Article Figures & Data
Figures
- Figure 1.
Trials evaluated
- Figure 2.
Time to progression on initial TKI in patients with and without flare after TKI discontinuation.
Tables
- Table 1.
Patient characteristics
Characteristic Male sex, n (%) 13 (21) Age at diagnosis in years, median (range) 58 (26–78) Smoking status Former/current 12 (20) Never (<100 cigarettes lifetime) 49 (80) EGFR mutation, n (%) Exon 19 deletions 41 (67) Exon 18 E709A and G719A 1 (2) Exon 21 L858R 19 (31) Time on gefitinib or erlotinib (mo) Median (range) 19 (7–78) Age at enrollment in years, median (range) 61 (27–80) Karnofsky performance status at enrollment (%) 90% 13 (21) 80% 37 (61) 70% 11 (18) Lines of therapy before gefitinib/erlotinib (n%) 0 37 (61) 1 20 (32) 2 4 (7) Lines of therapy after acquired resistance 0 41 (67) 1 12 (20) 2+ 8 (13) First-line gefitinib/erlotinib, n (%) Single agent 29 (48) With chemotherapy 8 (13) Maintenance after chemo 5 (9) Gefitinib/erlotinib/both, n (%) Erlotinib 50 (82) Gefitinib 6 (10) Gefitinib followed by erlotinib 5 (8) Acquired resistance to trial enrollment (mo) Median (range) 6 (0–48) - Table 2.
Disease characteristics and course of patients with disease flare after discontinuation of TKI
Age Sex EGFR mutation T790M Sites of disease Days off TKI Description of flare 47 Female Never smoker Exon 19 Deletion No Pleura, brain, and liver 21 d Progressive liver metastases with liver failure and death 64 Female Never smoker Exon 19 Deletion No Pleura 21 d Dyspnea 53 Female Never smoker Exon 19 Deletion Unknown Pleura, brain, bone 14 d CNS progression 60 Female Never smoker Exon 21 L858R Unknown Pleura, brain, and bone 7 d Hypoxia and bone pain 34 Male Never smoker Exon 19 Deletion No Pleura and brain 11 d Dyspnea 27 Female Never smoker Exon 19 Deletion Unknown Brain, liver, bone, and pericardium 11 d Bone pain 47 Female Never smoker Exon 21 L858R Yes Pleura 7 d New leptomeningeal disease 49 Male Never smoker Exon 19 Deletion Yes Bone and liver 7 d New brain metastases, seizure 61 Female Never smoker Exon 21 L858R No Pleura, brain, liver, and peritoneum 3 d Abdominal pain 45 Female Never smoker Exon 19 Deletion Yes Pleura and bone 8 d New leptomeningeal carcinomatosis, seizure, death 46 Female Former smoker Exon 19 Deletion Yes Pleura, liver, and bone 12 d Epidural progression 62 Female Never smoker Exon 19 Deletion Yes Pleura, bone, and pericardium 8 d Pericardial tamponade, death 42 Female Never smoker Exon 18 E709A and G719A Yes Pleura and bone 8 d Acute pleural effusion requiring drainage 67 Female Former smoker Exon 21 L858R No Pleura and brain 8 d Dyspnea - Table 3.
Characteristics associated with flare following discontinuation of TKI
Clinical characteristic Number % flare P Exon 19 deletion 41 22% 1 Exon 21 L858R 19 21% T790M 33 18% 0.5 No T790M 19 26% First-line TKI alone 29 34% 0.06 First-line chemo 32 13% TKI only 20 30% 0.5 Chemo 41 20% Symptoms of disease progression 20 40% 0.05 No symptoms 41 15% Karnofsky performance status 70% 11 36% 0.4 Karnofsky performance status 80%–90% 50 22% CNS involvement 14 50% 0.01 No CNS disease 47 15% Bone involvement 31 26% 0.8 No bony disease 30 20% Pleural involvement 36 33% 0.03 No pleural disease 25 8% Male 13 15% 0.7 Female 48 25% Erlotinib 40 33% 0.3 Gefitinib 11 9% Current/former smoker 12 16% 0.7 Never smoker 49 24%
October 2011
Volume 17, Issue 19
Volume 17, Issue 19
Disease Flare after Tyrosine Kinase Inhibitor Discontinuation in Patients with EGFR-Mutant Lung Cancer and Acquired Resistance to Erlotinib or Gefitinib: Implications for Clinical Trial Design
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