![]() Patients were not permitted to have received pre- or postoperative radiation therapy or EGFR TKI. Complete surgical resection with negative margins for tumor was required, and baseline brain imaging with either MRI or CT was performed prior to randomization. Patients had confirmed EGFR Ex19del or L858R mutations the presence of other coexisting EGFR mutations was permitted. The approval of osimertinib as adjuvant therapy was based on the ADAURA study, a double-blind, randomized, placebo-controlled trial in patients with primarily nonsquamous NSCLC classified postoperatively as stage IB to IIIA according to the American Joint Committee on Cancer (AJCC) 7th edition TNM staging system. 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). Orbis is cited by a total of 61 articles during the last 3 years (Preceding 2022).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. It is used for the recognition of journals, newspapers, periodicals, and magazines in all kind of forms, be it print-media or electronic. The best quartile for this journal is Q4.Īn International Standard Serial Number (ISSN) is a unique code of 8 digits. SJR acts as an alternative to the Journal Impact Factor (or an average number of citations received in last 2 years). It considers the number of citations received by a journal and the importance of the journals from where these citations come. SCImago Journal Rank is an indicator, which measures the scientific influence of journals. The overall rank of Orbis is 22435.Īccording to SCImago Journal Rank (SJR), this journal is ranked 0.143. Orbis is a journal covering the technologies/fields/categories related to Safety Research (Q4) Safety, Risk, Reliability and Quality (Q4) Sociology and Political Science (Q4).
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |