Princess Margaret Cancer Centre, Toronto, ON, Canada
Frances A. Shepherd , Wilfried Ernst Erich Eberhardt , Nasser K. Altorki , Mary E.R. O'Brien , Joe Wang , Jun Wu , Stan Gill , Kenneth Iwata , Frank C Richardson , Julie D. Horan , Margaret A. Foley , Karen Kelly
Background: Data on EGFRm in early stage NSCLC are limited. RADIANT was a prospectively randomized Phase 3 trial of adjuvant erlotinib (E) v placebo (P) in 973 patients (pts) with completely resected Stage IB–IIIA NSCLC that was EGFR +ve by IHC or FISH (ASCO14 #7501; ESMO14 #1178PD). Methods: EGFRm in exons 18–21 was determined by WAVE HS and confirmed by Sanger sequencing. Two EGFRm groups were defined: Common refers to exon del19 or L858R irrespective of the presence of another EGFRm; Rare Only refers to EGFRm without del19 or L858R. Exploratory analysis of disease-free survival (DFS) was performed by subgroup (June 11, 2014 data cutoff). Results: 921 pts had EGFRm status determined; 198 pts (21.5%) had EGFRm (161 Common, 37 Rare Only). There was no sex difference between the groups, but pts with Rare Only EGFRm were less likely to be Asian (32.4% v 47.2%) or non-smokers (48.6% v 62.7%). With a median follow-up of 5 years, updated DFS by mutation type is shown below. The DFS HR was lower in the Common group (HR [E/P] 0.75, CI 0.48, 1.16) than in the Rare Only group (HR 1.19, CI 0.44, 3.22). Conclusions: The effect of E on DFS in EGFRm subgroups remains inconclusive. Clinical trial information: NCT00373425
EGFRm (n) Subgroup | Arm | n | DFS | |||||||
---|---|---|---|---|---|---|---|---|---|---|
Events | Median (m) | HR (E/P), 95% CI | ||||||||
Common* (161): | Del 19/L858R | E P | 102 59 | 49 34 | 47.8 28.5 | 0.75 (0.48–1.16) | ||||
Del 19 | E P | 56 33 | 29 19 | 46.4 26.4 | 0.82 (0.46–1.46) | |||||
L858R | E | 46 | 20 | 54.1 | 0.68 (0.35–1.34) | |||||
P | 26 | 15 | 29.3 | |||||||
Rare Only (37): | All | E P | 19 18 | 7 9 | NR 46.5 | 1.19 (0.44–3.22) | ||||
Exon 20 (21) | E P | 11 10 | 4 6 | NR 40.7 | 0.96 (0.27–3.43) | |||||
Rare Only (n)** | Detail | Arm | n | DFS Min, Max | ||||||
Exon 18 G719X (8) | G719A, G719A+E709A, G719A+E709K | E | 5 | 0.0+, 58.0+ | ||||||
G719A | P | 3 | 39.7+, 47.6+ | |||||||
Other Exon 18 (4) | L692, G719A+E709A, G719A+E709K | E | 3 | 0.0+, 28.2 | ||||||
V689L | P | 1 | 59.7+ | |||||||
Exon 19 (2) | R748T | E | 1 | 54.4+ | ||||||
L747S | P | 1 | 57.5+ | |||||||
Exon 20 Ins_dup (17) | A767_S768Ins, H773_V774ins, V774_C775ins, A767_V769dup, N771_H773dup, P772_H773dup | E | 10 | 0.0+, 54.5+ | ||||||
N771_H773dup, P772_H773ins, A767_V769dup, A763_Y764ins, H773dup | P | 7 | 16.2, 59.7+ | |||||||
Exon 20 other (4) | S768I | E | 1 | 58.0+ | ||||||
R776H, S768I+V774M, R776H | P | 3 | 39.7+, 64.0+ | |||||||
Exon 21 (8) | L861Q, E868K | E | 2 | 1.9, 42.1+ | ||||||
D830N, L861Q, L844P, V845E | P | 6 | 1.8, 58.3+ | |||||||
NR = Not Reached. *Includes 12 pts with another EGFRm in addition to del19 or L858R. + Indicates censoring; **Pts may have > 1 rare EGFRm.
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
2024 ASCO Annual Meeting
First Author: Helena Alexandra Yu
2024 ASCO Annual Meeting
First Author: Jonathan N. Priantti
2024 ASCO Annual Meeting
First Author: Rossana Ruiz
2024 ASCO Annual Meeting
First Author: Zane Yang