abstracts Conclusions: HCG values correlate with the tumour stage and levels 2.000 IU/l are associated with an impaired outcome concerning OS. Our results should be considered for the risk stratification of HCG positive seminoma patients. Legal entity responsible for the study: The authors. Funding: Has not received any funding. Disclosure: T. Hermanns: Advisory / Consultancy: Bayer und MSD. U. De Giorgi: Research grant / Funding (self): AstraZeneca, Roche, Sanofi; Travel / Accommodation / Expenses: BMS, Ipsen, Janssen, Pfizer; Advisory / Consultancy: Astellas, Bayer, BMS, Ipsen, Janssen, Merck, Pfizer, Sanofi. R. Cathomas: Advisory / Consultancy: AstraZeneca, Astellas, Bayer, Janssen, Sanofi, BMS, MSD, Roche, Pfizer; Speaker Bureau / Expert testimony: Debiopharm, Astellas. C. Oing: Honoraria (self), Travel / Accommodation / Expenses: IPSEN, Medac; Research grant / Funding (institution): Roche. All other authors have declared no conflicts of interest.
Diagnosis, management, and burden of renal cell carcinomas: Results from a global patient survey in 43 countries
R. Giles1, D. Maskens2, R. Bick3, R. Martinez4, M. Packer5, A. Bex6, D.Y.C. Heng7, J.M.G. Larkin8, S.J. Maclennan9, M. Jewett10, E. Jonasch11 1 Chair, International Kidney Cancer Coalition, Duivendrecht, Netherlands, 2IKCC, Kidney Cancer Canada, Toronto, ON, Canada, 3Patient advocacy, Kidney Cancer Canada, Toronto, ON, Canada, 4Patient Advocacy, Smart Patients Inc, Mountain View, CA, USA, 5 Patient advocacy, Kidney Cancer UK, Harston, UK, 6Surgical Oncology/Urology, The Netherlands Cancer Institute Antoni van Leeuwenhoek Hospital, Amsterdam, Netherlands, 7Oncology, University of Calgary, Calgary, AB, Canada, 8Medicine, Royal Marsden Hospital NHS Foundation Trust, London, UK, 9Academic Urology Unit, Health Services Research Unit, University of Aberdeen, Aberdeen, UK, 10Urology, Princess Margaret Cancer Centre, Toronto, ON, Canada, 11GU Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA Background: The International Kidney Cancer Coalition (IKCC) is a federation of 38 affiliated patient organizations representing 1.2 million patients worldwide that is committed to reduce the global burden of kidney cancer. A large-scale global survey of RCC patients to capture real world experiences (RWE) has never been undertaken. Methods: The 35-question survey was designed to identify geographic variations in patient education, experience and awareness, access to care, best practices, quality of life, involvement in clinical trials and to highlight unmet needs. The survey was conducted in Sept-Oct 2018 and completed online or in paper form by kidney cancer patients and /or their caregivers identified by IKCC’s 38 Affiliate Organizations and through social media in 14 languages. Results: 1,983 responses were recorded from 43 countries. Analysis revealed that at diagnosis, 43% of all respondents had no understanding of their RCC sub-type; patients with clear cell carcinoma (64%) had a notably poorer understanding of their RCC subtype than did patients with rarer RCC subtypes. While 96% of respondents reported psychosocial impacts, surprisingly, only 50% disclosed them to their healthcare team. Of the 70% of patients who were never asked to participate in a clinical trial, 89% responded they would have “fairly likely” done so if asked. RCC patients <45 years old reported nearly twice as many barriers to treatment as patients >45 at diagnosis. Females reported longer delays to diagnosis than males. Shared decision making remains aspirational across major cancer centers and community hospitals: globally 29% of all patients reported no involvement in their treatment decision, responding ‘my doctor decided for me’. Conclusions: This exploratory research sheds light on the unmet needs in the RCC patient experience and warrants further analysis. This first-ever global survey serves as a benchmark for longitudinal data collection. RWE indicates opportunities to improve communication about diagnosis, psychosocial impacts, and clinical trials. Legal entity responsible for the study: The International Kidney Cancer Coalition. Funding: International Kidney Cancer Coalition. Disclosure: All authors have declared no conflicts of interest.
916P
Health-related quality of life (HRQoL) and updated follow-up from KEYNOTE-057: Phase II study of pembrolizumab (pembro) for patients (pts) with high-risk (HR) non-muscle invasive bladder cancer (NMIBC) unresponsive to bacillus calmette-gue´rin (BCG)
R. de Wit1, G.S. Kulkarni2, E. Uchio3, J.L. Boormans1, M. Roumiguie´4, L.E.M. Krieger5, E.A. Singer6, D.F. Bajorin7, A.M. Kamat8, P. Grivas9, H.K. Seo10, H. Nishiyama11, B.R. Konety12, T. Saretsky13, H. Li13, K. Nam13, E. Sbar13, A.V. Balar14 1 Medical Oncology, Erasmus MC, Rotterdam, Netherlands, 2Surgery & Surgical Oncology, UHN Princess Margaret Cancer Centre, University of Toronto, Toronto, ON, Canada, 3Urology, UC Irvine Health, Orange, CA, USA, 4Urology, Institut Universitaire du Cancer Toulouse Oncopole CHU, Toulouse, France, 5Medical Oncology, Royal North Shore Hospital, Northern Cancer Institute, St Leonards, Australia, 6Urologic Oncology, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ, USA, 7Medical Oncology, Memorial Sloan Kettering Cancer Center, New York, NY, USA, 8Urology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA, 9Medical Oncology, University of Washington, Seattle, WA, USA, 10Urology, National Cancer Center, Goyang, Republic of Korea, 11Urology, University of Tsukuba, Tsukuba, Japan, 12Urology, University of Minnesota, Minneapolis, MN, USA, 13Medical Oncology, Merck & Co., Inc., Kenilworth, NJ, USA, 14Medicine, Perlmutter Cancer Center, NYU Langone Health, New York, NY, USA
v364 | Genitourinary Tumours, Non-Prostate
Background: Efficacy and safety of pembro in pts with HR BCG-unresponsive NMIBC was evaluated in the single-arm phase 2 KEYNOTE-057 study (NCT02625961); updated follow-up of interim data and exploratory HRQoL analyses are reported. Methods: Pts with histologically confirmed HR BCG-unresponsive CIS with or without papillary tumors who received adequate BCG therapy and who were ineligible or refused radical cystectomy (cohort A) were eligible. Pts received pembro 200 mg Q3W for 24 mo or until recurrence, progression, or unacceptable toxicity; those who developed HR NMIBC or progressive disease were required to discontinue. Key end points: complete response rate (CRR), duration of response, and safety. HRQoL was assessed using the Functional Assessment of Cancer Therapy-Bladder Cancer (FACT-Bl) scale. Results: 102 pts enrolled in cohort A as of enrollment cutoff. Median (range) duration of follow-up was 21.1 mo (4.6-33.4); CRR was 41.2% (95% CI, 31.5-51.4) by central assessment. Among 42 pts with CR, median CR duration was 13.5 mo (range, 0þ to 26.8þ); 57.4% had CR 12 mo (Kaplan-Meier). 22 pts (52.4%) maintained CR at last follow-up. 20 (47.6%) experienced recurrent NMIBC after CR. At time of analysis, there were no occurrences of progression to muscle-invasive disease (T2) or metastatic bladder cancer. For pts with CR, HRQoL was stable over time. At a prespecified analysis timepoint of week 39, the majority of pts (71.1% for FACT-G total and 77.8% for FACT-G physical well-being score) had improved (7 or 3 point increase, respectively) or stable (change between –7 and þ7 or –3 and þ3 points, respectively) scores from baseline. Treatment-related adverse events (TRAEs) occurred in 67 (65.7%) pts; most frequent (10%) were fatigue (10.8%), pruritus (10.8%), and diarrhea (10.8%). Grade 3/4 TRAEs occurred in 13 (12.7%) pts. Conclusions: Pembro continued to show encouraging antitumor activity in pts with HR BCG-unresponsive CIS with or without papillary tumors plus maintenance of HRQoL. The safety profile was consistent with the known profile of pembro. Clinical trial identification: NCT02625961; December 9, 2015. Editorial acknowledgement: Matthew Grzywacz, PhD, of the ApotheCom pembrolizumab team (Yardley, PA, USA), funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. Legal entity responsible for the study: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. Funding: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. Disclosure: R. de Wit: Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Merck; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Sanofi; Honoraria (self), Advisory / Consultancy: Roche; Honoraria (self), Research grant / Funding (institution): Bayer; Honoraria (self): Janssen; Advisory / Consultancy: Clovis. G.S. Kulkarni: Advisory / Consultancy: Ferring; Advisory / Consultancy: Janssen; Advisory / Consultancy: Astellas; Advisory / Consultancy, Travel / Accommodation / Expenses: Bayer; Advisory / Consultancy: Theralase; Research grant / Funding (self): Biosyent; Honoraria (self), Travel / Accommodation / Expenses: AbbVie; Honoraria (self), Travel / Accommodation / Expenses: TerSera; Travel / Accommodation / Expenses: Sanofi; Advisory / Consultancy: Amgen. J.L. Boormans: Advisory / Consultancy: BMS; Advisory / Consultancy: Roche; Advisory / Consultancy: MSD; Advisory / Consultancy: Janssen; Research grant / Funding (self): GenomeDx Biosciences. L.E.M. Krieger: Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: Bayer; Advisory / Consultancy: AstraZeneca; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: BMS; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: MSD; Advisory / Consultancy, Travel / Accommodation / Expenses: Roche; Honoraria (self), Advisory / Consultancy: Janssen; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Ipsen; Honoraria (self), Advisory / Consultancy: Novartis; Speaker Bureau / Expert testimony: Pfizer; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Astellas. E.A. Singer: Research grant / Funding (self): Astellas/Medivation. D.F. Bajorin: Advisory / Consultancy, Research grant / Funding (self): Merck; Advisory / Consultancy: Genentech; Advisory / Consultancy: Bristol-Myers Squibb; Advisory / Consultancy: Urogen; Advisory / Consultancy, Research grant / Funding (self): Novartis. A.M. Kamat: Research grant / Funding (institution): FKD; Honoraria (self), Research grant / Funding (institution): Merck; Research grant / Funding (institution): Telesta; Research grant / Funding (institution): Adolor; Honoraria (self): TMC Innovation; Honoraria (self): BMS; Honoraria (self): Arquer; Honoraria (self): MDxHealth; Honoraria (self): Photocure; Honoraria (self): Theralase; Honoraria (self): Cepheid; Honoraria (self): Medac; Honoraria (self): Asieris; Honoraria (self): Pfizer; Honoraria (self): AstraZeneca. P. Grivas: Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Merck & Co., Inc.; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution), Educational unbranded activity: Genentech; Honoraria (self), Advisory / Consultancy: Dendreon; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Bayer; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Pfizer; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Educational unbranded activity: Bristol-Myers Squibb; Honoraria (self), Advisory / Consultancy: Exelixis; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: AstraZeneca; Honoraria (self), Advisory / Consultancy: Biocept; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Clovis Oncology; Honoraria (self), Advisory / Consultancy: EMD Serono; Honoraria (self), Advisory / Consultancy: Seattle Genetics; Honoraria (self), Advisory / Consultancy: Foundation Medicine; Honoraria (self), Advisory / Consultancy: Driver Inc.; Honoraria (self), Advisory / Consultancy: QED Therapeutics; Honoraria (self), Advisory / Consultancy: Heron Therapeutics; Honoraria (self), Advisory / Consultancy: Janssen; Research grant / Funding (institution): Mirati; Research grant / Funding (institution): Oncogenex; Research grant / Funding (institution): Bavarian Nordic, Immunomedics. B.R. Konety: Advisory / Consultancy, Research grant / Funding (institution): Photocure; Advisory / Consultancy: Pacific Edge; Advisory / Consultancy: Taris; Advisory / Consultancy: Boston Scientific; Advisory / Consultancy: NxThera; Research grant / Funding (institution): Genomic Health; Research grant / Funding (institution): Merck; Research grant / Funding (institution): BMS. T. Saretsky: Shareholder / Stockholder / Stock options, Full / Part-time employment: Merck and Co., Inc. H. Li: Shareholder / Stockholder / Stock options, Full / Part-time employment: Merck. K. Nam: Shareholder / Stockholder / Stock options, Full / Part-time employment: Merck. E. Sbar: Leadership role, Travel / Accommodation / Expenses, Shareholder / Stockholder / Stock options, Full / Part-time employment: MSD; Shareholder / Stockholder / Stock options: BMS; Shareholder / Stockholder / Stock options: Pfizer. A.V. Balar: Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Genentech; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Merck; Advisory / Consultancy: Incyte; Honoraria (self), Advisory / Consultancy, Research grant / Funding
Volume 30 | Supplement 5 | October 2019
Downloaded from https://academic.oup.com/annonc/article-abstract/30/Supplement_5/mdz249.014/5576319 by guest on 25 October 2019
915PD
Annals of Oncology