS status (aHR 0.7, 95 % CI 0.49-0.96, p = 0.03), progesterone (PgR) status (aHR 0.63, 95 % CI 0.44-0.85 p = 0.008), number of nodes involved (aHR 0.75, 95 % CI 0.56-1, p = 0.05). The multivariate analysis for OS found as significant factors: tumour grade (aHR 0.76, 95 % CI 0.61-0.95; p = 0.02) and PgR status (aHR 0.8, 95 % CI 0.56-0.99, p = 0.02). CONCLUSIONS: This study might suggest taking into account ECS status in the adjuvant decision-making process.

The purpose of this French survey was to evaluate the adherence to the guidelines (European Organisation for Research and Treatment of Cancer [EORTC]; American Society of Clinical Oncology [ASCO]; French Standards, Options, and Recommendations [SOR]; European Society of Medical Oncology [ESMO]; Food and Drug Administration [FDA]; and National Comprehensive Cancer Network [NCCN]) for the use of erythropoiesis-stimulating agents (ESAs) in the management of chemotherapy- induced anemia for patients with advanced breast and lung cancers.Two-hundred patients were recruited for each malignancy. The collected items were characteristics of ESA initiation, treatment, adjustment, and discontinuation. Metastatic breast cancer and stage IIIb/IV lung cancer patients who had received chemotherapy were eligible. The endpoint was to compare French daily practices with national and international guidelines.From November 2010 to December 2010, 185 breast cancer and 227 lung cancer files were collected. The main reason of ESA initiation was the correction of anemia (49% and 44%, respectively). The median baseline value of hemoglobin was 9.5 g/dL, and the median target value was 12 g/dL. The mean duration of treatment was 12 and 14 weeks, respectively. The mean gain of hemoglobin was 2.3 g/dL and 1.9 g/dL, respectively. In the breast cancer population, two patients (1%) developed a thromboembolic event, which is lower than what has been described in the literature. An iron supplement was prescribed in 55% of patients with breast cancer and 49% of those with lung cancer, with about one-third administered intravenous iron. The interruption of ESA and chemotherapy was synchronous in about 20% of cases, and was earlier in lung cancer patients than in breast cancer patients.The quality and the rigor of the sampling represent one of the key points of this survey. The French and international guidelines for the use of ESA were well respected by the physicians. Overall, the management of chemotherapy-induced anemia was improved compared with what was described in the historical surveys (European Cancer Anaemia Survey [ECAS], French Anaemia Cancer Treatment [F-ACT]).

Breast cancer incidence remains the highest among gynaecologic neoplasms. Once they have achieved their treatments, patients should undergo careful follow-up. It aims at detecting early local recurrence or controlateral breast cancer. Based on large cohorts, clinical and radiological follow-up procedures come from guidelines realised by scientific organisations. We evaluated our regional practices in Franche-Comté and compared them to current guidelines. Patients with early breast cancer positive for hormonal receptors filled a questionnaire concerning their follow-up. It included patients treated from 1999 to 2005. When frequency of consultation is evaluated, only half of the patients undergo what is recommended. Whereas mammography and non-validated complementary exams are more regularly realised. Patients consulting more one practician have a better compliance. Our study underlines significant disparities among patients follow-up. Better interactions between physicians and a greater implication of patients in their follow-up would increase its quality.

This study was designed to investigate the efficacy and safety of the epidermal growth factor receptor (EGFR) inhibitor cetuximab combined with irinotecan, folinic acid (FA) and two different doses of infusional 5-fluorouracil (5-FU) in the first-line treatment of EGFR-detectable metastatic colorectal cancer., Clinical Trial, Phase I, Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't, info:eu-repo/semantics/published

International audience; OBJECTIVE: Since screening for cancer has been advocated, funded, and promoted in France, it is important to evaluate the attitudes of subjects in the general population and general practitioners (GPs) toward cancer screening strategies. METHODS: EDIFICE is a nationwide opinion poll that was carried out by telephone among a representative sample of 1,504 subjects living in France and aged between 40 and 75 years and among a representative sample of 600 GPs. The questionnaire administered to subjects queried about previous screening for cancer. RESULTS: Ninety-three percent of women stated that they had undergone at least one mammography. Although rated "A" recommendation-strongly recommended-by the US Preventive Services Task Force, screening for colorectal cancer received less attention than prostate cancer screening which is rated "I"-insufficient evidence-(reported screening rates of 25% and 36%, respectively). Six percent of subjects stated that they had undergone lung cancer screening. GPs' attitudes toward cancer screening showed similar inconsistencies. CONCLUSIONS: It thus appears that understanding of cancer screening practices in the French general population does not match scientific evidence. To a lesser extent, this also holds for GPs.

Purpose Colorectal cancer (CRC) screening has been shown to decrease CRC mortality. Organised mass screening programs are being implemented in France. Its perception in the general population and by general practitioners is not well known. Methods Two nationwide observational telephone surveys were conducted in early 2005. First among a representative sample of subjects living in France and aged between 50 and 74 years that covered both geographical departments with and without implemented screening services. Second among General Practionners (Gps). Descriptive and multiple logistic regression was carried out. Results Twenty-five percent of the persons(N = 1509) reported having undergone at least one CRC screening, 18% of the 600 interviewed GPs reported recommending a screening test for CRC systematically to their patients aged 50–74 years. The odds ratio (OR) of having undergone a screening test using FOBT was 3.91 (95% CI: 2.49–6.16) for those living in organised departments (referent group living in departments without organised screening), almost twice as high as impact educational level (OR = 2.03; 95% CI: 1.19–3.47). Conclusion CRC screening is improved in geographical departments where it is organised by health authorities. In France, an organised screening programs decrease inequalities for CRC screening.

What is already known about this subject • Dihydropyrimidine dehydrogenase (DPD) deficiency is known to be a major cause of severe 5FU-related toxicity. • A link has been previously shown between 5FU toxicity and either low enzyme activity measured in peripheral blood mononuclear cells (PMNC) or germinal DPD mutations. • The link between the most common DPD mutation (IVS14+1G>A) and PMNC enzyme activity is poorly documented. What this study adds • This paper provides the largest series of case-reports (n = 131) with 5FU-related toxicity, analyzed for both PMNC-DPD activity and the IVS14+1G>A mutation. • A very low incidence of the IVS14+1G>A mutation (2.2%) was observed in this selected Caucasian population. • Present data suggest that IVS14+1 mutation screening has limited effectiveness in identifying patients at risk for severe 5FU toxicity. Also, patients with normal PMNC-DPD activity may develop life-threatening toxicity. Aims To examine retrospectively the relationship between DPD phenotype/genotype and the intensity of 5FU toxicity. Methods One hundred and thirty-one case-reports (81 women, 50 men) with 5FU-related toxicity were analyzed. Results The lower the DPD activity (10–504 pmol min−1 mg−1), the higher the toxicity grade was scored (P A mutation, analyzed in 93 patients, was detected in two patients (nonlethal toxicity). Conclusions The IVS14+1G>A mutation may not help prevent toxicity and patients with normal DPD activity may develop life-threatening 5FU toxicity.

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.

There was no significant difference in age (p = 0.917), educational level (p = 0.851), or BMI (p = 0.255) between CAM users and non-users. CAM users and non-users showed no significant difference in trust in conventional treatment (p = 0.374) or quality of life (p = 0.501). There was no significant difference in health specific locus of control. Vitamins and minerals were the most common (35.2%) used natural CAM product. Conclusion: CAM use is common among recently diagnosed breast cancer patients in the Netherlands. Physicians and other health care providers should increase their knowledge about CAM therapies. CAM should be discussed with patients, since CAM may cause clinically significant drug interactions.

6078 Background: The EDIFICE study aimed to allow better understanding of population’s adhesion to the tests available for the 4 most frequent cancers: breast, colorectal, prostate and lung. In 1998 the French National Consensus Conference advocated for mass cancer screening (CS) using Hemoccult II. The departments are divided according to the existence or not of an organized program: this screening was organized in 22 departments (3 “scout” started in 1998, 9 “first wave” in 2003 and 12 “second wave” in 2004). Results are reported hereunder. Methods: This first nationwide observational study was carried out in France from January 18th to February 2nd, 2005 among a representative sample of 1504 subjects aged between 40 and 75 years and a representative sample of 600 general practitioners (GPs). Information about participating subjects included socio-demographic characteristics, attitude towards CS, and about GPs’ medical practice regarding CS. Results: Only 25% of the 970 subjects aged between 50 and 74 years had undergone a colorectal screening test. In the organized departments (OD), the rate of persons who self-report any colorectal cancer screening was 34% vs 20% in unorganized departments (UD) (OR=1.99, CI95% 1.47- 2.69, p95% 1.91- 5.88, p95% 1.11–3.49). The rate of GPs who advocated systematically for screening was 40%, 29%, 26% and 13% for scout, first wave, second wave OD and baseline UD respectively. Organization reduced the rate of screening based on colonoscopy alone from 69% persons in UD to 35% in the OD. Conclusions: The main result of this survey comparing data in the same frame of time, in the same country, is that organized programs for colorectal cancer impact of health outcomes. No significant financial relationships to disclose.

10701 Background: The EDIFICE study aimed to allow better understanding of population’s adhesion to the screening tests available for the 4 most frequent cancers: breast, colorectal, prostate and lung. Implementation of breast cancer screening (CS) was generalized since 2003 in France: women aged between 50 and 74 years are invited to do a mammography (M) every second year. Methods: This nationwide observational study was the first implemented in France (from January 18th to February 2nd, 2005) among a representative sample of 1504 subjects aged between 40 and 75 years including 773 women and a representative sample of 600 general practitioners (GPs). Information about participating subjects included socio-demographic characteristics, attitude towards CS and actual experience of CS, and about GPs’ medical practice regarding CS. Results: Among the 507 participating women (PW) aged between 50 and 74 years, 93% had done at least one M: 55% underwent this test on their own initiative and 45% of PW had it during a systematic screening plan. Most PW in the systematic screening (89%) had a M dating from less than 2 years vs 74% of the others (X2 = 18.9; p < 0,01). Main reasons for not performing the biennial screening test were: lack of care (18%), “it’s not a priority” (18%) and no advice from the GPs (15%). 79% of the PW had at least one M before 50 years (1st test at the mean age of 37.9±6 years). Among the 600 GPs, 68% systematically recommended M to their patients. GPs’ perceptions of the reasons for women’s avoidance of screening test were their unwillingness to be aware of M results (44%) and their belief in painful symptoms related to M (52%). Conclusions: This first nationwide study has shown the high rate of PW’s attendance at M screening. It pointed out that systematic and organized screening played a major role in regularity of screening over 2 years, and GP is a key actor in heightening public awareness. No significant financial relationships to disclose.

3513 Background: Cetuximab is an IgG1 monoclonal antibody targeting the EGFR. In irinotecan-refractory metastatic CRC and in first-line therapy trials cetuximab has shown to be active (ASCO 2002, 2...

Introduction: Cognitive impairment occurs in a subset of cancer survivors and is generally subtle. Most evidence suggests that chemotherapy may be a cause, although other factors associated with the diagnosis and treatment of cancer may contribute. Recently, recommendations for future research in evaluating cognitive disorders have been suggested though different published studies. Nevertheless, there is a need to standardize this evaluation, particularly for neuropsychological tests. The various domains to be explored include memory disorders, decrease in oral fluency, care and concentration, slowing down of information processing. The main objective of this prospective study was to assess the feasibility for evaluating cognitive disorders with neuropsychological tests in different groups of homogeneous patients. The secondary objectives were to evaluate the cognitive disorders in these groups of patients and the impact of disease and therapeutic strategies with a follow-up period of 48 weeks. Patients and Methods: 124 previously untreated patients were included by 13 centers. 5 subgroups were defined: group 1, breast cancer T1N0 treated by local radiotherapy (n=24); group 2, breast cancer T1–T2, N+ treated by adjuvant chemotherapy and radiotherapy (n=52); group 3, diffuse large B-cell lymphoma treated by chemotherapy plus rituximab (n=8); group 4 colon cancer treated by adjuvant chemotherapy (n=11); group 5, multiple myeloma treated by 4–5 cycles of VAD followed by high dose therapy and autologous transplantation (n=23). Exclusion criteria included previous cognitive disorders or neurological diseases, HIV patients, other cancers, previous vascular disease or head trauma, sleep apnea, brain metastasis, metabolic disorders or neuropsychiatric drug intake. Hetero-evaluation was performed three times by neuropsychologists, at inclusion (pre-therapeutic, except for group 5 where inclusion corresponded to the pre-transplantation period), second evaluation, (24 weeks after 1st visit (V) for groups 1–4 and 12 weeks for group 5), and 3rd evaluation (48 weeks or 24 weeks respectively for groups 1–4 or 5). Intra- and inter-comparisons were made. Neuropsychological tests were performed in similar order and included: Brown Petterson test; Grober and Buschke (16 items) test; Double work; letter, number sequence; D2 test; code test; trail-making test; Stroop test; oral fluency. Statistical analysis included Mantel Haenszel tests. Results : Mean age was 57.14 years (range 31–85), with a sex ratio F:M=5.3. Body mass index and blood pressure were not significantly different between groups. Performance status was different among groups particularly for groups 3–5. Baseline evaluation included other co-morbidities and anxiety/depression status which was slightly abnormal in 7% of the patients. Test feasibility was good for the majority of them but was dependent on the group of patients, particularly for oral fluency test (not performed in 27.3% of patients in group 4). In addition, the percentage of patients who did not have other controls (V 2 and 3) varied from one group to another, but concerned less than 24% of the patients (particularly for groups 3,4 and 5). A significant increase of the number of patients presenting an alteration at V 2 and 3 but normal at V1 was observed, particularly in the trail making test (altered in 26.2% of the patients) and Brown Petterson test altered particularly after 12 months of radiotherapy (37% of patients). The Empan test was improved at visit 3 particularly for group 2. Conclusion: This pilot prospective multicenter study allows to define and validate neuro-psychological tests for evaluating cognitive disorders and estimate the percentage of patients having impaired cognitive functions due to treatment.

Background One of the main measures of the French national cancer plan is to encourage physicians to work collectively, and to minimize territorial inequities in access to care by rethinking the geographical distribution of oncologists. For this reason, cancer care services are currently being reorganized at national level. A new infrastructure for multidisciplinary cancer care delivery has been put in place in our region. Patients can receive multidisciplinary health care services nearer their homes, thanks to a mobile team of oncologists. The objective of our study was to assess, using a quality approach, the impact on medical management and on the costs of treating early breast cancer, of the new regional structure for cancer care delivery. Methods Before-and-after study performed from 2007 to 2010, including patients treated for early breast cancer in three hospitals in the region of Franche-Comté in Eastern France. The main outcome measures were quality criteria, namely delayed treatment (>12 weeks), dose-intensity and assessment of adjuvant chemotherapy. Other outcomes were 24-month progression-free survival (PFS) and economic evaluation. Results This study included 667 patients. The rate of chemotherapy tended to decrease, but not significantly (49.3% before versus 42.2% after, p=0.07), while the use of taxanes increased by 38% across all centres (59.6% before versus 98.0% after, p < 0.0001). There was a non-significant reduction in the time between surgery and adjuvant chemotherapy (6.0 ± 3.0 weeks before versus 5.6 ± 3.6 weeks after, p=0.11). Dose-dense chemotherapy improved slightly, albeit non significantly (86.3% versus 91.1% p=0.22) and time to treatment tended to decrease. The new regional infrastructure did not change 24-month PFS, which remained at about 96%. The average cost of treatment was estimated at €7000, with no difference between the two periods. Conclusions Despite a shortage of oncologists, the new organization put in place in our region for the provision of care for early breast cancer makes it possible to maintain local community-based treatment, without negative economic consequences. This new structure for cancer care delivery offers cancer services of similar quality with no modification of 24-month PFS in early breast cancer.