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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

4132 - Phase IV, open-label, multicentre trial of afatinib in patients (pts) aged _70 yrs with NSCLC harbouring common (Del19/L858R) EGFR mutations: preliminary results


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


Targeted Therapy

Tumour Site


Karen Reckamp


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


K.L. Reckamp1, P. Gilman2, B. Halmos3, M. Jahanzeb4, J. McCann5, H. Paripati6, L.C. Seneviratne7, J.A. Wallace8, B. Rueter9, A. Esler10, E. Dowling11, M. Koczywas12

Author affiliations

  • 1 Department Of Medical Oncology, City of Hope Comprehensive Cancer Center, 91010 - Duarte/US
  • 2 Cancer Center, Lankenau Medical Center, Wynnewood/US
  • 3 Department Of Oncology, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx/US
  • 4 Sylvester Comprehensive Cancer Center, University of Miami, Deerfield Beach/US
  • 5 D'amour Center For Cancer Care, Baystate Regional Cancer Program, Springfield/US
  • 6 Division Of Hematology/oncology, Mayo Clinic, Phoenix/US
  • 7 Los Angeles Hematology/oncology Medical Group, Los Angeles Cancer Network, Los Angeles/US
  • 8 Department Of Hematology/oncology And Geriatrics, UChicago Medicine: Ingalls, Harvey/US
  • 9 Cmda Oncology, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield/US
  • 10 Statistics, Syneos Health, Raleigh/US
  • 11 Study Management And Conduct, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield/US
  • 12 Department Of Medical Oncology And Therapeutic Research, City of Hope Comprehensive Cancer Center, Duarte/US


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Abstract 4132


The irreversible ErbB family blocker, afatinib, is approved for first-line treatment of metastatic NSCLC harbouring non-resistant EGFR mutations. While afatinib has demonstrated a predictable and manageable safety profile in pts with EGFR mutation-positive (EGFRm+) NSCLC, elderly pts are often under-represented in clinical trials. Here, we summarise the current status of, and preliminary data from, an ongoing Phase IV trial of afatinib in elderly pts with Del19/L858R EGFRm+ NSCLC (NCT02514174).


Pts aged ≥70 yrs with Stage IV/recurrent Del19/L858R EGFRm+ NSCLC naïve to prior systemic therapy have been enrolled to sites in the USA. Pts receive afatinib QD (starting dose 30 mg/day) until disease progression/intolerable AEs. Dose reduction to 20 mg/day is permitted in the case of select Grade 2/≥3 AEs. The primary endpoint is the occurrence of AEs leading to dose reduction. Secondary endpoints include occurrence of Grade ≥3 diarrhoea and Grade ≥3 rash/acne, stomatitis and paronychia (grouped terms). Other endpoints are AEs by NCI CTCAE grade, objective response (OR), PFS and overall survival. Preliminary safety data are reported here.


As of 7 Feb 2018, 26 pts have been enrolled across 9 sites, and 24 pts have entered into the trial. Twenty-three pts have been treated: 57% female; 30% Asian; 26%/74% ECOG PS 0/1; median age (range) 79 (71–93) yrs. Thirteen (57%) pts remain on treatment. Reasons for treatment discontinuation were progressive disease (26%), AEs (9%), refusal to continue study medication (4%), and other (4%). All pts have had at least one AE of any cause (Grade 3/4: 52%/0%), most commonly (preferred term [PT]) diarrhoea (87%), rash (61%) and fatigue (48%). The most common treatment-related AEs (PTs) reported are diarrhoea (83%), rash (57%) and dry skin (39%), and the most common serious AEs (PTs) reported are vomiting and dehydration (both 9%). Ten (43%) pts have achieved confirmed OR (complete/partial response: 1 [4%]/9 [39%]) and 10 (43%) pts have had stable disease.


In this preliminary analysis, afatinib (30 mg/day) demonstrated a predictable safety profile in pts aged ≥70 yrs with Del19/L858R EGFRm+ NSCLC. Updated data will be presented.

Clinical trial identification


Legal entity responsible for the study

Boehringer Ingelheim.


Boehringer Ingelheim.

Editorial Acknowledgement

Laura Winton of GeoMed, an Ashfield company, part of UDG Healthcare plc.


K.L. Reckamp: Consulting fees: Takeda, Tesaro, Euclises, and Boehringer Ingelheim. B. Halmos: Consulting fees, grants/funds: Boehringer Ingelheim, AstraZeneca, Takeda, Eli Lilly, Pfizer, Novartis; Consulting fees: Roche/Genentech, Foundation Medicine, Guardant Health; Grant/funds: Merck, Mirati, Eisai, Genentech. M. Jahanzeb: Grant funding: Boehringer Ingelheim. L.C. Seneviratne: Consulting fees and Honoraria for a Speaker's bureau: Novartis. J.A. Wallace: Honoraria: Genentech. B. Rueter, E. Dowling: Employee: Boehringer Ingelheim. A. Esler: Contracted: Boehringer Ingelheim. M. Koczywas: Honoraria for a Speaker bureau: AstraZeneca. All other authors have declared no conflicts of interest.

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