Final follow-up (f/u) results from RADIANT: A randomized double blind phase 3 trial of adjuvant erlotinib (E) versus placebo (P) following complete tumor resection in patients (pts) with stage IB–IIIA EGFR positive (IHC/FISH) non-small cell lung cancer (NSCLC).

Authors

null

Mary E.R. O'Brien

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

Organizations

Royal Marsden Hospital, London, United Kingdom, UC Davis Comprehensive Cancer Center, Sacramento, CA, Weill Medcl Coll of Cornell Univ, New York, NY, University Hospital - University Duisburg-Essen, Essen, Germany, Sarah Cannon Research Institute, Nashville, TN, Medical Oncology, S. Maria della Misericordia Hospital, Perugia, Italy, Division of Thoracic Oncology, Department of Chest Medicine, Taipei Veterans General Hospital & Department of Medicine, National Yang-Ming University, Taipei, Taiwan, Yonsei Cancer Center, Seoul, South Korea, Division of Hematology and Oncology, Department of Internal Medicine, Gachon University Gil Medical Center, Incheon, South Korea, University of Chicago Med Ctr, Chicago, IL, Division of Thoracic Surgery, Princess Margaret Cancer Center, University Health Network, Toronto, ON, Canada, Department of Thoracic Oncology, St. Petersburg State Medical University, St. Petersburg, Russia, Specjalistyczny Szpital im. Alfreda Sokolowskiego, Szczecin, Poland, Astellas Pharma Global Development, Northbrook, IL, Astellas Pharma Global Dev Inc, Northbrook, IL, Novella Clinical Rsrch, Boulder, CO, Princess Margaret Cancer Centre, Toronto, ON, Canada

Research Funding

Pharmaceutical/Biotech Company

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)
DFSMedian5556.20.94 (0.78–1.144)0.5620
# Events (%)280 (44.9)168 (48.0)
OSMedianNRNR1.12 (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)
DFSMedian47.828.50.75 (0.482–1.158)0.1906
# Events (%)49 (48.0)34 (57.6)
OSMedianNRNR1.19 (0.609–2.310)0.6142
# Events (%)26 (25.5)13 (22.0)

HR: Hazard Ratio; NR: Not Reached.

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Abstract Details

Meeting

2015 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers

Track

Lung Cancer

Sub Track

Local-Regional Non–Small Cell Lung Cancer

Clinical Trial Registration Number

NCT00373425

Citation

J Clin Oncol 33, 2015 (suppl; abstr 7540)

DOI

10.1200/jco.2015.33.15_suppl.7540

Abstract #

7540

Poster Bd #

287

Abstract Disclosures