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56. Supplemental_Table_1 – Supplemental material for Comparing real-world evidence among patients with metastatic pancreatic ductal adenocarcinoma treated with liposomal irinotecan

Author

Koeller, Jim, Surinach, Andy, Arikian, Steven R., Zivkovic, Marko, Janeczko, Patrick, Cockrum, Paul, and Kim, George

Subjects
110203 Respiratory Diseases, FOS: Clinical medicine, 111702 Aged Health Care, FOS: Health sciences, 111599 Pharmacology and Pharmaceutical Sciences not elsewhere classified, 111299 Oncology and Carcinogenesis not elsewhere classified
Abstract

Supplemental material, Supplemental_Table_1 for Comparing real-world evidence among patients with metastatic pancreatic ductal adenocarcinoma treated with liposomal irinotecan by Jim Koeller, Andy Surinach, Steven R. Arikian, Marko Zivkovic, Patrick Janeczko, Paul Cockrum and George Kim in Therapeutic Advances in Medical Oncology

Published
2020
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79. Additional file 1: of Real-world treatment patterns and adverse events in metastatic renal cell carcinoma from a large US claims database

Author

Sumanta Pal, Gong, Jun, Mhatre, Shivani, Shih-Wen Lin, Surinach, Andy, Ogale, Sarika, Vohra, Rini, Wallen, Herschel, and George, Daniel

Abstract

Table S1. Listing of AEs included for analysis, with ICD-9/ICD-10-CM codes. Table S2. Baseline characteristics by TK inhibitor type. Table S3. Baseline characteristics by VEGF inhibitor type. Table S4. Baseline characteristics by mTOR inhibitor type. (DOCX 71 kb)

Published
2019
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80. Evaluation of COVID-19 vaccine breakthrough infections among immunocompromised patients fully vaccinated with BNT162b2.

Author

Di Fusco, Manuela, Moran, Mary M., Cane, Alejandro, Curcio, Daniel, Khan, Farid, Malhotra, Deepa, Surinach, Andy, Miles, Amanda, Swerdlow, David, McLaughlin, John M., and Nguyen, Jennifer L.

Subjects
COVID-19 vaccines, IMMUNOCOMPROMISED patients, MEDICAL databases, HOSPITAL care, COMPUTER algorithms
Abstract

Objective: To evaluate COVID-19 vaccine breakthrough infections among immunocompromised (IC) individuals. Methods: Individuals vaccinated with BNT162b2 were selected from the US HealthVerity database (10 December 2020 to 8 July 2021). COVID-19 vaccine breakthrough infections were examined in fully vaccinated (≥14 days after 2nd dose) IC individuals (IC cohort), 12 mutually exclusive IC condition groups, and a non-IC cohort. IC conditions were identified using an algorithm based on diagnosis codes and immunosuppressive (IS) medication usage. Results: Of 1,277,747 individuals ≥16 years of age who received 2 BNT162b2 doses, 225,796 (17.7%) were identified as IC (median age: 58 years; 56.3% female). The most prevalent IC conditions were solid malignancy (32.0%), kidney disease (19.5%), and rheumatologic/inflammatory conditions (16.7%). Among the fully vaccinated IC and non-IC cohorts, a total of 978 breakthrough infections were observed during the study period; 124 (12.7%) resulted in hospitalization and 2 (0.2%) were inpatient deaths. IC individuals accounted for 38.2% (N=374) of all breakthrough infections, 59.7% (N=74) of all hospitalizations, and 100% (N=2) of inpatient deaths. The proportion with breakthrough infections was 3 times higher in the IC cohort compared to the non-IC cohort (N=374 [0.18%] vs. N=604 [0.06%]; unadjusted incidence rates were 0.89 and 0.34 per 100 person-years, respectively. Organ transplant recipients had the highest incidence rate; those with >1 IC condition, antimetabolite usage, primary immunodeficiencies, and hematologic malignancies also had higher incidence rates compared to the overall IC cohort. Incidence rates in older (≥65 years old) IC individuals were generally higher versus younger IC individuals (<65). Limitations: This retrospective analysis relied on coding accuracy and had limited capture of COVID-19 vaccine receipt. Conclusions: COVID-19 vaccine breakthrough infections are rare but are more common and severe in IC individuals. The findings from this large study support the FDA authorization and CDC recommendations to offer a 3rd vaccine dose to increase protection among IC individuals. [ABSTRACT FROM AUTHOR]

Published
2021
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90. Relationship Between Lenalidomide Dose Modification and Time to Next Treatment in Newly Diagnosed Multiple Myeloma Patients

Author

Saad Usmani, Binder, Gary, Milentijevic, Dejan, Hu, X. Henry, Nagarwala, Yasir, Corvino, Frank A., Arikian, Steven R., Surinach, Andy, and Harwin, William N.

Subjects
Immunology, Cell Biology, Hematology, Biochemistry
Abstract

Introduction: Multiple clinical studies in patients (pts) with newly diagnosed multiple myeloma (NDMM) have shown benefits from continuous lenalidomide (LEN) treatment (Tx), including extended progression-free survival (PFS), time to progression (TTP), and overall survival (OS) (Facon, Blood 2013; Palumbo, NEJM 2012). Dose modifications are commonly utilized by physicians as part of continuous Tx plans to sustain control of disease while managing toxicities. Previous analysis has shown that dose modification of LEN was associated with longer duration of therapy (DOT) relative to non-dose modification, in the real-world setting (Lang, Blood 2013). This study aimed to evaluate whether LEN dose modification is associated with a longer TTP in NDMM pts, utilizing time to next therapy (TTNT) as a proxy measure available from claims data. Methods: A retrospective study was conducted using a large US medical and pharmacy claims database, covering > 25 million lives annually. NDMM pts were identified with at least 2 outpatient claims or 1 inpatient medical claim associated with a diagnosis of MM (ICD-9-CM code 203.0X), with the first such claim used to define the index date. A minimum of 12 months' pre-index enrollment and 6 months' post-index continuous enrollment between Jan 1 2006 and December 31 2012 was required. The analysis focused on NDMM pts treated with LEN who did not have claims for stem cell transplantation (SCT), to avoid DOT limitations imposed by fixed-length induction Tx. Median DOT and TTNT were compared in NDMM pts with and without LEN dose modifications (dose increase or decrease). Charlson comorbidity scores were determined to compare baseline measures between the groups. Results: Of the 1,360 pts who met the inclusion criteria, 470 (35%) had LEN dose modifications, including 154 pts with at least one dose increase and 421 pts with at least one dose decrease. The majority of pts had an initial dose of 25mg. The median DOT was 447 days in pts with LEN dose modification and 182 days in those pts with no dose modification (p < 0.001). The median DOT in pts with dose modification was consistent regardless of whether they experienced a dose increase or decrease, with no significant difference. The median TTNT in pts with LEN dose modification was 3.5 yrs compared to 2.0 yrs in pts without dose modification (p < 0.001; Figure 1). Charlson comorbidity scores were similar in pts with and without LEN dose modification. Figure 1 Figure 1. Conclusions: For non-SCT NDMM patients treated with LEN, dose modifications during their treatment were associated with a doubling of the median therapy duration and a 71% longer median TNTT, compared to pts without LEN dose modification. The DOT and TTNT in pts with dose modification were similar to median values reported for the LEN continuous Tx arm of the FIRST clinical trial (Facon, Blood 2013). This analysis suggests that LEN dose modification in the Tx of NDMM may be an effective tool in the real-world setting for pts to achieve sustained disease Tx and the associated prolonged time to progression, based on the proxy measure of TTNT. Disclosures Usmani: Celgene Corporation: Consultancy, Honoraria, Research Funding; Millennium: Consultancy, Honoraria; Onyx: Consultancy, Honoraria, Research Funding; Sanofi: Consultancy; Array BioPharma: Research Funding; Janssen: Research Funding; Pharmacyclics: Research Funding. Off Label Use: Lenalidomide in newly diagnosed multiple myeloma patients. Binder:Celgene Corporation: Employment, Equity Ownership. Milentijevic:Celgene Corporation: Consultancy. Hu:Celgene: Employment. Nagarwala:Celgene Corporation: Employment. Corvino:Genesis Research LLC: Consultancy. Arikian:Genesis Research: Consultancy. Surinach:Genesis Research LLC: Consultancy. Harwin:Celgene Corporation: Honoraria.

Published
2014

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