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Recent advances in molecular profiling, have reclassified medulloblastoma, an undifferentiated tumor of the posterior fossa, in at least four diseases, each one with differences in prognosis, epidemiology and sensibility to different treatments. The recommended management of a lesion with radiological characteristics suggestive of MB includes maximum safe resection followed by a post-surgical MR 1.5 cm2, presence of micro- or macroscopic dissemination, and age > 3 years as well as pathological (presence of anaplastic or large cell features) and molecular findings (group, 4, 3 or p53 SHH mutated subgroup) determine the risk of relapse and should guide adjuvant management. Although there is evidence that both high-risk patients and to a lesser degree, standard-risk patients benefit from adjuvant craneoespinal radiation followed by consolidation chemotherapy, tolerability is a concern in adult patients, leading invariably to dose reductions. Treatment after relapse is to be considered palliative and inclusion on clinical trials, focusing on the molecular alterations that define each subgroup, should be encouraged. Selected patients can benefit from surgical rescue or targeted radiation or high-dose chemotherapy followed by autologous self-transplant. Even in patients that are cured by chemorradiation presence of significant sequelae is common and patients must undergo lifelong follow-up.

Most patients diagnosed with luminal metastatic breast cancer (MBC) who are seen in oncology consultations are elderly. MBC in elderly patients is characterized by a higher percentage of hormone receptor (HR) expression and a lower expression of human epidermal growth factor receptor 2 (HER2). The decision regarding which treatment to administer to these patients is complex due to the lack of solid evidence to support the decision-making process. The objective of this paper is to review the scientific evidence on the treatment of elderly patients with luminal MBC. For this purpose, the Oncogeriatrics Section of the Spanish Society of Medical Oncology (SEOM), the Spanish Breast Cancer Research Group (GEICAM) and the SOLTI Group appointed a group of experts who have worked together to establish consensus recommendations to optimize the treatment of this population. It was concluded that the chronological age of the patient alone should not guide therapeutic decisions and that a Comprehensive Geriatric Assessment (CGA) should be performed whenever possible before establishing treatment. Treatment selection for the elderly population should consider the patient's baseline status, the expected benefit and toxicity of each treatment, and the impact of treatment toxicity on the patient's quality of life and functionality.

Introduction Benefit from adjuvant chemotherapy (CT) is doubtful in a high percentage of patients with early breast cancer. The 21-gene recurrence-score (RS) assay (Oncotype DX, Genomic Health) is one gene-expression assay that provide prognostic and predictive information in hormone-receptor (RH) positive breast cancer. The results of the TAILORx study have confirmed that the majority of patients with tumors RH + and HER2 negative can avoid CT without increasing their risk of relapse. From 2012 to 2015 we used Mammaprint (MMP), in our institution and 60% of cases could avoided CT (communicated in SABCS 2015). Since 2017 we use RS for this purpose. Primary Objective To analyze the impact of using RS to change the indication of adjuvant CT. Secondary Objectives To analyze the association between different clinical pathological factors and the RS value, and calculate the difference between the cost of all RS test and the cost in direct expense of the treatment with CT of all patients who could avoid it thanks to the RS Material and methods We analyzed all RS test performed in the three ICO centers during 2017. We sent 112 tumor samples; in 2 samples adequated RNA for RS was not obtained. We compared the adjuvant treatment initially planned according to institutional treatment protocol with the treatment given after RS. We compared the direct economic costs of CT with the costs of the diagnostic test, and performed a logistic regression analysis of some pathological factors and RS value. Results The RS could be determined in 110 of 112 cases, in which there was indication of adjuvant CT. Only 14 patients received CT (12,72%) with the RS value, so CT was avoided in 96 patients (87,28%). The clinical-pathological characteristics of the series are summarized in the table 1. Of the risk factors analyzed, only grade 3 (p 0.001) and PR 25. No association was found between age, nodal status, tumor diameter, Ki67, Infiltrating Ductal Carcinoma vs neither Infiltrating Lobular Carcinoma nor Lympho-Vascular invasion. The cost of the genetic studies was 180000€ (1636€ each). The cost of each CT schedule (EC x 4 followed by paclitaxel x 12) was 7214€ and the total cost of 96 cases 692590€. Direct costs savings estimated from the reduction in CT treatment were 512590€ Conclusion: Our series shows that RS avoided unnecessary CT in 87% of cases and was more cost-effective than a previous series with MMP. G3 and RP 25. Table 1.Patients characteristics and clinical-pathological details from the analyzed tumorsPatient characteristicsAge, mean (range)53,76 (19 – 75)≥50y72 (65.5%) Citation Format: Ferrer M, Dorcas J, Quiroga V, Margelí M, del Barco S, Stradella A, Petit A, Falo C, Viñas G, Romeo M, Villanueva R, Cirauqui B, Vázquez S, Fernández A, Recalde S, Vethencourt A, Soler T, Pérez-Martín X, Gil-Gil M. Impact of oncotype dx genetic signature used in early breast cancer. Clinical and economic analisys of a 110 patient cohort treated in the Catalan Oncologic Institute (ICO), Spain [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P5-15-09.

BACKGROUND Glioblastoma (GB) is the most aggressive primary brain tumour. Despite the survival benefit associated with adjuvant therapy, most of patients (pts) relapse after initial therapy. Nitrosoureas (NU) are the standard treatment at relapse in Europe. Both fotemustine (FM) (Addeo schema) and lomustine (LM) (administered orally every 6 weeks) are used in this context. MATERIAL AND METHODS This retrospective cohort study included pts diagnosed with GB treated with NU at relapse in four Catalonia hospitals from 2010 to 2020. Clinical and pathological data were collected from medical records. We analysed 6months-progression-free survival (6m-PFS), progression-free survival (PFS) and overall survival (OS) from the start of NU to progression or death respectively. Differences in toxicity grade using CTCAE v5.0 were analysed globally as ‘non-toxicity’, ‘mild toxicity (grade 1 or 2)’ and ‘high toxicity (grade 3 or 4)’. RESULTS We identified 236 GB pts with a median age of 58 years old. 29% of the pts presented MGMT promotor methylation and only 3%(n=7) had IDH mutation. After a median follow-up of 20 months, 94% of the pts were dead at the time of the analyses. At first line, 83 pts were treated with FM and 18 with LM. Pts treated with FM had better performance status (PS) than those treated with LM (p=.010). Median PFS was 2 months and 6m-PFS was 12% vs 6% in FM and LM group respectively (p=.87). Median OS was 3 months with LM vs 6 months with FM, with no statistically significant differences even adjusted for prognostic factors (p=.79 HR:0.9 CI 95% 0.41–1.96).At second line, 78 were treated with FM and 24 with LM, no differences between groups. Median PFS was 2 months in both groups and median OS was 3 vs 5 months for pts treated with LM vs FM respectively, with no significant differences. 6m-PFS was 13% for LM vs 0% for the FM group (p=.39).Pts received a mean of 1.7 cycles (every 6 weeks) and 4.1 cycles (every 2 weeks) in LM and FM group, respectively. Thrombocytopenia was the most common serious side-effect, with a higher proportion of grade 1–2 toxicity in the FM group (p=.03) that also required more treatment delays (p=.01). CONCLUSION Despite being retrospective study and a few pts were treated with LM, there were no differences neither in PFS nor in OS in pts treated with LM vs FM at first or second line. Higher G1-2 thrombocytopenia was shown in the FM group probably due to a higher number of hematology samples collected.

Background The influence of nutrition on breast cancer prognosis is still inconclusive and therefore dietary interventions incorporating dietary biomarkers are needed to confirm compliance with dietary goals and clarify biological mechanisms. The present study assessed whether a lifestyle intervention in breast cancer survivors could affect dietary biomarkers of fruit and vegetables and fatty acids. Methods In this phase II single-arm trial, 37 overweight/obese early stage breast cancer patients completed a 12-week diet and exercise intervention. The intervention involved 1-h weekly diet sessions delivered by a dietician and 75-min bi-weekly physical activity sessions of moderate-to-high intensity led by trained monitors. Before and after the intervention, three 24-h dietary recalls were carried out to calculate nutrient intakes and, in addition, blood samples were taken to measure plasma carotenoids, vitamin E and retinol concentrations and erythrocyte membrane fatty acid (EFA) composition. Wilcoxon signed rank tests were used to assess changes in dietary and biomarkers measurements over the intervention period. Results After the intervention, there was a significant increase in the intake of dietary carotenoids (+15.1% compared to baseline) but not plasma carotenoids levels (+6.3%). Regarding the EFA levels, we observed a significant decrease in percentage of saturated fatty acids (-1.4%) and n-6 polyunsaturated fatty acids (-2.9%) and an increase in monounsaturated fatty acids (1.7%) and total and long-chain n-3 polyunsaturated fatty acids (by 13.1% and 13.7%, respectively). A favourable decrease in the ratio of long-chain n-6 to n-3 polyunsaturated fatty acids (-9.1%) was also observed. Conclusions After a short-term diet and exercise intervention in overweight/obese breast cancer survivors, we observed significant changes in dietary nutrients and fatty acid biomarkers, suggesting positive dietary changes that could be relevant for breast cancer prognosis.

Background Benefit derived from adjuvant chemotherapy (CT) is doubtful in a high percentage of patients (pt) with hormone-receptor–positive HER2 negative early breast cancer. The 21-gene recurrence-score (RS) assay Oncotype DX, provide prognostic and predictive information. Results of the TAYLORx study have confirmed that most of patients with negative node status and RS > 25 can avoid CT without increasing their risk of relapse. However, pt 20 showed benefit with CT. Methods Aim: To analyse the impact of age using RS test to change the indication of adjuvant CT and the relationship between different clinical pathological factors and the RS value. We analysed 240 cases out of 251 RS test performed in the 3 ICO Centers during 2017-2018. We compared the adjuvant treatment initially planned according to institutional protocol with the treatment given after RS in the total cohort and in pt Results CT was indicated in all pt before knowing the RS results. Only 46 pt (19%) received CT after RS results. 14 out of 88 pt 25 ( 25 in a multivariate analysis. Table . 209P Age median (range) 53 (19-76) Tumor size median 15 mm Histological grade G1 23% G2 69.7% G3 4.4% Progesterone receptor ≤20% 21% >20% 78% Ki67 median (p25-75) 20 (13,28) ≤14 27% 14-25 41% >25% 31% Nodal status pN0 57% pN1mic 15% pN1a 27% Conclusions 82% of pt of our series could avoid CT, however this proportion change after TAYLORx results in younger patients. Today 75% of these pt would had avoided CT. Ki67 > 25% and Progesterone Receptor ≤20% were the only pathological factors associated with an increased risk of RS > 25. Legal entity responsible for the study The authors. Funding Has not received any funding. Disclosure All authors have declared no conflicts of interest.

Background Standard treatment of glioblastoma (GBM) is focal radiation with concomitant and adjuvant temozolomide (TMZ) for 6 cycles. The GEINO-14-01 trial (NCT02209948) investigated the role of extending adjuvant TMZ to 12 cycles in a randomized multicenter study. Methods Between Aug/2014 and Nov/2018, 166 patients (p) were screened and 159 randomized to extend (80p) or not (79p) TMZ treatment to 12 cycles after proving lack of progression of the disease in the MRI performed before inclusion. The trial was stratified by MGMT status and presence or absence of residual disease (defined as a residual enhancement larger than 1cm on the MRI). The primary endpoint was differences in 6monthsPFS, secondary endpoints were differences in PFS, OS, toxicity, between arms and per stratification factors. Results Median age was 60.4 (range 29-83), all p had ECOG≤1 and 86.2% were without DXM treatment. MGMT status: Met: 97 (61%) UnMet:62 (39%). RD yes: 83 (52.2%) and no: 76 (47.8%). At the time of the abstract report 3 patients are still on treatment or control without a documented progression and 5 patients have not been yet 6m in the study: 31 patients (19.5) are still free of progression and 60 patients (37.7%) are still alive. Median (m) PFS has been reached: 7.9 months (95%CI: 6.1-9.8) as well as mOS: 20.9 (95%CI: 17.6-24.1). A methylated status was a factor of better PFS (HR = 0.29, 95% CI 0.46-0.95; p = 0.029) and better OS (HR = 0.43: 95% CI 0.28-0.66; p = 0.000) as well as the absence of residual disease (PFS: HR = 0.84: 95% CI = 0.71-1.01; p = 0.068; OS: HR = 0.77, 95%CI 0.63-0.96; p = 0.019). We didn’t find any difference in PFS (HR = 1.02, 95%CI 0.85-1.21; p = 0.82), or OS (HR = 0.90; 0.73-1.11; p = 0.34) on extending treatment with temozolomide longer than 6 cycles. Toxicity data and final results are expected for the congress. Conclusions There is no benefit of continuing TMZ treatment for more than 6 cycles in the adjuvant treatment of glioblastoma. Met status and absence of RD are factors of better SLP after adjuvant treatment. Supported by a Grant of the ISCIII: PI13/01751. Clinical trial identification NCT02209948. Legal entity responsible for the study GEINO (Grupo Espanol de Investigacion en Neurooncologia). Funding Supported by a Grant of the ISCIII. Disclosure M.A.V. Salgado: Advisory / Consultancy: Lilly; Research grant / Funding (institution): Pfizer; Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: pharmamar; Advisory / Consultancy: eisai; Advisory / Consultancy: Celgene. All other authors have declared no conflicts of interest.

Several studies have found an association between peripheral inflammatory cells and outcome. However, no study has explored their impact specifically in elderly patients. We have retrospectively examined pretreatment peripheral neutrophil/lymphocyte ratio (NLR), platelet/lymphocyte ratio (PLR), lymphocyte/monocyte ratio (LMR), and neutrophil/monocyte ratio (NMR) in 113 elderly breast cancer patients and correlated our findings with disease-free survival (DFS) and overall survival (OS). All patients ≥ 65 years diagnosed from 2004 to 2018 with locally advanced breast cancer were included and classified as high vs low NLR, PLR, LMR, and NMR based on previously identified cutoffs. Estimated 1-, 3-, and 5-year DFS and OS were compared by Chi square analysis. Among 104 evaluable patients, only PLR was significantly associated with estimated 3-year DFS (85.1% vs 63.6%; P = 0.04) and OS (89.3% vs 68.1%; P = 0.03). Among 69 patients with three or more years of follow-up, PLR (P = 0.05), absolute lymphocyte count (ALC) (P = 0.01), polychemotherapy (P = 0.04), number of comorbidities (P = 0.02), polypharmacy (P = 0.005), and clinical stage (P = 0.03) were associated with 3-year DFS. Polypharmacy (OR 4.9; P = 0.02) and ALC (OR 4.6; P = 0.04) retained their significance in the multivariate analysis. We have found an association between low PLR and longer DFS in elderly breast cancer patients that is in line with findings in patients with a wider range of ages. Our findings on NLR contrast with those of other studies, indicating a potential differential effect in elderly patients. In addition, the effect of polypharmacy on outcome in elderly patients warrants further investigation.

PurposeWe retrospectively examined the potential effect on overall survival (OS) of delaying radiotherapy to administer neoadjuvant therapy in unresected glioblastoma patients.Patients and methodsWe compared OS in 119 patients receiving neoadjuvant therapy followed by standard treatment (NA group) and 96 patients receiving standard treatment without neoadjuvant therapy (NoNA group). The MaxStat package of R identified the optimal cut-off point for waiting time to radiotherapy.ResultsOS was similar in the NA and NoNA groups. Median waiting time to radiotherapy after surgery was 13weeks for the NA group and 4.2weeks for the NoNA group. The longest OS was attained by patients who started radiotherapy after 12weeks and the shortest by patients who started radiotherapy within 4weeks (12.3 vs 6.6months) (P=0.05). OS was 6.6months for patients who started radiotherapy before the optimal cutoff of 6.43weeks and 19.1months for those who started after this time (P=0.005). Patients who completed radiotherapy had longer OS than those who did not, in all 215 patients and in the NA and NoNA groups (P=0.000). In several multivariate analyses, completing radiotherapy was a universally favorable prognostic factor, while neoadjuvant therapy was never identified as a negative prognostic factor.ConclusionIn our series of unresected patients receiving neoadjuvant treatment, in spite of the delay in starting radiotherapy, OS was not inferior to that of a similar group of patients with no delay in starting radiotherapy.

Pain is a highly prevalent symptom in patients with cancer. Despite therapeutic advances and well-accepted treatment guidelines, a percentage of patients with pain are under-treated. Currently, it has been recognized that several barriers in pain management still exist and, in addition, there are new challenges surrounding complex subtypes of pain, such as breakthrough and neuropathic pain, requiring further reviews and recommendations. This is an update of the guide our society previously published and represents the continued commitment of SEOM to move forward and improve supportive care of cancer patients.

Metastatic breast cancer is a heterogeneous disease that presents in varying forms, and a growing number of therapeutic options makes it difficult to determine the best choice in each particular situation. When selecting a systemic treatment, it is important to consider the medication administered in the previous stages, such as acquired resistance, type of progression, time to relapse, tumor aggressiveness, age, comorbidities, pre- and post-menopausal status, and patient preferences. Moreover, tumor genomic signatures can identify different subtypes, which can be used to create patient profiles and design specific therapies. However, there is no consensus regarding the best treatment sequence for each subgroup of patients. During the SABCC Congress of 2014, specialized breast cancer oncologists from referral hospitals in Europe met to define patient profiles and to determine specific treatment sequences for each one. Conclusions were then debated in a final meeting in which a relative degree of consensus for each treatment sequence was established. Four patient profiles were defined according to established breast cancer phenotypes: pre-menopausal patients with luminal subtype, post-menopausal patients with luminal subtype, patients with triple-negative subtype, and patients with HER2-positive subtype. A treatment sequence was then defined, consisting of hormonal therapy with tamoxifen, aromatase inhibitors, fulvestrant, and mTOR inhibitors for pre- and post-menopausal patien ts; a chemotherapy sequence for the first, second, and further lines for luminal and triple-negative patients; and an optimal sequence for treatment with new antiHER2 therapies. Finally, a document detailing all treatment sequences, that had the agreement of all the oncologists, was drawn up as a guideline and advocacy tool for professionals treating patients with this disease.

Background The Spanish Research Group in Neuro-oncology (GEINO) and Spanish Infrequent and Orphan Tumors Group (GETHI) initiated a Nervous System Tumors Registry (RETSINE) in September 2017 with the aim of evaluating accurate, basic data concerning this oncological pathology in Spain. (Spanish Agency of Medicines and Medical Devices code: GG-TIN-2017-01). Methods The RETSINE database collects demographic, diagnostic and treatment data from all the hospitals participating in the project. Secondarily, each researcher indicates if there is a tumor sample available for future studies that arise from the registry. Results From September 2017 to April 2019, the registry has included 1021 patients (p) from 26 different hospitals. P have been included at a rate of 60 per month. With a median age of 60 y (range: 16-89), there is a discrete predominance in males (56.1%). The main symptoms at presentation are seizures, cognitive impairment and ataxia (26.1%, 16.8% and 6.6% of p). Histology provided in 841 p = 764/841 glioma (90,8%) [High Grade Glioma 618/764 (80.9%), Low Grade Glioma 146/764 (19.1%)], 77/308 no glioma (9,2%). Primary surgical treatment= 42.4% total tumor removal; 38.9% subtotal tumor removal and 7.7% biopsy. The median overall survival is 18.1 m (95% CI 15.5-20.6): 115.6 m (95% CI 38.8-192.4) in Low Grade and 17.5 m (95% CI 15.4-19.5) in High Grade Glioma. Conclusions RETSINE is a valuable tool for analyzing the current situation of Nervous System Tumors in Spain. The possibility of carrying out clinical studies in tumors of low incidence will be increased and improved with records of cases with associated biological sample. The database provides medical information that can also assist the orientation of healthcare policies. Legal entity responsible for the study Spanish Research Group in Neuro-oncology (GEINO) and Spanish Infrequent and Orphan Tumors Group (GETHI). Funding Has not received any funding. Disclosure All authors have declared no conflicts of interest.

BACKGROUND Standard treatment of glioblastoma (GBM) is focal radiation with concomitant and adjuvant temozolomide (TMZ) for 6 cycles. The GEINO-14-01 trial (NCT02209948) investigated the role of extending adjuvant TMZ to 12 cycles in a randomized multicenter study. MATERIAL AND METHODS Between Aug/2014 and Nov/2018, 166 patients (p) were screened and 159 randomized to extend (80p) or not (79p) TMZ treatment to 12 cycles after proving stable disease in the MRI performed before inclusion. The trial was stratified by MGMT status and presence or absence of residual disease (defined as a residual enhancement larger than 1cm on the MRI). The primary endpoint was differences in 6monthsPFS, secondary endpoints were differences in PFS, OS, toxicity, between arms and per stratification factors. RESULTS Median age was 60.4 (range 29–83), 97p (61%) were methylated and 83 p (52.2%) were reported with residual disease. Median (m) PFS was 7.9 months (95%CI: 6.1–9.8) and mOS: 20.9 (95%CI: 17.6–24.1). A methylated status was a factor of better PFS (HR=0.29, 95% CI 0.46–0.95; p=0.029) and better OS (HR= 0.43: 95% CI 0.28–0.66; p=0.000) as well as the absence of residual disease (PFS: HR = 0.84: 95% CI =0.71–1.01; p=0.068; OS: HR=0.77, 95%CI 0.63–0.96; p=0.019). We didn’t find any difference in PFS (HR=1.02, 95%CI 0.85–1.21; p=0.82), or OS (HR=0.90; 0.73–1.11; p=0.34) on extending treatment with temozolomide longer than 6 cycles. CONCLUSION There is no benefit of continuing TMZ treatment for more than 6 cycles in the adjuvant treatment of glioblastoma. Final data will be presented at the congress. Supported by a Grant of the ISCIII: PI13/01751

Background: Bone is the most common lesion in metastatic breast cancer (MBC) patients. Pain due to bone disease is a very limiting and frequent symptom. We evaluated prospectively the BOMET-QoL questionnaire in the context of normal clinical practice, irrespectively of the treatment received, in order to assess the impact of bone metastasis on the Health-Related Quality of Life (HRQoL) of patients with MBC. Material and Methods: This is an observational, prospective, multicenter study conducted in Spain. Patients diagnosed of MBC with bone disease and a life expectancy ≥ 8 months were eligible. Patients completed the bone metastasis Quality of life questionnaire (BOMET-QoL), a Visual Analogue Scale (VAS) for pain and a self-perception of health status item at baseline and 4, 8, 12, 16, 20 and 24 months thereafter. Socio-demographic, clinical and therapeutic data were also collected. Assuming a level of significance of 0.05 and a 20% drop-out rate, 174 patients were to be included in the study in order to estimate the QoL with a precision of ±3.75. Results: From October-2007 to May-2010 172 evaluable patients were included in 15 Spanish institutions. Median age was 58 years (29.6-88.6). Bone disease was most frequently localized in the backbone (76.2% of patients), pelvis (53.5%) and ribs (45.3%). Seventy patients (40.5%) had visceral disease. Most patients (147, 88.5%) had ECOG 0-1. At study entry, 65 patients were receiving analgesic therapy (44 with NSAIDs and 21 with opioids) and 136 were receiving bisphosphonates. The values obtained on the BOMET-QoL and pain VAS scores at the different visits showed a moderate positive correlation (0.2-0.5; p Conclusions: The BOMET-QoL questionnaire is a consistent instrument to evaluate the HRQoL of patients with bone metastasis from breast cancer in regular clinical practice conditions, with regards to cross-sectional and longitudinal validity, feasibility and sensitivity to change. BOMET-QoL is easy to understand and can be completed in a short time by the majority of patients. Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P3-10-02.

Breast cancer represents the second most frequent etiology of brain metastasis (BM). It is estimated that 10–30 % of patients with breast cancer are diagnosed with BM. Breast cancer BM are increasing due to the aging population, detection of subclinical disease, and better control of systemic disease. BM is a major cause of morbidity and mortality affecting neurocognition, speech, coordination, behavior, and quality of life. The therapy of BM remains controversial regarding use and timing of surgical resection, application of whole-brain radiotherapy, stereotactic radiosurgery and systemic drugs in patients with particular tumor subtypes. Despite numerous trials, the range of interpretation of these has resulted in differing treatment perspectives. This paper is a review of the state of the art and a multidisciplinary guideline on strategies to improve the therapeutic index in this situation.

The purpose of this article is to update our previous work on the treatment and follow-up in early breast cancer. In this new version we have classified a treatment by immunohistochemistry subtypes of breast cancer. Latest advances in the management of this disease have been compiled, either in the adjuvant and neoadjuvant setting or chemotherapy and hormonal treatment. This review is presented in an easy way for oncologist, fellows and for other specialties.

Doxorubicin and gemcitabine are active as single agents in breast cancer, have different mechanisms of action, and mainly have non-overlapping side effects. Dose-dependent doxorubicin-related cardiac toxicity is the principal limitation in the metastatic setting. This open, multicenter, single-arm phase I/II study assessed the safety and activity of gemcitabine in combination with non-pegylated liposomal doxorubicin (Myocet), a more cardiac-friendly anthracycline, in the first-line treatment of patients with advanced breast cancer. We aimed to determine the optimal recommended dose (RD) of gemcitabine combined with Myocet in a population, with performance statusor=2 and LVEFor=50%. A formal phase II study was performed afterwards. A total of 53 patients were recruited. Gemcitabine 900 mg/m(2) intravenously day 1 and 8 combined with Myocet 55 mg/m(2) intravenously day 1, every 21 days, was the final RD. The principal toxicity observed was hematological, and 48% of patients developed grade 3-4 neutropenia. Other toxicities were mild and infrequent, including nausea and vomiting. There were no symptomatic cardiac events despite the fact that 36% of the patients had received prior treatment with adjuvant anthracyclines. Objective responses were observed in 51.1% of 47 evaluable patients (95% CI: 36-66%), including two complete response. In addition, 14 patients (29.8%) demonstrated stable disease. The combination of Myocet and gemcitabine at the RD is safe and has encouraging clinical activity in patients with advanced breast cancer, without apparent cardiac toxicity in anthracycline-pretreated patients. These data support further development of this combination.

Energy restriction from a low-calorie diet and increased energy expenditure induced by physical activity (PA) could promote weight loss/maintenance and be important determinants of breast cancer (BC) prognosis. The aim of this study was to assess participation and adherence of overweight and obese BC survivors to a lifestyle intervention and to demonstrate the capacity of this intervention to induce weight loss and nutritional changes. This single-arm pre-post study, which involved one-hourly weekly diet sessions delivered by a dietician and 75-min bi-weekly PA sessions of moderate-to-high intensity led by PA monitors, was offered to overweight and obese BC survivors shortly after treatment. Before and after the intervention, anthropometry, dietary information, quality of life (QoL) and cardiorespiratory fitness (CRF) were collected. A total of 112 BC survivors were invited to participate: 42 of them started the intervention and 37 completed it. Participants attended more than 90 % of the sessions offered and showed a significant weight loss of 5.6 ± 2.0 kg, as well as significant decreases in body mass index, fat mass and waist circumference. Significant decreases in total energy (-25 %), fat (-35 %), saturated fat (-37 %) and carbohydrate (-21 %) intakes were observed while QoL and CRF showed significant increases. This feasibility study demonstrated the success of a short-term diet and PA intervention to induce weight loss and promote healthful changes in BC survivors. Assessing the long-term effects of these changes, and in particular their possible impact of BC prognosis, and designing interventions reaching a wider number of BC survivors are still issues to be addressed.

Aim: Previous studies showed that FT may be useful as treatment in recurrent GB. The present study evaluate the activity and toxicity of FT in recurrent malignant GB patients in the clinical setting in Spain. Methods: Patients (age >18 years) with GB that was progressive (first or second recurrence) after prior standard radiotherapy plus temozolomide (TMZ) chemotherapy were eligible for the study. Patients were scheduled to receive FT in different schedules (Addeo vs others). Tumor response was assessed by MRI every 8-12 weeks. The primary end point was safety; secondary points included progression free survival (PFS), overall survival (OS). We analyze the differences between Addeo schedule (A) vs others (O) and 1° recurrence (1°R) vs 2° recurrence (2°R) in terms of safety and activity. Results: 84 patients were assessed; all of them began FT previously Nov 31, 2012. There were 46 males, and the median age was 56 years (ranged from 30 to 73). The median KPS was 70 (40-100). A schedule was used in 60 pts (71.4%). FT in first recurrence was used in 39 pts (46.2%) and 45 pts (51.2%) in second recurrence. The median PFS was (A 1°R / O 1°R/ A 2°R / O 2°R) 3.11/2.41/3.04/2.84 months, the median OS was (A 1°R / O1°R/ A 2° R / O 2°R) 6.15/5.29/4.36/3.87 months . The most common toxicities include thrombocytopenia and neutropenia. There were no statistical differences in Grade III or IV toxicities in relation with the type of schedule (A vs O) nor the 1° or 2° R (17%-7%). The patients received more frequent A schedule than O in 1°R or 2° R. No differences between A vs O in terms of clinical benefit, PS improve or less dexametasone use. Time to response: patients in A schedule spent less time to get the better response than patients with O schedules, whenever we use FT (no significant differences). Conclusions: FT has modest activity for recurrent GB with acceptable toxicity, regardeless the type of schedule. Probably, A get better response in less time than O schedules. Disclosure: All authors have declared no conflicts of interest.

INTRODUCTION: Primitive brain tumours (BT) represent 2% of adult malignancies. BT patients are treated by different clinical specialists in Spanish hospitals. This means that we did not know with certainty how these patients are treated in Spain. To improve this knowledge the Neuro-Oncology Investigation Spanish Group (GEINO) designed this prospective observational multicenter study. OBJECTIVE: Describe the clinical and pathological characteristics and therapeutic management of intra-axial BT patients diagnosed after January 2010 in Spain. PATIENTS AND METHODS: Patients >18 years old, diagnosed after January 2010 of a intra-axial BT, treated or not, and gave written informed consent. RESULTS: 397 patients from 22 hospitals were enrolled between 08/01/2012 and 12/03/2013. The median age was 56.9 (18-83) years. 58% were male and 42% female. 87% had ECOG ≤2. 48.5% had comorbidity. 9% had previous history of cancer (2% BT). Symptoms at diagnoses: seizures 30%, epilepsy 25%, cognitive impairment 23.5%, ataxia 7.5%. BT was located in frontal lobe in 33.5%, temporal 29%, parietal 13%, posterior fosse or brainstem 5%. By histology Glioblastoma (GBM) were 67%, anaplastic astrocytoma (AA) 12%, oligodendroglioma or oligoastrocytoma grade 2-3 were 11%, low-grade astrocytoma 6%, medulloblastoma 2% and ependymoma 1%. Of the 313 patients with GBM or AA 98% underwent surgery (SR): 40% complete resection, 41% partial, 11% stereotactic biopsy and 7% open biopsy. 8% of patients received neoadjuvant temozolomide (TMZ) + /- bevacizumab (BV) into a clinical trial. 94% of patients received radiotherapy (RT): 72% focal, 21% whole-brain and 6% hemi-brain. 83% of patients received adjuvant chemotherapy (QT): 99% TMZ with a median of 5 cycles (1-18) and 1% PCV (all were AA). Median Progression Free survival was 10.4 months (95%CI: 9-11.8) for GBM and 31.1 months (95%CI: 12.2-49.9) for AA. 130/167 (78%) of GBM or AA patients received treatment at 1st relapse: 14% SR, 8% RT and 96% QT (CPT11 + BV 31.5%, TMZ 20%, BV 15.5%, fotemustine 12%, dacomitinib 4%, lomustine 3% other 10%). Radiological response (RR) was documented in 26% of cases. 52 (32.5%) patients received treatment at 2nd relapse: SR 4%, RT 2% and QT 100% (Fotemustine 59%, CPT11 + BV 29%, BV alone 28.5%, other 8%). RR was documented in 9% of cases. Only 15 (9%) patients received treatment at 3th relapse. Median overall survival (OS) for GBM was 23.6 months (95%CI: 16-31.2. Median OS for AA was not reached. CONCLUSION: This study reflects the clinical and pathological characteristics and the treatment administered to patients with intra-axial brain tumors treated at Cancer Services in Spain. First treatment was the standard in almost all patients. The exceptionally good OS in GBM patients probably reflects a selection of patients with good ECOG. This information can be useful to homogenize and to optimize treatment and for future clinical trials in BT patients.

1090 Background: NVBO has shown high activity and good safety profile when given as single agent chemotherapy (CT) for MBC. Oral CT formulations allow maintenance of quality of life and minimal interference with a normal lifestyle. Methods: Main inclusion criteria for this observational analysis were: histologically or citologically confirmed MBC, no more than 1 prior CT line for MBC; prior (neo)adjuvant CT, hormonetherapy or radiotherapy allowed; adequate bone marrow, kidney, and liver function. All patients were treated with NVBO 60 mg/m2 weekly until progression or unacceptable toxicity. Between April 2006 and October 2009, 45 patients fulfilled the inclusion criteria. Patient's characteristics were: median age, 63 years (range 38-82); >75 years old, 16%; ECOG PS 0-1 in 41 p (91%) and PS 2 in 4 p (9%); ER+ and/or PR+, 24 p (53%); >2 metastatic sites in 64%; prior (neo)adjuvant CT in 41 p (91%); prior hormonotherapy, 30 p (67%). Measurable disease in 40 p (89%). 1 p received trastuzumab concomitantly. R...

18040 Background: The clinical benefit of non-cisplatin doublets vs a single agent in elderly or unfit p is still controversial. The present study focuses on clinical outcome with VRB/GEM in elderly p and the role of functional status and comorbidities. Genetic predictive markers of response to VRB/GEM will also be examined in genomic and cDNA from tumor and circulating tumor DNA. Methods: 145 chemonaive p with stage IIIB (pleural effusion or supraclavicular lymph nodes)-IV or recurrent NSCLC and age > 70 years were accrued at 32 sites between April 2004 and January 2006. Treatment consisted of VRB 25 mg/m2 IV or 60–80 mg/m2 oral plus GEM 1200 mg/m2, days 1, 8 every 21 days. Activities of daily living (ADL), instrumental activities of daily living (IADL) and comorbidities were evaluated. DNA samples were collected from primary tumors for the assessment of microtubule associated protein 4 (MAP4) and from serum for the checkpoint with forkhead-associated and ring finger (CHFR) methylation. Results: Data on 130 p is available. Median age 76 years (69–83); males: 86.8%; smokers: 70.5%; PS 0–1: 83.9%; adenocarcinoma: 34.4% / squamous: 48%; stage IIIB: 22.7%, IV: 77.3%. Self-sufficiency in ADL and IADL was 77.4% and 45.2% of the p analyzed. 68% of the p had comorbidities. Median cycles: 3 (1–8). Hematological toxicities (%p): grade 3/4 neutropenia, 7.8%/4.7%; grade 3/4 thrombocytopenia, 2.3%/0.8%; grade 3 anemia, 3.1%. Efficacy in evaluable population: PR, 23.2% (95% CI, 15.1% to 32.9%); SD, 41.1%. 24 p died during the treatment period (non toxicity related) and 21 p were not evaluable. With a median follow up of 5.8 months, median survival for the whole population was 4.97 months (m), progression free survival 4.53 m, event free survival 3.43 m, 1-year survival 26.6%. Statistically significant differences in median survival were observed among subgroups: PS 0–1/2, 6.5/2.3 m (p No significant financial relationships to disclose.

7126 Background: NVB i.v. day 1 (25 mg/ m2) & NVBo day 8 (60 mg/ m2) and CBDCA AUC 5 have been previously studied in chemonaive NSCLC patients (pts) (O’Brien et al, Ann Oncol 2004; 15: 921). We investigated the efficacy and safety of NVBo weekly with CBDCA AUC 5 q3w for 4 cycles(Cy) followed by maintenance therapy with single agent NVBo in non progressive pts. Methods: Inoperable NSCLC stage IIIB, stage IV or delayed relapse of any stage becoming unresectable, KPS ≥ 80%, treated with combination therapy every 3 weeks for 4 Cy: NVBo 60 mg/m2 on days 1, 8 and 15 (Cy1), 80 mg/m2 (Cy2–4) in absence of neutropenia NCI CTC V2 G3/4; CBDCA AUC 5 day 1, administered over 1 hour. Maintenance therapy if pts did not have a PD: NVBo 60 mg/m2 for the first three weekly administrations, followed by NVBo at 80 mg/m2/week until PD. Results: from December 2003 to January 2005 57/56 pts have been registered/treated: median age 61 yrs (37–71); median KPS 90%; male 71.4%; Squamous cell 30%, Adenocarcinoma 50%; Stage III/IV 32.1/62.5% ; median dose intensity NVBo (% RDI) : combination, 50.1 mg/m2/w (67.3%), maintenance 56.2 mg/m2/w (70.2%); pts with NVBo dose escalation from 60 to 80 mg/m2 during combination : 36/52 (69.2%). Tolerance (% of pts with G3/4 NCI CTC V2) : Neutropenia 23.2/44.6; Platelets 16.1/1.8; Hb 19.6/3.6; Nausea 7.1/0; Vomiting 7.1/0; Diarrhea 5.4/0. No G3/4 toxicity was reported for Infection, Bilirubin, Creatinine, Stomatitis, and motor/sensory Neuropathy. Febrile Neutropenia was reported in 5 patients (8.9%). Efficacy: (RECIST) Percent Overall Response rates (n =56 pts) PR 17.9, SD 53.6, PD 23.2, NE 5.4; Progression-Free Survival 4.3 (95% CI [3.1–5.1]) months; Overall Survival 9.7 (95% CI [7.7–11.9]) months. Conclusions: NVBo on a weekly schedule and CBDCA AUC5 in combination therapy for 4 Cy followed by NVBo in maintenance therapy is an effective and safe treatment regimen for advanced NSCLC. The avoidance of further CBDCA administrations after 4 Cy and the use of NVBo as a maintenance therapy until PD has promise as an alternative to the 6 Cy option and calls for further comparative studies. [Table: see text]

10691 Background: The combination of VRL and OXP was shown to be effective for the treatment of NSCLC. We designed a scheme for first line MBC consisting of administering IV VRL and OXP q2w to explore potential synergistic effects, to determine the maximal tolerated dose (MTD), recommended doses (RDs) and safety of the combination. Methods: Twelve patients (pts) entered the study. Four dose levels were established: A) VRL 25 mg/m2 with OXP 80 mg/m2, B) 25/90, C) 25/100 and D) 30/90, both drugs q2w. Patients/cycles analyzed were: A) 3/15, B) 3/21, C) 3/15, D) 3/19. Results: Median age 58 y (range; 39–78), 10 pts (83%) received prior (neo)adjuvant CT. No dose limiting toxicities were found at any of the dose levels. RD was established at IV VRL 30 mg/m2 and OXP 90 mg/m2/d both administered every 2 weeks. A total of 71 cycles were analyzed. Grade 3 neutropenia occurred in 4 pts (44%) and 13% of cycles, grade 4 in 1 pt (11%) and 1% of cycles. No complications were observed. No grade 4 non-haematological toxicity was seen. Grade 3 neurotoxicity occurred in 1 pt and 2 cycles, grade 3 fatigue occurred in 1 pt and 3 cycles. 2 partial responses were observed among the 6 evaluable patients for response. Conclusions: The combination of VRL and OXP is safe in the palliative setting of MBC. Phase II study explores the efficacy and safety of the combination of VRL 30 mg/m2 and OXP 90 mg/m2 q2w. Recruitment is ongoing. No significant financial relationships to disclose.

16006 Background: In non-urban areas, there is a controversy about whether medical cancer treatments should be administered exclusively in referral cancer centers (CC) or in community hospitals (CH) (Br J Cancer 2004; 90: 1688). Limitations such as geographical distance or absence of treatment guidelines may reduce the access to specialized cancer care or clinical trials. A network organization that involves at the same time a CC and the CH from the same geographical area may provide an adequate balance between proximity, equity and quality of cancer services. Methods: We designed a cancer network in 2003 in order to consolidate all Oncology resources in an area covering a population of 700,000. A CC is placed adjacent to a general hospital in a centrally located urban area of 250,000. The remaining area is served by 6 CH. Our cancer network is based on: 1) approximately half of the Medical Oncology Dpt staff members work part-time at a CH, participating in outpatient clinic, chemotherapy treatments administration, and multidisciplinary meetings; and 2) other cancer health professionals are organized in network groups like the pharmacy group and the chemotherapy nursing group. Specialized medical cancer care included concomitant radio-chemotherapy, complex outpatient or inpatient therapies, genetic counseling and therapy for some pre-defined malignancies such as germ cell and ovarian cancers. Results: From January to December 2004, 1862 new patients were visited, 1013 (54%) at the CC (Medical Oncology Dpt.), and 849 (46%) at the CH. One-hundred ninety-three cancer patients were referred from the CH to the CC. In total, 141 of the cancer patients seen at the CC were included in clinical trials. It is remarkable that clinical trial participation was much enhanced by referrals, since 101 (72%) of patients in clinical trials came from non-urban areas. Conclusions: The establishment of a cancer network facilitates access to specialized cancer care and clinical trials for patients living in non-urban areas, therefore contributing to therapeutic equity. No significant financial relationships to disclose.