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Poster display session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC - early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research

4178 - Afatinib versus erlotinib as second-line treatment of patients (pts) with advanced lung squamous cell carcinoma (SCC): final analysis of the global Phase III LUX-Lung 8 (LL8) trial


20 Oct 2018


Poster display session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC - early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research


Glenwood Goss


Annals of Oncology (2018) 29 (suppl_8): viii493-viii547. 10.1093/annonc/mdy292


G.D. Goss1, M. Cobo2, S. Lu3, K. Syrigos4, K.H. Lee5, E. Göker6, V. Georgoulias7, W. Li8, D. Isla9, A. Morabito10, Y.J. Min11, A. Ardizzoni12, A. Cseh13, S. Bender14, E. Felip15

Author affiliations

  • 1 Medical Oncology, University of Ottawa, K1N 6N5 - Ottawa/CA
  • 2 Medical Oncology, Hospital Carlos Haya, Malaga/ES
  • 3 Medical Oncology, Shanghai Chest Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai/CN
  • 4 3rd Department Of Medicine, Athens School of Medicine, Athens/GR
  • 5 Internal Medicine, Chungbuk National University College of Medicine, Cheongju/KR
  • 6 Medical Oncology, Ege University Faculty of Medicine, Izmir/TR
  • 7 Department Of Medical Oncology, University Hospital of Heraklion, Crete/GR
  • 8 Medical Oncology, The First Hospital of Jilin University, 130021 - Changchun/CN
  • 9 Medical Oncology, Hospital Lozano Blesa, Zaragoza/ES
  • 10 Thoracic Department, Istituto Nazionale Tumori, IRCCS - Fondazione G.Pascale, Napoli/IT
  • 11 Department Of Medicine, Uslan University Hospital, Uslan/KR
  • 12 Hematology-oncology, Policlinico S.Orsola, Bologna/IT
  • 13 Medical Oncology, Boehringer Ingelheim RCV GmbH & Co. KG, Vienna/AT
  • 14 Medical Oncology, Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield/US
  • 15 Medical Oncology, Vall d’Hebron University Hospital, Barcelona/ES


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Abstract 4178


Primary LL8 data showed significantly improved PFS and OS with afatinib compared with erlotinib as second-line treatment in pts with lung SCC, leading to the approval of afatinib in this setting. As previously reported (data cut-off: Apr 2015), PFS (2.6 vs 1.9 months; HR 0.81 [95% CI 0.69–0.96]; p = 0.01), objective response rate (ORR; 5.5 vs 2.8%; p = 0.06) and disease control rate (DCR; 50.5 vs 39.5%; p = 0.002) were higher with afatinib vs erlotinib. PFS and OS benefits on afatinib appeared even greater for pts with ErbB mutation-positive tumours vs ErbB wild-type tumours. Here we present the final analysis of OS and safety data. Other efficacy endpoints were not updated; as of Apr 2015, only 9 (1%) pts remained on treatment, so minimal changes would be expected.


This open-label, multicentre, Phase III trial enrolled pts with stage IIIB/IV lung SCC who had progressed on ≥ 4 cycles of platinum-based chemotherapy. Pts were randomised 1:1 to receive afatinib (40 mg/day) or erlotinib (150 mg/day) until progression. Primary endpoint was PFS by independent radiological review. The key secondary endpoint was OS; other endpoints included ORR, DCR and safety.


795 patients were included (398 on afatinib; 397 on erlotinib). Baseline characteristics were well balanced between arms. Updated OS (data cut-off: Mar 2018) was significantly longer for afatinib than erlotinib (7.8 vs 6.8 months; HR 0.84 [95% CI 0.73–0.97]; p = 0.019). Overall AE profile was comparable between arms: 57.4% of afatinib and 57.5% of erlotinib pts reported AEs ≥grade 3 (G3); serious AEs were reported for 44.4% and 44.3% of pts, respectively. A higher incidence of drug-related ≥G3 diarrhoea (10.5 vs 2.5%) and G3 stomatitis (4.1 vs 0%) was reported on afatinib, and a higher incidence of G3 rash/acne was reported on erlotinib (5.9 vs 10.4%). AEs leading to treatment discontinuation were comparable across arms (20.4 vs 16.7%). Updated data on pts with long-term disease control (treatment ≥1 year) will be presented.


Results are consistent with those previously reported for LL8. Updated OS was significantly greater for afatinib than erlotinib. The AE profile was comparable across arms and manageable.

Clinical trial identification


Legal entity responsible for the study

Boehringer Ingelheim.


Boehringer Ingelheim.

Editorial Acknowledgement

Christina Jennings of GeoMed, an Ashfield company, part of UDG Healthcare plc.


G.D. Goss: Speaker bureau: AstraZeneca, BMS, Pfizer, Celgene. A. Morabito: Honoraria: Roche, AstraZeneca, Boehringer, Pfizer, BMS, MSD. A. Ardizzoni: Membership on an advisory board or board of directors: MSD Corporate-sponsored research: BMS, Celgene. A. Cseh: Employment: Boehringer Ingelheim RCV GmbH & Co. KG. S. Bender: Employment: Boehringer Ingelheim Pharmaceuticals, Inc. E. Felip: Advisory Board: Eli Lilly, Pfizer, Roche, MSD, Boehringer Ingelheim; Lecture Fees: AstraZeneca, BMS, Novartis. All other authors have declared no conflicts of interest.

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