1265P - Patient-reported outcomes (PROs) in patients (pts) with advanced non-small cell lung cancer (NSCLC) receiving afatinib (A) monotherapy followed by...

Date 27 September 2014
Event ESMO 2014
Session Poster Display session
Topics Anticancer Agents
Non-Small Cell Lung Cancer
Biological Therapy
Presenter David Planchard
Citation Annals of Oncology (2014) 25 (suppl_4): iv426-iv470. 10.1093/annonc/mdu349
Authors D. Planchard1, K. Park2, J. Yang3, J. Kim4, F. De Marinis5, Y. Chen6, J. Feng7, C. Chouaid8, S. Lu9, R. Wiewrodt10, C. Zhou11, J. Bennouna12, X. Liu13, J. Lungershausen14, B. Wang15, V. Chand16, M. Schuler17
  • 1Medical Oncology, Gustave Roussy, 94805 - Villejuif/FR
  • 2Division Of Hematology/oncology, Samsung Medical Center, Seoul/KR
  • 3Department Of Oncology, National Taiwan University Hospital, Taipei/TW
  • 4Medical Oncology, Yonsei Cancer Center, Seoul/KR
  • 5And European Institute Of Oncology, 1st Oncological Pulmonary Unit, San Camillo, High Specialization Hospital, Rome, Italy, Milan/IT
  • 6Department Of Chest Medicine, Taipei Veterans General Hospital, Taipei/TW
  • 7Medical Oncology, Jiangsu Cancer Hospital, 210009 - Nanjing/CN
  • 8Pneumology, CHIC Creteil, Créteil/FR
  • 9Shanghai Lung Tumor Clinical Center, Shanghai Chest Hospital, Jiao Tong University, 20030 - Shanghai/CN
  • 10Department Of Medicine A, Münster University Hospital, Münster/DE
  • 11Medical Oncology, Shanghai Pulmonary Hospital, Shanghai/CN
  • 12Oncology/ Pneumology, Institut de Cancerologie de l’Ouest-site René Gauducheau, Nantes/FR
  • 13Cancer Center, Affiliated Hospital of the Academy of Military Medical Sciences, 100071 - Beijing/CN
  • 14Health Economics, Boehringer Ingelheim GmbH, Ingelheim/DE
  • 15Oncology, Boehringer Ingelheim, Ridgefield/US
  • 16Clinical Development - Oncology, Boehringer Ingelheim Pharmaceuticals, Inc., 06877 - Ridgefield/US
  • 17Department Of Medical Oncology, West German Cancer Center, University Hospital Essen, 45122 - Essen/DE



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.


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.


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).


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.


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.