Purpose Advanced breast cancer is a heterogeneous disease with several well-defined subtypes, among which, hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2–) is most prevalent. Determination of HR and HER2 status influences prognosis and, thus, disease management. Although literature on these prognostic factors exist, especially in the early breast cancer setting, it remains unclear to what extent these factors can guide clinical decision-making in the advanced disease setting. Therefore, we sought to identify the strength and consistency of evidence for prognostic factors in patients with HR+/HER2– advanced breast cancer. Methods A systematic literature review (SLR) of the major electronic databases was conducted in November 2018 for primary research studies published since 2010. Endpoints of interest were tumor response, progression-free survival (PFS), overall survival (OS), and breast cancer-specific survival (BCSS). Results Seventy-nine studies were included wherein all patients were diagnosed with advanced breast cancer and ≥50% of the population were HR+/HER2–. OS was the most commonly assessed endpoint (n=67) followed by PFS (n=33), BCSS (n=5) and tumor response (n=3). The prognostic factors with strongest evidence of association with worse OS were negative progesterone receptor status, higher tumor grade, higher circulating tumor cell (CTC) count and higher Ki67 level, number of metastatic sites (eg multiple vs single) and sites of metastases (eg presence of liver metastases vs absence), shorter time to recurrence or progression to advanced breast cancer, poor performance status, prior therapy attributes in the early or metastatic setting (type of therapy, treatment line, response of prior therapy), and race (black vs white). The prognostic factors that had strongest evidence of association with PFS included CTC count, number and sites of metastases, and absence of prior therapy or higher lines of therapy in the early or metastatic setting. The directionality of association was consistent for all prognostic factors except between lymph node and OS, and de novo metastatic breast cancer and PFS. Conclusion Multiple disease, treatment, and patient-related prognostic factors impact survival, particularly OS, in patients with HR+/HER2– advanced breast cancer. Treatment outcomes can vary considerably due to these factors. Understanding poorer prognostic factors for patients can result in improved clinical decision-making.

Objective To describe adherence, persistence, discontinuation, restarting, switching, dosing, and health care costs among patients with psoriatic arthritis (PsA) treated with ixekizumab (IXE). Methods MarketScan administrative claims databases were used to select adults (≥18 years) initiating IXE between January 1, 2016, and June 30, 2019, for this retrospective study (earliest IXE claim = index). Eligible patients had one or more PsA diagnoses during the 12 months preceding the index and had 12 months of follow‐up time after the index. Adherence (measured by proportion of days covered [PDC]) persistence (<60‐day gap), discontinuation (≥90‐day gap), switching, and dosing patterns were reported. Health care costs were reported per patient per month (PPPM) during follow‐up and were assessed after adjusting PsA treatment costs for discount rates reported by the Institute for Clinical and Economic Review (ICER). Results A total of 496 patients met the selection criteria (mean age, 51.1 years; 50.4% female). Over the 12‐month follow‐up, 52.8% remained persistent, 38.7% discontinued, 13.5% had no other treatment, 4.6% restarted, and 20.6% switched to a new biologic/traditional synthetic disease‐modifying antirheumatic drug. 70.6%of patients were identified as highly adherent (i.e. PDC > 0.80)to IXE prior to discontinuation. Dose values were consistent with prescribing information for patients with and without comorbid psoriasis. Although IXE costs ($5233 [SD = $2497]) accounted for 85.6% of PsA‐related health care costs, only 3.5% of IXE costs were patient out‐of‐pocket expenses. Adjusting for the ICER discounts decreased all‐cause and PsA‐related costs by $2509 PPPM. Conclusion Results from this real‐world analysis suggest that treatment patterns and costs among patients with PsA initiating IXE are consistent with prior literature for other biologics.

Background Advanced breast cancer (ABC) is a heterogeneous disease with several well-defined subtypes, among which, HR+, HER2- is the most prevalent. While clinical factors and genomic signatures have clear prognostic significance in the early breast cancer setting, this is less clear in the advanced disease setting. The aim of this systematic literature review was to identify the strength and consistency of evidence for prognostic factors in HR+, HER2-, ABC patients. Methods A comprehensive search was conducted of the major electronic databases (MEDLINE, EMBASE and Cochrane Controlled Register of Trials) in November 2018 for primary research clinical studies published since 2010 in HR+, HER2- ABC patients. Endpoints of interest were tumor response, progression-free survival (PFS), overall survival (OS), and breast-cancer specific survival (BCSS). Studies were screened by two independent reviewers for eligibility. Results Seventy-nine studies (72 full-text publications and 7 conference abstracts) were included wherein all patients were diagnosed with ABC and ≥50% of the population were HR+, HER2-. The majority were observational studies (n=71). Among the four endpoints, OS was the most commonly (n=67) assessed. Negative progesterone receptor (PR) status, higher tumor grade, higher CTC count, higher Ki67 level, number of metastatic sites (multiple vs. single) and sites of metastases (e.g., presence of liver metastases vs. absence), patients with relapsed BC compared with de novo metastatic BC, shorter time to recurrence or progression to ABC, poor performance status, prior therapy attributes in the early or metastatic setting (type of therapy, treatment line, response of prior therapy), and race (black vs. white) were consistently (&gt;50% of studies found significant association) associated with worse OS; the relationship was inconsistent for tumor size, histological type (lobular vs. ductal), lymph node involvement and age. Directionality of relationship was consistent for all factors except lymph node involvement. Strength of association with OS was moderate [hazard ratio (HR) between 1.5-2.9] for PR status, tumor grade, CTC count, and Ki67 level, number and site (e.g., bone, liver, lung) of metastases, time to recurrence or progression to ABC, performance status, prior therapy attributes, and weak (HR&lt;1.5) for de novo metastatic BC and race. Heterogeneity was observed across the studies in the composition of the patient population, definition and categorization for a few prognostic factors (e.g., number and sites of metastases, prior therapy, age). Similar results from fewer number of studies were observed for tumor response, PFS, BCSS. Conclusions Based on consistency and strength of the data PR status, tumor grade, CTC count, number and sites metastases, time to recurrence or progression to ABC, performance status, and prior therapy attributes were identified as the prognostic factors that had the strongest evidence. The application of these factors may be able to inform future research and clinical decision-making to improve outcomes in patients with HR+/HER2- ABC. Association between prognostic factors and overall survivalPrognostic factor Total no. of studies that assessed associationTotal no. of studies reporting significant association No. studies with significant multivariate analysis PR status1085Tumor Grade211411CTC count1097Ki67542No. of metastatic sites262313Site of metastasis332117De novo metastatic BC543Tumor size1255Lymph node1141Histological type 511Time to disease recurrence or progression18138Performance status14118Prior therapy352720Age371713Race1376 Citation Format: Gebra C Carter, Keri Stenger, Maitreyee Mohanty, Amy L Chong, Pradeep Basa, Shivaprasad Singuru, Sheena Singh, Vanita Tongbram, Sherko Kümmel, Valentina Guarneri, Sara M Tolaney. Prognostic factors associated with clinical outcomes in HR+, HER2- advanced breast cancer: Systematic literature review [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P3-08-40.

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