Jornal Brasileiro de Pneumologia · 2021 · 13 citations · 11 references
MedicineOncologyPharmacologyCancer Drug Toxicity ManagementCancer PharmacologyChemotherapyAdjuvant ChemotherapyChemotherapy Toxicity ManagementCombination ChemotherapyLung CancerToxicity ManagementAdjuvant Therapy After ResectionChemotherapy Administration SafetyCohort Study InvestigationNon-small Cell Lung Cancer Adjuvant TherapyNon-small Cell Lung Cancer TherapyNon-small Cell Lung Cancer TreatmentRecurrence-free SurvivalSafety Profile Characterization
OBJECTIVE: Adjuvant chemotherapy (AC) improves survival of patients with resected non-small cell lung cancer (NSCLC). However, the cisplatin-vinorelbine regimen has been associated with a significant risk of clinically relevant toxicity. We sought to evaluate the effectiveness, safety, and feasibility of AC for NSCLC patients in a real-world setting. METHODS: This was a single-center, retrospective cohort study of patients with stage I-III NSCLC undergoing surgery with curative intent between 2009 and 2018. AC was administered at the discretion of physicians. The patients were divided into two groups: AC group and no AC (control) group. Study outcomes included overall survival (OS) and recurrence-free survival (RFS), as well as the safety profile and feasibility of the cisplatin-vinorelbine regimen in a real-world setting. RESULTS: The study involved 231 patients, 80 of whom received AC. Of those, 55 patients received the cisplatin-vinorelbine regimen. Survival analyses stratified by tumor stage showed that patients with stage II NSCLC in the AC group had better RFS (p = 0.036) and OS (p = 0.017) than did those in the no AC group. Among patients with stage III NSCLC in the AC group, RFS was better (p < 0.001) and there was a trend toward improved OS (p = 0.060) in comparison with controls. Of those who received the cisplatin-vinorelbine regimen, 29% had grade 3-4 febrile neutropenia, and 9% died of toxicity. CONCLUSIONS: These results support the benefit of AC for NSCLC patients in a real-world setting. However, because the cisplatin-vinorelbine regimen was associated with alarming rates of toxicity, more effective and less toxic alternatives should be investigated.
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Peter Goldstraw, Kari Chansky, John Crowley et al. · Journal of Thoracic Oncology · 2016 · 4.6K citations · Full text
Real-World Evidence — What Is It and What Can It Tell Us?
Rachel E. Sherman, Steven A. Anderson, Gerald J. Dal Pan et al. · New England Journal of Medicine · 2016 · 2.1K citations