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
457P - The prevalence of vitamin D deficiency in Thai cancer patients, its dynamics and association with cancer survival
Presenter: Chavapon Ngokngarm
Session: Poster display session
Resources:
Abstract
458P - Mutation tracking in circulating tumour DNA predicts relapse in completely resected EGFR-mutated NSCLC
Presenter: Martin Filipits
Session: Poster display session
Resources:
Abstract
460P - Mendelian randomization study showed no causality between metformin use and lung cancer risk
Presenter: Jiayi Shen
Session: Poster display session
Resources:
Abstract
461P - Blood trace minerals and lung cancer: A Mendelian randomization study
Presenter: Wei Xian
Session: Poster display session
Resources:
Abstract
463P - Prediction of invasiveness in lung adenocarcinoma using machine learning algorithm based on 3D-CT imaging
Presenter: Yusuke Saeki
Session: Poster display session
Resources:
Abstract
459P - Fish intake, dietary polyunsaturated fatty acids, and lung cancer: systematic review and dose-response meta-analysis of 1.7 million men and women
Presenter: Chao Cao
Session: Poster display session
Resources:
Abstract
462P - Usefulness for prevention of postoperative cerebrovascular complications in patients with lung cancer using carotid ultrasonography
Presenter: Sadanori Takeo
Session: Poster display session
Resources:
Abstract
468P - Histological type analysis of 10-year follow-up of WJTOG0105: A phase III study comparing second- and third-generation regimens with concurrent thoracic radiotherapy in unresectable stage III non-small cell lung cancer
Presenter: Masahiro Tsuboi
Session: Poster display session
Resources:
Abstract
469P - Comparison of combined chemoradiotherapy regimens; Paclitaxel plus carboplatin and cisplatin plus etoposide for locally advanced non-small cell lung cancer: A randomised phase III trial
Presenter: Alper Ata
Session: Poster display session
Resources:
Abstract
472P - Integration of expression rate and absolute cell counts of PD-1+ stromal tumour-infiltrating lymphocytes: Prognostic significance in esophageal squamous cell carcinoma
Presenter: Qingkun Song
Session: Poster display session
Resources:
Abstract