Patient-Reported Outcomes (Pros) in Patients (Pts) with Advanced Non-Small Cell Lung Cancer (Nsclc) Receiving Afatinib (A) Monotherapy Followed By a + Paclitaxel (A + P) Vs Investigator'S Choice of Single-Agent Chemotherapy (Ic): Lux-Lung 5 (Ll5)

Aim: A is an irreversible ErbB family blocker. In Part A of the open-label LL5 study, pts with advanced NSCLC who had failed ≥1 line of chemotherapy and erlotinib/gefitinib received A (50 mg/day; n = 1154). In Part B, pts with >12 weeks of clinical benefit on A were eligible for randomisation and received A + P (40 mg/day, 80 mg/m2/week; n = 132) or IC (n = 60). A + P significantly improved progression-free survival (PFS) vs IC (5.6 vs 2.8 months; HR 0.6; p = 0.003); overall survival was similar (12.2 vs 12.2 month; HR 1.0; p = 0.994). Pre-specified PRO analyses are presented here. Methods: Lung cancer symptoms were assessed every 28 days until progression using the EORTC (QLQ-C30/LC13) questionnaires. Analyses of cough, dyspnea and pain were preplanned, including percentage of patients improved on therapy, time-to-deterioration (TTD) of symptoms and change in symptoms over time. Results: Baseline symptom burden was low. Median TTD in Part A was 2.8, 2.8 and 4.5 months for dyspnea, pain and cough, respectively. In Part B, compared with IC, A + P showed a trend delaying TTD for dyspnea (3.1 vs 1.8 months; HR [95% CI] 0.78 [0.55, 1.09]; p = 0.144) and pain (4.3 vs 3.5 months; HR [95% CI] 0.80 [0.56, 1.14]; p = 0.212) but not cough (5.7 vs 6.5 months; HR [95% CI] 1.13 [0.79, 1.62]; p = 0.505). Numerically, more A + P than IC patients showed improvements in dyspnea (45% vs 35%; p = 0.222) and cough (46% vs 36%; p = 0.225). Differences in mean scores over time also numerically favored A + P over IC for dyspnea (-2.9; p = 0.191) and cough (-3.8; p = 0.201). There was no significant change in the global health status (GHS)/quality of life (QoL) scale of QLQ-C30 over time with A + P (p = 0.767). Conclusions: A + P showed trends for symptom improvement and delayed TTD vs IC in heavily-pretreated NSCLC patients. GHS/QoL was maintained over time despite a doubling of median treatment time and PFS with A + P. Disclosure: D. Planchard: I have attended Advisory Boards for: AstraZeneca, Boehringer Ingelheim, Lilly, Novartis, Pfizer and Roche; K. Park: Advisory Boards for: Astellas, AstraZeneca, Boehringer Ingelheim, Clovis, Eli Lilly, Roche, Novartis, Kyowa Hakko Kirin; J. Yang: Advisory Boards for: AstraZeneca, Boehringer Ingelheim, Roche/Genentech, Merck Serono, Pfizer, Clovis Oncology, Novartis, Eli Lilly, Takeda, Innopharma, Bayer Corporate sponsored research for: Boehringer Ingelheim; J. Kim: Sponsor initiated trials for: Pfizer, Boehringer Ingelheim, Lilly and Roche; F. De Marinis: Advisory Board for: Pfizer, Boehringer Ingelheim and Roche; Y. Chen: Advisory Boards for: Roche, AstraZeneca; J. Feng: Corporate sponsored research for Boehringer Ingelheim; C. Chouaid: Advisory Boards for: Lilly, Boehringer Ingelheim, Amgen and Roche; S. Lu: Advisory Boards for: AstraZeneca and Boehringer Ingelheim; R. Wiewrodt: Advisory Boards for: Boehringer Ingelheim, Grifols, Lilly, Novartis, Roche, Talecris Corporate sponsored research for: Bayer, Boehringer Ingelheim, Lilly, Genentech, Roche; C. Zhou: Advisory Boards for: Boehringer Ingelheim, Roche and Lilly; J. Bennouna: Advisory Boards for: Boehringer Ingelheim, Roche and Novartis; J. Lungershausen: Employee of Boehringer Ingelheim; B. Wang: Employee of: Boehringer Ingelheim; V. Chand: Corporate sponsored research: Boehringer Ingelheim Employee of: Boehringer Ingelheim; M. Schuler: Advisory Board for: AstraZeneca, Boehringer Ingelheim, Novartis and Pfizer Corporate sponsored research: Boehringer Ingelheim and Novartis Patents for: University Duisburg-Essen. All other authors have declared no conflicts of interest.