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e15724 Background: The majority of pancreatic cancers are diagnosed in advanced stages with a median survival of 3 to 5 months. From 2005 to 2012, the US Food and Drug Administration approved 41 oncology drugs; surrogate endpoints were used in 84% of the trials providing the basis of approval. The aim of this systematic review was to evaluate the relationship between PFS/TTP and OS in metastatic pancreatic cancer. Methods: A systematic literature review used the Centre for Reviews and Dissemination principles to identify studies that reported median PFS or TTP and OS. We searched Medline, Medline In-Process, and Embase, with the following additional limits: English language and published 1/1990 to 7/ 2016. Selection criteria, defined a priori, included chemo, immuno or targeted therapy, randomized controlled studies (Phase 2 or 3) in patients with metastatic pancreatic cancer. Studies were assessed for quality using the Cochrane Risk of Bias tool and the Jadad scale. Studies were excluded if full-text articles were not available, and if patients received chemotherapy plus radiotherapy or surgery. Correlation analyses and weighted linear regression were used to assess the association between median PFS/TTP and median OS. The distributions of median PFS/TTP and OS were examined using scatterplots. Results: 1,691 studies were identified. After screening by title and abstract, 212 full articles were assessed, of which 28 studies (evaluating 6,734 patients) met the selection criteria. The mean median PFS/TTP and OS were, respectively, 3.82 months (range 1.2 to 6.8 months), and 7.06 months (range 2.5 to 11.9 months). The correlation coefficient was 0.837; 95% CI (0.734-0.903) indicating a very strong positive correlation between median OS and median PFS/TTP. Regression analysis indicated that median PFS/TTP was a highly significant predictor of median OS = 2.177 + 1.247 * median PFS/TTP (p < 0.001). Conclusions: The analysis demonstrates a very strong positive correlation of median PFS/TTP with median OS for the treatment of metastatic pancreatic cancer, which reinforces the hypothesis that PFS or TTP is a useful surrogate endpoint for OS in this cancer setting.

280 Background: Clinical trials suggest that patients with mPDA are at high risk of TE from both disease and treatment. TE rates and anticoagulant use among mPDA patients after first line chemo were investigated. Methods: Medicare beneficiaries enrolled in parts A, B, and D; diagnosed with mPDA; aged ≥ 65 years; and starting chemo between 1/1/2007 and 12/31/2012 were obtained from Surveillance, Epidemiology, and End Results (SEER)-Medicare data. Eligible patients were enrolled from 12 months before chemo and followed until death, post-chemo disenrollment, or 12/31/2012. Arterial (ICD-9 410-411, 433-434), venous (ICD-9 415.1x, 453.4x, 453.8x, 453.9), and total TE were defined as ≥ 2 outpatient diagnoses ≥ 30 days apart, one inpatient diagnosis, or one outpatient diagnosis followed by outpatient anticoagulants within 90 days. Post-chemo TE incidence was calculated as the number of first events per 100 person-years (PY) for patients with and without TE 12 months before chemo. Time from chemo to first TE was estimated using the Kaplan-Meier (KM) method. Results: Among 1,308 eligible patients, mean age was 74 years [range 65-93]; 56% were female; 85% had no prior TE. Overall, 419 (32%) had a TE after chemo including 121 (9%) arterial and 363 (28%) venous TE. The table shows incidence, and time to TE for those with and without prior TE. Outpatient anticoagulants were prescribed for 276 (25%) patients with no prior TE and 110 (57%) patients with prior TE. Table. TE incidence and time to TE among mPDA patients after chemo Conclusions: mPDA patients face a substantial risk of TE after chemo, with nearly one-third of patients without prior TE and one-half of patients with prior TE experiencing events during treatment. These high rates of TE indicate the importance of conducting risk assessments for preventive measures early during a patients’ care.[Table: see text]

e15749Background: Ventana Medical Systems, Inc. is developing in collaboration with Halozyme Therapeutics an affinity histochemical companion diagnostic to aid in selecting patients with pancreatic...

380 Background: Clinical trials suggest that patients with metastatic pancreatic ductal adenocarcinoma (mPDA) are at a high risk of thromboembolic events (TEs) as a result of both disease and treatment. Real-world data on TE rates are limited for patients with mPDA. Methods: Using a retrospective cohort design, patients with mPDA aged ≥ 65 years and treated with chemotherapy during 2007-2012 were identified using the Surveillance, Epidemiology, and End Results (SEER)-Medicare database. Patients enrolled in Medicare parts A, B, and D were followed from the start of first-line chemotherapy (index date) to the earliest of disenrollment from Medicare, death, or 12/31/2012. The baseline (BL) period was defined as 12 months prior to the index date. The incidence of TEs was calculated as the number of events per 100 person-years (PY) of follow-up (F/U) among patients without a BL TE. Anticoagulant use during F/U was categorized as preventive (before first TE, if any) and treatment (on or after first TE date) among patients with no BL TE. Results: Of 1,308 patients meeting the selection criteria, the mean age was 74 years, and 56% were female. The prevalence of TEs during the study period (BL or F/U) was 58% (n = 755). Excluding the 427 patients (33%) with TEs during BL, 328/881 (37%) of patients had a first TE during F/U, for an incidence rate of 85/100PY, including 29/100PY arterial and 59/100PY venous events. In the full study cohort, only 467/1,308 (36%) had a claim for any anticoagulant during the study period, although inpatient anticoagulant use is likely under-reported. Among patients receiving anticoagulants, 287/467 (61%) received low molecular weight heparin (LMWH). Preventive anticoagulant use was observed in 74/881 (8%) of patients without a BL TE; anticoagulation treatment was observed for 159/328 (48%) patients with a first TE during F/U. Conclusions: Real-world mPDA patients face a significant risk of TEs both before and after starting chemotherapy. Although inpatient use of anticoagulants including LMWH is incomplete in this database, it is clear that use of anticoagulants for treatment, and for prevention, of TEs is sub-optimal.