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1.
J Clin Oncol ; 42(3): 324-335, 2024 Jan 20.
Article in English | MEDLINE | ID: mdl-37976444

ABSTRACT

PURPOSE: The phase III SKYSCRAPER-02 study determined whether the benefits of atezolizumab plus carboplatin and etoposide (CE) could be enhanced by the addition of tiragolumab in untreated extensive-stage small-cell lung cancer (ES-SCLC). We report final progression-free survival (PFS) and overall survival (OS) analyses. METHODS: Patients received tiragolumab 600 mg/placebo, plus atezolizumab 1,200 mg and CE (four cycles), then maintenance tiragolumab/placebo plus atezolizumab. Primary end points were investigator-assessed PFS and OS in patients without history/presence of brain metastases (primary analysis set [PAS]). Additional end points included PFS and OS in all patients regardless of brain metastases status (full analysis set [FAS]), response, and safety. RESULTS: Four hundred ninety patients were randomly assigned (FAS): 243 to tiragolumab arm and 247 to control arm. At the cutoff date (February 6, 2022; median duration of follow-up, 14.3 months [PAS] and 13.9 months [FAS]), final analysis of PFS in the PAS (n = 397) did not reach statistical significance (stratified hazard ratio [HR], 1.11; P = .3504; median, 5.4 months tiragolumab v 5.6 months control). At the cutoff date (September 6, 2022; median duration of follow-up, 21.2 months [FAS]), median OS in the PAS at final OS analysis was 13.1 months in both arms (stratified HR, 1.14; P = .2859). Median PFS and OS in the FAS were consistent with the PAS. The proportion of patients with immune-mediated adverse events (AEs) in the tiragolumab and control arms was 54.4% and 49.2%, respectively (grade 3/4: 7.9% and 7.7%). AEs leading to treatment withdrawal occurred in 8.4% and 9.3% of tiragolumab- and control-treated patients, respectively. CONCLUSION: Tiragolumab did not provide additional benefit over atezolizumab and CE in untreated ES-SCLC. The combination was well tolerated with no new safety signals.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols , Lung Neoplasms , Small Cell Lung Carcinoma , Humans , Antibodies, Monoclonal/therapeutic use , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Brain Neoplasms/drug therapy , Etoposide , Lung Neoplasms/drug therapy , Lung Neoplasms/pathology , Small Cell Lung Carcinoma/drug therapy
2.
Consult Pharm ; 32(5): 281-284, 2017 May 01.
Article in English | MEDLINE | ID: mdl-28483008

ABSTRACT

Adverse drug events (ADE) are a leading cause of mortality in the United States. Recent studies have demonstrated a high level of complex medication regimens in institutionalized residents. Evidence of the relationship between medication regimen complexity (MRC) and ADE-related rehospitalizations or emergency department (ED) visits is evolving. Therefore, there is a demand for better characterization and study of MRC as an objective identifier to quickly screen and prioritize high-risk patients for follow-up medication management therapy. This manuscript will serve as a brief summary review of the current findings regarding the relationship between MRC and hospital readmission and ED usage and provide strategies for pharmacists to more efficiently evaluate complex medication regimens and optimize therapies.


Subject(s)
Drug-Related Side Effects and Adverse Reactions/etiology , Emergency Service, Hospital , Hospitalization , Long-Term Care , Medication Therapy Management , Nursing Homes , Pharmacists , Polypharmacy , Drug-Related Side Effects and Adverse Reactions/diagnosis , Drug-Related Side Effects and Adverse Reactions/prevention & control , Humans , Patient Readmission , Professional Role , Time Factors
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