RT Journal Article
T1 Updated Efficacy Analysis Including Secondary Population Results for OAK: A Randomized Phase III Study of Atezolizumab versus Docetaxel in Patients with Previously Treated Advanced Non-Small Cell Lung Cancer.
A1 Fehrenbacher, Louis
A1 von-Pawel, Joachim
A1 Park, Keunchil
A1 Rittmeyer, Achim
A1 Gandara, David R
A1 Ponce-Aix, Santiago
A1 Han, Ji-Youn
A1 Gadgeel, Shirish M
A1 Hida, Toyoaki
A1 Cortinovis, Diego L
A1 Cobo, Manuel
A1 Kowalski, Dariusz M
A1 De-Marinis, Filippo
A1 Gandhi, Mayank
A1 Danner, Bradford
A1 Matheny, Christina
A1 Kowanetz, Marcin
A1 He, Pei
A1 Felizzi, Federico
A1 Patel, Hina
A1 Sandler, Alan
A1 Ballinger, Marcus
A1 Barlesi, Fabrice
K1 Atezolizumab
K1 Cancer immunotherapy
K1 Checkpoint inhibitor
K1 Non–small cell lung cancer
K1 PD-L1
AB The efficacy and safety of atezolizumab versus the efficacy and safety of docetaxel as second- or third-line treatment in patients with advanced NSCLC in the primary (n = 850) and secondary (n = 1225) efficacy populations of the randomized phase III OAK study (respectively referred to as the intention-to-treat [ITT] 850 [ITT850] and ITT1225) at an updated data cutoff were assessed. Patients received atezolizumab, 1200 mg, or docetaxel, 75 mg/m2, intravenously every 3 weeks until loss of clinical benefit or disease progression, respectively. The primary end point was overall survival (OS) in the ITT population and programmed death-ligand 1-expressing subgroup. A sensitivity analysis was conducted to evaluate the impact of subsequent immunotherapy use in the docetaxel arm on the observed survival benefit with atezolizumab. Atezolizumab demonstrated an OS benefit versus docetaxel in the updated ITT850 (hazard ratio [HR] = 0.75, 95% confidence interval: 0.64-0.89, p = 0.0006) and the ITT1225 (HR = 0.80, 95% confidence interval: 0.70-0.92, p = 0.0012) after minimum follow-up times of 26 and 21 months, respectively. Improved survival with atezolizumab was observed across programmed death-ligand 1 and histological subgroups. In the immunotherapy sensitivity analysis, the relative OS benefit with atezolizumab was slightly greater in the ITT850 (HR = 0.69) and ITT1225 (HR = 0.74) than the conventional OS estimate. Fewer patients receiving atezolizumab experienced grade 3 or 4 treatment-related adverse events (14.9%) than did patients receiving docetaxel (42.4%); no grade 5 adverse events related to atezolizumab were observed. The results of the updated ITT850 and initial ITT1225 analyses were consistent with those of the primary efficacy analysis demonstrating survival benefit with atezolizumab versus with docetaxel. Atezolizumab continued to demonstrate a favorable safety profile after longer treatment exposure and follow-up.
PB Elsevier
YR 2018
FD 2018-05-17
LK http://hdl.handle.net/10668/12488
UL http://hdl.handle.net/10668/12488
LA en
NO Fehrenbacher L, von Pawel J, Park K, Rittmeyer A, Gandara DR, Ponce Aix S, et al. Updated Efficacy Analysis Including Secondary Population Results for OAK: A Randomized Phase III Study of Atezolizumab versus Docetaxel in Patients with Previously Treated Advanced Non-Small Cell Lung Cancer. J Thorac Oncol. 2018 Aug;13(8):1156-1170. doi: 10.1016/j.jtho.2018.04.039. Epub 2018 May 17. Erratum in: J Thorac Oncol. 2018 Nov;13(11):1800
DS RISalud
RD Apr 8, 2025