e14142 Background: An Anemia Clinic program was started Sept. 2016 as part of system wide implementation of Patient Blood Management (PBM) initiated in 2015. Methods: The Anemia Clinic accepted referrals for non-cancer anemia, predominantly preoperative cardiovascular surgery (CVS) Pts. Hgb thresholds were < 13 g/dL in men and < 12 g/dL in women. Non-anemia cytopenias triggered Hematology referral. All Pts were screened for iron, B12, folate, and reticulocyte. Nutrient deficiencies were supplemented. Pts with CKD or chronic disease were considered for erythropoiesis stimulating agents. Results: PBM implementation resulted in a drop in packed red blood cell (PRBC) usage (Table). Of CVS Pts pre-operatively anemic in 2019, 180 were referred to the Anemia Clinic and 301 were not. Anemia Clinic identified iron (N = 114), vitamin B12 (N = 24), and folate (N = 18) deficiencies. The percentage of Pts who received PRBCs after Anemia Clinic referral was not statistically different from those who were not referred (65.6% vs. 61.8% Chi-Square p = 0.44). Of preoperatively anemic Pts who were transfused in 2019, an average of 2.34 PRBCs were used in the referred group vs. an average of 2.21 PRBCs in those in the not referred group (Poisson Means p = 0.46). Length of stay (LOS) which was a median 10d ( P 25 = 7d, P 75 = 17d) in the referred group vs a median 12d ( P 25 = 7d, P 75 = 19d) in the non-referred group was not statistically different between groups (Smirnov p = 0.39). LOS analyses of observed-to-expected (O/E) ratios used the Premier Healthcare Providers Alliance Database (PHD) which contains data on approximately 45% of US hospital discharges. For 2019 through Nov. the referred group had an O/E = 1.03 (observed LOS μ geo = 11.58 days, expected LOS μ geo = 11.21 days, N = 167). The not referred group had an O/E = 1.06 (observed LOS μ geo = 12.24 days, expected LOS μ geo = 11.58 days, N = 272). Conclusions: PBM decreased PRBC use through systematization of best practices during the initial year. Subsequent addition of Anemia Clinic services has not decreased PRBC use further. There is a trend toward shorter LOS for patients referred to Anemia Clinic but it is not statistically significant. Our methods improved nutrient deficiency identification which may improve both later health outcomes not detected here and access to treatment for hematologic malignancies. [Table: see text]
TPS3624 Background: To improve survival for patients with mCRC, efforts are needed to identify and treat actionable genomic alterations. HER2 is amplified in approximately 5-8% of patients with KRAS and NRAS (RAS) wild-type mCRC. HER2 functions as an oncogenic driver and a mediator of EGFR antibody (Ab) resistance. Although prior studies have shown that anti-HER2 therapies are active in patients with HER2+ (HER2 IHC 3+ or HER2 amplified) mCRC, there are no HER2-directed therapies approved for these patients. Tucatinib is a potent and highly selective oral small molecule tyrosine kinase inhibitor of HER2, currently being developed to treat metastatic breast cancer. In HER2+ CRC patient derived xenograft models, tucatinib has substantial anti-tumor activity. The addition of the anti-HER2 monoclonal Ab trastuzumab augments tumor growth inhibition. Methods: This single-arm phase II study will test the combination of tucatinib and trastuzumab in patients with HER2+ mCRC. Eligible patients include those with RAS wild-type mCRC who have been previously treated with 5-FU, oxaliplatin, irinotecan, and an anti-VEGF monoclonal Ab. Patients must have HER2+ disease by IHC, FISH, or NGS. Prior treatment with anti-HER2 targeting therapy is excluded. The primary objective is to assess the objective response rate for the combination. Secondary objectives are to evaluate the efficacy (PFS, OS, clinical benefit rate), safety, and tolerability of the combination. Correlation between tissue and blood-based biomarkers and clinical outcomes will be explored. Blood will be collected at baseline and each restaging to determine if the combination eliminates HER2 amplified circulating tumor DNA. Subjects will receive tucatinib at a dose of 300mg by mouth daily, and trastuzumab will be administered every 3 weeks (8 mg/kg IV day 1 of cycle 1, then 6 mg/kg IV Q3 weeks). Response will be assessed every 3 cycles (9 weeks) per RECIST version 1.1. Both agents will be provided by the study. This study was initiated in February 2017. Recruitment is ongoing at 8 sites in the Academic and Community Cancer Research United (ACCRU) network. Clinical trial information: NCT03043313.
664 Background: We are in the midst of a paradigm shift in the treatment of stage 1 pancreatic ductal adenocarcinoma (PDAC) from surgery first followed by adjuvant therapy (AT) to Neoadjuvant therapy (NAT) first followed by surgery and this is reflected in the current NCCN guidelines as well. Data comparing these two modalities are limited. AIM: To compare long term survival between Surgery + AT and NAT + Surgery in a large National Cancer Database for stage 1 PDAC. Methods: We identified patients with the NCDB with surgically resected AJCC clinical stage 1, 1A, and 1B PDAC between 2004-2016. Patients were stratified into two groups to assess outcomes: AT and NAT. Patients with incomplete survival and sequence of therapy were excluded. Baseline demographic data, 90-Day Mortality, Median survival, and Hazard ratios (HR) for survival was evaluated. Results: 9017 pts with Clinical stage 1, 1A, 1B PDAC between 2004-2016 were identified. Of these 7453 pts had surgery followed by AT; and 1564 pts had NAT followed by surgery. There was a statistically significant difference in age (66.0±9.9 years for AT vs. 64.7±9.78 years for NAT, p < 0.001) but no difference in Charlson Comorbidity Scoring (p = 0.618) or sex (p = 0.073). 90-Day Mortality was 0.35% in the AT group compared to 0.83% in the NAT group (p = < 0.001). Median survival was 28.5 (95% CI 26.5-29.9) months in the NAT group compared to 25.4 (95% CI 24.7-26.1) months in the AT group. With AT as the reference group for survival, there was a HR of 0.904 (95% CI 0.845-0.968, p = 0.003) for NAT. Conclusions: In this retrospective cohort of patients, NAT was associated with increased overall survival. However, NAT was associated with an increased 90 day mortality. A randomized, controlled trial is necessary to further support the superiority of NAT in the management of stage 1 PDAC.
Plasma exchange with plasma replacement has been the mainstay for the treatment of thrombotic thrombocytopenic purpura (TTP) for several decades. Recently an anti-von Willebrand factor (VWF) medication, caplacizumab, has been approved for treatment of TTP when used with plasma exchange. We report a patient with immune-mediated TTP that had an anaphylactic reaction to plasma who was then given caplacizumab daily for 1 week without further plasma exchange therapy with a good clinical and laboratory response.A 63-year-old woman with acute confusion and multiple ecchymoses after tooth extraction developed TTP with a hemoglobin (Hb) of 6.3 g/dL, white blood cell count 15 × 109 /L, platelets (PLTs) 12 × 109 /L, lactate dehydrogenase (LDH) 1212 IU/mL, and creatinine 0.9 mg/dL. Her ADAMTS13 level was less than 5% and plasma exchange was started. During the first plasma exchange the patient developed anaphylaxis with hypotension, shortness of breath, angioedema, and urticaria. She recovered from this reaction with treatment and no further plasma exchanges were performed. Instead she was given methylprednisolone, caplacizumab, and later rituximab. The caplacizumab was given daily for 8 days during which her PLT counts and ADAMTS13 levels improved. Her Hb level also increased. She continued to receive oral prednisone and rituximab after discharge was doing well latest follow up (Day 114).Caplacizumab may be used safely and effectively without concomitant plasma exchange in a patient with anaphylaxis to plasma.
e21000 Background: VIA Oncology evidence-based pathways have been integrated into our medical oncology workflows since November 2014. Within 3 months, compliance was high for our 42 medical oncologists at 19 sites working with a common EHR with over 85% of pts treated on pathway. The aim of this study was to determine if there was a significant difference in the overall cost of treatment between pts treated on pathway versus off pathway, and whether on pathway pts had a lower rate of ED use and unplanned admissions within 30 days of chemotherapy as required in the new CMS directives. Methods: Newly diagnosed NSCLC pts diagnosed between January 1, 2017 to December 31, 2018 were identified from the tumor registry for the system. The VIA database was queried to separate these pts into two groups – those pts who were treated on pathway, and those who were off pathway. In addition, we divided pts into early diagnosis, advanced/curative, and advanced/non-curative. The data warehouse was utilized to determine the total charges of adjuvant medical oncology treatment for these pts. In addition, data was extracted for the same groups to determine those pts who sought ED evaluation and or hospital admission within 30 days of chemotherapy treatment (CMS-35). Statistical analysis was performed using Chi-square/Fisher’s exact test to compare proportions and t-test for independent samples to compare treatment costs and ED/hospitalizations between the on and off pathway groups. Results: During the 2 years, 407 (81.4%) NSCLC pts were treated on pathway (including clinical trials); 93 (18.6%) were off pathway. All patients undergoing treatment were ECOG 0-2 Performance Status. Mean cost for treating the on-pathway group was $104,436 compared to $183,717 for the off-pathway pts (p = 0.01). Since implementing pathways, clinical trial entry rose from 27 to 66/yr. 25.8% of on pathway compared to 29% of off pathway fell into the CMS 35 group. Conclusions: Standardized usage of evidence-based pathways can be used successfully across a large number of providers over wide geography. Adherence to pathways results in significant cost savings for each patient and significant rise in clinical trial entry.
In BriefMedical oncologist workflows have changed dramatically in view of precision medicine, new therapeutic agents, and sub-specialization in oncology. Relative value unit (RVU)-based practice plans lack financial incentive for cooperation and sharing of knowledge and patients, which is required for current best practices in cancer care. To improve cooperation and sharing, Aurora Health Care formed a Practice Plan Development Committee of medical oncologists, service line leadership, finance leadership, and a practice plan consultant. The committee established goals that would enhance collaboration, modify physician behavior to meet the needs of the group, allow payment for non-RVU-generating activities, create a more equitable distribution of expertise, facilitate intra-group consultation, and create more evenly developed compensation. A plan was developed to reward non-RVU-generating activities that benefited the cancer program and medical group. This plan included the creation of a pool where a percentage of compensation, above a threshold, was established and equally divided at the end of the calendar year. Citizenship criteria were established to benefit the health system, medical group, and individuals and demonstrably modified behavior. All members of the medical group (physician practice) agreed to move to the new model. It has resulted in continuous improvement of defined goals with reduced variation in income, increased clinical trial volume by 400 percent, and increased sub-specialization within the medical oncology group.
100 Background: Current guidelines recommend esophagectomy for submucosal T1b esophageal cancer. Data regarding efficacy of endoscopic resection (ER) of T1b esophageal cancer are limited. Our goal was to compare survival outcomes of ER as opposed to conventional surgical resection (SR) in a large cohort of patients with T1b cancers from a large national database. Methods: Data were obtained from the large national database maintained by the Commission on Cancer. Patients with T1b esophageal cancers with clinical stage 1A and 1B who underwent ER and SR between 2010 and 2014 were identified using the American Joint Committee on Cancer (AJCC Version 7). Patients undergoing ER and SR were identified. Patients who underwent neoadjuvant therapy or had incomplete survival data were excluded. The primary outcome was survival for age and Deyo-Charlson comorbidity index. We also evaluated 30-Day and 90-Day Mortality outcomes. Results: There were 1071 patients with T1b esophageal cancer with complete mortality data. After selecting and excluding patients above, 141 patients were identified who underwent EET and 286 who underwent esophagectomy. Average age was 71.5 years in the ER group and 64.5 years in the SR group (p < 0.001). In the group, 30-Day mortality after surgery was 1/134 (0.8%, 7 missing) compared to surgery with 30-Day mortality of 6/283 (2.1%, 3 missing) (P = 0.308). 90-Day mortality after surgery for the ER group was 3/134 (2.2%, 7 missing) compared with the surgery with 90-Day mortality of 11/281 (3.9%, 5 missing) (P = 0.377). Adjusted for age and Deyo-Charlson comorbidity index, there was a HR of 1.051 (95% CI 0.695-1.589, p = 0.815) for mortality associated with surgery compared with ER. Mean follow-up of 42.6 months for the ER group and 55.7 months for surgery group. Conclusions: Based on the data from a large national cancer data base ER seems to be comparable to SR in terms of short term (30 day and 90 day) mortality. Overall survival seems to be similar in both groups Prospectively done randomized studies comparing ER versus SR are desirable.
e18799 Background: An Anemia Clinic program was started Sept. 2016 as part of system wide implementation of Patient Blood Management (PBM) initiated in 2015. Methods: The Anemia Clinic accepted referrals for non-cancer anemia, predominantly preoperative cardiovascular surgery (CVS) Pts. Hgb thresholds were < 13 g/dL in men and < 12 g/dL in women. Non-anemia cytopenias triggered Hematology referral. All Pts were screened for iron, B12, folate, and reticulocyte count. Nutrient deficiencies were supplemented. Pts with CKD or chronic disease were considered for erythropoiesis stimulating agents. Results: PBM implementation resulted in a drop in packed red blood cell (PRBC) usage (Table). Of CVS Pts pre-operatively anemic in 2021, 169 were referred to the Anemia Clinic and 352 were not. The percentage of Pts who received PRBCs after Anemia Clinic referral was statistically different from those who were not referred (67.5% vs. 52.8% chi-square p = 0.002). Of preoperatively anemic Pts who were transfused in 2021, an average of 2.67 PRBCs were used in the referred group vs. an average of 2.36 PRBCs in those in the not referred group (negative binomial p = 0.18). Length of stay (LOS) which was a median 10d ( P 25 = 7d, P 75 = 18d) in the referred group vs a median 10d ( P 25 = 6d, P 75 = 16.5d) in the non-referred group was not statistically different between groups (Smirnov p = 0.36). LOS analyses of observed-to-expected (O/E) ratios used the Premier Healthcare Providers Alliance Database (PHD) which contains data on approximately 45% of US hospital discharges. For 2021 through Nov. the referred group had an O/E = 0.93 (observed LOS μ geo = 10.88 days, expected LOS μ geo = 11.67 days, N = 154). The not referred group had an O/E = 1.04 (observed LOS μ geo = 10.56 days, expected LOS μ geo = 10.18 days, N = 305). Conclusions: PBM decreased PRBC use through systematization of best practices during the initial year, and that decrease has persisted for six years. Subsequent addition of Anemia Clinic services did not decrease PRBC use further. A trend toward shorter LOS for patients referred to Anemia Clinic did not continue this year, but the difference in LOS from the not referred group was not statistically significant and observed LOS for the referred group was lower than expected LOS. Our methods improved nutrient deficiency identification which may improve both later health outcomes not detected here and access to treatment for hematologic malignancies.[Table: see text]
335 Background: There has been a paradigm shift in the treatment of stage 1 pancreatic adenocarcinoma (PAC) from surgery first followed by adjuvant therapy (AT) to Neoadjuvant therapy (NAT) first followed by surgery and this is reflected in the current NCCN guidelines as well. Data comparing these two modalities are limited. AIM: To compare long time survival between surgery vs Surgery + AT and NAT + Surgery in a large National Cancer Database. Methods: We identified patients with surgically resected AJCC clinical stage 1, 1A, and 1B PAC between 2004-2014. Patients were stratified into 3 groups to assess outcomes. Exclusion criteria: those with incomplete survival and sequence of therapy data. Hazard ratios (HR) were calculated for evaluation of survival, as well as for 30-Day and 90-Day Mortality between the 3 groups. Results were adjusted for age and Deyo-Charlson comorbidity index. Results: A total of 9684 pts with Clincal stage 1, 1A, 1B PAC between 2004-2014 were identified. Of these 2266 pts underwent surgery alone; 6222 had surgery followed by AT; and 1196 pts had neoadjuvant therapy followed by surgery. There was a HR of 0.995 (95% CI 0.935-1.058 p = 0.864) and 0.984 (95% CI 0.924-1.048, p = 0.617) for 30- and 90-Day mortality comparing upfront surgery to NAT, respectively. With AT as the reference group for survival, there was a HR of 1.362 (95% CI 1.286-1.443, p < 0.001) for surgery only and HR of 0.929 (95% CI 0.859-1.004, p = 0.064) for NAT. Conclusions: 1. Surgery alone had worse overall survival. 2. There was no significant difference in overall survival when comparing AT and NAT 3. A prospective randomized trial evaluating the differences in survival is needed.
e18273 Background: Pegfilgrastim is used in patients at significant risk for febrile neutropenia following myelosuppresive chemotherapy. Labeling for pegfilgrastim requires administration the day after administration of chemotherapy. The pegfilgrastim on-body injector allows for delivery at home, without having to return to the clinic. Rates of appropriate delivery of pegfilgrastim via the on-body injector have not been studied in large scale outside of controlled environments. This retrospective review investigates the rate of appropriate delivery of pegfilgrastim via the on-body injector in a large heath system. Methods: Reports were created listing monthly clinic administration of the pegfilgrastim on-body injector at nineteen outpatient cancer care clinics from July 1 st , 2016 to December 31 st , 2016. Patient charts were reviewed for reported non-delivery of the medication. Results: Three hundred eighty-nine injections from 149 patient charts were reviewed. Of these injections, eight were not delivered (non-delivered rate = 2.1%). Four other administrations resulted in only partial dose delivery or unknown if dose was delivered (partial/unknown rate = 1%), leading to a failure rate of 3.1 with an appropriate delivery rate of 96.9%. Conclusions: In one health system’s experience, 96.9% of pegfilgrastim on-body injector administrations were delivered as planned. A process for real time evaluation of delivery rates should be created to address the 3-4% non-delivered dosing.
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