Objective To estimate the incidence rates (IRs) of outcomes of interest in paediatric patients (aged 1 to <2 years) treated with intravenous pantoprazole.Methods This real-world, non-interventional, retrospective study was conducted using Optum’s longitudinal electronic health records database between 1 January 2007 and 31 December 2020. Eligible patients receiving ≥1 dose of intravenous pantoprazole were included. Premature patients and those with birth weight <2.36 kg were excluded. Patients were divided into three subgroups based on diagnosis of gastro-oesophageal reflux disease (GORD) and erosive oesophagitis (EO): subgroup 1 (GORD and EO), subgroup 2 (GORD and no EO) and subgroup 3 (absence of both GORD and EO). The IRs (per 1000 person-years) of outcomes of interest were estimated in the overall and subgroups and stratified by duration of intravenous pantoprazole treatment (<4 days vs ≥4 days).Results Of 981 patients, none were identified in subgroup 1, while subgroup 2 and subgroup 3 comprised 462 (47.1%) and 519 (52.9%) patients, respectively. The highest IRs in the overall cohort were observed for vomiting (711.8), diarrhoea (412.4), abdominal distension (234.9), hypokalaemia (195.4) and hyponatraemia (182.5) with comparable IRs between subgroups 2 and 3. The IRs were higher for vomiting, diarrhoea, hypokalaemia, abdominal distension, hyponatraemia and thrombocytopenia in patients receiving ≥4 days of pantoprazole treatment versus <4 days.Conclusion The real-world incidence of the outcomes of interest is consistent with the established safety profile of pantoprazole and may provide key insights for use of intravenous pantoprazole in paediatric patients excluding those born preterm or with low birth weight.

OBJECTIVE:To estimate the incidence rates (IRs) of outcomes of interest in paediatric patients (aged 1 to <2 years) treated with intravenous pantoprazole. METHODS:This real-world, non-interventional, retrospective study was conducted using Optum's longitudinal electronic health records database between 1 January 2007 and 31 December 2020. Eligible patients receiving ≥1 dose of intravenous pantoprazole were included. Premature patients and those with birth weight <2.36 kg were excluded. Patients were divided into three subgroups based on diagnosis of gastro-oesophageal reflux disease (GORD) and erosive oesophagitis (EO): subgroup 1 (GORD and EO), subgroup 2 (GORD and no EO) and subgroup 3 (absence of both GORD and EO). The IRs (per 1000 person-years) of outcomes of interest were estimated in the overall and subgroups and stratified by duration of intravenous pantoprazole treatment (<4 days vs ≥4 days). RESULTS:Of 981 patients, none were identified in subgroup 1, while subgroup 2 and subgroup 3 comprised 462 (47.1%) and 519 (52.9%) patients, respectively. The highest IRs in the overall cohort were observed for vomiting (711.8), diarrhoea (412.4), abdominal distension (234.9), hypokalaemia (195.4) and hyponatraemia (182.5) with comparable IRs between subgroups 2 and 3. The IRs were higher for vomiting, diarrhoea, hypokalaemia, abdominal distension, hyponatraemia and thrombocytopenia in patients receiving ≥4 days of pantoprazole treatment versus <4 days. CONCLUSION:The real-world incidence of the outcomes of interest is consistent with the established safety profile of pantoprazole and may provide key insights for use of intravenous pantoprazole in paediatric patients excluding those born preterm or with low birth weight.

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To estimate the incidence rates (IR) of prespecified outcomes of interest in pediatric patients (1 month to < 1 year) treated with intravenous (IV) pantoprazole using Optum’s longitudinal electronic health records database (Optum Market Clarity) from the United States (US). This real-world, non-interventional, retrospective cohort study was conducted from 01 January 2007 to 31 December 2020 in patients who received IV pantoprazole. Premature patients and those weighing < 2.36 kg were excluded. Patients were categorized based on diagnosis of gastroesophageal reflux disease (GERD) and erosive esophagitis (EE) into: Subgroup 1 (GERD and EE), Subgroup 2 (GERD and no EE), and Subgroup 3 (absence of GERD and EE). Overall IRs (per 1000 person-years [PY]) and 95

e20577 Background: Previous studies have investigated overall survival (OS) among small cell lung cancer (SCLC) patients with data through 2015. Using data through mid-2019, this study strives to make the body of studies more current, and to provide more recent data on the baseline characteristics and OS of treated SCLC patients, stratified by stage at diagnosis. Methods: This retrospective cohort study identified adult patients with confirmed SCLC between January 1, 2016 - December 31, 2018 that initiated anti-cancer treatment using real-world data from electronic medical records (ConcertAI, including data from CancerLinQ, an initiative of the American Society of Clinical Oncology). Exclusion criteria included evidence of other primary cancer at baseline, no initial stage recorded, death prior to diagnosis, or participation in a clinical trial. Patients entered the cohort upon receipt of their first anti-cancer treatment after SCLC diagnosis and were assigned up to three progression intervals to assess overall survival for each progression-based line of therapy. Patients were followed until death, end of data, or end of the study period (June 30, 2019). Kaplan-Meier analyses were conducted to assess median survival time as estimated by the survival curve. Results: Characteristics among the 82 limited stage (LS) and 217 extensive stage (ES) patients at 1L treatment were similar; however, LS patients were slightly older (mean age: LS = 67.5, ES = 66.4), and ES patients had a higher comorbidity score given their metastatic disease status (mean score: LS = 3.9, ES = 7.3). Both groups had very similar ECOG performance scores prior to 1L (ECOG: 0-1 ≅ 40%, 2+ ≅ 25%, Missing ≅ 35%). For the 299 patients that began 1L treatment (LS = 82, ES = 217), median OS time was 8.41 months (LS = 12.35 months, ES = 7.98 months). For the 124 of the 299 patients who progressed and were treated with 2L therapy, median OS time was 4.30 months. For the 44 of the 124 patients that progressed and were treated with 3L therapy, median OS time was 3.88 months. Of the 299 treated patients, 216 died before the end of the study period, representing 57% of the LS patients and 78% of the ES patients. Conclusions: These results reveal a difference in OS between LS and ES patients treated in 1L. The short survival time in patients with later lines of therapy highlights the need for new treatments in 2L and 3L.[Table: see text]

e20576 Background: With emerging treatment options for small-cell lung cancer (SCLC) patients after initial treatment failure, the real-world management of this disease should be assessed. This study aims to describe treatment patterns of real-world SCLC patients in the second-line therapy (2L) and third-line therapy (3L) setting. Methods: This was a descriptive study of real-world data sourced from ConcertAI electronic medical records, including data from CancerLinQ, an initiative of the American Society of Clinical Oncology of adults (age ≥ 18 years) with confirmed SCLC between January 1, 2016 and December 31, 2018. Patients were excluded based on evidence of other primary cancer at baseline, missing stage, death prior to diagnosis, or clinical trial participation. Patients entered the cohort on their SCLC diagnosis date and were followed through three tumor progressions to assess treatment patterns. Treatment patterns were assessed in 2L and 3L. Baseline characteristics were assessed in the 6 months prior to each line. Patients were classified as having unknown treatment if they had a gap in medical records > 90 days or no recorded tumor response or death within 180 days. Results: Overall, 538 patients were identified; 131 with unknown treatment, 108 with no treatment, 299 with 1st line therapy (1L), 124 with 2L, and 44 3L. The majority (76%) of patients were diagnosed in a community hospital setting. The most common comorbidities were chronic obstructive pulmonary disease (2L 25%, 3L 16%), diabetes (2L 15%, 3L 14%), congestive heart failure (2L 7%, 3L 9%), and myocardial infarction (2L 3%, 3L 2%). Radiation therapy was commonly used in 2L and 3L (2L 48%, 3L 43%) as were immunotherapies (2L 23%, 3L 23%). The most common systemic therapy in 2L and 3L was nivolumab (19% and 16%). Topotecan accounted for 11% of patients treated in 2L and 7% of those in 3L. Conclusions: During this treatment era (pre-immunotherapy 1L approval) there were limited treatment options available for SCLC patients. Radiation therapy and immunotherapies were frequently used as 2L and 3L therapy.[Table: see text]