Virtual Library
Start Your Search
A. Tamiya
Author of
-
+
Immunotherapy and next-generation TKIs: From second to frontline treatment (ID 55)
- Event: ELCC 2018
- Type: Poster Discussion session
- Track:
- Presentations: 1
- Now Available
- Moderators:P. Garrido Lopez, S. Ekman, S. Ortiz-Cuaran, E. Wauters
- Coordinates: 4/12/2018, 07:45 - 09:00, Room A
-
+
143PD - Competing central nervous system or systemic progression analysis for patients with EGFR mutation-positive NSCLC receiving afatinib in LUX-Lung 3, 6, and 7 (Now Available) (ID 561)
10:54 - 10:54 | Author(s): A. Tamiya
- Abstract
Background:
CNS metastases are known complications of advanced EGFRm+ NSCLC, thus, LUX-Lung (LL) trials investigating afatinib allowed enrolment of patients (pts) with brain metastases (BM). LL3, 6 and 7 previously demonstrated activity of afatinib in pts with BM, with the magnitude of progression-free survival (PFS) improvement with afatinib vs chemotherapy or gefitinib in pts with BM being similar to that observed in pts without BM (HR 0.54, 0.47, and 0.76 in LL3, 6 and 7, respectively).[1,2] PFS was significantly improved with afatinib vs chemotherapy in a combined analysis of LL3 and 6 in pts with asymptomatic BM (HR 0.50, p = 0.0297).[1] To investigate whether afatinib can prevent CNS progression or metastasis, competing risk analyses for the progression and metastasis pattern in the CNS or non-CNS region were carried out in pts with and without BM in LL3, 6 and 7.
Methods:
Competing risk analyses were performed in pts with stage IIIB/IV EGFRm+ NSCLC who received afatinib 40 mg/d in LL3, 6 and 7. Analyses were performed separately for pts with baseline BM and without baseline BM. Risk of CNS progression vs non-CNS progression or death was calculated based on the cumulative frequency of the event of interest vs the competing risk event.
Results:
In pts with baseline BM receiving afatinib in LL3 and 6 (n = 48; median follow-up 10.3 mo), 31.3% had CNS progression vs 52.1% with non-CNS progression: cumulative incidence at 6 and 12 mo (CNS vs non-CNS) was 15.5% vs 17.7%, and 24.5% vs 24.4%, respectively. In pts without baseline BM receiving afatinib in LL3, 6 and 7 (n = 485; median follow-up 13.0 mo), risk of de novo CNS progression was very low (6.4%) compared with non-CNS progression (78.4%). Cumulative incidence at 6 and 12 mo (CNS vs non-CNS) was 1.3% vs 17.2%, and 2.6% vs 41.2%, respectively.
Conclusions:
Competing risk analyses using data from LL3, 6 and 7 add to the existing evidence that support afatinib use in pts with EGFRm+ NSCLC and CNS metastases. Taken together, these results suggest afatinib delays the onset/progression of BM. 1. Schuler. J Thorac Oncol 2016;11:380–90 2. Park. Lancet Oncol 2016;17: 577–89
Clinical trial identification:
NCT00949650, NCT01121393, NCT01466660
Legal entity responsible for the study:
Boehringer Ingelheim
Funding:
Boehringer Ingelheim
Disclosure:
J.C-H. Yang: Honoraria/advisory board: Boehringer Ingelheim, Eli Lilly, Bayer, Roche/Genentech/Chugai, Astellas, MSD, Merck Serono, Pfizer, Novartis, Clovis Oncology, Celgene, Merrimack, Yuhan Pharma, BMS, Ono Pharma Daiichi Sankyo, Astrazeneca. Y-L. Wu: Honoraria: AstraZeneca, Roche, Eli Lilly, Pfizer, Sanofi. V. Hirsh: Advisory Board: BI. K. O'Byrne: Advisory board & Honoraria: Astrazeneca, BMS, Roche-Genentech, MSD, Pfizer, Boehringer-Ingelheim, Novartis Speaker bureau activities: Astrazeneca, BMS, Roche-Genentech, MSD, Pfizer, Boehringer-Ingelheim Travel to international conferences: Astrazeneca, BMS, Roche-Genentech, MSD, Pfizer, Boehringer-Ingelheim 3 patents –1 on novel drugs and 2 on biomarkers – IP held by University. N. Yamamoto: Membership on an advisory board or board of directors: BI, AZ, Chugai Corporate-sponsored research: BI. S. Popat: Membership on an advisory board or board of directors: BI. A. Tamiya: Grants from Ono Pharmaceutical, Bristol-Myers Squibb Received personal fees from Eli Lilly, Ono Pharmaceutical, Chugai Pharmaceutical, Boehringer Ingelheim, AstraZeneca, Bristol-Myers Squibb. A. Märten: Employment Boehringer Ingelheim. M. Schuler: Employment: Universität Duisburg-Essen, Universitätsklinikum Essen, Ruhrlandklinik Consultant (compensated): AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Novartis, Roche Consultant (not compensated): Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG) Honoraries (CME presentations): Abbvie, Alexion, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Lilly, MSD, Novartis Research funding (institution) Boehringer Ingelheim, Bristol Myers-Squibb, Novartis Pantent: Universität Duisburg-Essen.
