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Introduction Bevacizumab (BEV) combined with chemotherapy prolongs PFS and OS in metastatic colorectal cancer (mCRC) independently of KRAS status. This study investigated the role of anti-vascular endothelial growth factor therapy on clinical response, mean progression-free survival (mPFS) and mean overall survival (mOS) according to KRAS status and metastatic sites. Methods 108 patients (pts) were treated with first-line FOLFIRI or FOLFOX chemotherapy in combination with BEV. Tissue samples were analyzed for DNA sequencing to identify KRAS mutations. Before therapy and after 3 months of chemotherapy pts were investigated with CT scan. Statistical association was evaluated by chi-square test and logistic regression analysis to objective response rate (RR). Results RR was available in 108 pts while mPFS and mOS in 106 pts. Overall, 45 (41.7%) pts had a stable disease, 43 (39.8%) showed a partial response, 4 (3,7%) complete response and 16 (14.8%) disease progression, accounting for RR of 43.5%. mPFS was 11.3 months and mOS was 26.9 months. 53 pts presented only hepatic metastases. RR was higher in pts with only hepatic metastasis as compared to those with extra-hepatic or multiple metastases, although the difference failed to reach a statistical significant (49% vs 39%; HR: 1.23; 95% CI: 0.79 – 1.90; p=0.36). In pts with only hepatic metastases mPFS was 12 months vs 11 months in pts with multiple metastatic sites or extra-hepatic metastases, while mOS was 24.8 months vs 27.1 months respectively. KRAS mutations were investigated in 108 patients. 69 patients were wild-type (wt 64%) while 39 patients were mutated ( mut 36%). RR was 49.3% in wt group vs 33,3% in mut group (HR: 0,51; 95% CI: 0,23 - 1,16; p=0.11), mPFS was 12.8 months in KRAS wt group vs 10 months in KRAS mut group and mOS was 28.8 months vs 23.9 months respectively. Conclusion RR in KRAS groups was different with an advantage in KRAS wt, but this difference was not statistical significant. mPFS and mOS tended to be higher in KRAS wt pts. There was evidence of not statistical significant advantage, in terms of clinical response to treatment with Bevacizumab, in pts with only hepatic metastases. Therefore in this subset of pts a favorable trend was demonstrated. Unfortunately, despite positive trend, an increase in mPFS and mOS compared to pts with extra-hepatic metastases or multiple metastatic sites was not shown.

e14654 Background: SHARP was pivotal in determining the safety and efficacy of sorafenib in advanced hepatocellular carcinoma (HCC) in patients with predominately good liver function. In practice, many patients with advanced HCC receive radioembolization (RE). Investigators from the European Network on RE with yttrium-90 resin microspheres (ENRY) group conducted an analysis of safety and survival among consecutive patients who met the SHARP inclusion criteria. Methods: 58% of patients (189 of 325) who had received RE between 09/2003 and 12/2009 were considered SHARP-equivalents. Of these, 11.6% received sorafenib 4.7 months (median) after RE for a median duration of 2.8 months. Safety and tolerability analyses were conducted up to day 90 post RE; changes from baseline were recorded and transitions in CTCAE grades >3 tested. Statistical analyses used SAS (SAS, Cary NC) version 9.2 XP Pro. Results: Like the SHARP sorafenib cohort, most patients had advanced HCC (BCLC stage C: 72.5%), good liver function (Child–Pugh class A: 100%) and ECOG performance status (0–1: 90.5%). Macroscopic vascular invasion (MVI), extrahepatic spread (EHD) or both was present in 33.9%. 20.1% had received prior surgical procedures, 8.5% prior ablative procedures and 33.3% prior vascular [chemo]embolization. RE was predominantly a single whole-liver procedure (median activity 1.7 GBq). Median overall survival was 10.8 months (95% CI: 8.8–12.8) in the SHARP-equivalent cohort, 10.2 months (8.3–11.8) in patients with MVI/EHD, 9.7 months (7.6–10.9) in advanced HCC (BCLC stage C) and 16.6 months (11.2–22.8) in intermediate HCC (BCLC stage B). Treatment-related adverse events (all grades; grade >3) were: fatigue (50.3%; 2.1%), abdominal pain (25.9%; 2.1%), nausea/vomiting (31.2%; 0.5%) and GI ulcer (3.2%; 1.0%). At baseline, raised bilirubin (all grades) was present in 20.3%, increasing to 49.4% of patients evaluated up to day 90. Bilirubin grade was unchanged in 58.1% and increased in 37.8%; 4.0% had ≥grade 3 events. Conclusions: In patients matching the inclusion criteria for SHARP, RE was well tolerated with a median overall survival which compares favorably with sorafenib.

4099 Background: Radioembolization (RE), which enables the delivery of high dose radiation preferentially to liver tumors, is used in some specialist centers as part of the multimodal treatment of ...

e11577 Background: To evaluate the effectiveness, the toxicity and survival rates of radioembolization with yttrium-90 (Y90), in patients affected by advanced breast liver metastasis refractory to ...

e14618 Background: The effects of advancing age on the tolerance and clinical outcomes following radioembolization in elderly patients with HCC are largely unknown. Methods: A retrospective analysi...

4027 Background: The prognosis in HCC was evaluated in a large series of patients receiving radioembolization (RE). Methods: 250patients with unresectable HCC were recruited consecutively from 8 Eu...