Real-World Analysis of Post-Progression Treatment Patterns and Outcomes for EGFR Mutation-Positive Patients Treated with First-Line Osimertinib
Abstract
1. Introduction
2. Materials and Methods
2.1. Patient Selection
Clinical Response and Outcome to Systemic Therapies
2.2. Statistical Methods
3. Results
3.1. Baseline Characteristics and Response to Osimertinib
3.2. Post-Osimertinib Treatment Patterns
- Group A (n = 41): upon progression, 1L osimertinib was continued >90 days.
- Group B (n = 15): upon progression, 1L osimertinib was terminated and 2L systemic therapy was initiated.
- Group C (n = 30): upon progression, 1L osimertinib was terminated, and no further systemic therapy was received.
3.3. CNS Disease and Non-Systemic Modes of Disease Control
3.4. Systemic Therapy Regimens Post-Progression
3.4.1. Osimertinib Therapy > 90 Day Post Progression
3.4.2. Second-Line Systemic Therapy Regimens Post-Progression
3.5. Treatment Strategy and Outcome
4. Discussion
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Characteristic | Entire Cohort (n = 150) | Progressive Disease Noted during 1L Osimertinib Therapy (n = 86) | ||
---|---|---|---|---|
Osimertinib ≥ 90 Days Post-PD Group A (n = 41) | 2L Systemic Therapy at PD Group B (n = 15) | No additional Systemic Therapy at PD Group C (n = 30) | ||
Sex | ||||
Female Male | 93 (62) 57 (38) | 24 (58) 17 (42) | 9 (60) 6 (40) | 22 (73) 8 (27) |
Smoking history | ||||
Ever Never | 66 (44) 84 (56) | 22 (54) 19 (46) | 8 (53) 7 (47) | 18 (60) 12 (40) |
Age (years) | ||||
Median (IQR) | 68.3 (61.3–78.4) | 64.3 (54.9–77.6) | 69.2 (59.4–75.3) | 71.5 (62.4–80.4) |
Asian ancestry | ||||
No Yes | 104 (69) 46 (31) | 25 (61) 16 (49) | 12 (80) 3 (20) | 19 (63) 11 (37) |
EGFR mutation | ||||
Exon 19 deletion Exon 21L858R | 87 (58) 63 (42) | 23 (56) 18 (44) | 5 (33) 10 (67) | 17 (57) 13 (43) |
ECOG at 1L osimertinib initiation | ||||
ECOG < 2 ECOG ≥ 2 | 100 (67) 50 (33) | 34 (83) 7 (17) | 12 (80) 3 (20) | 10 (33) 20 (67) |
TNM 8th Edition M-stage at 1L osimertinib initiation | ||||
M0 M1a M1b M1c | 16 (11) 37 (24) 48 (32) 49 (33) | 5 (13) 10 (24) 16 (39) 10 (24) | 0 (0) 4 (26) 4 (26) 7 (48) | 2 (7) 6 (20) 10 (33) 12 (40) |
≥3 sites of metastatic disease at 1L osimertinib initiation | ||||
No Yes | 112 (81) 29 (19) | 36 (88) 5 (12) | 8 (54) 7 (46) * | 24 (60) 6 (20) |
Metastatic disease in liver, bone or CNS present upon 1L osimertinib initiation | ||||
Liver Bone Central Nervous System | 28 (19) 72 (48) 35 (23) | 7 (17) 19 (46) 8 (20) | 2 (13) 10 (67) 5 (33) | 10 (67) * 15 (100) * 6 (40) |
Concurrent mutations (known at time of osimertinib initiation) | ||||
None BRAF KRAS PIK3CA ERBB2 | 141 (94) 1 (<1) 1 (<1) 7 (5) 0 (0) | 40 (98) 1 (2) 0 (0) 0 (0) 0 (0) | 15 0 (0) 0 (0) 0 (0) 0 (0) | 26 (87) 0 (0) 1 (3) 3 (10) 0 (0) |
Duration of treatment (months) Median (IQR) | 15.6 (6.0–26.9) | 26.8 * (18.7–33.8) | 9.4 (6.9–16.0) | 8.0 (2.7–25.7) |
Tolerability | ||||
Adverse events—no intervention required | 71% | 83% | 67% | 57% |
Toxicity | ||||
Adverse events—intervention required (dose reduction, treatment break, hospitalization, treatment termination) | 35% | 29% | 40% | 17% |
Real-world objective response rate (rwORR) | 49% | 54% | 60% | 56% |
Real-world disease control rate (rwDCR) | 82% | 100% | 100% | 76% * |
Primary resistance | 5% | 0% | 0% | 3% |
Time to progression | ||||
Median [95% confidence interval] | 17.4 [14.7–23.3] | 13.5 [10.0–17.2] | 8.8 [5.6–11.9] | 8.6 [5.8–16.2] |
Nature of progression | ||||
Unknown (rapid clinical decline) Thoracic progression only Distant progression only Thoracic + distant progression | - | 0 (0) 22 (54) 11 (27) 8 (19) | 0 (0) 6 (40) 3 (20) 6 (40) | 15 (50) 6 (20) 3 (10) 6 (20) |
Metastatic disease in liver, bone or CNS present upon progression | ||||
Liver Bone Central Nervous System | - | 7 (17) 25 (61) 10 (24) | 6 (40) 10 (67) 5 (33) | 4 (13) 17 (57) 5 (17) |
≥3 Unique sites of metastatic disease upon progression | ||||
No Yes | - | 29 (71) 12 (29) | 7 (46) 8 (53) | 22 (73) 8 (27) |
Development or progression of CNS disease | ||||
No Yes | - | 38 (93) 3 (7) | 13 (7) 2 (13) | 29 (97) 1 (3) |
Survival post-progression on with osimertinib | ||||
Median [95% Confidence interval] | - | 14.9 [8.7–24.9] | 11.8 [4.9–17.0] | 1.9 * [0.9–3.7] |
Survival following osimertinib initiation | ||||
Median [95% Confidence interval] | 28.9 [25.9–NR] | 34.7 [25.2–45.9] | 22.8 [15.4–NR] | 9.5 * [7.1–18.5] |
3-year survival rate | 27% | 46% | 33% | 0% * |
Characteristic | Osimertinib ≥ 90 Days Post-PD Group A (n = 41) n (%) |
---|---|
Sex | |
Female Male | 24 (58) 17 (42) |
Age (years) at 1L osimertinib continuation | |
Median (IQR) | 65.1 (56.4–78.1) |
Asian ancestry | |
No Yes | 25 (61) 16 (39) |
EGFR mutation | |
Exon 19 deletion Exon 21L858R | 23 (56) 18 (44) |
TNM 8th Edition M-stage at 1L osimertinib continuation | |
M0 M1a M1b M1c | 4 (10) 11 (27) 11 (27) 15 (36) |
≥3 sites of metastatic disease | |
No Yes | 29 (71) 12 (29) |
Metastatic disease in liver, bone or CNS present upon 1L osimertinib continuation | |
Liver Bone Central Nervous System | 7 (17) 25 (61) 10 (24) |
CNS present (but controlled) at 1L osimertinib continuation | 7/10 (70%) |
Osimertinib continued on reduced dose | |
No Yes (50% reduction to 40mg/day) | 37 (82) 7 (17) |
Adverse events post-progression (requiring intervention) | |
Treatment break (Grade 2 Fatigue; 14 days) | 1 (2) |
Duration of treatment post-progression (months) | |
Median (IQR) | 6.9 (4.3–14.3) |
Reason for osimertinib termination | |
Toxicity Death New treatment identified Further progressive disease Osimertinib ongoing | 1 (2) 12 (29) 1 (2) 15 (37) 12 (29) |
Second-Line (non-osimertinib) therapy received | 11 (38) |
Clinical Measure | By Post-Osimertinib Systemic Therapy Line | ||
---|---|---|---|
2L n (%) (n = 26) | 3L n (%) (n = 7) | 4L n (%) (n = 2) | |
Cytotoxic chemotherapy | 17 (65) | 6 (86) | 0 (0) |
Platinum-doublet NSCLC regimen Single-agent regimen | (n = 17) (n = 0) | (n = 0) (n = 6) | |
Immune checkpoint inhibitor | 0 (0) | 0 (0) | 1 (50) |
Targeted therapy | 7 (27) | 1 (14) | 1 (50) |
Second generation EGFR TKI Osimertinib rechallenge after treatment break SAVANNAH (osimertinib + savolitinib) trial Tepotinib | (n = 2) (n = 1) (n = 4) (n = 0) | (n = 0) (n = 1) (n = 0) (n = 0) | (n = 0) (n = 0) (n = 0) (n = 1) |
Cytotoxic chemotherapy and targeted therapy | 2 (8) | 0 (0) | 0 (0) |
Platinum-doublet + osimertinib MARIPOSA-2 trial (Arm C: platinum doublet + amivantamab + lazertinib) | (n = 1) (n = 1) | ||
ECOG at initiation | |||
ECOG < 2 ECOG ≥ 2 | 19 (73) 7 (27) | 4 (57) 3 (43) | 1 (50) 1 (50) |
M-stage at initiation | |||
M0 M1a M1b M1c | 1 (4) 4 (15) 7 (27) 14 (54) | 0 (0) 1 (15) 1 (15) 5 (70) | 0 (0) 0 (0) 0 (0) 2 (100) |
Duration of treatment (months) Median (IQR) | 3.7 (1.4–11.4) | 1.8 (0–4.2) | 3.8 (2.5–5.1) |
Real-world progression-free survival (months) Median [95% confidence interval] | 7.0 [5.2–9.0] | 5.0 [0.7–NR] | NR |
Nature of initial progression | (n = 18) | (n = 6) | (n = 2) |
Thoracic progression only Distant progression only Both thoracic and distant progression | 7 (39) 3 (17) 8 (44) | 2 (33) 2 (33) 2 (33) | 0 (0) 1 (50) 1 (50) |
Progressive disease in the brain upon initial progression | (n = 18) | (n = 6) | (n = 2) |
No Yes | 9 (50) 9 (50) | 6 (100) 0 (0) | 1 (50) 1 (50) |
Reason for treatment termination | |||
Treatment ongoing Completed as planned Progressive disease ECOG decline/death Adverse events | 6 (23) 1 (3) 12 (44) 4 (15) 4 (15) | 1 (14) 1 (14) 4 (58) 1 (14) 0 (0) | 1 (50) 0 (0) 0 (0) 1 (50) 0 (0) |
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Gibson, A.J.W.; Dean, M.L.; Litt, I.; Box, A.; Cheung, W.Y.; Navani, V. Real-World Analysis of Post-Progression Treatment Patterns and Outcomes for EGFR Mutation-Positive Patients Treated with First-Line Osimertinib. Curr. Oncol. 2024, 31, 2427-2440. https://doi.org/10.3390/curroncol31050182
Gibson AJW, Dean ML, Litt I, Box A, Cheung WY, Navani V. Real-World Analysis of Post-Progression Treatment Patterns and Outcomes for EGFR Mutation-Positive Patients Treated with First-Line Osimertinib. Current Oncology. 2024; 31(5):2427-2440. https://doi.org/10.3390/curroncol31050182
Chicago/Turabian StyleGibson, Amanda Jane Williams, Michelle Liane Dean, Ishjot Litt, Adrian Box, Winson Y. Cheung, and Vishal Navani. 2024. "Real-World Analysis of Post-Progression Treatment Patterns and Outcomes for EGFR Mutation-Positive Patients Treated with First-Line Osimertinib" Current Oncology 31, no. 5: 2427-2440. https://doi.org/10.3390/curroncol31050182
APA StyleGibson, A. J. W., Dean, M. L., Litt, I., Box, A., Cheung, W. Y., & Navani, V. (2024). Real-World Analysis of Post-Progression Treatment Patterns and Outcomes for EGFR Mutation-Positive Patients Treated with First-Line Osimertinib. Current Oncology, 31(5), 2427-2440. https://doi.org/10.3390/curroncol31050182