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
5383 - A pilot trial to investigate the impact of a personalised self-management lifestyle programme using mobile technology on the health and wellbeing of cancer survivors
Presenter: Mary Grace Kelly
Session: Poster Display session 3
Resources:
Abstract
5084 - The BRIGHTLIGHT national survey of the impact of specialist teenage and young adult cancer care on caregivers’ information and support needs
Presenter: Rachel Taylor
Session: Poster Display session 3
Resources:
Abstract
4328 - Life beyond cancer: Occupational health care service support in returning work experienced by cancer survivals
Presenter: Minna Nurmi
Session: Poster Display session 3
Resources:
Abstract
3337 - Investigating the factors related to primary caregivers' burden in oncology patients in Greece
Presenter: Ourania Govina
Session: Poster Display session 3
Resources:
Abstract
3387 - Factors Influencing the Level of Emotional Support from Nurses Perceived by Patients Undergoing Haematopoietic Stem Cell Transplantation in Protective Isolation
Presenter: Michela Piredda
Session: Poster Display session 3
Resources:
Abstract
935 - Progressive Muscle Relaxation and Guided Imagery Techniques and the Way of Coping of Parents of Children with Malignancies: A randomized controlled trial
Presenter: Tsitsi Theologia
Session: Poster Display session 3
Resources:
Abstract
3457 - Pharmacist and Nurse Led Melanoma Immunotherapy Clinic
Presenter: Dharmisha Chauhan
Session: Poster Display session 3
Resources:
Abstract
5160 - Measuring the impact of the Irish Cancer Society's Cancer Information Services
Presenter: Aileen McHale
Session: Poster Display session 3
Resources:
Abstract
4297 - It's Great to Talk
Presenter: Noreen Andersen
Session: Poster Display session 3
Resources:
Abstract
4444 - Impact of Burn-Out Syndrome in Oncology personnel and its improvement through specific interventions
Presenter: Inmaculada Ortega
Session: Poster Display session 3
Resources:
Abstract