1263P - Afatinib (A) followed by A + paclitaxel (P) or investigator's choice of single-agent chemotherapy (IC) in patients (pts) with advanced squamous cel...

Date 27 September 2014
Event ESMO 2014
Session Poster Display session
Topics Anticancer Agents
Non-Small Cell Lung Cancer
Biological Therapy
Presenter Keunchil Park
Citation Annals of Oncology (2014) 25 (suppl_4): iv426-iv470. 10.1093/annonc/mdu349
Authors K. Park1, J. Kim2, M. Schuler3, D. Planchard4, F. De Marinis5, Y. Chen6, C. Zhou7, J. Bennouna8, L. Xiaoqing9, J. Feng10, P. Bidoli11, J. Strausz12, C. Chouaid13, M. Huang14, L. Ho15, B. Wang16, V. Chand17, J. Yang18
  • 1Division Of Hematology/oncology, Samsung Medical Center, 135-710 - Seoul/KR
  • 2Department Of Medical Oncology, Yonsei University College of Medicine, KR-120-752 - Seoul/KR
  • 3Department Of Medical Oncology, West German Cancer Center, University Duisburg-Essen, Essen/DE
  • 4Department Of Medical Oncology, Gustave Roussy, Villejuif/FR
  • 5And European Institute Of Oncology, 1st Oncological Pulmonary Unit, San Camillo, High Specialization Hospital, Rome, Italy, Milan/IT
  • 6Department Of Chest Medicine, Taipei Medical University and Taipei Veterans General Hospital, TW-112 - Taipei/TW
  • 7Medical Oncology, Shanghai Pulmonary Hospital, Shanghai/CN
  • 8Department D’oncologie Medicale, Centre René Gauducheau, 44805 - Saint-Herblain cedex/FR
  • 9Oncology, 307 Hospital of PLA, 100071 - Beijing/CN
  • 10Medical Oncology, Jiangsu Cancer Hospital, 210009 - Nanjing/CN
  • 11Medical Oncology, San Gerardo Hospital, IT-20052 - Monza/IT
  • 12Department Vi., Korányi National Institute, Budapest/HU
  • 13Pneumology, CHIC Créteil, Créteil/FR
  • 14School Of Medicine, Kaohsiung Medical University, Kaohsiung/TW
  • 15Department Of Medicine, Tri-Service General Hospital, Taipei/TW
  • 16Oncology, Boehringer Ingelheim, Ridgefield/US
  • 17Clinical Development, Oncology, Boehringer Ingelheim, Ridgefield/US
  • 18Department Of Oncology, National Taiwan University Hospital, TW-100 - Taipei/TW



While treatment options for SCC are limited, some pts derive modest benefit with erlotinib (E) or gefitinib (G). We previously reported interim data suggesting that A, an irreversible ErbB family blocker, had activity in pts with SCC (LL5, Part A). Subsequently, we demonstrated that continuation of ErbB blockade with A (plus P) in pts with non small cell lung cancer (NSCLC) progressing after benefit on E/G and A improved progression free survival (PFS),objective response rate (ORR) and disease control rate (DCR) vs IC (LL5, Part B). A pre-specified analysis of pts with SCC in LL5 is presented.


Pts with advanced NSCLC who failed ≥1 line of chemotherapy and E/G (after ≥12 wks benefit) were treated with A (50 mg/day; n = 1154; Part A). Upon progression on A (after >12 wks benefit), pts were randomized to receive A + P (40 mg/day, 80 mg/m2/week; n = 134) or IC (n = 68; Part B). The primary endpoint was PFS in Part B (RECIST 1.1).


90 pts with SCC received A in Part A (median age: 63 years; male: 71%; East Asian: 31%; never smoked: 24%). Median PFS was 3.7 months, ORR was 6%, DCR was 60.0%. Seventeen pts met eligibility criteria for Part B randomization and were treated with A + P (n = 11) or IC (n = 6). Median PFS (8.8 vs 1.9 months; p = 0.003) and OS (14.9 vs 6.6 months; p = 0.433) were observed to be longer with A + P vs IC. ORR (45.5% vs 0.0%) and DCR (72.7% vs 16.7%) were both higher with A + P than IC. In Part A, diarrhea (83.3%; grade 3, 13.3%) and rash (60.0%; grade 3, 10.0%) were the most frequently reported adverse events (AEs) in pts with SCC. In Part B, 8 (72.7%) and 2 (40.0%) SCC pts experienced grade 3 AEs with A + P and IC, respectively. The most common AEs were asthenia (27.3%) and diarrhea (18.2%). 22.2% of pts discontinued A due to AEs (Part A); 27.3% of pts discontinued A+ P due to AEs (Part B).


In this small group of pts with SCC we observed prolonged PFS, higher OR and trend towards longer OS in patients treated with A + P vs IC following A. Such signs of activity with both A and A + P in this difficult-to-treat population are encouraging and warrant further investigation. AEs were similar to those observed in the whole trial.


K. Park: Advisory Boards for: Astellas, AstraZeneca, Boehringer Ingelheim, Clovis, Eli Lilly, Roche, Novartis, Kyowa Hakko Kirin; J. Kim: Sponsor initiated trial from Pfizer, Boeringer Ingelheim, Lilly, Roche; M. Schuler: Advisory board: AstraZeneca, Boehringer Ingelheim, Novartis, Pfizer Corporate sponsored research: Boehringer Ingelheim, Novartis Other substantive relationships: University Duisburg-Essen (Patents); D. Planchard: Advisory board: AstraZeneca, Boehringer Ingelheim, Lilly, Novartis, Pfizer; F. De Marinis: Advisory board: Pfizer, Boehringer, Roche; Y. Chen: Advisory board: Roche, Astra-Zeneca; C. Zhou: Advisory board: BI, Roche, Lily; J. Bennouna: Advisory board: Boehringer Ingelheim, Roche, Novartis; J. Feng: Corporate sponsored research: Boehringer Ingelheim; C. Chouaid: Advisory board: Lilly, Boeringher Ingelheim, Amgen, Roche; L. Ho: Advisory board:Boehringer Ingelheim Corporate sponsored research: Taiwan Lung Cancer Clinical Trial Consortium (TALCC); V. Chand: Corporate sponsored research: Employee of Boehringer Ingelheim Pharm. Inc. Other substantive relationships: Employee of Boehringer Ingelheim Pharm. Inc.; J. Yang: Advisory board: Astrazeneca, Boehringer Ingelheim, Roche/Genetech, Merck Serono, Pfizer, Clovis Oncology, Novartis, Eli Lilly, Takeda, Innopharma, Bayer Corporate sponsored research: Boehringer Ingelheim. All other authors have declared no conflicts of interest.