Abstract 481P
Background
The phase II trial evaluated the efficacy and safety of low starting dose of afatinib in patients with advanced epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC). In primary analysis, progression free survival (PFS) met the primary endpoint. Here, we report updated survival outcomes.
Methods
This study was a multi-center, single-arm, open-label phase II trial. Treatment-naïve patients with common EGFR mutation-positive NSCLC were treated with afatinib starting at a dose of 20 mg/day. If tolerated, the dose is increased by 10- mg increments up to 50mg/day. PFS and overall survival (OS) were re-evaluated at the final data cut-off point (October 2018).
Results
46 patients were enrolled. Median age was 73 years (range, 43-86). The median follow-up was 31.9 months. Median PFS of entire population was 15.2 months (95% confident interval (CI), 13.2–21.2), and 2-year PFS rate was 27.7% (95% CI, 17.1-44.7). Median OS was not estimated, and the 2-year overall survival was 76.1% (95% CI, 64.7-89.5). Performance status (PS) and existence of brain metastases at study entry were revealed to have significant impact on the survival with Cox-regression test. Among patients with disease progression on afatinib (n = 36), rebiopsy was performed on 29 patients, and T790M was proved positive on 14 patients. Twelve out of the 14 patients positive for T790M received osimertinib as a second line therapy. Median time from enrollment to progression on the osimertinib (PFS2) was 32.6 months (95%CI: 20.5-NE).
Conclusions
Low starting dose afatinib therapy demonstrated promising OS outcome. PS and existence of brain metastases were predictive factors of this therapy.
Clinical trial identification
UMIN 000016444.
Editorial acknowledgement
Legal entity responsible for the study
Kyoto Thoracic Oncology Research Group.
Funding
Has not received any funding.
Disclosure
T. Yokoyama: Honoraria (self): Boehringer Ingelheim Japan; Honoraria (self): Chugai Pharmaceutical; Honoraria (self): Taiho Pharmaceutical; Honoraria (self): Bristol-Myers Squibb; Honoraria (self): Novartis; Honoraria (self): AstraZeneca; Honoraria (self): Ono pharmaceutical; Honoraria (self): MSD. H. Yoshioka: Honoraria (self): Boehringer Ingelheim; Honoraria (self): Chugai Pharmaceutical; Honoraria (self): Taiho Pharmaceutical; Honoraria (self): Eli Lilly Japan; Honoraria (self): Bristol-Myers Squibb; Honoraria (self): Novartis; Honoraria (self): Merck Serono; Honoraria (self): Kyowa Kirin; Honoraria (self): AstraZeneca; Honoraria (self): Ono pharmaceutical; Honoraria (self): Daiichi Sankyo; Honoraria (self): MSD. D. Fujimoto: Honoraria (self), Research grant / Funding (self): AstraZeneca KK; Honoraria (self): Ono Pharmaceutical Co Lt; Honoraria (self): Bristol-Myers Squibb Co Ltd; Honoraria (self): Taiho Pharmaceutical Co ; Honoraria (self), Research grant / Funding (self): Chugai Pharmaceutical Co Ltd; Honoraria (self): MSD KK; Honoraria (self): Boehringer Ingelheim Japan Inc; Honoraria (self): Eli Lilly Japan KK. K. Hirano: Honoraria (self): Boehringer Ingelheim Japan. T. Ishida: Honoraria (self): Boehringer Ingelheim Japan. T. Hirai: Research grant / Funding (institution): Boehringer Ingelheim Japan. All other authors have declared no conflicts of interest.
Resources from the same session
27P - The prognostic value of neutrophil to lymphocyte ratio (NLR) and 18F-FDG PET SUV in breast cancer patients underwent neoadjuvant chemotherapy
Presenter: Soong June Bae
Session: Poster display session
Resources:
Abstract
28P - Accuracy of core biopsy in predicting pathologic complete response in the breast in patients with complete/near complete clinical and radiological response (Complete Responders in the Breast – CRBr): A feasibility study
Presenter: Nisha Hariharan
Session: Poster display session
Resources:
Abstract
29P - Tumour response to neoadjuvant chemotherapy in breast cancer: Routine pathologic markers improve the predictive power of a cell-loss metric based on release of thymidine kinase 1 into blood
Presenter: Bernhard Tribukait
Session: Poster display session
Resources:
Abstract
30P - Comparison of metabolic changes between neoadjuvant chemotherapy and neoadjuvant endocrine therapy in premenopausal women with ER positive, HER2 negative breast cancer
Presenter: Ho-hyun Ryu
Session: Poster display session
Resources:
Abstract
31P - Circulating miR-155 as a potential therapeutic monitoring marker in breast cancer
Presenter: Sumadi Lukman Anwar
Session: Poster display session
Resources:
Abstract
32P - Profile of breast cancer epidemiology in Sanglah General Hospital, Denpasar, Bali from 2012 to 2019
Presenter: Citra Aryanti
Session: Poster display session
Resources:
Abstract
33P - Contrast enhanced chest CT in patients with breast cancer: Comprehensive imaging analysis and correlation with biological markers
Presenter: Bo Hwa Choi
Session: Poster display session
Resources:
Abstract
34P - Verification of metabolic regulatory mechanisms in androgen receptor-positive triple negative breast cancer
Presenter: Yuka Asano
Session: Poster display session
Resources:
Abstract
35TiP - Ribociclib plus goserelin with hormonal therapy versus physician choice chemotherapy in pre-/perimenopausal patients with HR+, HER2– inoperable locally advanced breast cancer (ABC): RIGHT choice study
Presenter: Yen-Shen Lu
Session: Poster display session
Resources:
Abstract
36TiP - A prospective study to assess response to neoadjuvant hormonal therapy in postmenopausal women with hormone-receptor positive breast cancer at a regional cancer centre in South India
Presenter: Shina Goyal
Session: Poster display session
Resources:
Abstract