Abstract 968
Aim/Background
The SQUIRE trial showed that neci added to gemcitabine + cisplatin (GC) improves overall survival (OS) in advanced squamous NSCLC pts. We report results of the EA subgroup.
| Variable | EA | Non-EA | ||
|---|---|---|---|---|
| Neci + GC | GC | Neci + GC | GC | |
| Efficacy, median mos (95% CI) | n = 43 | n = 41 | n = 502 | n = 507 |
| OS | 12.0 (7.3, 15.2) | 12.2 (5.5, 14.7) | 11.5 (10.5, 12.6) | 9.8 (8.8, 11.1) |
| HR (95% CI)* | 0.805 (0.484, 1.341) | 0.839 (0.730, 0.964) | ||
| PFS | 5.6 (4.7, 6.4) | 5.3 (2.8, 5.6) | 5.7 (5.6, 6.0) | 5.5 (4.8, 5.6) |
| HR (95% CI)* | 0.720 (0.439, 1.180) | 0.862 (0.749, 0.993) | ||
| Safety, n (%) | n = 41 | n = 39 | n = 497 | n = 502 |
| Treatment- emergent AE | 41 (100) | 37 (94.9) | 492 (99.0) | 492 (98.0) |
| Neci related | 30 (73.2) | 0 | 378 (76.1) | 0 |
| SAE | 27 (65.9) | 20 (51.3) | 230 (46.3) | 183 (36.5) |
| Neci related | 1 (2.4) | 0 | 31 (6.2) | 0 |
| Grade ≥3 | 36 (87.8) | 25 (64.1) | 352 (70.8) | 308 (61.4) |
| Neci related | 5 (12.2) | 0 | 84 (16.9) | 0 |
| With outcome death | 7 (17.1) | 3 (7.7) | 59 (11.9) | 54 (10.8) |
| Neci related | 0 (0) | 0 | 2 (0.4) | 0 |
* neci + GC/GC.
Methods
Eligible pts were chemotherapy naive, ≥18 years, had stage IV squamous NSCLC, ECOG performance status 0-2, and unknown EGFR mutation status. Pts were randomly assigned to ≤ six 3-week cycles of G (1250 mg/m2) C (75 mg/m2) ± neci (800 mg). OS (median [months], 95% CI) and progression-free survival (PFS) of pts from EA (Korea, Taiwan, Singapore, Thailand, and Philippines) and non-EA countries treated with neci + GC or GC were estimated using the Kaplan-Meier method. Hazard ratios (HR) and 95% CIs of neci + GC vs GC were estimated from stratified Cox proportional hazards models.
Results
Baseline characteristics were similar between EA groups. OS and PFS were improved in EA pts treated with neci + GC vs GC, and were similar for EA vs non-EA pts treated with neci + GC (Table). The percentages of serious adverse events (SAEs), AEs Grade ≥3, and AEs with outcome of death were higher in EA pts treated with neci + GC vs GC, and in EA vs non-EA pts treated with neci + GC (Table). The percentages of AEs causally related to neci only were similar in EA and non-EA pts (Table).
Conclusions
The efficacy of neci in EA pts with advanced squamous NSCLC was consistent with those in non-EA pts. The overall percentage of AEs with neci + GC was higher in EA pts than in non-EA pts; however, the AEs related to neci were similar.
Clinical trial identification
NCT00981058
Disclosure
K. Park: consulted/advised for Astellas, Astra-Zeneca, AVEO, and Boehringer Ingelheim. M.-J. Ahn: consulted/advised for Eli Lilly and Company. V. Soldatenkova, H. Depenbrock, T. Puri, M. Orlando: employee of Eli Lilly and Company and own shares in Eli Lilly Pty Ltd. All other authors have declared no conflicts of interest.