In developed countries, more than half of all tumor's cases occurs in patients aged 65 or more, for this reason a (multidisciplinary approach)combinated work between oncologist and geriatric is becoming more and more usefull in pratical oncology. At the same time, however, the oncological treatment results in elderly are far from satisfactory; treatment varies from therapeutic obstinacy to therapeutic abandonment. The understanding of elderly pantient condition and his needs become very important to allow healt, political and social strategies. Aim of the study: 150 patients were submitted to oncogeriatric evaluation, from February 2015 to March 2016. All were evaluatde for:-recognize patients fit for standard oncological treatments and patients in whome the risk of toxicity overcome potential benefits.-organize all medical, psycological and social support to improve treatment tolerance. Material and methods: all patients ( aged 65 or more) were screened with G8 (evaluation tool for geriatric patient); G8 allows to divide patients in 2 groups; those below the cut off score of 14 were sended oncogeriatric unit. Those with score 14 or more were sended directly to the oncology unit. We used CGA as instrument of geriatric evalutation. Results: 150 patients with a score <14 were sended for oncogeriatric evalutation; we identified 106 patients aged >65 that would have required chemoterapy (adiuvant and metastatic setting) 81/106 patients started chemioterapy with an adequate dose reduction (mono- or polychemotherapy) 25 resulted unfit for chemotherapy and were sended to palliative care unit. 52 well tollerated chemotherapy with adequate supportive therapy (myeloid stimulating factors, antiemetic therapy) toxicity was mild (1multifocal pneumonia an 1 anafilactic reaction) 27 patients dead after progression disease. no patient stopped treatment for toxicity, nor was hospitalized Conclusions: oncogeriatric evaluation is important to select patients fit for chemotherapy, getting better the clinical outcome, the management, the assistance and the therapeutical iter so reducing the frequency hospitalization.

Introduction: Nanoparticle Albumin-bound Paclitaxel linked to albumin nanoparticles,wich it makes soluble,allowing drug delivery inside tumor tissue. Moreover,with Nab-P, the usual steroid premedication required for solvent-based paclitaxel (Cremophor) can be avoided. Methods: Between Genuary 2014 to April 2016, 30 patients (pts):18Metastatic Breast Cancer (MBC) and 12 metastatic Pancreatic Cancer (mPC) were treated with Nab-P: as monotherapy in MBC and in combination with Gemcitabine in mPC. All pts had PS: 0-2 (ECOG). Median age was 56 years (range: 39–78) in MBC and 60 years (range 50–74) in mPC. MBC 6 pts received Nab-P as first Line; 5 pts as second Line; 3 pts as third Line, 3 pts as fourth Line and 1 pts as fifth Line. 10/18 patients had HR positive disease HER2 positive status was find in 1/18 patients (Fish Test) HR positive and HER2 positive pts received one or more hormonal therapies and Trastuzumab and Lapatinib based regimen, respectively. Nab-P was administered at 260mg/mq i.v. day 1 every 21 days. Not corticosteroid premedication. mPC Pts mPC received in first Line Nab-P 125mg/mq days 1-8-15 every 28 days plus Gemcitabine 1000mg/mq. days 1-8-15 every 28 days.Not corticosteroid premedication. Toxicity -Results: The main observed toxicities were neurosensory toxicity (G2-3): 56% of pts (17/30); neutropenia(G2-3):40% (12/30); thrombocytopenia (G1-2): 20% (6/30); anemia (G1-2): 30% (9/30); mucositis: 33%(10/30); fatigue (G2): 16% (5/30); nausea (G2): 20% (6/30); diarrhoea (G1): 13% (4/30); alopecia (G3-4): 73% (22/30); emesis(G1): 23% (7/30); arthromyalgie(G2): 36% (11/30). Not febrile neutropenia was observed. 2 pts with neurosensory toxicity (G3) delayed the treatment for 20 days. 2 pts (MBC) presented an Herpes Zoster infection that required treatment suspension for 18 days. To maintain dose-intensity, leukopenia and anemia were managed with G-CSF and Eritropoietin respectively. At a median follow-up of 27 months, median PFS was: MBC: Time to Progression (TTP): 30 weeks (range 12-51); ORR was 88% (16/18); Partial Remission (PR): 10 pts (55%); Stable Disease (SD): 4 pts (22%); Progression Disease (PD): 2 pts.(11%); Complete Remission (CR): 2 pts.(11%) mPC:TTP: 20 weeks (range 3–40); ORR was 75% (9/12); PR: 7 pts (58%); SD: 3 pts (25%); PD: 2 pts (16%). Conclusion: Our experience confirm the discrete tolerability and the efficacy of Nab-P in MBC and in mPC. The avoidance of premedication with corticosteroid required for solvent-based taxanes makes the novel Nab-P an important advance in the treatment of these tumours.

Aim: Progress made in the treatment and better management of cancer pts has significantly improved overall survival. Early involvement of palliative care can translate into improvements in quality of care, QoL and survival.

Nutritional problems due to oral mucositis in patients with head and neck cancer un- dergoing concomitant radio-chemotherapy (RT/CT) significantly correlate with outcome. The aim of our prospective study was to investigate the impact of an early and intensive nutritional pro- gram, intensive dietary counseling, and enteral nutrition through a nasogastric tube on perfor- mance status and quality of life in head and neck cancer patients undergoing RT/CT. Thirty-five consecutive patients with locally advanced, unresectable head and neck cancer who were referred for RT/CT were enrolled. All patients were evaluated for nutritional status (PG-SGA score), serum prealbumin, ECOG performance status and quality of life (measured with EORTC QLQ- C30 version 3.0) before, at the end of, and 1 month after completion of RT/CT. Sixteen patients (46%) were compliant with the nutritional program. Placement of the nasogastric tube was sim- ple, safe and well tolerated by patients. The median duration of enteral nutrition was 31 days (range, 10-93 days). At the end of and 1 month after RT/CT, 94% of compliant patients had main- tained or improved their nutritional status, while in all noncompliant patients the nutritional sta- tus had worsened at the end of RT/CT, and 1 month later nutritional status had improved in only 1 of them (p<0.001). Nutritional status correlated significantly with ECOG performance status and quality of life. (Nutritional Therapy & Metabolism 2006; 24: 176-82)

e15036 Background: It’s well known that in patients with hormone refractory prostate cancer (HRPC) who progressed after first line chemotherapy there are not a lot of therapeutic possibilities. Androgen and androgen receptor interactions are crucial for disease development and progression. In preclinical models the topoisomerase II inhibitor etoposide interfere with androgen mediated cell growth and reduce both intracellular and secreted PSA levels. So, etoposide can be considered not only classical cytotoxic drug but even an agent that directly targets androgen receptor function. Methods: 35 patients were enrolled. All had HRPC progressed after docetaxel and mitoxantrone, first and second line treatment respectively, and were almost asymptomatic (PS 0-1). Patients received oral estramustine (10 mg/kg/die) and intravenous etoposide (100 mg/mq/die 1-3 q21) until disease progression or grade 4 toxicity development. Disease progression was defined as rising PSA over 25% from base line or appearance of new lesions on radiological evaluation. PSA level was detected at every cycle. Median number of cycles administered was 4 (range 2-8). Results: 20 patients (57%) experienced a decreased level of PSA > 50% from baseline. Overall median time to progression was 15 weeks (range 3-35). Median survival of responders was 14 months, compared with 9 months for non responders. Observed toxicities (none more than grade 3) were thrombocytopenia, anemia, nausea and diarrhea, all easily manageable. Conclusions: We conclude that estramustine and etoposide is an active and well tolerated regimen in heavily pretreated and outpatient HRPC

BACKGROUNDA number of anaemic cancer patients are not responsive to treatment with recombinant human erythropoietin (rHuEPO). The aim of the present study is to investigate whether serum levels of tumour necrosis factor-alpha (TNF-alpha), interleukin (IL)-1beta, IL-6 and additional laboratory parameters, together with clinical variables, can predict the clinical outcome of treatment with rHuEPO in anaemic cancer patients.PATIENTS AND METHODSThirty-five cancer patients and 25 healthy controls were enrolled in this study. Patients were treated with epoetin alfa at the dose of 150 IU/kg s.c. three times a week for 12 weeks. If the haemoglobin (Hb) level failed to improve at least 2 g/dl above baseline by week 6 of treatment, dose was increased to 300 IU/kg s.c. for the remainder of the treatment period. All patients filled out the Brief Fatigue Inventory (BFI), a questionnaire for the self-evaluation of cancer-related fatigue. Serum samples from patients and control groups were frozen at -80 degrees C and TNF-alpha, IL-1beta and IL-6 were later examined by enzyme-linked immunosorbent assay.RESULTSFatigued cancer patients had significant higher levels of circulating TNF-alpha, IL-1beta and IL-6 than healthy controls. Responders (Rs) to erythropoietin had significant lower medium levels of TNF-alpha and IL-6 than nonresponders (NRs). Fatigued patients with a general BFI score > or =6 presented higher medium level of cytokines than nonfatigued patients (general BFI score <6), but each group responded similarly to treatment with rHuEPO.CONCLUSIONSHigh serum levels of TNF-alpha and IL-6 at the baseline are significantly correlated with a negative response to administration with rHuEPO. Thus, pretreatment evaluation of TNF-alpha and IL-6 serum levels can help to select those patients who are most likely to benefit from treatment with rHuEPO. On the contrary, Hb level, red blood cell count, lactate dehydrogenase and BFI score do not predict the outcome of treatment with rHuEPO.

e20718 Background: Anemia, defined as a hemoglobin level < 12 g/dL, is frequent in cancer and affect quality of life and performance status. Of all the pretreatment possible causes of cancer-related anemia, unintentional weight loss, early indicator of malnutrition, is often underestimated or completely ignored. The aim of this study is to evaluate the possible pretreatment correlation between hemoglobin level, recent unintentional weight loss (≥ 5% in the last three months) and inflammatory status (C-reactive protein ≥ 10 mg/dL) in NSCLC. Methods: 56 consecutive outpatients with NSCLC (IIIB - IV stage), 68% males, 32% females, were enrolled. Criteria for eligibility included absence of comorbidity (diabetes, hepatic or renal failure) and not previous oncological treatment All patients were evaluated for hemoglobin level (Hb), percentage of involuntary weight loss (WL) and C- reactive protein (CRP) before chemotherapy. Results: 25% of patients had a Hb level < 12 g/dL, 38% referred a recent WL ≥ 5% and 54% had a CRP ≥ 10 mg/dL. Hb was WL-related (p = 0.001) and not CRP-related (p = 0.160), WL was CRP-related (p = 0.022). In the subgroup of patients, the differences of haemoglobin concentrations were minimal, but stastically significant only when inflammatory status was associated with WL. On Table we reported the mean concentrations of haemoglobin as measured in the subgroups of patients. Conclusions: Our data suggest that an early and intensive management of weight loss might prevent or reduce anemia in NSCLC before treatment. [Table: see text] No significant financial relationships to disclose.

20539 Background: Unintentional weight loss (WL) is an early indicator of malnutrition risk and is present in about 50% of cancer patients before treatment. Cancer-related malnutrition significantly correlates with quality of life (QoL) and outcome. Even if about 30% of all patients are malnourished before treatment, WL is frequently underestimated or completely ignored also in the management of older, though they are at increased risk of malnutrition, because of frailty and functional reserve limitation. The aim of this study was to evaluate the influence of WL on QoL in elderly cancer patients before chemo and/or radiotherapy. Methods: Between 2003 to 2007, 387 consecutive outpatients affected by solid tumor of different origin were submitted to nutritional screening before treatment; 104 of them (27%) were aged ≥ 70 years (median 73, range 70 - 85), 44 males, 60 females. All patients were evaluated for nutritional status (assessed with PG-SGA) and QoL (measured with EORCT QLQ-C30 v. 3.O). Results: At baseline, WL (median 6%, range 0 - 28) was observed in 62 older patients (60%), 37% of them had a WL ≥10%. The median PG-SGA score was 12 (range 2 - 20). Patients with WL had worse QLQ-C30 functional scales (FS 65 ± 25 vs 87 ± 10; p=0.001), symptom scales (SS 28 ± 24 vs 5 ± 10; p<0.001) and global health status too (GH 47 ± 21 vs 71 ± 9; p<0.001). In patients with WL ≥ 10% physical functioning scale reduced (PF 63 ± 26 vs 89 ± 9; p<0.001) and fatigue increased (FA 53 ± 34 vs 8 ± 16; p<0.001). Conclusions: Even if patients were heterogeneous, data demonstrated that the majority of new elderly cancer patients presenting to a medical oncologist are at risk of malnutrition or malnourished. WL was frequent and affected QoL. Our experience suggests that an early, careful and intensive pretreatment nutritional support might improve QoL. No significant financial relationships to disclose.

5122 Background: Most patients (pts) with disseminated CRPC have bone metastases. Docetaxel is the current standard of care in CRPC. We assessed the association of docetaxel and samarium, a radio-pharmaceutical with a high affinity to bone, as consolidation treatment after docetaxel-estramustine. Methods: This is a prospective, bi-center phase II trial. Pts with bone metastases from CRPC received docetaxel 70 mg/m2 day 2 + estramustine 10 mg/Kg/day, day 1–5 (1 cycle/ 3 weeks). Pts with a response or stabilization after 4 cycles were given consolidation therapy: docetaxel 20 mg/m2/week × 6 weeks + samarium 37 MBq/Kg during week 1. Zoledronic acid was routinely used and was stopped 1 month before samarium infusion. A Simon design was used with a target of 39 pts receiving consolidation treatment. Response was defined according to the working group criteria (Bubley, J Clin Oncol 1999). The primary endpoint was progression-free survival (PFS). Results: From 01/04 to 12/05, 43 pts were included in the trial: 31 (72%), 11 (26%) and 1 (3%) achieved a PSA response, stabilization, and progression, respectively. After induction therapy, a pain response (defined as a decrease in pain intensity by at least 2/10 on a pain visual analog scale (VAS) in pts with a baseline pain level = 2/10) was achieved in 60% (18/30) and was confirmed in 69% (20/29) after consolidation therapy. Consolidation docetaxel-samarium was feasible with most pts experiencing a mild (grade 1–2) and rapidly reversible thrombocytopenia at week 5. The 7 months PSA-PFS rate was 48% (33–62%). While PSA relapse eventually occurred in all cases, this strategy resulted in an excellent long-term control of pain, with a median pain level on the VAS of 4/10, 1/10, and 0.5/10 at baseline, 12, and 18 months, respectively. With a median follow-up of 14 months, the median survival has not been reached and the 1-year survival rate is 71% (55–84%). Conclusions: Combining docetaxel and samarium is feasible and well-tolerated. It yields a major pain improvement that lasts long after consolidation therapy in pts with bone metastases from CRPC. Survival data are promising in this population of symptomatic metastatic CRPC. This approach should be tested in phase III trials. No significant financial relationships to disclose.

4608 Background: Most patients (pts) with disseminated CRPC have bone metastases. Samarium is a radio-isotope with a high affinity to bone. Docetaxel is currently the standard of care in CRPC. We assess the efficacy of combining docetaxel and samarium as consolidation treatment after docetaxel-estramustine in pts with CRPC. Methods: This is a prospective, bi-center phase II trial. Pts with bone metastases from CRPC received docetaxel 70 mg/m2 day 2 + estramustine 10 mg/Kg/day, day 1–5 (1 cycle every 3 weeks). Pts with a response or stabilization after 4 cycles were given consolidation therapy: docetaxel 20 mg/m2/week x 6 weeks + samarium 1 injection during week 1 (37 MBq/Kg). Zoledronic acid was routinely used and was stopped 1 month before samarium infusion. This study used a Simon two-step design with a final target of 39 pts receiving the consolidation treatment. Biological responses were defined according to the working group criteria (Bubley, J Clin Oncol 1999). The primary endpoint was progression-free survival (PFS). Results: From 01/2004 to 12/2005, 43 pts were included in the trial and the accrual is over. Of the 39 pts currently fully evaluable after induction treatment, 28 (72%), 10 (26%) and 1 (3%) achieved a PSA response, stabilization, and progression, respectively. Of 30 pts currently evaluable after consolidation treatment, 20 (65%), 5 (16%) and 5 (16%) achieved a PSA response, stabilization, and progression, respectively. A pain response (defined as a decrease in pain intensity by at least 2/10 on a pain analog visual scale in pts with a baseline pain level ≥ 2/10) was achieved in 89% (16/18) after consolidation treatment. The consolidation docetaxel-samarium regimen was feasible with most pts experiencing a mild (grade 1–2) and rapidly reversible thrombocytopenia at week 5. Data on PFS and overall survival are pending. Conclusions: Combining docetaxel and samarium is feasible and well-tolerated. It yields a high PSA response rate and a major pain improvement in pts with bone metastases from CRPC. [Table: see text]

10664 Background: The efficacy and the antiangiogenic effect of low dose continous (metronomic) administration of chemotherapy are well known. In thi study we tested the clinical activity of oral Ciclophosphamide (CTX) and Methotrexate (MTX) in advanced breast cancer (ABC). Methods: From november 2004 to september 2005 35 ABC patients were enrolled. Median age 59 (range 36–74), ECOG PS 0–2. All patients received at least two prior chemotherapeutic regimens (range 2–4). Metastatic sites were as follow: liver (16), lung (6), bone (9) and skin (4). patients with CNS involvement were excluded. All patients received CTX at the dose of 50 mg/die and MTX at the dose of 2.5 mg twice daily on days 3 and 4 of each week. After two months of treatment patients were re-evalated for disease response. Results: All patients were evaluable for response. After 2 months of treatment we observed 3 PR (8.5%) and 12 SD (34%), for an overall RR of 42%. 23 patients experienced PD. On the whole treatment was well tolerated, with mild toxicity; no patients discontinued treatment due to toxicity. Grade 2 or 3 neutropenia was observed in 14/35 patients and grade 2 trombocytopenia was observed in 9/35 patients. No grade 4 toxicity was observed. Conclusions: Metronomic administration of chemotherapy is well tolerated even in pretreated patients and shows moderate activity in advanced breast cancer No significant financial relationships to disclose.

Adult living donor liver transplantation (ALDLT) is an accepted procedure to overcome the organ shortage. The advantages of ALDLT must be balanced against the first concern of donor safety. We analyzed the results of our early experience among a series of eight ALDLT performed between April 2001 and October 2003. All patients were listed as United Network for Organ Sharing UNOS status 2b and 3. Transplant recipients consisted of four men and four women. The living donors included four sons, three daughters, and one son-in-law (ages 20 to 45 years). One donor was anti-HBc-positive and negative for hepatitis B virus-DNA by polymerase chain reaction analysis in serum and in liver tissue. GR/WR >0.8 and fatty liver <10% were considered suitable for the hepatectomy. Residual left lobe volume was at least 33%. No exogenous blood and blood products were transfused into the donors and a cell-saver device was used in all donors (blood loss 490 +/- 160 mL). All procedures were right lobe hepatectomy; in one case the middle hepatic vein was withdrawn with the right graft. The mean ischemia time was 1.5 +/- 0.5 hours. All donors survived the procedure. Median hospital stay was 8.5 +/- 2.1 days in all donors but one who had a long stay because of drug-related hepatitis. One graft was lost and one donor aborted because of preoperative overestimated volumetry. Complications were experienced by two donors (25%). Five recipients (62.5%) experienced major complications; one patient underwent retransplantation because of donor graft loss. Two biliary and two vascular complications (33.3%) occurred in three patients. No perioperative death occurred. Two patients died at 9 and 10 months after transplant because of heart and respiratory failure in the first case and tumor recurrence in the second. One-year actuarial survival is 75%. ALDLT using right lobe has gained acceptance to overcome the organ shortage. Donor selection criteria must be stringent with respect to residual donor hepatic volume, steatosis, and liver function.

Recently, the use of eicosapentanoic acid (EPA) in the prevention or treatment of cancer cachexia has gained a lot of interest. EPA may attenuate weight loss due to an im- munomodulating and anti-inflammatory effect Due to taste alterations or taste loss, preference for foods or nutritional supplements may also change. The enrichment of a sip feed with EPA may influence palatability and thus compliance of the sip feed. In our study we investigated the compliance and the effects of a protein and en- ergy dense ω-3 fatty acid enriched oral supplement in cancer patients. From october 2003 to June 2004 we selected 40 ambulatory patients affected by different cancer diseases. The inclu- sion criteria was: cancer patients for whom nutritional supplementation was recommended. The exclusion criteria was: life expectancy of < 3 months, patients requiring a fibre free diet and comorbidity like diabetes, liver or renal failure. The parameters investigated was BMI, ECOG performance status, Prealbumin, Retinol binding protein and the effect on change in body weight before and after four weeks of treatment with sip feed (two cans/day = EPA 2g/day). The sip feed used was Prosure ® - Abbott. The patients for whom was recommended a nutritional supplementation with a sip feed was 22; only in 11 patients (50%) the supplement intake reached the goal (1.5-2 cans/day) and only in these patients we observed a positive cor- relation with their supplement intake and both weight gain, kg 3 ± 1 (range 2-4 kg) and perfor- mance status improvement. In conclusion, the data obtained suggest that the patients' adher- ence to oral nutritional supplements, and the consequent clinical benefits, are strictly depen- dent upon supplement's palatability and its acceptance by the patient. Improving compliance to disease-specific oral supplements therefore appears a key issue in the prevention and treatment of cancer-related weight loss. (RINPE 2005; 23: 43-6)