Abstract 2293
Background
Antacids (AA) are commonly used in the elderly population. Proton pump inhibitors and other drugs to neutralize the gastral pH level and to prevent gastroesophageal reflux are suspected to reduce the efficacy of tyrosine kinase inhibitors. To our knowledge, the effect of AA therapy on SUN efficacy has not been investigated in a real-world mRCC population yet.
Methods
STAR-TOR is a German multicenter registry for pts with mRCC (NCT00700258) which was amended to include SUN pts in June 2010 with regulatory and ethic committee’s approval. Objectives are the evaluation of the safety profile, the tolerability and anti-tumor activity of SUN. Here, we present data on the impact of AA therapy on the therapeutic efficacy of SUN in first-line mRCC pts.
Results
From July 2010 to February 2019, 109 active study sites recruited 550 first line SUN pts. 378 (69%)of these were reported to use AA therapy at baseline, 172 (31%) were AA non-users. Characteristics (AA yes/no): male 66.1/75.1%, median age 67.0/68.0 years, clear cell component: 81.4/81.5%. For all 550 pts, most common drug-related toxicities (incidence ≥ 15%) of any grade were gastrointestinal disorders (38.0%), general disorders including fatigue, mucosal inflammation and edema (29.1%), skin and subcutaneous tissue disorders including hand-foot syndrome (22.7%), nervous system disorders, and blood and lymphatic system disorders (both 19.1%). There was no relevant difference in adverse event rates between AA users and non-users. Efficacy (AA yes vs no): overall response rate 15.1 vs 27.4% (n = 426, p = 0.007), PFS 5.8 vs 8.0 months (mo), p = 0.11; OS 20.3 vs 25.7 mo, p = 0.01.
Conclusions
In our real-world data set, we found a relevant efficacy difference between SUN-treated first-line mRCC pts who used AA therapy at baseline compared with AA non-users, especially in terms of OS. This should be taken into account when prescribing SUN in this setting.
Clinical trial identification
NCT00700258.
Editorial acknowledgement
Legal entity responsible for the study
Pfizer Pharma GmbH, Berlin, Germany.
Funding
Pfizer Pharma GmbH, Berlin, Germany.
Disclosure
K. Schlack: Advisory / Consultancy: Roche, Ipsen, Amgen, Novartis; Travel / Accommodation / Expenses: Bayer, Ipsen, Astellas, Takeda, Pfizer, Sanofi, Janssen-Cilag. M. Boegemann: Honoraria (self): Pfizer, Eisai, MSD, BMS, Ipsen, Eusa Pharma, Novartis. M. Woike: Full / Part-time employment: Pfizer Pharma GmbH. G. Krekeler: Full / Part-time employment: Pfizer Pharma GmbH. T. Fischer: Full / Part-time employment: Winicker-Norimed GmbH. L. Bergmann: Research grant / Funding (institution): BMS; Advisory / Consultancy: BMS, Eusa, Ipsen, Novartis, Pfizer, Roche. M. Rink: Advisory / Consultancy: BMS, Ipsen, MSD, Novartis, Pfizer, Roche. A. Strauss: Advisory / Consultancy: Bayer, MBS, Eisai, Novartis, Pfizer, Roche; Honoraria (self): Amgen, Bayer, BMS, Eisai, Ipsen, MSD, Novartis, Pfizer, Roche, Sanofi-Aventis; Travel / Accommodation / Expenses: Ipsen, Novartis. All other authors have declared no conflicts of interest.
Resources from the same session
5517 - Molecular fingerprinting in breast cancer (BC) screening using Quantum Optics (QO) technology combined with an artificial intelligence (AI) approach applying the concept of “molecular profiles at n variables (MPnV)”: a prospective pilot study.
Presenter: Jean-Marc Nabholtz
Session: Poster Display session 3
Resources:
Abstract
2152 - Inferring the correlation between incidence rates of melanoma and the average tumor-specific epitope binding ability of HLA class I molecules in different populations
Presenter: Istvan Miklos
Session: Poster Display session 3
Resources:
Abstract
4382 - Thermal Liquid Biopsy as a Valuable Tool in Lung Cancer Screening Programs
Presenter: Alberto Rodrigo
Session: Poster Display session 3
Resources:
Abstract
2465 - Towards a screening test for cancer by circulating DNA analysis
Presenter: Rita Tanos
Session: Poster Display session 3
Resources:
Abstract
3788 - Evaluation of a successful launch of the MammaPrint and BluePrint NGS kit
Presenter: Leonie Delahaye
Session: Poster Display session 3
Resources:
Abstract
3863 - Analysis of prognostic factors on overall survival in elderly women treated for early breast cancer using data mining and machine learning
Presenter: Pierre Heudel
Session: Poster Display session 3
Resources:
Abstract
1993 - Circulating tumor cell detection in epithelial ovarian cancer using dual-component antibodies targeting EpCAM and FRα
Presenter: Na Li
Session: Poster Display session 3
Resources:
Abstract
4281 - CEUS of the breast: Is it feasible in improved performance of BI-RADS evaluation of critical breast lesions?——A multi-center prospective study in China
Presenter: Jun Luo
Session: Poster Display session 3
Resources:
Abstract
2268 - Classification of abnormal findings on ring-type dedicated breast PET for detecting breast cancer
Presenter: Shinsuke Sasada
Session: Poster Display session 3
Resources:
Abstract
4035 - Prediction of benign and malignant breast masses using digital mammograms texture features
Presenter: Cui Yanhua
Session: Poster Display session 3
Resources:
Abstract