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
4614 - Predictors of Response to Checkpoint Inhibitors in Naïve and Ipilimumab-Refractory Melanoma
Presenter: Domenico Mallardo
Session: Poster Display session 3
Resources:
Abstract
2901 - IFN-γ/IL-10 ratio as predictive biomarker for response to anti-PD-1 therapy in metastatic melanoma patients
Presenter: Emilio Giunta
Session: Poster Display session 3
Resources:
Abstract
2306 - Multiplex Chromogenic Immunohistochemistry (IHC) for Spatial Analysis of Checkpoint-Positive Tumor Infiltrating Lymphocytes (TILs)
Presenter: Scott Ely
Session: Poster Display session 3
Resources:
Abstract
1678 - The role of PD-L1 expression as a predictive biomarker in advanced renal cell carcinoma: a meta-analysis of randomized clinical trials.
Presenter: Alberto Carretero-Gonzalez
Session: Poster Display session 3
Resources:
Abstract
5138 - Radiomic Features as a Non-invasive Biomarker to Predict Response to Immunotherapy in Recurrent or Metastatic Urothelial Carcinoma
Presenter: Kye Jin Park
Session: Poster Display session 3
Resources:
Abstract
5800 - Integrative combination of high-plex digital profiling techniques and cluster analysis to reveal complex immune biology in the tumor microenvironment of mesothelioma
Presenter: Carmen Ballesteros-Merino
Session: Poster Display session 3
Resources:
Abstract
5736 - Predictive factors of response to immunotherapy in 198 patients with metastatic non-microcytic lung cancer (mNSCLC): real world data from 2 university hospitals in Spain
Presenter: Juan Felipe Cordoba Ortega
Session: Poster Display session 3
Resources:
Abstract
5645 - Evaluating Lung CT Density Changes Among Patients with Extensive Stage Small Cell Lung Cancer (ES-SCLC) Treated with Thoracic Radiotherapy (TRT) alone or TRT Followed by Combined Ipilimumab (IPI) and Nivolumab (NIVO).
Presenter: Kujtim Latifi
Session: Poster Display session 3
Resources:
Abstract
1540 - Immuno-oncology therapy biomarkers differences between polyoma-virus positive and negative Merkel cell carcinomas
Presenter: Zoran Gatalica
Session: Poster Display session 3
Resources:
Abstract
4538 - Can we improve patient selection for phase 1 clinical trials (Ph1) based on Immuno-Oncology score prognostic index (VIO)?
Presenter: Ignacio Matos Garcia
Session: Poster Display session 3
Resources:
Abstract