213o Distant Recurrences at Median of 5-years among 9.779 Postmenopausal Women with Hormone Receptor-positive Early Breast Cancer Treated on the Team Trial of Adjuvant Endocrine Therapy

237P CMF-likeN % AnthracyclinesN % Anthra and TaxanesN % TaxanesN % Total Not Classified 9 14.8 26 42.6 23 37.7 3 4.9 61 ER+ HER2+ Ki67>19 4 3.7 57 53.3 43 40.2 3 2.8 107 ER+ HER2+ Ki67<20 3 5.8 22 42.3 27 51.9 0 0.0 52 ER+ HER2Ki67>19 26 9.7 131 48.7 101 37.5 11 4.1 269 ER+ HER2Ki67<20 29 10.1 137 47.9 106 37.1 14 4.9 286 ERHER2+ Ki67>19 4 4.9 44 53.7 33 40.2 1 1.2 82 ERHER2+ Ki67<20 0 0.0 10 58.8 7 41.2 0 0.0 21 ERHER2Ki67<20 3 11.1 13 48.1 9 33.3 2 7.4 27 ERHER2Ki67>19 16 10.0 80 50.0 57 35.6 7 4.4 160 Total 94 8.9 520 49.0 406 38.3 41 3.9 1061 Volume 21 | Supplement 8 | October 2010 doi:10.1093/annonc/mdq516 | viii85 Annals of Oncology abstracts Downloaded from https://academic.oup.com/annonc/article-abstract/21/suppl_8/viii78/178213 by guest on 15 January 2018 treatments (0,8%) were delayed. RDI of E and D were 97,4% ± 8 and 94,5% ± 16 respectively, RDI superior to 90%: E in 88,2%, and D in 83,9%. Prophylaxis with GCSF was applied in 279 treatments (11,3%). HT were observed in 243 treatments (9,8%). Febrile neutropenia was observed in 67 patients (2,7%) and was more frequent after cycle 1 and 4. A total of 51 patients (12.2%) had N, that was more frequent in the first year of application of the treatment (p=0,003). There was no differences on the application of growth factors during the treatment, but patients referred less comorbidities in the second year of experience (p=0.016). N implicated a significant decrease of RDI of E (p=0.003) and D (p=0.007). Anemia was the most frequent HT (16% of patients) and was independently correlated with age older than 50 and presence of co-morbidities. Discussion and Conclusions: The differences of N in the different years were probably related with better patient selection. FEC-D treatment is safe in terms of hematological toxicity in a day-to-day clinical practice. Disclosure: All authors have declared no conflicts of interest. 239P NEMESI: A RETROSPECTIVE OBSERVATIONAL LONGITUDINAL STUDY TO INVESTIGATE PATIENT CHARACTERISTICS AND TREATMENT IN THE EARLY BREAST CANCER (EBC) IN ITALY M. Clavarezza, M. Venturini, G. Benedetti, A. Casadei Giardini, S. Gildetti, L. Del Mastro, A. Molino, F. Riccardi, S. Rossi, F. Cognetti Oncology Division, Sacro Cuore Don Calabria Hospital, Negrar/ITALY, Oncology Unit, Hospital of Macerata, Macerata/ITALY, UO Medical Oncology, IRST, Meldola (FC)/ITALY, Oncology Unit, Università G. D’Annunzio ASL 2 of Chieti, Chieti/ITALY, S.c. Medical Oncology A, Istituto Nazionale per la ricerca sul cancro di Genova, Genoa/ITALY, Medical Oncology, Policlinico G.B.Rossi, Verona/ITALY, U.O.C. of Medical Oncology, AORN Cardarelli di Napoli, Napoli/ ITALY, Medical Department, sanofi-aventis, Milan/ITALY, Medical Oncology, Regina Elena National Cancer Institute, Roma/ITALY Background: NEMESI examined the clinical practice in the Italian Oncology Institutions on adjuvant treatment in EBC. Methods: This retrospective observational study describes adjuvant treatment in EBC in Italy, involving, between January 1 and June 30, 2008, at least 1,500 cases, 30 consecutive in each center and representative of the italian situation, in terms of geographical distribution and type of Institution, as evidence from the census reported on the white Book of the Italian Association of Medical Oncology (AIOM). Inclusion criteria: age ‡ 18 years, histological diagnosis of early stage operated breast cancer (stage I-II TNM AJCC version VI), ‡1 cycle of adjuvant chemotherapy (CT) and/or hormone therapy. Results: A total of 1,894 were included. Tumor characteristics: pT1: 67.0% (22.3%: pT1mic + pT1a + pT1b); pN0: 61.0%; pN1: 29.1%; pN2: 6.3%; pN3: 3.6%; ER pos (‡10%): 81.2%; ER neg (0-9%): 18.6%; median ki67: 15%; HER2 pos:16.1%. Adjuvant treatment without CT was administered in 799 patients (42.2%), while the remaining 1.095 (57.8%) received systemic CT. Administration of CT is influenced by pN: 43.5% of pts with pN0 received CT; 76.6% of pN1; 89.1% of pN2; 94.2% of pN3. In the pN0 group administration of CT is influenced by pT: 30.6% of pts with pT 0.1-1.0 cm received CT; 60.4% of pT 1.1-2.0 cm; 71.6% of pT >2.0 cm. Type of CT used is influenced by recurrence risk. The use of Anthracycline and Taxanes increases with risk: pN1 45.0%, pN2-pN3 >70%. Conclusions: Italian Oncology Centers frequently use adjuvant CT in EBC. Choice of adjuvant CT is still influenced by prognostic factors (pT and pN). There is still widespread use of first-generation CT drugs, independent from disease severity. In particular for pN0-pN1 class there is an underuse of taxane-based CT, which is administered above all for EBC with high recurrence risk (pN2 and pN3). Study sponsored by sanofi-aventis Italy. Disclosure: M. Venturini: Membership of the advisory board of this study. S. Rossi: Employed by sanofi-aventis as Medical Advisor in Oncolgy, Medical Department. All other authors have declared no conflicts of interest. 240P ABDOMINAL OBESITY AND WEIGHT GAIN AS A CONSEQUENCE OF TAXANE-BASED ADJUVANT CHEMOTHERAPY FOR BREAST CANCER E. Saloustros, D. Hatzidaki, I. Gioulbasanis, K. Koutsoudaki, M. Nikoloudaki, A. Margiolaki, M. Zeniodi, E. Ganotakis, V. Georgoulias, D. Mavroudis Department of Medical Oncology, University General Hospital of Heraklion, Heraklion/GREECE, Department of Internal Medicine, University General Hospital of Heraklion, Heraklion/GREECE Background: Women receiving adjuvant chemotherapy for breast cancer usually gain weight. The effect of taxane-based chemotherapy on body weight and abdominal obesity is not well studied. The aim of this study is to evaluate the prevalence and the magnitude of weight gain and central obesity during adjuvant chemotherapy containing taxane. Methods: Preand post-menopausal women were recruited. Body weight was measured prior to and after completion of chemotherapy and the percentage of change was calculated. Abdominal adiposity changes were evaluated by measurement of the waist circumference. Spearman Rho Correlations and Multiple Regression analysis were performed. Results: Data were collected for 151 women treated with taxane (+/antrhracycline)based chemotherapy (median age=54 years). Ninety-eight (65%) of patients were postmenopausal. All patients received steroids prior to taxane administration, although their use as antiemetic treatment was uncommon. Ninety-four women (62.3%) gained weight (mean 4.024 kg or 5.6%; p<0.0001), 21 (13.9%) lost weight (mean 2.65 kg or 3.4%; p<0.0001) and 36 (23.8%) maintained stable weight. Notably, the increase of body weight was associated with an increase of central obesity (mean increase of waist circumference 2.53 cm p<0.0001). These effects were more pronounced in premenopausal women. Of them 81% gained weight compared to 52.0% of postmenopausal (p=0.002). The mean increase was 4.4 kg vs 3.6 kg (p=0.037) or 6.6% vs 4.9% (p=0.007) for the preand post-menopausal respectively. Finally, the mean increase of waist circumference, although non-statistically significant, was higher for the premenopausal (4.81cm vs 3.71cm p=0.152). Conclusion: As previous studies with non taxane-containing regimens have shown, a high incidence of weight gain was found in women receiving adjuvant taxane-based chemotherapy for breast cancer. Weight gain was accompanied by abdominal adiposity especially in premenopausal women. Given the adverse consequences of weight gain in terms of both breast cancer prognosis and general health, it is necessary to inform patients about this side effect and to develop strategies for weight maintenance during and after systemic therapy. Disclosure: All authors have declared no conflicts of interest. 241P IMPACT OF MAMMAPRINT ON THE ROUTINE TREATMENT DECISION MAKING PROCESS IN AN UNSELECTED EARLY BREAST CANCER PATIENT POPULATION IN BELGIUM P.G. Cusumano, F. Liebens, B. Carly, G. Jerusalem, E. Lifrange, J. Janssens, J. Vlasselaer, V. Jossa Breast Unit, CHC Liege, Liege/BELGIUM, Breast Unit, CHU St Pierre, Brussels/BELGIUM, Medical Oncology, CHU Liege, Liege/BELGIUM, Oncology, University of Hasselt, Hasselt/BELGIUM Background: Multidisciplinary teams nowadays decide on oncological adjuvant treatments by using common clinical and biological criteria. Differences in the quality of IHC analysis and medical board interpretation of prognostic and predictive factors can substantially affect the adjuvant strategy resulting in risks for underand overtreatment. The main objective of this study is to compare decisions taken when diagnostic gene expression analysis (70-gene MammaPrint assay) (MP) is added prospectively, to the traditional treatment decision making process in an unselected patient Methods: In 2009, we collected fresh tumour samples during surgery in 162 breast cancer patients. Sufficient RNA for microarray analysis was obtained from 135 patients; MammaPrint Low risk (MP LR) profiles were found in 42%, MammaPrint high risk (MP HR) profiles in 58% of the patients. Following conventional treatment recommendations, 11 of 57 (19%) MP LR patients received chemotherapy and 34 of 78 (44%) MP HR patients received no chemotherapy. The MP HR patients receiving no chemotherapy (CT) and MP LR patients receiving CT were considered unmatched cases and submitted for second opinion to three independent academic teams initially blinded and subsequently unblinded for the MP Abstract: 239P Table 1 239P Table 1 pN N %CMF-like N % Anthracycline N % Taxane + anthracycline N % Taxane alone N pN0 67 13.4% 320 63.7% 100 19.9% 15 3.0% 502 pN1 23 5.5% 189 44.8% 190 45.0% 20 4.7% 422 pN2 7 6.6% 13 12.2% 83 78.3% 3 2.8% 106 pN3 3 4.6% 12 18.5% 47 72.3% 3 4.6% 65 Total 100 9.1% 534 48.8% 420 38.4% 41 3.7% 1095 viii86 | abstracts Volume 21 | Supplement 8 | October 2010 abstracts Annals of Oncology Downloaded from https://academic.oup.com/annonc/article-abstract/21/suppl_8/viii78/178213 by guest on 15 January 2018 Results: According to the initial recommendation (blinded for MP) of these 3 academic teams, 13 of 34 MP HR patients remained without CT and 9 of 11 MP LR patients would still receive chemotherapy. Subsequently, unblinded for the MammaPrint result, these 3 academic teams changed their recommendation in 6 of 13 MP HR patients. Ultimately, from the 78 patients classified as High risk by MammaPrint, 7 remained without chemotherapy treatment recommendation in this multidisciplinary adjuvant treatment planning (9%). Conclusions: This study demonstrates high variability in the adjuvant strategies between multidisciplinary teams based on traditional patient and tumour related parameters. In our study population, the MammaPrint gene profile would have modified adjuvant treatment recommendation in at least 10% of patients Disclosure: All authors have declared no conflicts of interest. 242P THE OUTCOMES OF THE SPECIALIZED GENETIC PROGRAM PROVIDED FOR THE CARRIERS OF THE GENETIC ALTERATIONS PREDISPOSING TO THE BREAST CANCER M. Zimovjanova, J. Novotny, Z. Kleibl, L. Petruzelka, P. Pohlreich Dept. Oncology, General Teaching Hospital, First Faculty of Medicine, Prague/ CZECH REPUBLIC, Dept. of Oncology, First Faculty of Medicine, Charles University in Prague, Prague/CZECH REPUBLIC, Inst. of Biochemistry and Experimental Oncology, First Faculty of Medicine, Charles University in Prague, Prague/CZECH REPUBLIC, Oncology, First Medical Faculty of Charles University, Prague/CZECH REPUBLIC The f-up program for individuals carrying mutations in breast/ovarian cancer predisposing genes has been provided at the specialized unit of the Dept. of Oncol., General Teaching Hospital, Prague, in close collaboration with the Dept. of Med. Genetics and Biochem. and Exp. Oncol. since 1999. The mutation status of the BRCA1 and BRCA2 genes has been analyzed since its beginning, testing of other genes involved in hereditary breast cancer (HBC) development has been introduced later (Table 1). The median f-up of the whole population is 41 months. During this period, 7 malignancies have been found in BRCA1/2 and CHEK2 healthy mutation carriers. One BC has been detected during the initial visit. Median time to the detection of malignancy was 28 months. One BC has been diagnosed in stage 0, 5 in stage I and 1 in stage IIB. The first abnormal findings were CA 19-9 elevation in 3 patients, breast MRI in 2 patients, mammography in 1 and breast ultrasound in 1 patient. Six of these BC have been detected during regular f-up visits. One BC occurred as an interval carcinoma. Nine secondary malignancies have been identified among 135 HBC patients carrying mutation in BRCA1/2 gene (6 BC, 1 ovarian carcinoma, 1 pancreatic cancer and 1 lung carcinoma). 23 risk reducing salpingo-oophorectomies and/or hysterectomies have been performed among 90 healthy BRCA1/2 mutation carriers (26%). In the same cohort, prophylactic mastectomy has been carried out in 4 of 90 women (4.5%). The low proportion of prophylactic surgical procedures is caused by low mean and median ages of these women. Conclusion: Specific preventive program for mutation carriers is an effective option for identification of high/risk BC patients at early and highly curable stages. Acknowledgement: The study was supported by the grant MSM0021620808. Disclosure: All authors have declared no conflicts of interest. 243P ADJUVANT CHEMOTHERAPY PRESCRIPTION ACCORDING TO MULTIDISCIPLINARY TEAM DECISION OR THE MINDACT PROTOCOL (MICROARRAY IN NODE-NEGATIVE AND 1 TO 3 POSITIVE LYMPH NODE DISEASE MAY AVOID CHEMOTHERAPY) (EORTC10041 BIG 3-04) C. Mitine, A. Doneux, F. Majois, V. Samartzi, D. Goddart, Y. Neybuch, B. Petit, C. Confente, M. Beauduin, R. Gerard Radiotherapy, Jolimont Hospital, Haine Saint Paul/BELGIUM Introduction: The European-based MINDACT trial is a multicentre prospective phase III randomised study. It compares a genomic test (G) (MammaPrint ) developed with microarray technology to traditional clinical-pathological (C) criteria (age, tumor grade, stage, hormone receptor expression) included in a modified version of Adjuvant! Online (A!O) for assessing the risk of recurrence in women with lymph node negative or 1-3 node positive breast cancer. Patients assessed as ‘‘High Risk’’ by both MammaPrint and A!O are advised to have CT whereas for those assessed ‘‘Low risk’’ by both methods no chemotherapy is recommended. Discordant cases are randomised to treatment decision based on G or C criteria. We compared the prescription of CT defined by the protocol to the one decided in the multidisciplinary tumour board as traditionally done. Materials and methods: Among the 35 patients enrolled between May 2008 and January 2010, 16 patients were classified as low risk (CL-GL) by both methods, 4 patients were classified as high risk (CH-GH) by both methods and 15 patients were in the discordant group. Results: The 16 CL-GL patients did not receive CT in accordance with the protocol. Eight of these patients would have been proposed CT by the tumour board. The 4 CH-GH patients were proposed CT in accordance with the protocol and would also have been recommended CT by the tumour board. For the 2 patients with a CL-GH randomised to no CT, the decision was also identical between the protocol and the tumour board. Among the 13 patients with CH-GL, 12 would have received CT according to the tumour board while following the protocol randomisation only seven received CT. Overall, from the 35 patients included, 15 (43%) avoided CT due to the MINDACT protocol. Conclusions: Since breast cancers with similar clinical characteristics can have strongly different outcomes, even if treated similarly, the current decision-making for adjuvant CT needs to be improved. If the added value of the molecular profile is validated, a personalisation of the treatment strategy could be considered for each patient. Disclosure: All authors have declared no conflicts of interest. 244P DYNAMICS OF CIRCULATING ENDOTHELIAL CELLS AND ENDOTHELIAL PROGENITOR CELLS IN BREAST CANCER PATIENTS RECEIVING CYTOTOXIC CHEMOTHERAPY Y.H. Kuo, C.H. Lin, W. Shau, T. Chen, S. Yang, S. Huang, A. Cheng, Y. Lu Department of Oncology, National Taiwan University Hospital, Taipei/TAIWAN, Center for Drug Evaluation, Taipei/TAIWAN, Department of Internal Medicine, National Taiwan University, College of Medicine, Taipei/TAIWAN Background: Anti-angiogenic therapy has become an important field in cancer treatment. Few studies have described circulating endothelial cells (CECs) and circulating endothelial progenitor cells (CEPs) values change after cycles of chemotherapy. However, there is no study to describe the CEC and CEP dynamic change ‘‘during’’ each consecutive cycle of chemotherapy in human, of which may give us a way to evaluate the timing of adding anti-angiogenesis agents. Materials and methods: We collected blood samples from breast cancer patients who received systemic chemotherapy. CECs, viable circulating endothelial cells (V-CECs) and CEPs were measured by six-color flow cytometry. CECs and CEPs levels were examined within 7 days prior to chemotherapy, twice a week during first and second cycle chemotherapy, then once a week at subsequent cycles of chemotherapy. When analyzing, point of measurement were divided into Day 1 of chemotherapy, 1st week of chemotherapy and after 1st weeks of chemotherapy. The Day 1 of chemotherapy was set as reference point. Results: There were total 56 courses of chemotherapy for the 15 patients included in our study. The means of CEC, V-CEC and CEP were all significantly decreased in the 1st week of chemotherapy compared to those in the Day 1 of treatment, the differences were -2.05 /lL, 95% CI = (-3.98,-0.12); -1.57/lL, 95%CI =(-3.00,-0.14); and -0.40/lL, 95% CI = (-0.60, -0.20) respectively. After 1st week of chemotherapy, the means of CEC, V-CEC, and CEP came back to a similar level compared to Day 1 of treatment. The differences were 0.07/lL, 95%CI =(-1.71, 1.85); 1.11/lL, 95%CI=(-1.49,1.70); and -0.35/lL, 95% CI= (-0.54, -0.16) respectively. There is a trend towards increase in total number of CEP after cycles of chemotherapy. The other factors including existence of tumor, status of operation, drug used, and use of GCSF, were not statistically significantly affected these results. Conclusions: Although the CECs and CEPs decrease in one week after chemotherapy, the number recovered soon, and with a trend towards increase in CEP number after several cycles of chemotherapy. The possible impact of this phenomenon on tumor re-grow warrant further studies. Disclosure: All authors have declared no conflicts of interest. 245P IMPACT OF DIFFERENT PROGNOSTIC FACTORS ON THE DEVELOPMENT OF BRAIN METASTASIS IN ADJUVANT BREAST CANCER PATIENTS S.F. Amin, R.R. Abdel Malek Medical Oncology, Cairo-oncology Center, Giza/EGYPT, Clinical Oncology, Cairo University, Cairo/EGYPT Background and aim: The brain is increasingly being recognized as a sanctuary site for metastatic tumor cells in high risk breast cancer patients. Symptomatic brain metastasis develop in 10%-20% of patients with metastatic breast cancer, most often following disease progression at other sites, carrying a poor 1and 2-year survival rates of only 20% and <2%, respectively. Patients and methods: We retrospectively analyzed breast cancer patients eligible for adjuvant systemic treatment who presented to us in the period from 2000 till 2006. Relationship between BFS and different factors was done. Table 1. Basic characteristic of tested population. Analyzed gene No. tested individuals No. tested families No. mut. carriers BRCA1 1336 156 190 BRCA2 1336 48 67 CHEK2 1336 7 7 P53 1211 4 4 ATM 1211 5 5 Volume 21 | Supplement 8 | October 2010 doi:10.1093/annonc/mdq516 | viii87 Annals of Oncology abstracts Downloaded from https://academic.oup.com/annonc/article-abstract/21/suppl_8/viii78/178213 by guest on 15 January 2018 Results: Our study included 1752 patients of which 75 developed brain metastasis. The 5-year BFS was 84.5% for ER-ve, 86.4% for PR –ve, 84.2% for Her-2/neu +ve patients compared to 93.5% for ER +ve (p<0.001), 93.7% for PR +ve (0.006) and 92.5% for Her-2/neu –ve (0.002) patients respectively. Patients with grade III tumors had a lower 5-year BFS of 81.2% compared to 93.1% for those with grade I-II disease (p<0.001). Positive lymph nodes had a marginal significance of a lower BFS as well (90.2% vs. 94.5%; p=0.042). There was no significant difference seen according to age, pathological type or menopausal status. In a multivariate analysis model, histological grade and negative hormonal receptor status were the most significant. Her-2/neu score was missing in a quite a large number of patients which did not allow us to draw solid conclusions regarding its predictive value. By comparing BFS among different subgroups of Breast cancer namely Hormone Receptor positive (HR+), Her2 positive (Her2+) and Triple negative (TN), no statistical significant difference was found with median BFS of 33.7, 26.3, 26.9 months respectively (p=0.487) Conclusion: Patients with poorly differentiated tumors appear to have a higher probability of developing brain metastases as well as those with negative hormonal status. We could not draw solid conclusions regarding the predictive value of Her-2/ neu gene. These patients could be good candidates for trials investigating the role of any prophylactic intervention to decrease their risk to develop brain metastases. Disclosure: All authors have declared no conflicts of interest. 246P ARE BREAST CANCER (BC) PROGNOSTIC FACTORS DIFFERENT IN YOUNG PATIENTS? Z. Baretta, E. Orvieto, L. Evangelista, M. Lo Mele, G. Artioli, S. Ziampiri, J. Pigozzo, A. Jirillo, C. Ghiotto Oncology, Istituto Oncologico Veneto IRCCS, Padova/ITALY, Pathology, Azienda Ospedaliera di Padova, Padova/ITALY, Radiotherapy and Nuclear Medicine, Istituto Oncologico Veneto IRCCS, Padova/ITALY, Medical Sciences, Azienda Ospedaliera di Mirano, Mirano/ITALY Background: BC in young patients has worse prognosis than older women, but a clear identification of prognostic factors in this population is still fuzzy. The aim of this study was to find independent predictors of disease free survival (DFS) and overall survival (OS) in patients aged < 40 years. Materials and methods: Data of 219 women (mean age 35+4) were retrospectively analyzed (period: 1996-2006). Clinico-pathological and follow-up data were derived from medical records. Kaplan Meier method and Cox regression model were used to obtain survival curves and independent prognostic factors, respectively. Results: Table 1 reports the histological features of study population. Follow-up data were available (mean 75±31 months) for 214 patients (98%). Of these, 10% developed local relapse, 25% distant relapse, 3% contra-lateral BC and 3% second tumor. DFS and OS were significant different for stage (p<0.001 for both), pN (p<0.001 and p<0.01, respectively), LhRh-analogues therapy (p<0.005 and p<0.05, respectively) and amenorrhea (p<0.05 for both). At univariate analysis, stage (HR 1.82, p<0.001), pN (HR 1.99, p<0.005), LhRh-analogues therapy (HR 0.48, p<0.005) and amenorrhea (HR 0.58, p<0.05) were significant predictors of DFS, while stage (HR 2.25, p<0.001), pN (HR 3.05, p<0.005), MIB-1 (HR 2.3, p<0.05), G (HR 2.4, p<0.01), LhRh-analogues therapy (HR 0.42, p<0.05) and amenorrhea (HR 0.42, p<0.05) of OS. At multivariate analysis, only stage maintained a significant relevance for DFS (HR 2.08, p<0.001) and OS (HR 2.05, p<0.05). Conclusions: In young BC patients, prognostic relevance appears to be symbolized by different factors than in older women; in particular, hormonal changes induced by therapy seem to influence prominently outcomes, mainly in positive hormone receptors patients. Table 1. Histological features of study population (n=219) Disclosure: All authors have declared no conflicts of interest. 247P LOW EXPRESSION LEVEL OF NUCLEOSTEMIN (GNL3), STIMULATOR OF CANCER STEM CELL FEATHER, IS A PROMISING BIOMARKER TO PREDICT PATHOLOGIC COMPLETE RESPONSE (PCR) IN NEOADJUVANT TREATMENT WITH BREAST CANCER K. Tamura, H. Yamamoto, C. Shimizu, T. Kinoshita, M. Ando, M. Yunokawa, F. Koizumi, K. Masutomi, H. Tsuda, Y. Fujiwara Breast and Medical Oncology Division, National Cancer Center Hospital, Tokyo/JAPAN, Division of Breast Cancer and Medical Oncology, National Cancer Center Hospital, Tokyo, tokyo/JAPAN, National Cancer Center Hospital, Tokyo/JAPAN, Surgical Oncology Division, National Cancer Center Hospital, Tokyo/JAPAN, Shien Lab, National Cancer Center Hospital, Tokyo/ JAPAN, Cancer Stem Cell Project, National Cancer Center Hospital, Tokyo/ JAPAN, Pathology, National Cancer Center Hospital, Tokyo/JAPAN Background: Both nucleostemin (GNL3) and guanine nucleotide binding protein-like 3 (GNL3L) are interacting proteins with human telomerase reverse transcriptase (hTERT). These proteins promote cell proliferation and tumorigenicity in vivo, and up-regulate CD44 and CD133 which are already established marker for cancer-stem cell, in the GNL3/ GNL3L tranfected cells. Thus, both GNL3 and GNL3L are considered as ‘‘cancer stem cell initiator’’ and novel therapeutic molecular targets. Methods: We have conducted a prospective phase II trial in neoadjuvant setting with operable or locally advanced breast cancer. Eligible criteria include, stage IIA-IIIC, chemotherapy-naı̈ve, measurable disease, age 3 20, PS 0 or 1, and adequate organ function. Patients were treated preoperatively with four cycles of fluorouracil / epirubicin / cyclophosphamide (FEC) (500 /100/500 mg/m) followed by 12 cycles of weekly paclitaxel (80 mg/m) with or without trastuzumab (2mg/kg; with a loading dose of 4 mg/kg). mRNA levels of both GNL3 and GNL3L were evaluated by real time RT-PCR. Results: Between December 2007 and February 2010, one hundred and forty five patients were enrolled in the prospective study. Sixty eight primary cancer tissues before the treatment by needle biopsy are available. Sufficient mRNA for real time RTPCR was extracted in 53 cases. Pathological responses have been fixed in 34 cases out of them at the point on April 2010. Median age was 47. PS 0/1: 29/5; Stage IIA/IIB/IIIA/ IIIB/IIIC: 8/16/4/4/2; HER2 positive/negative: 10/24; Hormone receptor positive/ negative 12/22; Historical grade 1/2/3: 1/14/19. pCR rate was 29.4%. Expression of GNL3 have correlated with that of GNL3L (R=0.78). Low expression of GNL3 have statistically correlated with pCR (p=0.018) by ANOVA test. Conclusion: Our results indicated that there are chemo-resistant populations with cancer stem cell features in operable breast cancer. Low expression of GNL3 is a promising predictive marker of pCR in neoadjuvant treatment with breast cancer. This is the first report that expression of GNL3 correlated with chemo-resistant in clinical study. Disclosure: All authors have declared no conflicts of interest. 248P PREDICTIVE FACTORS FOR COMPLETE PATHOLOGICAL RESPONSE AFTER NEOADJUVANT CHEMOTHERAPY IN BREAST CANCER. RESULTS FROM A SINGLE INSTITUTION V. Pons, J.A. Pérez-Fidalgo, D. Roda, B. Bermejo, O. Burgues, A. Bosch, F. Martinez-Ruiz, J. Ferrer, A. Lluch Hematology and Medical Oncology, University Hospital Valencia, Valencia/ SPAIN, Medical Oncology, Hospital Clinico Universitario, Valencia/SPAIN, Hospital Clinico Universitario, Valencia/SPAIN, Medical Oncology, Hospital Clinico de Valencia, Valencia/SPAIN Introduction: Pathological complete response (pCR) has been identified as the most important prognostic factor for survival in the neoadjuvant setting for breast cancer. The aim of our study was to assess both clinical and molecular factors with prognostic importance in a series of patients with stage IIA-IIIB breast cancer treated with neoadjuvant chemotherapy (CT). Material and methods: We performed a retrospective analysis of predictive factors for pCR in stage IIA-IIB breast cancer treated with neoadjuvant CT in Hospital Clı́nico of Valencia from 1993 to 2001. Potential molecular and clinical prognostic factors were recorded from medical history. Univariant and multivariant analysis was performed in order to assess prognostic value of each variable. Histological features Patients, n (%) Pathological stage* 0 5 (2%) I 92 (42%) II 82 (38%) III 37 (17%) unknown 3 (1%) Lymph nodes involvement (pN) positive 93 (43%) negative 126 (57%) Grading (G) G1 30 (14%) G2 80 (36%) G3 109 (50%) Estrogen and Progesterone receptors (ER, PGR) ER+PGR+ 149 (68%) ER+PGR14 (6%) ER-PGR56 (26%) Proliferative Index (MIB-1) 0-20% 140 (64%) >20% 79 (36%) HER-2 positive 56 (26%) negative 145 (66%) 2+ (FISH unknown) 18 (8%) *49 patients underwent neo-adjuvant chemotherapy and determination of pathological stage was available in 216 of 219 patients. viii88 | abstracts Volume 21 | Supplement 8 | October 2010 abstracts Annals of Oncology Downloaded from https://academic.oup.com/annonc/article-abstract/21/suppl_8/viii78/178213 by guest on 15 January 2018 Results: Median age of the 170 patients included, was 56 years (43,8-64,3), 37.1% were premenopausal and 62.9% were postmenopausal. Estrogen receptors in our series were positive in 64.2%, progesterone receptors were positive in 44.7%. Grade was I in 11.2%, II in 55.9% and III 32.9%. HER2 was positive in 21%. Clinical stage was IIA 36.6%, IIB 23.3%, IIIA 20.3% and IIIB 19.8%. Surgery of the primary tumor was conservative in 39.4% and mastectomy in 60.6%. Patients received a median of 4 cycles (3-8) of neoadjuvant CT, 70.3% with anthracyclines and 29.7% with anthracyclines associated to taxanes. pCR obtained was 14% in schedules with anthracyclines and 23% in CT containing both anthracyclines and taxanes. In the univariant analysis, patients obtaining pCR presented significantly an increased rate of grade 3 tumors and negative estrogen and progesterone receptors. Patients with pCR completed an increased number of cycles of CT and surgery underwent was more frequently conservative. In the multivariant analysis molecular prognostic factors maintaining significance were grade and estrogen receptors. Conclusions: Negative estrogens receptors, and grade 3 are both predictive factors useful for decision in the neoadjuvant setting. Tumors with these features are strongly associated with an increased probability of obtaining pCR in this setting. Disclosure: All authors have declared no conflicts of interest. 249P THE 70-GENE EXPRESSION PROFILE FOR BREAST CANCER PATIENTS IN ITALIAN HOSPITALS D. Generali, F. Zanconati, P. Querzoli, A. Sapino, M. Di Bonito, T. Perin, P. Pronzato, C. Giardina, C. Tinterri, A. Di Napoli Senologia E Breast Unit, Istituti Ospitalieri di Cremona, Cremona/ITALY, Ospedale Maggiore, Trieste/ITALY, Dip. di Medicina Sperimentale E Diagnostica, Istituto Di Patologia, Università di Ferrara, Ferrara/ITALY, Dip. Scienze Biomediche ed Oncologia Umana, Ospedale Molinette, Torino/ITALY, Istituto Nazionale Tumori, Anatomia Patologica e Citopatologica, Napoli/ITALY, Centro Di Riferimento Oncologico Irccs, Istituto di Anatomia Patologica,, Aviano/ITALY, Dip. di Oncologia Medica, Istituto Nazionale Tumori, genova/ ITALY, Università Degli Studi Di Bari, Istituto di Anatomia Patologica, Bari/ ITALY, Istituto Clinico Humanitas IRCCS, Unità di Senologia, Milano/ITALY, Istituto di Istopatologia, Ospedale Sant’Andrea, Roma/ITALY Background: The 70-gene tumor expression profile ‘‘MammaPrint’’ was established as a powerful predictor of disease outcome in breast cancer. The St Gallen 2009 recommendations include gene-expression signatures as an indicator for adjuvant therapy. Here we determined in an Italian cohort how the 70-gene profile could assist in patient management. Methods: Fresh tumor samples (n=584) from breast cancer patients (clinical T1-4N03M0) aged 26 to 98 years (median age 63 years), were collected in 12 Italian hospitals IN 2008 and 2009 by core needle biopsy or from a surgical specimen (study protocol MP 090). We assessed agreement between the treatment advice as recommended by the 2009 St Gallen Highlights and classification according to the 70-gene MammaPrint profile. Results: According to the St Gallen 2009 treatment recommendations, 4 patients could forego any adjuvant treatment (<1cm, LN0, PVI 0). Of these patients, 3 were classified to be poor prognosis signature by MammaPrint. Another 17 patients with tumors <1cm, LN0, PVIare ER+ and are recommended endocrine treatment, of whom 9 are MammaPrint high risk. The 126 Her2+ patients would be recommended anti-HER2 treatment as well as adjuvant chemotherapy according to the 2009 recommendations. Of these patients, 19 (15%) were classified as good prognosis signature by MammaPrint. All 47 (ER-) patients who are recommended chemotherapy alone are classified as poor prognosis by MammaPrint. For the 389 ER+, HER2patients, 17 would be recommended no adjuvant chemotherapy (Grade I and LN0 and £2cm and ER >50%) and 198 would be recommended adjuvant chemotherapy being either Grade III, or 4LN, or >5cm, or ER <50%. Of these 215 patients, 73 (34%) are classified as low risk by MammaPrint. The remaining 174 ER+, HER2patients fall in the subgroup for which St Gallen 2009 states that they have characteristics that are not useful for decision making; MammaPrint classified 101 (58%) as poor prognosis and 73 (42%) as good prognosis. Conclusion: For the majority (93%) of these 584 breast cancer patients from 12 Italian community hospitals, the St Gallen 2009 either recommends or suggests considering treatment with cytotoxic adjuvant therapy for whom MammaPrint indicates a low risk of recurrence in 30% of cases. Disclosure: All authors have declared no conflicts of interest. 250P EVALUATION OF COMPLETENESS AND QUALITY OF THE INFORMATION PROCESS DURING GENETIC COUNSELLING FOR CANCER PREDISPOSITION. PRELIMINARY RESULTS OF THE GENETIC COUNSELLING SERVICE (GCS) OF SOUTHERN SWITZERLAND E. Scaffidi, O. Pagani, G. Bianchi Micheli, P. Saletti, C. Cafaro Greco, N. Galli, P.J. Schulz, F. Cavalii Genetic Counselling Service, Institute of Oncology of Southern Switzerland, Viganello/SWITZERLAND, Institute of Communication and Health, University of Southern Switzerland, Lugano/SWITZERLAND, Institute of Oncology of Southern Switzerland, Viganello/SWITZERLAND Introduction: Phase I studies showed the way information is provided can impact patients’ comprehension of risk, their concerns and anxiety, the last two dimensions being generally overestimated by physicians. Informative and relational dimensions of cancer predisposition assessment can affect individuals’ quality of life and negatively impact their psychological condition. Subjects and methods: A pilot prospective survey assessed satisfaction and distress associated with genetic counselling in patients and probands of the GCS of Southern Switzerland. Subjects were given: 1) The STAI (C.D. Spielberger) to evaluate State and Trait Anxiety. 2) A specifically designed questionnaire (26 items) to evaluate informative, emotional and interactive dimensions of the counselling interview and genetic testing indication. Preliminary results: The survey was conducted in 100 consecutive subjects: 55% affected patients and 45% probands. Age was < 50 years in 53% of subjects, 72% were females and 66% had at least a high school degree. The vast majority of the subjects (84%) reported to be satisfied with the consultation, the proportion being slightly higher in patients (49%) as compared to probands (35%). Sixty-nine per cent of the responders seemed to understand the implications and consequences of genetic testing with no apparent difference between the 2 subgroups. As regards the psychological impact, 70% of the population reported the same level of concern and fear as compared to pre-consultation. Conclusions and future perspectives: Overall, the preliminary data analysis showed a high degree of satisfaction in terms of well-being during the consultation, clarity and understanding of the information given. The degree of anxiety before and immediately after counselling, as specifically investigated by the STAI instrument, is being currently analysed. Next steps include a detailed qualitative analysis of weaknesses and limits of the questionnaire (i.e. type and formulation of some questions) in order to develop an improved tool to be shared with different cancer genetic services in Northern Italy. Disclosure: All authors have declared no conflicts of interest. 251P BREASTFEEDING IN BREAST CANCER SURVIVORS: PATTERN, BEHAVIOUR AND EFFECT ON BREAST CANCER OUTCOME H.A. Azim Jr, G. Bellettini, S.J. Liptrott, M.E. Armeni, V. Dell’Acqua, F. Torti, B. Di Nubila, V. Galimberti, F.A. Peccatori Medical Oncology, Jules Bordet, Brussels/BELGIUM, ASL Città di Milano, Milan/ITALY, University Hospital South Manchester NHS Foundation Trust, Manchester/UNITED KINGDOM, Rome, Rome/ITALY, European Institute of Oncology, Milan/ITALY, Division of Breast Surgery, European Institute of Oncology, Milan/ITALY, Haematology-Oncology, European Institute of Oncology, Milan/ITALY Background: We have recently presented a metaanalysis confirming the safety of pregnancy in breast cancer (BC) survivors [Azim HA Jr et al; EBCC 2010]. However, very little is known regarding the safety and feasibility of breastfeeding in these women Methods: We searched the database of the European Institute of Oncology from 19882006 for women £ 40 years at BC diagnosis. We constructed a questionnaire and performed a survey among patients who had a completed pregnancy following BC therapy to examine their lactation behaviours and its effect on BC outcome Results: 32 women were identified, 20 were reachable and accepted to take the survey. 15 women were previously subjected to breast conservative surgery (BCS) while the rest were subjected to mastectomy. Only 10 (50%) women initiated breastfeeding. The main reasons for not initiating breastfeeding were ‘‘uncertainty regarding maternal safety’’ and ‘‘a priori unfeasibility’’ expressed either by the obstetrician or by the medical oncologist. In those who breastfed their babies, 4 stopped within 1 month and 6 had long-term success with a median period of 11 months (7-17 m). The latter were all previously subjected to BCS and received lactation counselling at delivery. Out of 15 women who underwent BCS and radiotherapy, 14 reported hypoplasia of the irradiated breast during pregnancy. 7/15 attempted to breastfeed from the affected breast but milk production was significantly reduced with difficulty in latching. Only 2 women were able to breastfeed from both breasts but only for 2 weeks. At a median of 48 months following delivery, all 20 women were alive with 2relapses; 1 in each group (i.e. lactating and non-lactating) Conclusions: Breastfeeding from the affected breast is challenging but exclusive lactation from the contralateral breast is feasible. Previous mastectomy was associated with short lasting (< 1 month) breastfeeding, even if all women who had a previous BCS used 1 breast for lactation. This emphasizes the importance of body image in the Volume 21 | Supplement 8 | October 2010 doi:10.1093/annonc/mdq516 | viii89 Annals of Oncology abstracts Downloaded from https://academic.oup.com/annonc/article-abstract/21/suppl_8/viii78/178213 by guest on 15 January 2018 success of breastfeeding. Acknowledging the small sample size, breastfeeding does not seem to affect the prognosis of these women. Proper fertility and survivorship counselling is crucial and requires more attention in breast cancer clinics Disclosure: All authors have declared no conflicts of interest. 252 EARLY OSTEOPOROSIS RISK IN PREMENAPOUSAL WOMEN WITH BREAST CANCER AFTER OVARIAN ABLATION M. Dikilitas, M. Altınbas, A.T. Ersozlu, G.G. Dogu, M. Ozkan, O. Er Medical Oncology, Erciyes University Medical Faculty, Kayseri/TURKEY, Medical Oncology,Yildirim Beyazit Hospital, Ankara/TURKEY, Erciyes UNL, Kayseri/TURKEY, Erciyes University, Kayseri/TURKEY, Medical Oncology, Erciyes University, Kayseri/TURKEY Objective: In this study, we intended to investigate osteoporosis progression in the early stages after ovarian ablation in premenopausal women with breast cancer whose hormone receptors were positive. Materials and methods: The study group consisted of 34 premenopausal women with breast cancer. The diagnosis was histopathologically proven and hormone receptors were positive in all patients. Control group consisted of 15 healthy individuals. 18 patients were observed over 2 years, 16 patients were observed over one year. Ovarian ablation was made in 7 of 34 patients by chemotherapy, and in 27 of 34 patients by hormone therapy. The levels of baseline, sixth month, first year, and second year of calcium, phosphate, ionized calcium, ALP, FSH, LH, estradiol, urine deoxyprydioline, osteocalcine, and PTH were obtained. Lumbar spine and femur neck bone mineral density was measured. Results: The measurements of patients and control groups in baseline counts showed no significant statistical difference. Patients observed over 2 years (18/34) had no significant statistical difference in calcium, phosphate, ionized calcium, ALP, FSH, LH, estradiol, urine deoxyprydioline levels. However, osteocalcine levels were significantly increased at second year (P=0.004). Levels of estradiol were significantly decreased at sixth month, first year and second year (P<0.001). When compared with the basic measurement there was a statistically significant decrease in L1-4 bone mineral density of at 6th month, 1st year, 2nd year (P<0.001). T and Z scores of lumbar spine decreased in 6th month, 1st year, 2nd year compared with the basic measurement (P<0.001). There is a statistically significant decrease in T score of femur neck between baseline and sixth month and second year (P=0.038). While none of the patients had osteoporosis at the beginning, at the end of 1st year one patient and at the end of 2nd year 3 of 18 patients had osteoporosis. Among patients observed through one year only one patient had developed osteoporosis. Conclusion: Ovarian insufficiency caused by hormone therapy may result in osteoporosis and decrease in bone mineral density. 10% of patients undergo ovarian ablation; these patients must be followed closely due to these risks. Disclosure: All authors have declared no conflicts of interest. 253 TRASTUZUMAB AS ADJUVANT THERAPY IN HER21 EARLY BREAST CANCER – CARDIAC SAFETY ANALYSIS M. Ferreira, R.H.V.S. Soares, J. Godinho, Y. Shvets, N. Couto, N. Afonso, D. Pereira, H. Rodrigues Medical Oncology, Portuguese Oncology InstitutePorto, Porto/PORTUGAL, Medical Oncology, Instituto Português de Oncologia Dr. Francisco Gentil Porto, E.P.E., Porto/PORTUGAL, Medical Oncology, Instituto Português de Oncologia Porto, Porto/PORTUGAL Background: Trastuzumab (T) is effective in human epidermal growth factor receptor 2-positive (HER2+) breast cancer (BC), but it increases frequency of cardiac dysfunction (CD) when used with or after anthracyclines. Purpose: To assess cardiac safety of T in the adjuvant treatment of BC at Instituto Português de Oncologia do Porto. Material and methods: Patients (pts) with HER2+ early BC treated with fluorouracil, epirubicin and cyclophosphamide followed by docetaxel (FEC-D) plus 1 year of T as adjuvant therapy, from 11.07 to 06.09, were included in this retrospective study. Descriptive analysis of clinical and treatment data was performed. Left ventricular ejection fraction (LVEF) was assessed by multigated acquisition scan or echocardiogram. Cardiac events (CE) were reviewed and an association with risk factors was tested using Fisher‘s exact test and univariate log-rank analysis. Results: Of 96 HER2+ pts treated with FEC-D, 88 received T (66% sequential, 34% concurrent). Median follow-up from T was 9 months (0-22). Median age was 53 years (24-71) and 24% of pts had comorbidities: hypertension (10%), cardiac disease (9%) or diabetes (5%). All pts completed FEC-D. Median baseline LVEF was 64% (50-79) and median decrease after FEC was 2%. Decrease in LVEF ‡ 10% from baseline occurred in 38% of pts and decrease to LVEF < 50% in 11% of pts. That was more frequent in pts with hypertension (67%), diabetes (50%) and baseline or post-FEC LVEF = 50-54% (67% or 44%) (p= NS). No pt had congestive heart failure or cardiac death. Pts discontinued T because asymptomatic decline in LVEF (2%) or recurrence (1%). Cardiac function improved following T discontinuation and cardiac medication. T was withheld in 10% of pts for asymptomatic decline in LVEF (decrease ‡ 12% from baseline or decrease of 7-12% from baseline to less 50%) and in 1% for cardiac symptoms. No statistically difference between T arms. More than half of pts (n= 48) were still in T. Hypertension was associated with subsequent decrease in LVEF (p= .033). Baseline LVEF was marginally significant (p= .087). Conclusion: Despite short follow-up, CE were not different between sequential vs concurrent T. Hypertension is associated with increased risk of asymptomatic CD in pts receiving T following FEC. Disclosure: All authors have declared no conflicts of interest. 254 EVALUATION OF PROGNOSTIC VALUE OF HER2 AND VASCULAR ENDOTHELIAL GROWTH FACTOR (VEGF) EXPRESSION FOR PREDICTING EARLY FAILURE IN PATIENTS WITH OPERABLE BREAST CANCER S. Vasovic, L. Stamatovic, Z. Tomasevic, A. Karaferic, L. Pavlovic K. Karadzic, I. Jovanic Medical Oncology, Institute for Oncology and Radiology of Serbia, Belgrade/ SERBIA, Pathology, IORS, Belgrade/SERBIA Background: Tumor angiogenesis is important for tumor cell growth and progression. VEGF is considered to be an important angiogenic factor and high expression of VEGF has been found to worsen the outcome of breast cancer (BC) patients (pts). HER2 overexpression and amplification have been correlated with shorter disease-free survival and overall survival in BC pts. Aim: To investigate possible associations between expression of HER2 and VEGF and routine prognostic factors in prediction of early failure (EF=recurrence within 2 years) in premenopausal (pM), node-positive (N+) BC pts. Patients and methods: IHC analysis of VEGF, HER2, ER and PR was performed in 101 pM, N+, BC pts who underwent surgical treatment (radical mastectomy vs. conservative surgery), and received standard 6 cycles of adjuvant FAC chemotherapy+/-adjuvant hormonotherapy (ovarian ablation/suppression +/tamoxifen). HER2 status was scored according to the Hercept test (Dako). Slides evaluated as 3+, and slides scored with 2+ (CISH +) were considered as HER2 positive . Imunoreactivity for VEGF was evaluated using a combined score system based on the sum of staining intensity (0=negative, 1=weak, 2=intermediate, 3=strong) and percentage of positive cells (0=0%, 1=1-25%, 2=26-50%, 3>50%). Scores of 0-3 were considered as VEGF negative while scores 4-6 as positive. Results: A total number of 101 pts, median age 52 years (32-70) were included in retrospective analysis. HER2 was + in 22 pts (22%) while VEGF was + in 41 pts (40%). Both markers were + in 14 pts (14%) and both negative in 52 pts (51%). EF was detected in 50 pts (49%). The only significant difference between pts with and without EF was the size of primary tumor (P=0.0026). By Logistic regression model younger age (P=0.008), bigger size of primary tumor (P=0.031), radical mastectomy (P=0.001) and negative PR (P=0.037) were selected as risk factors for EF. Overall percentage of correctly classified pts was 72%. Conclusion: HER2 overexpression is not related to higher expression of VEGF. Neither HER2 nor VEGF constitute independent prognostic factor for predicting early failure in N+, preM pts with operable BC. Disclosure: All authors have declared no conflicts of interest. 255 DOES ADJUVANT CHEMOTHERAPY BENEFIT PATIENTSWITH NODE-POSITIVE, HORMONE-RECEPTOR POSITIVE, AND HER2 NEGATIVE BREAST CANCER? K. Harano, K. Hashimoto, C. Shimizu, T. Hirata, K. Yonemori, K. Tamura, N. Katsumata, M. Ando, Y. Fujiwara Breast and Medical Oncology Division, National Cancer Center Hospital, Tokyo/JAPAN, National Cancer Center Hospital, Tokyo/JAPAN, Outpatient Treatment Center, National Cancer Center Hospital, Tokyo/JAPAN Background: The benefit of adjuvant chemotherapy (Cx) is proved in non-selected node-positive (N+) breast cancer (BC) patients (pts). However, recent studies have suggested that its benefit may be limited in hormone-receptor positive and HER2 negative (HR+HER2-) BC pts, and endocrine therapy (Ex) alone is listed as an option for recommendation for the intermediate risk HR+HER2BC according to St. Gallen guideline (2007). Therefore, we performed an institutional-based review to investigate the impact of omitting Cx on clinical outcome in HR+HER2BC pts. Methods: Patients included in this study were as follows; node-positive breast cancer patients who received breast surgery between 2001 and 2009 at the National Cancer Center Hospital; patients pathologically proven hormone-receptor positive and HER2 negative BC; patients who received Ex, Cx, or Ex+Cx. Disease-free survival (DFS) were compared to identify the benefit of Cx by Kaplan-Meier method. Results: There were 412 patients included in this analysis. The median age was 55 (2489). Of these, 308 (75%) patients had 1-3 lymph node metastases (intermediate risk in St. Gallen 2007 risk categories), and 104 (25%) patients had more than 4 lymph node metastases (high risk). In the intermediate risk group, 229 patients received Ex+Cx and 79 patients received Ex alone. The DFS at 5 years in patients who received Ex+Cx and Ex alone was 87% and 91% at a median follow-up period of 45 months (3-97) viii90 | abstracts Volume 21 | Supplement 8 | October 2010 abstracts Annals of Oncology Downloaded from https://academic.oup.com/annonc/article-abstract/21/suppl_8/viii78/178213 by guest on 15 January 2018 (p=0.41). We also analyzed the DFS in the high risk patients who were treated with Ex+Cx (n=93) or Ex alone (n=11); the DFS at 5 years were 86% and 82% (p=0.99). Conclusion: Our results showed that the adjuvant Cx did not change the short-term outcome of N+ HR+HER2BC pts irrespective of estimated risk of recurrence. Further follow up and validation is warranted. Disclosure: All authors have declared no conflicts of interest. 256 FEATURES OF RECURRENCE OF TRIPLE NEGATIVE (TN) NON-METASTATIC BREAST CANCER (NMBC) PATIENTS: A SINGLE INSTITUTION STUDY A.E. Alarcon-Rozas, M.R. Cueva, J.A. Galarreta, J. Ramirez, J. Torres, E. Gonzales Oncologia Clinica, Hospital Guillermo Almenara, Lima/PERU, Patologia Mamaria, Hospital Guillermo Almenara, Lima/PERU Background: TN breast cancer (BC) are the most agressive type of BC, and we do not have a target therapy against this type. Our goal is to determine the rate of recurrence, the affected organs and the DFS in these patients. Materials and methods: We reviewed 1042 charts of all diagnosed BC patients from January/2000 to December/2005 and choose 215 who were TN-NMBC. The data was analized by analitic and descriptive statistics in SPSS v. 17.0 Results: The rate of TN-NMBC were 20.6%(215) of them 18.6%(40) patients had recurrences with an average age of 52.5(31-93) years. The median DFS were 27 months with a median follow-up of 64 months. The Stage I, II and III were 7.5%(3); 32.5%(13) and 60%(24) respectevely for patients with recurrence. The most frequent involved organs with recurrence were visceral (lung and liver) 37.5%(15), bone 25%(10), skin 20%(8), CNS 12.5%(5) and contralateral breast 5%(2). Additionally we found five patients with history of familiar BC, and four of them were stage II with negative lymph node at diagnoses. Conclusion: TN-NMBC are 20.6% of all BC, the majority of them were stage III (60%), the median DFS for patients with recurrence were 27 months, and the most frequent sites involved were visceral (37.5%) and bone (25%). It is very interesting pay attention even in early stages to patients with history of familiar BC for risk of recurrence, BRCA positive?. Disclosure: All authors have declared no conflicts of interest. 257 RETROSPECTIVE ANALYSIS OF TRIPLE-NEGATIVE BREAST CANCER IN ONE HUNGARIAN CENTER G. Rubovszky, Z. Horváth, I. Láng, M. Kásler Dept. of Medical Oncology ‘‘B’’, National Institute of Oncology, Budapest/ HUNGARY Genetic investigations have unveiled the great diversity of breast cancers even in the triple-negative subtype. 10% of the generally high-risk triple-negative breast cancers (TNBC) are of low metastatic potential and has favorable prognosis even without adjuvant systemic therapy. There is a great need to investigate disease grpup to reach better prognostic accuracy and treatment efficacy. There are publications dealing with the characteristics of TNBC, but only rare data derives from Middle-East Europe. Material: the database of National Institute of Oncology in Hungary was searched for early TNBC operated from January 2005 to October 2008. Clinical and pathological characteristics were investigated in connection with survival data. Patient charts were excluded where other malignancy were known in the previous 10 years or where no data could be collected about perioperative treatment and survival. Results: Charts of 234 female patients were eligible. Mean age at clinical presentation was 56.3 years (25-86 y), 31 patients were younger than 40. The tumours were typically invasive ductal carcinomas (80%) with high histological grade (93.6%). According to stage: St I/II/III 31%/46.7%/22%. Lymph node metastasis was present in 41%. Pathologic report described necrosis (71%), lymphocyte infiltration (80%), extensive vascular invasion (14%) and p53 (53%) in many cases. However, 89% of patients were given perioperative chemotherapy with a median of 42.6 months follow-up, 65 relapses and 48 deaths occurred. Stage, lymph node status, type of adjuvant chemotherapy and vascular invasion showed significant impact on survival. Conclusion: Genetic testing is an attractive method for predicting prognosis and chemo-resistance, high costs hinders its widespread use. Classical pathologic assessment still has additional possibilities to better characterize breast tumors certainly with rigorous standardization. Disclosure: All authors have declared no conflicts of interest. 258 CLINICAL RESPONSE OF TRIPLE NEGATIVE BREAST CANCER TO TAXANES K. Saito, T. Mizuno, M. Taniguchi, Y. Yamashita, K. Yamamura, S. Tamaru, S. Kageyama, N. Katayama Medical Oncology, Mie University Hospital, Tsu/JAPAN, Internal Medicine, Yamada Red Cross Hospital, Ise/JAPAN Background: Most of triple-negative breast cancer (TNBC) has close association with the BRCA1 gene dysfunction. It has been demonstrated that BRCA1 genotype affects sensitivity of breast cancer to chemotherapeutic agents. DNA-damaging agents such as platinum are promising in the treatment of TNBCs harboring BRCA1 dysfunction. Although previous experimental studies have indicated that tumors with BRCA1 mutation are less sensitive to taxanes, it remains to be clinically determined whether TNBCs are sensitive to taxanes. Objective: The aim of this study is to analyze the clinical response of TNBC patients to the neoadjuvant chemotherapy with taxanes. Patients and methods: Between 2003 and 2010 at our institutes, patients were retrospectively selected for this study according to the following criteria: (1) Female breast cancer patients who received 4 cycles of doxorubicin (60 mg/m) or epirubicine (90 mg/m) and cyclophosphamide (600 mg/m) every 3 weeks followed by 12 cycles of weekly paclitaxel (80 mg/m) or 4 cycles of triweekly docetaxel (75 mg/m) as a neoadjuvant setting. (2) Patients who were evaluated by the imaging studies as CT or MRI following in the three points: 1) before treatment, 2) after anthracyclines and 3) after taxanes. A total of 71 patients fulfilled the eligibility criteria for this study. We compared the clinical responses of TNBCs to taxane with that of non-TNBCs. Result: There were 24 TNBCs (33%). The median age of TNBCs was 52 years (31-68 years). Eight and 16 patients were clinical stage II and III respectively. Twenty-three patients received weekly paclitaxel, and one patient received triweekly docetaxel. Overall clinical responses of AC (EC) followed by taxanes in TNBCs were 91% (CR, 5; PR, 17). Primary tumor progression was seen in 4 patients (16.6%) while receiving taxanes. One of 4 patients experienced progressive disease (PD) by the RECIST criteria. Four patients with tumor progression were associated with young age or having family history or great response to anthracycline. No tumor progression while receiving taxanes occurred in the patients with non-TNBCs. Conclusion: These data suspect that TNBCs, especially associated to BRCA dysfunction, may be less sensitive to taxanes in clinical settings. Disclosure: All authors have declared no conflicts of interest. 259 FACTORS INFLUENCING THE TIME OF SENTINEL NODE VISUALIZATION IN BREAST CANCER PATIENTS USING INTRADERMAL INJECTION OF THE RADIOTRACER S. Sajjadi, M.N. Forghani, A. Abdollahi, R. Sadeghi, K. Anvari, S.A. Aledavood Internal Medicine, Medical University of Mshhad, Mashhad/IRAN, Surgery, Omid Hospital, Mashhad University, Mashhad/IRAN, Surgery, University of Medical Sciences, Mashhad/IRAN, Department of Nuclear Medicine, University of Medical Sciences, Mashhad/IRAN, Radiotherapy Oncology, Cancer Research Center, Omid Hospital, Mashhad University, Mashhad/IRAN, Radiation Oncology, Mashhad University of Medical Sciences, Mashhad/IRAN Background: The objective of our study was to determine the important factors which have influence on the time of sentinel node visualization using intradermal injection of Tc-Antimony sulfide colloid. Methods: 250 consecutive patients with the diagnosis of early stage breast cancer were evaluated. Anterior and lateral views were acquired in various intervals after intradermal injection of the tracer till 180 minutes or visualization of the sentinel node. The effect of several variables on the time of sentinel node visualization was evaluated by univariate and multivariate analyses. Results: The time of sentinel node visualization was significantly correlated with age, BMI, and interval between biopsy and sentinel node mapping. Standardized beta values for these variables were 0.1, 0.3, -0.55 respectively. Conclusions: Older age and higher BMI can result in slow sentinel node visualization. Longer interval between biopsy and sentinel node mapping can be associated with rapid sentinel node detection. Disclosure: All authors have declared no conflicts of interest. 260 SENTINEL LUMP NODE MAPPING IN EXCISIONAL BIOPSY M.N. Forghani, S. Sajjadi, A. Abdollahi, R. Sadeghi, K. Anvari, S.A. Aledavood Surgery, Omid Hospital, Mashhad University, Mashhad/IRAN, Internal Medicine, Medical University of Mshhad, Mashhad/IRAN, Surgery, University of Medical Sciences, Mashhad/IRAN, Department of Nuclear Medicine, University of Medical Sciences, mashhad/IRAN, Radiotherapy Oncology, Cancer Research Center, Omid Hospital, Mashhad University of Medical Sciences, Mashhad/IRAN, Radiation Oncology, Mashhad University of Medical Sciences,