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
YO20 - Can "Superman" have Chronic Myelomonocytic Leukemia?
Presenter: Alexander Luchinin
Session: Poster display session
Resources:
Abstract
YO21 - Sanctuary Site Central Nervous System Relapse-Refractory DLBCL Responding to Nivolumab and Lenalidomide.
Presenter: Irappa Madabhavi
Session: Poster display session
Resources:
Abstract
YO22 - External Auditory Canal Mass: A Case Series of Squamous Cell Carcinoma
Presenter: Mel Valerie Cruz-Ordinario
Session: Poster display session
Resources:
Abstract
YO23 - Soft tissue Giant cell tumor presented as Nasopharyngeal mass: A case report
Presenter: Emmelyn Buenacosa-Nepucpan
Session: Poster display session
Resources:
Abstract
YO25 - Hyperprogression after pembrolizumab in recurrent oropharyngeal cancer and the use of nab-paclitaxel as salvage treatment- A case report.
Presenter: Izzati Rosli
Session: Poster display session
Resources:
Abstract
YO26 - Exacerbation of radiation necrosis around the radiotherapy-pretreated brain metastases site after immune checkpoint inhibitors.
Presenter: Minako Nishio
Session: Poster display session
Resources:
Abstract
YO27 - Comparative Study Of 20Gray/5Fraction And 30Gray/10 Fraction Whole Brain Radiation In Brain Metastasis
Presenter: Pradip Bhandari
Session: Poster display session
Resources:
Abstract
YO28P - The response to anaplastic lymphoma kinase (ALK) inhibitor in metastatic anaplastic thyroid carcinoma (ATC)
Presenter: Nur Faizah Ab Muin
Session: Poster display session
Resources:
Abstract
YO29 - Acute kidney injury secondary to bilateral renal artery tumor thrombosis in a case of posterior mediastinal undifferentiated sarcoma: case report
Presenter: Ritsu Ibusuki
Session: Poster display session
Resources:
Abstract
YO30 - Follicular dendritic cell sarcoma of the tonsil- a multimodality approach
Presenter: Rich Ericson King
Session: Poster display session
Resources:
Abstract