Afatinib (A) vs erlotinib (E) as second-line therapy of patients (pts) with advanced squamous cell carcinoma (SCC) of the lung following platinum-based chemotherapy: Overall survival (OS) analysis from the global phase III trial LUX-Lung 8 (LL8).
Bildiriler > Özet Bildiri
Yazarlar: Jean-Charles Soria, Enriqueta Felip, Manuel Cobo, Shun Lu, Konstantinos N. Syrigos, Ki Hyeong Lee, Erdem GÖKER, Vassilis Georgoulias, Wei Li, Dolores Isla, Salih Zeki Guclu, Alessandro Morabito, Young Joo Min, Andrea Ardizzoni, Shirish M. Gadgeel, Bushi Wang, Vikram K. Chand, Glenwood D. Goss, LUX-Lung 8 Investigators
Journal of Clinical Oncology, , , Uluslararası, Özet Bildiri, Wos, cilt 33, ss 8002-8002
DOI: 10.1200/jco.2015.33.15_suppl.8002
Özet
8002 Background: Treatment options for pts with advanced SCC of the lung progressing after platinum-based chemotherapy are limited. Overexpression of EGFR, ErbB receptors and the dysregulation of their downstream pathways are implicated in SCC pathobiology. Primary analysis of LL8 (2nd line A, an irreversible ErbB family blocker vs E, a reversible EGFR tyrosine kinase inhibitor [TKI; only TKI approved in this setting], in pts with SCC of the lung) showed significantly better progression-free survival (PFS) with A. OS and updated PFS are reported here. Methods: Pts with stage IIIB/IV disease were randomized 1:1 to receive A (40 mg/day) or E (150 mg/day) until disease progression. Primary endpoint: PFS; key secondary endpoint: OS. Other endpoints: objective response (ORR), disease control (DCR), patient reported outcomes and safety. 632 events and a sample size of 800 pts was needed to detect a HR of 0.8 with 80% power for OS. Results: OS was significantly better with A (n = 398) vs E (n = 397), with a 19% reduced risk of death (median 7.9 vs 6.8 mos; HR [95% CI] 0.81 [0.69–0.95]; p = 0.008). Significant differences in OS were seen at 6 (63.6 vs 54.6%; p = 0.010), 12 (36.4 vs 28.2%; p = 0.016) and 18 (22.0 vs 14.4%; p = 0.013) mos. PFS (median 2.6 vs 1.9 mos; HR [95% CI] 0.81 [0.69–0.96]; p = 0.010), ORR (5.5 vs 2.8%; p = 0.055) and DCR (50.5 vs 39.5%; p = 0.002) were all better for A vs E. More pts had improved global health status/quality of life (35.7 vs 28.3%; p = 0.041), cough (43.4 vs 35.2%; p = 0.029) and dyspnea (51.3 vs 44.1%; p = 0.061) with A vs E. Adverse event (AE) profiles were comparable (G ≥ 3 AEs: 57.1 and 57.5% for A vs E) with a higher incidence of drug-related G3/4 diarrhea (9.9/0.5 vs 2.3/0.3%), G3 stomatitis (4.1 vs 0%) with A and a higher incidence of G3 rash/acne with E (5.9 vs 10.4%). Preliminary data from FoundationOne analysis of tumor blocks will be shown. Conclusions: A significantly improved OS vs E in pts with SCC of the lung in a 2nd line setting. PFS and DCR were also significantly better. With a manageable AE profile, added QoL benefit, and symptom control seen in LL8, A should be preferred over E for these pts. Clinical trial information: NCT01523587.