美国埃默里大学温希普癌症研究所Suresh S. Ramalingam研究组近日取得一项新成果。他们研究了奥希替尼对未经治疗的EGFR突变的晚期非小细胞肺癌患者总生存期的影响。相关论文2019年11月21日发表在《新英格兰医学杂志》上。
Title: Overall Survival with Osimertinib in Untreated, EGFR-Mutated Advanced NSCLC
Author: Suresh S. Ramalingam, M.D.,, Johan Vansteenkiste, M.D., Ph.D.,, David Planchard, M.D., Ph.D.,, Byoung Chul Cho, M.D., Ph.D.,, Jhanelle E. Gray, M.D.,, Yuichiro Ohe, M.D., Ph.D.,, Caicun Zhou, M.D., Ph.D.,, Thanyanan Reungwetwattana, M.D.,, Ying Cheng, M.D.,, Busyamas Chewaskulyong, M.D.,, Riyaz Shah, M.D.,, Manuel Cobo, M.D.,, Ki Hyeong Lee, M.D., Ph.D.,, Parneet Cheema, M.D.,, Marcello Tiseo, M.D., Ph.D.,, Thomas John, M.D., Ph.D.,, Meng-Chih Lin, M.D.,, Fumio Imamura, M.D., Ph.D.,, Takayasu Kurata, M.D., Ph.D.,, Alexander Todd, M.Sc.,, Rachel Hodge, M.Sc.,, Matilde Saggese, M.D.,, Yuri Rukazenkov, M.D., Ph.D.,, and Jean-Charles Soria, M.D., Ph.D.
Osimertinib is a third-generation, irreversible tyrosine kinase inhibitor of the epidermal growth factor receptor (EGFR-TKI) that selectively inhibits both EGFR-TKI–sensitizing and EGFR T790M resistance mutations. A phase 3 trial compared first-line osimertinib with other EGFR-TKIs in patients with EGFR mutation–positive advanced non–small-cell lung cancer (NSCLC). The trial showed longer progression-free survival with osimertinib than with the comparator EGFR-TKIs (hazard ratio for disease progression or death, 0.46). Data from the final analysis of overall survival have not been reported.
In this trial, we randomly assigned 556 patients with previously untreated advanced NSCLC with an EGFR mutation (exon 19 deletion or L858R allele) in a 1:1 ratio to receive either osimertinib (80 mg once daily) or one of two other EGFR-TKIs (gefitinib at a dose of 250 mg once daily or erlotinib at a dose of 150 mg once daily, with patients receiving these drugs combined in a single comparator group). Overall survival was a secondary end point.
The median overall survival was 38.6 months (95% confidence interval [CI], 34.5 to 41.8) in the osimertinib group and 31.8 months (95% CI, 26.6 to 36.0) in the comparator group (hazard ratio for death, 0.80; 95.05% CI, 0.64 to 1.00; P=0.046). At 3 years, 79 of 279 patients (28%) in the osimertinib group and 26 of 277 (9%) in the comparator group were continuing to receive a trial regimen; the median exposure was 20.7 months and 11.5 months, respectively. Adverse events of grade 3 or higher were reported in 42% of the patients in the osimertinib group and in 47% of those in the comparator group.
Among patients with previously untreated advanced NSCLC with an EGFR mutation, those who received osimertinib had longer overall survival than those who received a comparator EGFR-TKI. The safety profile for osimertinib was similar to that of the comparator EGFR-TKIs, despite a longer duration of exposure in the osimertinib group.
The New England Journal of Medicine：《新英格兰医学杂志》，创刊于1812年。隶属于美国麻省医学协会，最新IF：70.67