This study prospectively assessed outcomes in a group of patients who were randomly switched from Clozaril to generic clozapine (Gen-Clozapine). The authors examined data from rating scales administered before the switch and at points after the switch. There were no statistically significant differences between the groups on any baseline measures, including psychiatric status and dose of medication. In the group of patients who were switched to the generic formulation, there was a significant increase in Global Assessment Scale scores by the end of the 6-month monitoring period. In the group of patients who remained on Clozaril, a significant decrease in the 32-item Behavior and Symptom Identification Scale scores was found at the end of the monitoring period. The results of this study suggest that clinical equivalence indeed followed bioequivalence when switching from Clozaril to Gen-Clozapine.

PURPOSE Electronic health record (EHR) data are widely used in precision medicine, quality improvement, disease surveillance, and population health management. However, a significant amount of EHR data are stored in unstructured formats including scanned documents external to the treatment facility presenting an informatics challenge for secondary use. Studies are needed to characterize the clinical information uniquely available in scanned outside documents (SODs) to understand to what extent the availability of such information affects the use of these real-world data for cancer research. MATERIALS AND METHODS Two independent EHR data abstractions capturing 30 variables commonly used in oncology research were conducted for 125 patients treated for advanced non–small-cell lung cancer at a comprehensive cancer center, with and without consideration of SODs. Completeness and concordance were compared between the two abstractions, overall, and by patient groups and variable types. RESULTS The overall completeness of the data with SODs was 77.6% as compared with 54.3% for the abstraction without SODs. The differences in completeness were driven by data related to biomarker tests, which were more likely to be uniquely available in SODs. Such data were prone to missingness among patients who were diagnosed externally. CONCLUSION There were no major differences in completeness between the two abstractions by demographics, diagnosis, disease progression, performance status, or oral therapy use. However, biomarker data were more likely to be uniquely contained in the SODs. Our findings may help cancer centers prioritize the types of SOD data being abstracted for research or other secondary purposes.

e19527 Background: Patients previously diagnosed with melanoma have a higher risk of developing subsequent chronic lymphocytic leukemia (CLL). Similarly, melanoma risk has been observed to be elevated among patients with a history of CLL. However, previous studies have reported inconsistent results on whether being diagnosed with both cancers significantly reduces patient survival. Additional research is needed to assess the potential reduction in survival among this unique cohort of patients diagnosed with both melanoma and CLL. In addition, the timing of the cancer development needs to be assessed to further explore unique patient characteristics. Methods: A retrospective cohort study was conducted using data from adult patients who were diagnosed and/or treated for melanoma (n = 5,511) or chronic lymphocytic leukemia (CLL, n = 571) at Moffitt Cancer Center (MCC) in 2008-2020. Clinical characteristics and survival information were obtained from the MCC Cancer Registry including, date of diagnosis, vital status, time of death or last contact, and tumor stage at diagnosis. The Kaplan-Meier method was used to estimate survival for three patient groups: patients diagnosed with only melanoma, patients diagnosed with only CLL, and patients who were diagnosed with both cancers. The timing of the two cancer diagnoses were assessed among the 17 patients diagnosed with both melanoma and CLL. Results: The estimated 5-year survival was 78.5% and 82.9% among patients diagnosed with only melanoma and only CLL, respectively. Among patients who were diagnosed with both cancers, the 5-year survival since melanoma diagnosis was 61.4% whereas the 5-year survival since the CLL diagnosis further reduced to 60.2%. When analyzing the timing of the diagnoses of the two cancers, 13 out of 17 patients were diagnosed with melanoma prior to CLL. Further, among these 13 patients, 12 patients had CLL diagnosed within 100 days after the melanoma diagnosis. Conclusions: Patients diagnosed with both melanoma and CLL experienced poorer survival outcomes as compared to patients who were diagnosed with only one of these cancers. Among patients who were diagnosed with both cancers, more than 70% of the patients were diagnosed with CLL shortly after their melanoma diagnosis. Additional research using larger national cancer registry databases can help to advance the understanding of the underlying disease mechanism and confirm the observed timing of diagnoses is due to the CLL being diagnosed incidentally as result of node biopsies for melanoma.

No abstract

20 Background: Moffitt Cancer Center (MCC) has developed evidence-based cancer care pathways which are integrated into the Electronic Health Record (EHR). We retrospectively compared the 1 year (yr) total cost of care in patients (pts) with newly diagnosed prostate cancer (PCA) treated at MCC based on EHR tool utilization and pathway alignment. Methods: Using existing Cancer Registry data, we retrospectively identified all pts presenting with newly diagnosed PCA between 7/1/2015-6/30/2017 who received all 1st course treatment (tx) at MCC. Pts direct costs were tracked for 1 yr from the Cancer Registry “date of 1st contact.” Tx was categorized as either radiation (RT) +/- hormone tx (HT), surgery (S) +/- HT, active surveillance only (ASO), HT only, palliative care, chemotherapy (CT), or mixed (a combination of S, RT, or CT). Pathway alignment was either electronically tracked through the EHR pathway tool or determined through manual chart review for pts tx’ed off the pathway tool. Results: 477 pts met inclusion criteria, including men with: low or favorable intermediate (n=259); unfavorable intermediate, high, or very high (n=186); and metastatic (n=32) risk group PCA. The majority (n=396, 83%) had tx in alignment with a pathway. The major tx modalities on pathway were S-HT (n=139), RT-HT (n=113), or ASO (n=110) and off pathway were RT-HT (n=52, 64%), S-HT (n=10), or ASO (n=9). Overall, treatment in alignment with a pathway was significantly associated with lower 1 yr total cost compared to off pathway tx (p <0.001) with a mean difference of $5,500 per pt yr. Conclusions: Clinical pathway alignment was significantly associated with less aggressive therapy and lower 1 yr cost of care for PCA pts treated at MCC. Cost of care was highly associated with tx modality selected. Further analyses are needed to understand the association between pathway alignment, patient risk factors and tx modality selection.