Abstract 211P
Background
The ATLAS trial compared axitinib (AXI) vs placebo in patients (pts) with locoregional renal cell carcinoma at risk of recurrence after nephrectomy. ATLAS was stopped due to futility at a pre-planned interim analysis. A subgroup analysis was performed to describe differences between Asian vs Non-Asian pts and different Asian groups by geography in baseline characteristics and safety.
Methods
The exploratory subgroup analysis population included 363 pts randomized to receive AXI and 361 randomized to placebo. The primary endpoint was disease-free survival (DFS).
Results
DFS had the largest treatment effect in highest risk pts for Asian and Non-Asian pts: Hazard ratio = 0.731 (Asians) vs. 0.755 (Non-Asians). A similar trend was noted for Fuhrman Grade 3-4. Additional key results from the analysis are presented in the table.
Table: 211P Summary of key findings
Axitinib N = 363 | Placebo N = 361 | |||
---|---|---|---|---|
Asian N = 262 | Non- Asian N = 101 | Asian N = 264 | Non- Asian N = 97 | |
Key Pts Characteristics | ||||
Pts in Highest Risk Group, % | 51.9 | 72.3 | 51.5 | 66.0 |
Median time since diagnosis, wk | 8.7 | 10.3 | 8.6 | 10.0 |
Drug Treatment Differences | ||||
Completed 3y Treatment, % | 31.5 | 15.0 | 31.1 | 15.6 |
Median Treatment Duration, mo | 25.3 | 15.6 | 27.0 | 22.9 |
Median Daily Dose, mg | 6.6 | 8.6 | 9.9 | 10.0 |
Pts Safety Experience | ||||
Frequency of Dose Reduction, % | 68.5 | 50.0 | 11.7 | 7.3 |
AE Leading to Dose Reduction, % | 58.8 | 46.0 | 7.6 | 10.4 |
AE Leading to Discontinuation, % | 27.3 | 15.0 | 12.1 | 10.4 |
AE=adverse events Asian pts on AXI had higher frequencies of proteinuria, hypothyroidism, and nasopharyngitis and lower frequencies of fatigue and asthenia compared to Non-Asian pts on AXI. Within major Asian groups, proteinuria, hypothyroidism, nasopharyngitis and hypertension were more common in Japanese > Korean > Chinese pts.
Conclusions
DFS did not vary based on ethnicity. Asian pts had a lower median daily dose, and more frequent dose reduction vs non-Asian pts. More Asian pts had AEs leading to dose reductions of AXI and study withdrawals vs non-Asian pts. There were notable differences in AEs between Asian and Non-Asian pts and between Japanese, Korean and Chinese pts.
Clinical trial identification
NCT01599754.
Editorial acknowledgement
The study is sponsored by Pfizer. Medical writing support was provided by Charles Cheng, MS, of Engage Scientific Solutions, and funded by Pfizer.
Legal entity responsible for the study
This study was sponsored by Pfizer Inc and SFJ Pharmaceuticals.
Funding
This study was sponsored by Pfizer Inc and SFJ Pharmaceuticals.
Disclosure
C.F. Ng: Advisory / Consultancy, Speaker Bureau / Expert testimony: Boston Scientific; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): Janssen; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): Astellas; Speaker Bureau / Expert testimony, Research grant / Funding (institution): Ferring; Speaker Bureau / Expert testimony: Amgen; Research grant / Funding (institution): Olympus. T.G. Kwon: Research grant / Funding (institution): Kyungpook National University Chilgok Hospital. M. Eto: Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (self): ONO; Advisory / Consultancy, Speaker Bureau / Expert testimony: Bristol-Myers Squibb; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (self): Pfizer; Advisory / Consultancy, Speaker Bureau / Expert testimony: Novartis; Speaker Bureau / Expert testimony: Bayer. S.I. Seo: Honoraria (self): Ipsen; Honoraria (self): Pfizer; Research grant / Funding (self): Alvogen. B. Rosbrook: Shareholder / Stockholder / Stock options, Full / Part-time employment: Pfizer. E. Grande: Honoraria (self), Research grant / Funding (self): Pfizer; Honoraria (self): Bristol-Myers Squibb; Honoraria (self), Research grant / Funding (self): IPSEN; Honoraria (self), Research grant / Funding (self): Roche; Honoraria (self): Eisai; Honoraria (self): Eusa Pharma; Honoraria (self): MSD; Honoraria (self): Sanofi-Genzyme; Honoraria (self): Adacap; Honoraria (self): Novartis; Honoraria (self): Pierre Fabre; Honoraria (self), Research grant / Funding (self): Lexicon; Honoraria (self): Celgene; Research grant / Funding (self): AstraZeneca; Research grant / Funding (self): MTEM/Threshold. M. Gross-Goupil: Advisory / Consultancy, Research grant / Funding (self), Travel / Accommodation / Expenses: Pfizer; Advisory / Consultancy, Research grant / Funding (self), Travel / Accommodation / Expenses: BMS; Advisory / Consultancy, Research grant / Funding (self), Travel / Accommodation / Expenses: MSD; Advisory / Consultancy, Research grant / Funding (self): Ipsen; Advisory / Consultancy, Travel / Accommodation / Expenses: Roche; Travel / Accommodation / Expenses: Amgen. D.I. Quinn: Advisory / Consultancy: Pfizer; Advisory / Consultancy: Bayer; Advisory / Consultancy: Novartis; Advisory / Consultancy: Bristol-Myers Squibb; Advisory / Consultancy: Merck; Advisory / Consultancy: Exelixis; Advisory / Consultancy: Genentech; Advisory / Consultancy: Roche; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Astellas. All other authors have declared no conflicts of interest.
Resources from the same session
511P - Phase II trial of carboplatin, nab-paclitaxel and bevacizumab for advanced non-squamous non-small cell lung cancer (CARNAVAL study; TORG1424/OLCSG1402)
Presenter: Toshio Kubo
Session: Poster display session
Resources:
Abstract
485P - A real-world experience of first-line afatinib in Korean patients with EGFR-mutant non-small cell lung cancer
Presenter: Seong Hoon Yoon
Session: Poster display session
Resources:
Abstract
522P - Weekly nab-PTX and weekly PTX for relapsed small cell lung cancer
Presenter: Hajime Oi
Session: Poster display session
Resources:
Abstract
512P - A phase I and extension study of S-1 and carboplatin for previously untreated patients aged 75 years or more with advanced non-small cell lung cancer
Presenter: Hisao Imai
Session: Poster display session
Resources:
Abstract
497P - Real-word efficacy of osimertinib in patients with metastatic EGFRm NSCLC: An interim analysis from a multi-center study in China
Presenter: Xiangyun Ye
Session: Poster display session
Resources:
Abstract
507P - Immune checkpoint inhibitors for patients acquired resistance to tyrosine kinase inhibitors with EGFR mutated non-small cell lung cancer: A multicenter retrospective study
Presenter: Takeshi Uenami
Session: Poster display session
Resources:
Abstract
516P - Clinical outcomes in elderly patients with advanced non-small cell lung cancer: A prospective multicenter study of the National Hospital Organization in Japan
Presenter: Masahiro Shimada
Session: Poster display session
Resources:
Abstract
486P - Phase II study of low-dose afatinib maintenance treatment for patients with EGFR-mutated non-small cell lung cancer (NJLCG1601)
Presenter: Mami Morita
Session: Poster display session
Resources:
Abstract
515P - Polypharmacy as a prognostic factor in elderly patients with advanced non-small cell lung cancer treated with immune checkpoint inhibitors
Presenter: Taiki Hakozaki
Session: Poster display session
Resources:
Abstract
518P - Real world prospective clinical impact of finding actionable genomic alterations by plasma cell-free DNA next generation sequencing in advanced non-small cell lung cancer
Presenter: Beung chul Ahn
Session: Poster display session
Resources:
Abstract