Clinical and Economic Burden Associated With Acute Graft-Versus-Host Disease After Allogeneic Hematopoietic Cell Transplantation in Germany.

BACKGROUND: Acute graft-vs-host disease (aGVHD) is a serious complication of allogeneic hematopoietic stem cell transplantation (allo-HSCT), yet there are limited data on the clinical and economic burden of aGVHD in Germany. This real-world study aimed to evaluate clinical and economic outcomes among patients in Germany with or without aGVHD after allo-HSCT. METHODS: This retrospective cohort study used administrative claims extracted from the German statutory health insurance database. Eligible adult patients underwent allo-HSCT between 1 January 2009 and 31 December 2017 for any hematological malignancy. Clinical (severe infections and mortality) and economic (health care resource use [HCRU] and costs) outcomes were compared in "aGVHD" patients and "no GVHD" patients. Propensity score matching (1:1) was used to balance covariates between the aGVHD and no GVHD groups. RESULTS: After propensity score matching, 95 aGVHD and 95 no GVHD patients were included in the analysis. The aGVHD group had significantly higher odds of mortality than the no GVHD group (odds ratio [OR] 2.2; 95% CI 1.2-4.0). Odds of severe infection were similar between the 2 groups (OR 1.7; 95% CI 0.9-3.3). Patients in the aGVHD group had significantly more overnight hospitalizations per patient-year (mean [SD]: 3.7 [3.0] and 2.7 [2.5], P = .029), and total direct costs were 1.6-fold higher than those in the no GVHD group. CONCLUSION: Among patients who underwent allo-HSCT, aGVHD was associated with significantly higher mortality, HCRU, and costs, highlighting the need for effective prophylaxis and treatment options to prevent or reduce the incidence of aGVHD.

Treatment patterns of patients with HR+/HER2- metastatic breast cancer receiving CDK4/6 inhibitor-based regimens: a cohort study in the French nationwide healthcare database.

PURPOSE: To assess real-world treatment patterns in patients diagnosed with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) metastatic breast cancer (mBC) who received cyclin-dependent kinase 4/6 (CDK4/6) inhibitors in combination with an aromatase inhibitor (AI) or fulvestrant at first line. METHODS: Patient characteristics, treatment history, and outcomes data were extracted from the French 'Système National des Données de Santé' (SNDS) database for patients diagnosed with HR+/HER2- mBC between January 2014 and June 2019 and who received combination therapy with a CDK4/6 inhibitor and endocrine therapy. Kaplan-Meier methodology was used to assess time to next treatment (TTNT) and time to treatment discontinuation (TTTD). RESULTS: The cohort comprised 6061 patients including 4032 patients who received CDK4/6 inhibitors + AIs and 2029 patients who received CDK4/6 inhibitors + fulvestrant. Median follow-up was 13.5 months (IQR 9.5-18.1). The median TTTD of first line treatment with CDK4/6 inhibitors + AIs and CDK4/6 inhibitors + fulvestrant was 17.3 months (95% CI 16.8-17.9) and 9.7 months (95% CI 9.0-10.2), respectively. Chemotherapy was the most common second line therapy. Median TTTD of subsequent treatment lines was progressively shorter following first line treatment with CDK4/6 inhibitors + AIs (2nd line: 4.6 months (95% CI 4.4-4.9) and with CDK4/6 inhibitors + fulvestrant (2nd line: 4.7 months (95% CI 4.3-5.1). TTNT was longer than TTTD across lines of therapy. CONCLUSION: This real-world analysis confirms the effectiveness of CDK4/6 inhibitor-based regimens in French patients and highlights the frequent use of chemotherapy as second line therapy.