Abstract 575P
Background
The data for dacomitinib, a second-generation EGFR-TKI, treating patients with advanced non-small cell lung cancer (NSCLC) and brain metastasis was lacking. This study aimed to explore the efficacy and safety of dacomitinib in treating EGFR-mutated advanced NSCLC with brain metastasis in first-line settings.
Methods
Eligible patients were treatment-naïve advanced NSCLC patients with ≥1 brain metastasis no less than 5mm treated with dacomitinib. The primary endpoint was intracranial objective response rate (iORR). Secondary endpoints included intracranial progression-free survival (iPFS), intracranial disease control rate (iDCR), sytemic ORR and DCR, PFS, overall survival (OS), and safety. Response was evaluated per modified Response Evaluation Criteria in Solid Tumors (mRECIST, version 1.1) and Response Assessment in Neuro-oncology, Leptomeningeal Metastasis (RANO-LM) criteria.
Results
Between Jul 2nd, 2019, and Sep 30th, 2022, a total of 87 treatment-naïve patients from four hospitals were included. Data cutoff date was Mar 24th, 2023. Median follow-up time was 17.5 (1.6-34.7)months. For 87 patients with evaluable brain metastasis, iORR was 89.7% and iDCR was 97.7%per mRECIST criteria. Based on RANO-LM criteria, iORR was 71.3% and iDCR was 97.7%. Median iPFS was 26.0 months, and the 1-year and 2-year iPFS rate were 68.9% and 51.5%, respectively. For 75 patients with evaluable extracranial lesions, systemic ORR was 73.8% and DCR was 96.4%. Systemic median PFS was 14.0 months and median OS was 34.0 months (Table). Overall, 86 of 87 (98.9%) patients experienced adverse events (AEs) of any grade. Most AEs were grade 1-2 and no patients died due to severe AEs. The most common (≥20%) AEs included rash (89.7%), oral ulcer (74.2%), diarrhea (67.8%), paronychia (59.8%). Table: 575P
Summary of intracranial and systemic efficacy
| Intracranial efficacy (N=87) | Systematic efficacy (N=75) | ||
| per mRECIST criteria | per RANO-BM criteria | ||
| Complete response, n (%) | 42 (48.3) | 42 (48.3) | 2 (2.7) |
| Partial response, n (%) | 36 (41.8) | 20 (23.0) | 51 (68.0) |
| Stable disease, n (%) | 7 (8.0) | 23 (26.4) | 21 (28.0) |
| Objective response rate(95%CI) | 89.7 (81.3-95.2) | 71.3 (60.6-80.5) | 73.8 (63.1-82.8) |
| Disease control rate (95%CI) | 97.7 (91.9-99.7) | 97.7 (91.9-99.7) | 96.4 (89.9-99.3) |
| Progression-free survival, median (95%CI) | 26.0 (22.5-29.5) | 14.0 (11.1-16.9) | |
| One-year progression-free survival rate | 68.9% | 53.1% | |
| Two-year progression-free survival rate | 51.5% | 24.1% |
Conclusions
Dacomitinib showed promising efficacy and manageable safety profile for advanced NSCLC with brain metastasis harboring EGFR mutation in the first-line treatment.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
471TiP - A group sequential, response-adaptive randomized double-blinded clinical trial to evaluate add-on olanzapine plus pregabalin to prevent chemotherapy-induced nausea and vomiting (CINV ) in patients belonging to low socio-economic status
Presenter: Mathan Ramasubbu
Session: Poster Display
Resources:
Abstract
472P - Risk of recurrence and optimal adjuvant treatment in invasive lung adenocarcinomas manifesting as radiological part-solid nodules
Presenter: Yang Wo
Session: Poster Display
Resources:
Abstract
473P - Treatment (tx) patterns in resectable stage IA–IIIA non-small cell lung cancer (NSCLC) in China: Subgroup analysis of a global real-world (rw) study
Presenter: Chih-Chi Yang
Session: Poster Display
Resources:
Abstract
474P - The efficacy of image guided coil localisation for surgical resection of undiagnosed solitary lung nodule
Presenter: Jun Rey Leong
Session: Poster Display
Resources:
Abstract
475P - 5-year overall survival and disease free survival outcome between lobectomy and segmentectomy for early stage lung cancer in a mixed Asian population
Presenter: Jianye Chen
Session: Poster Display
Resources:
Abstract
478P - Peri-operative risks in curative lung resection of early stage primary lung cancer patients above 70 years old in a mixed Asian population
Presenter: Ian Goh
Session: Poster Display
Resources:
Abstract
480P - Aumolertinib as adjuvant therapy for resectable stage I-III EGFR-mutant NSCLC: Also effective in EGFR co-mutation
Presenter: Lin Wu
Session: Poster Display
Resources:
Abstract
481P - Comparative analysis of three NGS platforms assessing tumor mutational burden and mutational landscape in resectable non-small cell lung cancer
Presenter: Jii Bum Lee
Session: Poster Display
Resources:
Abstract
482P - Prevalence of EGFR mutations (EGFRm) and its subtypes in patients (pts) with resected stage I-III NSCLC: Results from EARLY-EGFR Singapore cohort
Presenter: Puey Ling Chia
Session: Poster Display
Resources:
Abstract
483P - Genetic profiles and evolutionary trajectory of early stage lung adenocarcinoma (AAH, AIS, MIA and IAC) revealed by multiplex sequecing
Presenter: lixuan lin
Session: Poster Display
Resources:
Abstract