Royal Marsden Hospital, London, United Kingdom
Mary E.R. O'Brien , Karen Kelly , Nasser K. Altorki , Wilfried Ernst Erich Eberhardt , David R. Spigel , Lucio Crino , Chun-Ming Tsai , Joo-Hang Kim , Eun Kyung Cho , Philip C. Hoffman , Shaf Keshavjee , Sergey Orlov , Piotr Serwatowski , Joe Wang , Margaret A. Foley , Julie D. Horan , Frances A. Shepherd
Background: Adjuvant chemotherapy for NSCLC has reached a plateau. The use of the tyrosine kinase inhibitor (TKI), E, was explored in the adjuvant setting given success in advanced setting.We report final f/u from RADIANT. Methods: Completely resected IB–IIIA NSCLC pts were randomized 2:1 to receive E 150 mg daily or P for 2 years. The primary endpoint was disease free survival (DFS) in the full analysis set (FAS). Secondary endpoints included overall survival (OS) in the FAS and DFS and OS in EGFR mutation (M+) subset (del19/L858R). 973 pts were randomized and the planned final analysis was performed after 410 DFS events (April 2013 data cutoff, ASCO14 #7501). A subsequent exploratory analysis occurred after final f/u (June 2014 cutoff). Results: The median f/u is 59.6m (95% CI 56.7–61.2). There was no statistically significant difference in DFS or OS overall or in the EGFR M+ group. The OS data remain immature with 33.5% deaths in the E arm and 31.4% in the P arm. The most common site of relapse (>15% pts) overall and in EGFR M+ were lung and brain in E treated pts and lung, bone and brain in P pts. Among the 13 pts in the EGFRM+ subgroup with brain as site of relapse, 11 of these patients relapsed after E cessation. There were no new safety concerns. Conclusions: Overall adjuvant E did not prolong DFS; a trend for E benefit previously observed (ASCO14 #7513) in EGFR M+ subgroup is no longer apparent. EGFR mutation status was not a stratification factor in this trial and was not a prognostic factor (ESMO14 #1177PD). Further results from ongoing trials are awaited to determine the role of TKI in EGFR M+ early stage lung cancer. Clinical trial information: NCT00373425
Full Analysis Set | |||||
---|---|---|---|---|---|
HR (95% CI) | P-Value | ||||
E (N=623) | P (N=350) | ||||
DFS | Median | 55 | 56.2 | 0.94 (0.78–1.144) | 0.5620 |
# Events (%) | 280 (44.9) | 168 (48.0) | |||
OS | Median | NR | NR | 1.12 (0.890–1.413) | 0.3306 |
# Events (%) | 209 (33.5) | 110 (31.4) | |||
EGFR M+ Subset | |||||
HR (95% CI) | P-Value | ||||
E (N=102) | P (N=59) | ||||
DFS | Median | 47.8 | 28.5 | 0.75 (0.482–1.158) | 0.1906 |
# Events (%) | 49 (48.0) | 34 (57.6) | |||
OS | Median | NR | NR | 1.19 (0.609–2.310) | 0.6142 |
# Events (%) | 26 (25.5) | 13 (22.0) |
HR: Hazard Ratio; NR: Not Reached.
Disclaimer
This material on this page is ©2024 American Society of Clinical Oncology, all rights reserved. Licensing available upon request. For more information, please contact licensing@asco.org
Abstract Disclosures
2023 ASCO Annual Meeting
First Author: Satoshi Ikeda
2023 ASCO Annual Meeting
First Author: Amin Nassar
2023 ASCO Annual Meeting
First Author: Heather A. Wakelee
2023 ASCO Annual Meeting
First Author: Yuming Zhu