Importance Adults with acute myeloid leukemia (AML) typically remain hospitalized after induction or salvage chemotherapy until blood count recovery, with resulting prolonged inpatient stays being a primary driver of healthcare cost. Pilot studies suggest that outpatient management following chemotherapy might be safe and could reduce cost for these patients. Objective To compare safety, resource utilization, infections and cost between adults discharged early following AML induction or salvage chemotherapy and inpatient controls. Design Non-randomized phase 2 study. Setting Single center study conducted at the University of Washington Medical Center in Seattle, WA. Participants Over a 43-month period (January 1, 2011 – July 31, 2014), 178 adults receiving intensive AML chemotherapy were enrolled. After completion of chemotherapy, 107 met pre-designated medical and logistical criteria for early discharge (ED), while 29 met medical criteria only and served as inpatient controls. Interventions for Clinical Trials ED patients were discharged from the hospital at the completion of chemotherapy, and supportive care was provided in the outpatient setting until count recovery (median 21 days, range 2–45 days). Controls received inpatient supportive care (median 16 days, range 3–42 days). Main Outcome Measures 1) differences in early mortality 2) differences in resource utilization (ICU days, transfusions/study-day and IV antibiotics/study-day) 3) numbers of infections and 3) total and inpatient charges/study-day between early discharge patients and controls. Results Four patients discharged early (4%) but no controls died within 30 days of enrollment (p=0.58). Nine patients discharged early (8%) but no controls required intensive care unit-level care (p=0.20). No differences were noted in the average daily number of red blood cell (p=0.55) or platelet (p=0.31) transfusions. Patients discharged early did have more positive blood cultures (p=0.04) but required fewer days of IV antibiotics (p=0.007). Overall, daily charges among discharged patients were significantly lower (median $3,840 vs. $5,852; p<0.001) despite increased charges per inpatient day when readmitted (median $7,405 vs. $6,267; p<0.001). Conclusions and Relevance Early dischargefollowing intensive AML chemotherapy can reduce cost and use of IV antibiotics, but attention should be paid to complications that may occur in the outpatient setting. This study was registered at www.ClinicalTrials.gov (NCT01235572).

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4519 Background: Gemcitabine (G) is standard for metastatic pancreatic cancer (PC), with median survivals of 6 months (m). Second cytotoxic or biologic agents do not substantially advance survival. EGFR is expressed on PC and a phase II trial of G plus cetuximab (C) resulted in favorable 1 year survival. A phase II trial of irinotecan/docetaxel (I/D) chemotherapy reported a median survival for metastatic patients (pts) of 9 m. We conducted this randomized phase II trial to confirm the activity of this non-G regimen, and determine whether combining it with C was feasible and active. The primary endpoint was response. Methods: Pts required histologic confirmation of adenocarcinoma of the pancreas, evidence of distant metastases, ECOG PS 0–1, normal bilirubin, written informed consent, and were randomly assigned to Arm A (N=47) or B (N=45). Imaging with CT or MR within 4 weeks (wk) was used for tumor measurement. Dexamethasone was given 12 hours (h), 1 h before and 12 h after chemotherapy. Pts on Arm A received D 35 mg/m2 over 1 h and I 35 mg/m2 over 30 minutes weekly x 4 in a 6 wk cycle. Pts on Arm B received the same therapy, but C (loading dose 400 mg/m2 wk 1, 250 mg/m2 weekly thereafter) was given before D. Pts not receiving therapeutic anticoagulation received enoxaparin 40 mg per day. Pts were restaged (RECIST) after 2 cycles. Results: Median age Arm A: 59.9, Arm B: 60.2 years. Arm A 55% male, 32% PS 0, 97% EGFR immuno+. Arm B 84% male, 42% PS 0, 97% EGFR +. Median number of cycles for each arm 2 (1 -10). >4 cycles were delivered to 10.5% of pts Arm A, 20.9% Arm B. Grade ¾ neutropenia 26% Arm A, 33% Arm B. Grade 3 nausea 28% Arm A, 18% Arm B; Grade ¾ diarrhea 33% Arm A, 44.4% Arm B. 1 treatment-related death per arm. Median overall survival (OS), with 70.2% of pts known to have died, 6.5m [(95% CI (4.8, 8.6)] in Arm A. With 86.7% of pts known to have died in Arm B, OS 7.4 m [95% CI (4.4, 10.7)]. Response/progression data will be available at time of presentation. Conclusions: Weekly I/D ± C is associated with high rates of grade ¾ neutropenia/diarrhea. Median survival is 6.5m for I/D and 7.4m for I/D/C. Non-G containing therapy is active in metastatic PC. [Table: see text]

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