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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

5097 - A phase II study of first-line afatinib for patients aged 75 or older with EGFR mutation-positive advanced non-small cell lung cancer: North East Japan Study Group Trial NEJ027.

Date

20 Oct 2018

Session

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

Presenters

tomoiki aiba

Citation

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

Authors

T. aiba1, Y. Minegishi2, O. Yamaguchi3, S. Kuyama4, S. Watanabe5, K. Usui6, M. Mori7, O. Hataji8, T. Nukiwa9, S. Morita10, K. Kobayashi11, A. Gemma12

Author affiliations

  • 1 Respiratory Medicine, Sendai Kousei Hospital, 980-0873 - Sendai/JP
  • 2 Department Of Pulmonary Medicine And Oncology, Nippon Medical School, 113-8602 - Tokyo/JP
  • 3 Department Of Respiratory Medicine, Saitama Medical University International Medical Center, Saitama/JP
  • 4 Department Of Respiratory Medicine, National Hospital Organization Iwakuni Clinical Center, Iwakuni, Yamaguchi/JP
  • 5 Department Of Respiratory Medicine And Infectious Diseases, Niigata University Graduate School of Medical and Dental Sciences, Niigata/JP
  • 6 Division Of Respirology, NTT Medical Center Tokyo, 141-0022 - Tokyo/JP
  • 7 Department Of Thoracic Oncology, National Hospital Organization Toneyama National Hospital, Toyonaka/JP
  • 8 Respiratory Center, Matsusaka City Hospital, 515-8544 - Matsusaka/JP
  • 9 Professor Emeritus, Tohoku University, Sendai/JP
  • 10 Biomedical Statistics And Bioinformatics, Kyoto University Graduate School of Medicine 54 Kawahara-cho,Shogoin,Sakyo-ku, Kyoto/JP
  • 11 Department Of Respiratory Medicine, Saitama Medical University Internatl Medical Centre, 350-1298 - Saitama/JP
  • 12 Division Of Pulmonary Medicine And Oncology, Nippon Medical School, 113-8603 - Tokyo/JP
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Resources

Abstract 5097

Background

The aim of this study was to assess the efficacy and safety of afatinib, an epidermal growth factor receptor (EGFR) tyrosin kinase inhibitor (TKI), for elderly Japanese patients with EGFR mutation-positive advanced non-small cell lung cancer (NSCLC).

Methods

NEJ027 was single-arm, multicenter, open-label phase II study of first-line afatinib monotherapy. Patients aged 75 or older with stage IIIB/IV or recurrent non-squamous NSCLC harboring EGFR mutations were enrolled. The patients received afatinib at a start dose of 40mg/day until disease progression or unacceptable toxicity. The primary endpoint was overall response rate (ORR), and the secondary endpoints were disease control rate (DCR), progression-free survival (PFS), overall survival (OS) and safety profile.

Results

Between January 28, 2016, and September 14, 2017, a total of 38 patients with a median age of 77 years (range, 75-91) were enrolled (15 males; 21 Eastern Cooperative Oncology Group performance status 0; all adenocarcinoma; 23 EGFR exon 19 deletion mutation) in safety analysis and 37 in the full analysis set. The ORR was 75.7% (95% confidence interval: CI 61.9-89.5) and DCR was 89.2%. The median PFS was 14.3 months (95% CI 9.9-not reached). The common grade 3 or 4 adverse events were diarrhea (10 [26.3%]), stomatitis (5 [13.2%]), rash (2 [5.3%]), appetite loss (5 [13.2%]), nail abnormality (4 [10.5%]) and pneumonitis (2 [5.3%]). 30 patients (78.9%) required 1 step or more dose reduction.

Conclusions

Although the percentage of patients requiring dose reduction seemed relatively higher than that in previous studies, first-line afatinib at a start dose of 40mg/day was found to be well-tolerated by dose adjustment and effective in elderly patients with advanced non-squamous NSCLC harboring EGFR mutations.

Clinical trial identification

UMIN000017050.

Legal entity responsible for the study

North East Japan Study Group.

Funding

Japan Agency for Medical Research and Development.

Editorial Acknowledgement

Disclosure

O. Yamaguchi: Honoraria: Bristol-Myers Squibb, Ono Pharm and AstraZeneca. S. Watanabe: Grants: Boehringer Ingelheim, during the conduct of the study; Grants and personal fees: Boehringer Ingelheim, personal fees: Chugai Pharma, Ono Pharmaceutical, Lilly, AstraZeneca, Taiho Pharmaceutical, Pfizer, Bristol-Myers Squibb and Novartis Pharma. M. Mori: Lecture fees: Boehringer Ingelheim. O. Hataji: Lecture fees: Novartis, Boehringer Ingelheim; Research fundings: Novartis, Boehringer Ingelheim, Kyorin Pharm, Bayer Health Care, Daiichi Sankyo, Glaxo Smith Kline. S. Morita: Corporate-sponsored research: Boehringer Ingelheim; Honorarium: Boehringer Ingelheim. K. Kobayashi: Advisory board: AstraZeneca. A. Gemma: Lecture fee: Boehringer Ingelheim. All other authors have declared no conflicts of interest.

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