Afatinib (A) vs erlotinib (E) as second-line treatment of patients (pts) with advanced squamous cell carcinoma (SCC) of the lung: LUX-Lung 8 (LL8), a phase III trial
Bildiriler > Özet Bildiri
Yazarlar: Shirish Gadgeel, Jean-Charles Soria, Enriqueta Felip, Manuel Cobo, Shun Lu, Konstantinos Syrigos, Ki Hyeong Lee, Erdem GÖKER, Vassileios Georgoulias, Wei Li, Dolores Isla, Salih Zeki Guclu, Alessandro Morabito, Young Joo Min, Andreas Ardizzoni, Bushi Wang, Vikram Chand, Glenwood Goss, For the LUX-Lung 8 Investigators
11.1 Lung Cancer, , , Uluslararası, Özet Bildiri, ss OA265-OA265
DOI: 10.1183/13993003.congress-2015.oa265
Özet
Background: A is an irreversible ErbB family blocker that has shown clinical activity in pts with SCC of the head/neck and lung. This phase III trial prospectively compared A and E in pts with SCC of the lung following failure of platinum-based first-line chemotherapy. Methods: Pts with stage IIIB/IV SCC were randomized 1:1 to receive A (40 mg/day; n=335) or E (150 mg/day; n=334) until progression. The primary endpoint was PFS. Secondary endpoints were OS, ORR, DCR, patient-reported outcomes (PROs) and safety. Results: Baseline characteristics were well balanced between arms. Median PFS was significantly higher for A than E (2.4 vs 1.9 mths; HR [95% CI]: 0.82 [0.68–1.00]; p=0.04). Also, ORR (4.8 vs 3.0%; p=0.23) and DCR (45.7 vs 36.8%; p=0.02) were higher with A vs E. Overall AE profile was comparable (≥G3 AEs: 50.2 and 49.1%, serious AEs: 39.2 and 38.0% for A and E, respectively) with higher incidence of drug-related ≥G3 diarrhoea (9.7 vs 2.4%) and G3 stomatitis (3.3 vs 0%) with A and higher incidence of G3 rash/acne with E (5.5 vs 9.0%). AEs leading to treatment discontinuation were comparable (17.9 vs 13.9%). More pts had improved global health status/quality of life (36.4 vs 27.1%; p=0.03) with A than E. Changes in mean scores over time significantly favoured A vs E for cough, dyspnoea and pain. Primary OS, updated PFS, response and PRO data will be presented at the meeting. Conclusions: LL8 is the largest prospective trial comparing A vs E, an approved TKI in pts with pretreated SCC. PFS, DCR and improved global health status were significantly better for A than E. AEs were comparable and manageable.