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
143P - NOTCH3 expression predicts poor survival in advanced esophageal squamous cell cancers
Presenter: Raja Pramanik
Session: Poster display session
Resources:
Abstract
144P - Severe hypovitaminosis D in metastatic gastric cancer patients from the Northern and Southern hemispheres: Data from the EXPAND phase III trial
Presenter: Radka Obermannova
Session: Poster display session
Resources:
Abstract
145P - Role of Glasgow prognostic score in chemo-naïve patients with advanced biliary tract cancer and good performance status
Presenter: Toshikazu Moriwaki
Session: Poster display session
Resources:
Abstract
146P - Anatomic versus non-anatomic resection for hepatocellular carcinoma: A meta-analysis of high-quality studies
Presenter: Bin Zhang
Session: Poster display session
Resources:
Abstract
147P - Clinical outcomes of proximal gastrectomy versus total gastrectomy for locally advanced proximal gastric cancer: a propensity score matching analysis
Presenter: Yingtai Chen
Session: Poster display session
Resources:
Abstract
148P - Efficacy of capecitabine and oxaliplatin versus S-1 as adjuvant chemotherapy in gastric cancer after D2 lymph node dissection according to lymph node ratio and N stage
Presenter: Seunghwan Lee
Session: Poster display session
Resources:
Abstract
150P - A Phase Ib Study of IMU-131 HER2/neu peptide vaccine plus chemotherapy in patients with HER2/neu overexpressing metastatic or advanced adenocarcinoma of the stomach or gastroesophageal junction
Presenter: Yee Chao
Session: Poster display session
Resources:
Abstract
151P - Gene expression profiling for a better understanding of gastric cancer: From the perspective of metabolic rearrangement
Presenter: Midie Xu
Session: Poster display session
Resources:
Abstract
152P - Long-term outcomes of three-dimensional conformal radiotherapy-based and intensity-modulated radiotherapy-based concurrent chemoradiotherapy in patients with thoracic esophageal squamous cell carcinoma
Presenter: Chia-Lun Chang
Session: Poster display session
Resources:
Abstract
153P - Exosomal LINC00174 facilitates epithelial-mesenchymal transition in residual hepatocellular carcinoma after insufficient radiofrequency ablation by regulating c-JUN/MYCBP/c-Myc axis
Presenter: Dening Ma
Session: Poster display session
Resources:
Abstract