![]() ![]() ![]() In a pooled analysis by the Lung Adjuvant Cisplatin Evaluation collaborative group, the HR for overall survival (OS) in patients with early-stage NSCLC who were treated with adjuvant chemotherapy versus no chemotherapy after resection was 0.89 (95% CI, 0.82–0.96), corresponding to a 5-year absolute benefit of 5.4% from chemotherapy the HR for disease-free survival (DFS) was 0.84 (95% CI, 0.78–0.91 ref. ![]() However, disease recurrence or death following surgery and adjuvant chemotherapy is high across all disease stages, with 5-year survival rates ranging from 39% for stage IIIA to 67% for stage IB disease ( 5). Although surgery is the primary treatment for patients with early-stage NSCLC, adjuvant platinum-based chemotherapy is recommended for patients with resected stage II to IIIA disease and a select group of patients with stage IB disease with high-risk features. 3) and only 30% of patients present with resectable disease at the time of diagnosis ( 4). In the United States, approximately 80% to 85% of lung cancer is non–small cell lung cancer (NSCLC ref. This is the first targeted therapy adjuvant approval for NSCLC and has practice-changing implications.ĭespite reports of decreasing mortality with advances in treatment, lung cancer remains the leading cause of cancer deaths worldwide ( 1, 2). This application was reviewed under FDA's Project Orbis, in collaboration with Australia Therapeutic Goods Administration, Brazil ANVISA, Health Canada, Singapore Health Sciences Authority, Switzerland Swissmedic, and the United Kingdom Medicines and Healthcare products Regulatory Agency. Overall survival data were not mature at the time of the approval. Median DFS was not reached for the osimertinib arm compared with 27.5 months (95% CI, 22.0–35.0) for patients receiving placebo. Disease-free survival (DFS) in the overall population (stage IB–IIIA) was improved for patients who received osimertinib, with an HR of 0.20 95% confidence interval (CI), 0.15–0.27 P < 0.0001. The approval was based on the ADAURA study, in which 682 patients with NSCLC were randomized to receive osimertinib ( n = 339) or placebo ( n = 343). On December 18, 2020, the FDA approved osimertinib as adjuvant therapy in patients with non–small cell lung cancer (NSCLC) whose tumors have EGFR exon 19 deletions or exon 21 (L858R) mutations, as detected by an FDA-approved test. ![]()
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |