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528 Background: Hypertension is a common adverse event of bevacizumab and recent data demonstrates that this event is associated with a better clinical course. However, a blood pressure drop after bevacizumab administration and its clinical significance have not yet been reported. Methods: Between August 2007 and October 2010, 85 patients with colorectal cancer underwent palliative chemotherapy using bevacizumab at Kyoto University Hospital. For these patients, we obtained data using both the designated database system (CyberOncology, CyberLaboratory Co. Ltd., Ibaragi, Japan) and the hospital’s electronic medical records system on blood pressure values at 0 min (before administration), at 90 min and 180 min after the initiation of bevacizumab during the first three cycles of bevacizumab treatment. Out of the 85 patients, there were 81 for whom two or more sets of blood pressure data from the first three cycles were available. Therefore, we retrieved data from a total of 162 bevacizumab administrations in 81 patients (data from 2 separate administrations per patient). Results: Twenty-five patients (30%) demonstrated an average temporary drop of 20 mm Hg or more in systolic blood pressure between 0 and 90 min. We classified these 25 patients as group A and the others as group B. In group A the mean blood pressure drop between 0 and 90 min was 25 and 30 mm Hg in the first and second monitoring, respectively, compared with 3 and 5 mm Hg in group B. There were no significant differences between the 2 groups in their baseline characteristics. Interestingly, median time to treatment failure (TTF) was significantly longer in group A compared to group B (291 vs. 162 days; hazard ratio, 0.53; 95% CI, 0.31 – 0.89; P = 0.02). Furthermore, the proportion of patients who required intervention with antihypertensive drugs during bevacizumab treatment was significantly higher in group A compared to group B (36% vs 4%; P < 0.01). Conclusions: Our current study suggests that a temporary blood pressure drop after bevacizumab administration could be a predictive marker for bevacizumab treatment.

e19642 Background: Gemcitabine is an active anticancer drug approved for various kinds of cancers and has relatively few adverse events except for bone marrow toxicity, but we have sometimes experienced vascular pain during intravenous administration of gemcitabine. In retrospective analysis, we reported that the use of 5% glucose solution for dissolution of gemcitabine decreased frequency of vascular pain compared with that of saline solution for. However, there were no reports which demonstrated the difference in frequencies of vascular pain between 5% glucose solution and saline for gemcitabine dissolution. Therefore, we conducted this double-blind randomized study to compare the frequency and degree of vascular pain during administration of gemcitabine between them. Methods: Ninety patients were enrolled in a double-blind, randomized, crossover, and multicenter study from July 2009 to June 2010. The primary endpoint was frequency of vascular pain, and the secondary endpoints were degree and duration o...

e15563 Background: Although sorafenib has been reported to prolong survival of patients with advanced hepatocellular carcinoma (HCC), the prognosis of those who did not respond to or are not candidate to transarterial chemoembolization (TACE) remains poor. The aim of this outcome analysis is to evaluate the safety and efficacy of hepatic arterial infusion chemotherapy (HAIC) via a subcutaneously implanted injection port in the treatment of such patients. Methods: From the prospective cohot database of Outpatient Oncology Unit, Kyoto University Hospital, patients with HCC who had been treated with HAIC using low dose cisplatin and 5-FU (cisplatin 10mg and 5-FU 250mg for day 1–5, repeated serially for three or four weeks, then repeated once weekly) between October 2003 and December 2008 were searched for. All adverse events were assessed according to Common Terminology Criteria for Adverse Events v3.0. Survival analysis was performed by using Kaplan-Meier method. Prognostic factors were assessed using Log-rank test. Results: Forty-one patients were identified. The indications of HAIC were: (1) the presence of portal vein tumor thrombus (20/41 cases, 49%), (2) failure to TAE (19/41, 46%) or (3) not candidate for TAE due to the presence of extrahepatic disease (2/41 case, 5%). One complete response and 7 partial responses were observed, overall response rate being 19.5% (95%CI, 7.4–31.6%). Median overall survival was 26.1 month (95%CI: 9.6–45.6). Commonly observed grade 3/4 adverse events were thrombocytopenia (10 cases, 16.3%) and neutropenia (10 cases, 16.3%). There was a trend that fewer death occur in patients who responded to HAIC (1/8 cases, 12.5%) as compared to patients who did not (11/33, 33.3%), but log-rank test failed to detect a statistical significance (P=.145). Conclusions: HAIC for patients with advanced HCC who are not candidate for TACE warrants randomized controlled trial. No significant financial relationships to disclose.

17066 Background: The information generated in daily practices is critical to assure safety and efficacy of therapeutic interventions. Clinical investigators are faced with enormous amounts of data and a greater need to organize it in a meaningful and coherent manner than ever before. Computerization could offer many advantages that clinical data systematically accumulated in the course of routine medical care can provide researchers with the clues to resolve many medical questions. Methods: We developed a novel clinical database system, named CyberOncology, integrated in EMR of Kyoto University Hospital. It contained summarized treatment history, national cancer registry and consecutive clinical database. All adverse events according CTCAE ver.3, response to the treatment based on RECIST criteria and survival data were collected. The medical staffs have routinely used the CyberOncology since its starting on October 2003. The CyberOncology directly collected all data concerning oncology management of inpatient and outpatient care from EMR, and simultaneously analyzed clinical outcomes. Results: For three years since October 2003, consecutive 1,516 new cancer patients including 590 GI, 435 lung, 234 breast cancer, and 140 lymphoma with 19,767 chemotherapeutic administrations were registered in the CyberOncology. Main benefits are improvement of the quality of patient care and safety, practice standardization, and the quickness and the reliability of collecting the data. Moreover, it had the capability to serve a cross-sectional approach of cancer and drug-orientated analysis. For example, this system can easily provided with a review of clinical practice in a real time manner. Conclusions: The CyberOncology form integrated EMR successfully meets requirements of electronic case report. It has been useful in monitoring outcomes of care, effectiveness, efficiency and adherence to clinical trial. No significant financial relationships to disclose.

14122 Background: At present, outcomes of advanced biliary tract cancers are dismal despite the prognosis of other many cancers are improving. Methods: We retrospectively analyzed survivals of 46 advanced biliary tract cancer patients, who were diagnosed between January 2001 and June 2005, and treated with gemcitabine 600–1,000 mg/m2 as an intravenous 30-min infusion on days 1, 8, and 15 for every 28 days, thereafter. Results: The median age was 63 (range 41–76) with 28 males and 18 females. Twenty-nine (63.0%) had no prior chemotherapy and 18 (30.4%) patients were inoperable cases. One (2.2%) achieved complete response; 5 (10.9%) achieved partial responses; 25 (54.3%) had stable diseases; 9 (19.6%) had progressive disease; and 6 (13.0%) were not evaluated for response. The median survival time and the 1 year-survival of all advanced biliary cancer patients were 8.6 months and 43.9%, respectively, those of the patients, who had the recurrence or residual cancer lesions after surgical resection were 13.5 months and 68.8%, and those of the inoperable patients were 5.4 months and 8.3%. Patients reported grade 3/4 neutropenia/leucopenia (4.3%) and grade 3 thrombocytopenia (2.2%). Grade 3 non-hematologic toxicities were general fatigue (4.3%) and renal failure (2.2%). Multivariate analysis demonstrated that history of surgical resection with tumor recurrence or with residual tumor was the independent predictors for survival. Moreover, except the features of the history of surgical resection, the prognosis of patients with low levels of serum albumin (< 3.7 g/dl) or ≥ 70 ages was worse than that of high levels of serum albumin (≥ 3.7 g/dl) or < 70 ages. Conclusions: In the treatment of biliary tract cancer, it seems that surgical resection even with possible residual tumor is beneficial for patients with good surgical candidate. The present study also suggests the possibility that the prognosis of patients with low levels of serum albumin (< 3.7 g/dl) or ≥ 70 ages might be worse than that of high levels of serum albumin (≥ 3.7 g/dl) or < 70 ages. No significant financial relationships to disclose.