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e13006Background: Approximately 20% of breast cancers (BC) are HER-2+. Trastuzumab (T) has dramatically changed the outcome, both in early and in advanced settings in HER2+BC. Pertuzumab (P) plus T...

e12510 Background: Approximately 20% of breast cancers (BC) are HER-2+. Trastuzumab (T) has substantially improved the outcome, both in early and in advanced settings, in HER-2+BC. Pertuzumab (P), combined with T and taxanes, ameliorated progression free survival (PFS) and overall survival (OS) in the phase III CLEOPATRA study. In order to verify the results of the trial in unselected patients (pts), we performed a multicenter, retrospective-prospective, observational study, in HER-2+ metastatic BC (MBC) pts. Methods: We analyze the outcome of all HER-2+ MBC pts treated with P+T and taxanes, as first line therapy since the availability of P in Italy, at 11 general and university hospitals. Results: Up to February 1stdata from 103 HER-2+ MBC pts were recorded. Main pts’ characteristics were: median (M) age 52 y (28-78), m ECOG PS 0 (0-2), ER/PgR positive 68 pts (66%). Most common metastatic sites: liver 51 pts (49.5%), bone 64 pts (62.1%), lung 26 pts (25.2%). Thirty pts (29.1%) had bone and soft tissue disease only; 78 pts (75.7%) had metastatic disease on presentation. m number of metastatic sites was 3 (1-7); 25 pts (24.3%) received neo/adjuvant chemotherapy (CT) + T and 36 pts (34.9%) adjuvant endocrine therapy; 71 pts (69%) and 32 pts (31%) received docetaxel (D) and paclitaxel (P) respectively. m number of CT cycles was 6 for both drugs (D range 3-12; P range 1-18).At the time of the present analysis 12 pts are still on CT and 78 on maintenance; response is available for 91 pts and ORR is 80.2% (22 pts and 51 pts obtained CR and PR respectively), 6 pts experienced PD during CT. Median PFS is 13.9 months (1.5+ - 33.8+).Among hematological toxicities leucopenia (any grade) was recorded in 29 pts (28.1%), g 3 febrile neutropenia in 6 pts (5.8%). No change of left ventricular ejection fraction (LVEF) was recorded during CT; 4 pts interrupted maintenance P due to drop in LVEF and 1 due to rash. Onicopathy, nausea, alopecia, rash and arthro-myalgia were the most common non-hematological toxicities. Conclusions: Our preliminary results highlight the activity and the safety of the combination of CT plus P and T in unselected HER2+ MBC patients. The study is ongoing and updated results will be presented.

e11573 Background: Several studies suggest that newer therapies can improve survival in MBC, but a different impact on overall survival (OS) is observed according to histology, extension of disease and prognostic factors. This survey was performed for evaluate Italian experience in cancer treatment in the last ten years. Methods: We collected data from 13 Italian Medical Oncology Unit; we registered all consecutive patients (pts) with breast cancer who have developed metastasis between 2000 and 2008. Demographic data, pathological characteristics and treatment were reported. OS was calculated from time of recurrence and stratified according to biological characteristics and to recurrence date. Results: 1542 pts was suitable for analysis; median age 61,7 (range 22-94); MBC at diagnosis 21,8%. Site of disease recurrence: bone 26,2%, visceral 25,4%, bone and visceral 20,7%, soft tissue 11,5%, soft tissue and visceral 8,4%, bone and soft tissue 7,8%. Molecolar classification: luminal A 66,3%, luminal B 14,5%, triple negative 11,5%, HER2+ like 7,7%. Pts received a median of 2 lines of chemotherapy (range 0-10) and 1 line of hormonal therapy (range 0-7); 22,5% received biological drugs. 15,5% of metastatic pts were enrolled in clinical trials. After a median follow up of 7.1 years 84,1% pts died (1297/1542 pts) and median OS was 2,7 years (range 2,6-2,9). We did not observe difference in OS for pts divided into 3 groups according to recurrence date (2000-2002, 2003-2005, 2006-2008). A longer median OS was observed in luminal B (3,8 years) versus luminal A and HER2+ like (2,8 years) and triple negative disease (1,2 years). Conclusions: Our survey describe a large number of MBC pts treated in 13 Italian Oncology Unit. OS analysis did not show significant differences according to recurrence date, but for different prognostic factors. OS data are superimposable to literature ones, showing a good transfer from clinical trials to clinical practice.

e11550 Background: Overall results from past and recent trials favor ovarian ablation, with luteinizing hormone-releasing hormone (LHRHa) analogues alone or in combination with the anti-estrogen tamoxifen (TAM), rather than with chemotherapy. The aim of this survey was to obtain more informations about the clinical practice of adjuvant endocrine therapy. Methods: 11 items electronic questionnaire was submitted to italian oncologists and 611 filled questionnaires were collected. The results were examined globally and according to sex, age, working institution and geographical origin of the oncologists. Results: 97.7% of patients less than 40 years needing only hormonal therapy would receive both TAM and LHRHa; 2.3% TAM or LHRHa alone. 93.6% of patients over 40 years would receive the combination with TAM or LHRHa When LHRHa would be added to TAM the treatment length would be: 5 years in 60% and 44%, 3 years in 20.8% and 26.4%, 2 years in 19.2% and 29.6%, in patients aged under and over 40 respectively. At least one risk factors like positive nodes, high ki-67, G3, vascular invasion, HER2 3+, influence neither the therapeutic options nor the length of LHRHa use. In patients under 40 with chemotherapy induced amenorrhea, the oncologists would prescribe: TAM in 22.4%, TAM and LHRHa in 68,1% (LHRHa for 5 years in 55.3%, for 3 years in 22.1%, for 2 years in 22.6%), aromatase inhibitor (AI) +/- LHRHa in 6.6%, LHRHa alone in 2.9%. A greater number of patients would be treated with AI among women aged over 40 (11%). The reasons to add LHRHa toTAM and the length of treatment would be: in higher efficacy of the combination: 45.5%; patient’s age: 30.1%; risk of recurrence: 20.8%; and, side effect: 3.6%. Conclusions: A high concordance between the Italian Oncologist attitude and the European Guidelines is confirmed by this large survey. However, a wide preference for a TAM/LHRHa combination is reported, as well as a significant preference for LHRHa and AI combination in women under 40 years with chemotherapy induced amenorrhoea.

e11502 Background: The combination of B with P as first-line treatment for patients (pts) with HER2-ve mBC showed clinical benefits in terms of progression-free survival (PFS) and objective respons...

e19093 Background: Patients with SCLC progressed after first-line chemotherapy (FL) have a poor prognosis and the evidence of a benefit of SL is still limited.This retrospective analysis evaluates the clinical outcomes of patients who received a SL treatment after failure of a FL for SCLC Methods: Retrospectively we reviewed 166 consecutive patients who failed a FL and received a second or third-line treatment, between 1993 and 2008 in 17 institutions. We divided patients for analysis in four subgroups, according to the type of SL administered: 1) Platinum-based (P) rechallenge 2) Non-platinum-based polichemotherapy 3) Non-topotecan monochemotherapy 4) topotecan monochemotherapy. Our endpoints were Overall survival (OS), Progression free survival (PFS) and Response Rate. Survival curves were designed with Kaplan-Meier method and Cox proportional hazard model was used for investigating factors which influence survival Results: Median age was 63 (range 25–86). Median OS from the SL was 6.2 months and PFS 2.9. 163 patients received a platinum based chemotherapy as FL, among them 67% obtained a response (CR=14%, PR=53.7%) and 19% had a progressive disease. 74% of patients had a PS 0–1 when started on SL. Moreover, 50 patients underwent also a third-line chemotherapy. Of the 23 CR at FL, 7 patients achieved a response in SL(30%), of the 85 PR only 19 (22%) and of the PD+SD only 6 (16%) (test for trend p=.03). No statistical differences among regimens groups were found; however, patients rechallenged with P went better then others when a long PFS in FL was demonstrated (p=.02) Conclusions: The clinical benefit of SL therapy for SCLC is poor and strictly dependent on response and on duration of response with FL treatment. Our retrospective analysis confirms that median OS for patients receiving SL is about 6 months and median PFS 2.9 months. A rechallenge with platinum should be the best options in patients with a long PFS in FL. Single agent topotecan, the most investigated agent in the literature, did not show evidence of superiority against other chemotherapy regimens No significant financial relationships to disclose.

11594 Background: Male breast cancer is an uncommon disease, 1%(0.7 %) of all breast cancer. Its aetiology, clinical behaviour and treatment are not well-known. The objective of our report was to analyze the form of presentation and the clinical evolution of patients with male breast cancer studied from 1987 to 2006. Methods: A total of 142 men with a diagnosis of breast carcinoma were registered and treated at the cancer-based hospitals linked to ORION collaborative group. 138 men had nonmetastatic breast carcinoma at diagnosis and were included in this analysis. Patients’ charts were retrospectively reviewed to obtain details of patient characteristics, adjuvant therapy, and outcomes. Analysis was performed with descriptive statistics; the log-rank test was used to compare outcomes. Results: The median patient age was 61.9 years (range, 38–84 yrs). Positivity for family cancer history: 16 out of 123 cases, 3 were unknown. Pathological characteristics included: pT1 tumors 22 pts (15.5%); pT2a 33 (23%), p...

2583 Background Among the several problems in planning and carrying out clinical trials with ex-vivo-generated, tumor antigen-loaded DCs for solid tumors, the pts selection, the optimal time to take blood for generating DCs and the impact on them of number and types of previous CT could also play a role. To date, high quantity of DCs can be generated after high-dose CT plus G-CSF in both BC and NHL pts. We investigated the DC yield obtainable from ABC pts in objective response after a SD, taxane-based CT program, considering these patients potentially candidate to DC-based vaccination programs. Patients and Methods Sixteen pts, aged 56 (range 43- 65), were studied 1 to 3 month after an objective response was obtained with a 1st-line CT (Epirubicin+Docetaxel combination at standard dosages, without the scheduled utilization of G-CSF) for their metastatic disease. DCs were generated from 25 ml of blood and following the standard procedure; the monocyte selection was performed with anti-CD14 microbeads (Milt...