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1. APF530 versus ondansetron, each in a guideline-recommended three-drug regimen, for the prevention of chemotherapy-induced nausea and vomiting due to anthracycline plus cyclophosphamide–based highly emetogenic chemotherapy regimens: a post hoc subgroup analysis of the Phase III randomized MAGIC trial

Author

Schnadig ID, Agajanian R, Dakhil C, Gabrail N, Vacirca J, Taylor C, Wilks S, Braun E, Mosier MC, Geller RB, Schwartzberg L, and Vogelzang N

Subjects
APF530, extended release granisetron, chemotherapy induced nausea and vomiting (CINV), highly emetogenic chemotherapy (HEC), anthracycline, cyclophosphamide, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Ian D Schnadig1, Richy Agajanian2, Christopher Dakhil3, Nashat Gabrail4, Jeffrey Vacirca5, Charles Taylor6, Sharon Wilks7, Eduardo Braun8, Michael C Mosier9, Robert B Geller10, Lee Schwartzberg11, Nicholas Vogelzang12 1Compass Oncology, US Oncology Research, Tualatin, OR, 2The Oncology Institute of Hope and Innovation, Whittier, CA, 3Cancer Center of Kansas, Wichita, KS, 4Gabrail Cancer Center, Canton, OH, 5North Shore Hematology Oncology, East Setauket, NY, 6Tulsa Cancer Institute, Tulsa, OK, 7Cancer Care Centers of South Texas, San Antonio, TX, 8Michiana Hematology Oncology, Westville, IN, 9Biostatistics, EMB Statistical Solutions, LLC, Overland Park, KS, 10Medical Affairs, Heron Therapeutics, Inc., San Diego, CA, 11West Cancer Center, Germantown, TN, 12Comprehensive Cancer Centers of Nevada, Las Vegas, NV, USA Background: APF530, a novel extended-release granisetron injection, was superior to ondansetron in a guideline-recommended three-drug regimen in preventing delayed-phase chemotherapy-induced nausea and vomiting (CINV) among patients receiving highly emetogenic chemotherapy (HEC) in the double-blind Phase III Modified Absorption of Granisetron In the prevention of CINV (MAGIC) trial.Patients and methods: This MAGIC post hoc analysis evaluated CINV prevention efficacy and safety of APF530 versus ondansetron, each with fosaprepitant and dexamethasone, in patient subgroup receiving an anthracycline plus cyclophosphamide (AC) regimen. Patients were randomized 1:1 to APF530 500 mg subcutaneously (granisetron 10 mg) or ondansetron 0.15 mg/kg intravenously (IV) (≤16 mg); stratification was by planned cisplatin ≥50 mg/m2 (yes/no). Patients were to receive fosaprepitant 150 mg IV and dexamethasone 12 mg IV on day 1, then dexamethasone 8 mg orally once daily on day 2 and twice daily on days 3 and 4. Patients were mostly younger females (APF530 arm, mean age 54.1 years, female, 99.3%; ondansetron arm, 53.8 years, female 98.3%). The primary end point was delayed-phase (>24–120 hours) complete response (CR). Results: APF530 versus ondansetron regimens achieved numerically better CINV control in delayed and overall (0–120 hours) phases for CR, complete control, total response, rescue medication use, and proportion with no nausea. APF530 trends are consistent with the overall population, although not statistically superior given the underpowered AC subgroup analysis. The APF530 regimen in this population was generally well tolerated, with safety comparable to that of the overall population.Conclusion: APF530 plus fosaprepitant and dexamethasone effectively prevented CINV among patients receiving AC-based HEC, a large subgroup in whom CINV control has traditionally been challenging. Keywords: APF530, extended release granisetron, chemotherapy-induced nausea and vomiting (CINV), highly emetogenic chemotherapy (HEC), anthracycline, cyclophosphamide

Published
2017

2. Cabozantinib in hepatocellular carcinoma: results of a phase 2 placebo-controlled randomized discontinuation study

Author

Kelley, RK, Verslype, C, Cohn, AL, Yang, T-S, Su, W-C, Burris, H, Braiteh, F, Vogelzang, N, Spira, A, Foster, P, Lee, Y, and Van Cutsem, E

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Liver Disease, Clinical Trials and Supportive Activities, Clinical Research, Cancer, Liver Cancer, Digestive Diseases, Rare Diseases, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Adult, Aged, Anilides, Carcinoma, Hepatocellular, Disease-Free Survival, Double-Blind Method, Drug-Related Side Effects and Adverse Reactions, Female, Humans, Kaplan-Meier Estimate, Liver Neoplasms, Male, Middle Aged, Niacinamide, Phenylurea Compounds, Protein Kinase Inhibitors, Pyridines, Sorafenib, hepatocellular carcinoma, cabozantinib, vascular endothelial growth factor receptor, progression-free survival, overall survival, tumor response, Oncology & Carcinogenesis, Clinical sciences, Oncology and carcinogenesis
Abstract

BackgroundCabozantinib, an orally bioavailable inhibitor of tyrosine kinases including MET, AXL, and VEGF receptors, was assessed in patients with hepatocellular carcinoma (HCC) as part of a phase 2 randomized discontinuation trial with nine tumor-type cohorts.Patients and methodsEligible patients had Child-Pugh A liver function and ≤1 prior systemic anticancer regimen, completed ≥4 weeks before study entry. The cabozantinib starting dose was 100 mg daily. After an initial 12-week cabozantinib treatment period, patients with stable disease (SD) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 were randomized to cabozantinib or placebo. The primary endpoint of the lead-in stage was objective response rate (ORR) at week 12, and the primary endpoint of the randomized stage was progression-free survival (PFS).ResultsAmong the 41 HCC patients enrolled, the week 12 ORR was 5%, with 2 patients achieving a confirmed partial response (PR). The week 12 disease control rate (PR or SD) was 66% (Asian subgroup: 73%). Of patients with ≥1 post-baseline scan, 78% had tumor regression, with no apparent relationship to prior sorafenib therapy. Alpha-fetoprotein (AFP) response (>50% reduction from baseline) occurred in 9 of the 26 (35%) patients with elevated baseline AFP and ≥1 post-baseline measurement. Twenty-two patients with SD at week 12 were randomized. Median PFS after randomization was 2.5 months with cabozantinib and 1.4 months with placebo, although this difference was not statistically significant. Median PFS and overall survival from Day 1 in all patients were 5.2 and 11.5 months, respectively. The most common grade 3/4 adverse events, regardless of attribution, were diarrhea (20%), hand-foot syndrome (15%), and thrombocytopenia (15%). Dose reductions were utilized in 59% of patients.ConclusionsCabozantinib has clinical activity in HCC patients, including objective tumor responses, disease stabilization, and reductions in AFP. Adverse events were managed with dose reductions.Trial registration numberNCT00940225.

Published
2017

3. Efficacy and safety of rucaparib in previously treated, locally advanced or metastatic urothelial carcinoma from a phase 2, open-label trial (ATLAS)

Author

Grivas, P., Loriot, Y., Morales-Barrera, R., Teo, M. Y., Zakharia, Y., Feyerabend, S., Vogelzang, N. J., Grande, E., Adra, N., Alva, A., Necchi, A., Rodriguez-Vida, A., Gupta, S., Josephs, D. H., Srinivas, S., Wride, K., Thomas, D., Simmons, A., Loehr, A., Dusek, R. L., Nepert, D., and Chowdhury, S.

Published
2021
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4. Health-related quality of life and pain outcomes with [177Lu]Lu-PSMA-617 plus standard of care versus standard of care in patients with metastatic castration-resistant prostate cancer (VISION): a multicentre, open-label, randomised, phase 3 trial

Author

Fizazi, K., Herrmann, K., Krause, B.J., Rahbar, K., Chi, K.N., Morris, M.J., Sartor, O., Tagawa, S.T., Kendi, A.T., Vogelzang, N., Calais, J., Nagarajah, J., Wei, X.X., Koshkin, V.S., Beauregard, J.M., Chang, B., Ghouse, R., DeSilvio, M., Messmann, R.A., and Bono, J. de

Subjects
All institutes and research themes of the Radboud University Medical Center, Oncology, Tumours of the digestive tract Radboud Institute for Molecular Life Sciences [Radboudumc 14]
Abstract

Item does not contain fulltext BACKGROUND: In VISION, the prostate-specific membrane antigen (PSMA)-targeted radioligand therapy lutetium-177 [(177)Lu]Lu-PSMA-617 (vipivotide tetraxetan) improved radiographic progression-free survival and overall survival when added to protocol-permitted standard of care in patients with metastatic castration-resistant prostate cancer. Here, we report additional health-related quality of life (HRQOL), pain, and symptomatic skeletal event results. METHODS: This multicentre, open-label, randomised, phase 3 trial was conducted at 84 cancer centres in nine countries in North America and Europe. Eligible patients were aged 18 years or older; had progressive PSMA-positive metastatic castration-resistant prostate cancer; an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2; and had previously received of at least one androgen receptor pathway inhibitor and one or two taxane-containing regimens. Patients were randomly assigned (2:1) to receive either [(177)Lu]Lu-PSMA-617 plus protocol-permitted standard of care ([(177)Lu]Lu-PSMA-617 group) or standard of care alone (control group) using permuted blocks. Randomisation was stratified by baseline lactate dehydrogenase concentration, liver metastases, ECOG performance status, and androgen receptor pathway inhibitor inclusion in standard of care. Patients in the [(177)Lu]Lu-PSMA-617 group received intravenous infusions of 7·4 gigabecquerel (GBq; 200 millicurie [mCi]) [(177)Lu]Lu-PSMA-617 every 6 weeks for four cycles plus two optional additional cycles. Standard of care included approved hormonal treatments, bisphosphonates, and radiotherapy. The alternate primary endpoints were radiographic progression-free survival and overall survival, which have been reported. Here we report the key secondary endpoint of time to first symptomatic skeletal event, and other secondary endpoints of HRQOL assessed with the Functional Assessment of Cancer Therapy-Prostate (FACT-P) and EQ-5D-5L, and pain assessed with the Brief Pain Inventory-Short Form (BPI-SF). Patient-reported outcomes and symptomatic skeletal events were analysed in all patients who were randomly assigned after implementation of measures designed to reduce the dropout rate in the control group (on or after March 5, 2019), and safety was analysed according to treatment received in all patients who received at least one dose of treatment. This trial is registered with ClinicalTrials.gov, NCT03511664, and is active but not recruiting. FINDINGS: Between June 4, 2018, and Oct 23, 2019, 831 patients were enrolled, of whom 581 were randomly assigned to the [(177)Lu]Lu-PSMA-617 group (n=385) or control group (n=196) on or after March 5, 2019, and were included in analyses of HRQOL, pain, and time to first symptomatic skeletal event. The median age of patients was 71 years (IQR 65-75) in the [(177)Lu]Lu-PSMA-617 group and 72·0 years (66-76) in the control group. Median time to first symptomatic skeletal event or death was 11·5 months (95% CI 10·3-13·2) in the [(177)Lu]Lu-PSMA-617 group and 6·8 months (5·2-8·5) in the control group (hazard ratio [HR] 0·50, 95% CI 0·40-0·62). Time to worsening was delayed in the [(177)Lu]Lu-PSMA-617 group versus the control group for FACT-P score (HR 0·54, 0·45-0·66) and subdomains, BPI-SF pain intensity score (0·52, 0·42-0·63), and EQ-5D-5L utility score (0·65, 0·54-0·78). Grade 3 or 4 haematological adverse events included decreased haemoglobin (80 [15%] of 529 assessable patients who received [(177)Lu]Lu-PSMA-617 plus standard of care vs 13 [6%] of 205 who received standard of care only), lymphocyte concentrations (269 [51%] vs 39 [19%]), and platelet counts (49 [9%] vs five [2%]). Treatment-related adverse events leading to death occurred in five (1%) patients who received [(177)Lu]Lu-PSMA-617 plus standard of care (pancytopenia [n=2], bone marrow failure [n=1], subdural haematoma [n=1], and intracranial haemorrhage [n=1]) and no patients who received standard of care only. INTERPRETATION: [(177)Lu]Lu-PSMA-617 plus standard of care delayed time to worsening in HRQOL and time to skeletal events compared with standard of care alone. These findings support the use of [(177)Lu]Lu-PSMA-617 in patients with metastatic castration-resistant prostate cancer who received previous androgen receptor pathway inhibitor and taxane treatment. FUNDING: Advanced Accelerator Applications (Novartis). 01 juni 2023

Published
2023
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6. Efficacy and safety of pembrolizumab in metastatic urothelial carcinoma:results from KEYNOTE-045 and KEYNOTE-052 after up to 5 years of follow-up

Author

Balar, A. V., Castellano, D. E., Grivas, P., Vaughn, D. J., Powles, T., Vuky, J., Fradet, Y., Lee, J. L., Fong, L., Vogelzang, N. J., Climent, M. A., Necchi, A., Petrylak, D. P., Plimack, E. R., Xu, J. Z., Imai, K., Moreno, B. H., Bellmunt, J., de Wit, R., O'Donnell, P. H., Balar, A. V., Castellano, D. E., Grivas, P., Vaughn, D. J., Powles, T., Vuky, J., Fradet, Y., Lee, J. L., Fong, L., Vogelzang, N. J., Climent, M. A., Necchi, A., Petrylak, D. P., Plimack, E. R., Xu, J. Z., Imai, K., Moreno, B. H., Bellmunt, J., de Wit, R., and O'Donnell, P. H.

Abstract

Background: Immune checkpoint inhibitors are a standard therapy in metastatic urothelial carcinoma (UC). Long-term follow-up is necessary to confirm durability of response and identify further safety concerns. Patients and methods: In KEYNOTE-045, patients with metastatic UC that progressed on platinum-containing chemotherapy were randomly assigned 1:1 to receive pembrolizumab or investigator's choice of paclitaxel, docetaxel, or vinflunine. Primary endpoints were progression-free survival per RECIST version 1.1 by blinded independent central review (BICR) and overall survival. In KEYNOTE-052, cisplatin-ineligible patients with metastatic UC received first-line pembrolizumab. The primary endpoint was objective response rate per RECIST version 1.1 by BICR. Results: A total of 542 patients (pembrolizumab, n = 270; chemotherapy, n = 272) were randomly assigned in KEYNOTE-045. The median follow-up was 62.9 months (range 58.6-70.9 months; data cut-off 1 October 2020). At 48 months, overall survival rates were 16.7% for pembrolizumab and 10.1% for chemotherapy; progression-free survival rates were 9.5% and 2.7%, respectively. The median duration of response (DOR) was 29.7 months (range 1.6+ to 60.5+ months) for pembrolizumab and 4.4 months (range 1.4+ to 63.1+ months) for chemotherapy; 36-month DOR rates were 44.4% and 28.3%, respectively. A total of 370 patients were enrolled in KEYNOTE-052. The median follow-up was 56.3 months (range 51.2-65.3 months; data cut-off 26 September 2020). The confirmed objective response rate was 28.9% (95% confidence interval 24.3-33.8), and the median DOR was 33.4 months (range 1.4+ to 60.7+ months); the 36-month DOR rate was 44.8%. Most treatment-related adverse events for pembrolizumab in either study were grade 1 or 2 and manageable, which is consistent with prior reports. Conclusion: With ∼5 years of follow-up, pembrolizumab monotherapy continued to demonstrate durable efficacy with no new safety signals in patients with platinum-re

Published
2023

8. [177Lu]Lu-PSMA-617 dans le cancer de la prostate métastatique positif au PSMA et résistant à la castration : analyses des sous-groupes de traitement antérieurs et concomitants de l’essai vision

Author

Bernard Tessier, A., primary, Fizazi, K., additional, Vaishampayan, N., additional, Morris, M., additional, Krause, B., additional, Vogelzang, N., additional, Kendi, A., additional, Nordquist, L., additional, Nagarajah, J., additional, Beer, T., additional, El-Haddad, G., additional, and Sartor, O., additional

Published
2022
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9. Renal Cancer

Author

Ryan, C. W., Vogelzang, N. J., Vokes, Everett E., editor, and Golomb, Harvey M., editor

Published
2003
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11. Mesothelioma

Author

Kindler, H. L., Vogelzang, N. J., Vokes, Everett E., editor, and Golomb, Harvey M., editor

Published
2003
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12. Résultats de qualité de vie liée à la santé, douleur et tolérance de l’étude de phase 3 VISION du 177Lu-PSMA-617 chez des patients atteints d’un CPRCm

Author

Fizazi, K., primary, Flippot, R., additional, Hermann, K., additional, Krause, B.J., additional, Rahbar, K., additional, Chi, K.N., additional, Morris, M.J., additional, Sartor, O., additional, Tagawa, S.T., additional, Kendi, A.T., additional, Vogelzang, N., additional, Calais, J., additional, Nagarajah, J., additional, Wei, X.X., additional, Koshkin, V.S., additional, Beauregard, J.M., additional, Chang, B., additional, DeSilvio, M., additional, Messmann, R.A., additional, and de Bono, J., additional

Published
2022
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22. Re: Intermittent versus Continuous Androgen Deprivation in Prostate Cancer

Author

Hussain, M., Tangen, C. M., Berry, D. L., Higano, C. S., Crawford, E. D., Liu, G., Wilding, G., Prescott, S., Sundaram, Kanaga S., Small, E. J., Dawson, N. A., Donnelly, B. J., Venner, P. M., Vaishampayan, U. N., Schellhammer, P. F., Quinn, D. I., Raghavan, D., Ely, B., Moinpour, C. M., Vogelzang, N. J., and Thompson, I. M., Jr.

Published
2013
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23. Alpha Emitter Radium-223 and Survival in Metastatic Prostate Cancer

Author

Parker, C., Nilsson, S., Heinrich, D., Helle, S. I., OʼSullivan, J. M., Fosså, S. D., Chodacki, A., Wiechno, P., Logue, J., Seke, M., Widmark, A., Johannessen, D. C., Hoskin, P., Bottomley, D., James, N. D., Solberg, A., Syndikus, I., Kliment, J., Wedel, S., Boehmer, S., DallʼOglio, M., Franzén, L., Coleman, R., Vogelzang, N. J., OʼBryan-Tear, C. G., Staudacher, K., Garcia-Vargas, J., Shan, M., Bruland, Ø. S., and Sartor, O.

Published
2013
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24. Lenvatinib plus pembrolizumab in patients with advanced endometrial cancer: Final analysis of a multicentre, open-label, single-arm, phase 2 trial

Author

Makker, V., primary, Rasco, D., additional, Vogelzang, N., additional, Brose, M., additional, Cohn, A., additional, Mier, J., additional, DiSimone, C., additional, Hyman, D.M., additional, Stepan, D., additional, Dutcus, C., additional, Schmidt, E., additional, Guo, M., additional, Sachdev, P., additional, Shumaker, R., additional, Aghajanian, C., additional, and Taylor, M., additional

Published
2020
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43. Prospective Observational Study of Pazopanib in Patients with Advanced Renal Cell Carcinoma (PRINCIPAL Study)

Author

Schmidinger, M. Bamias, A. Procopio, G. Hawkins, R. Sanchez, A.R. Vázquez, S. Srihari, N. Kalofonos, H. Bono, P. Pisal, C.B. Hirschberg, Y. Dezzani, L. Ahmad, Q. Jonasch, E. Gimeno, R.A. Herranz, U.A. Ardavanis, A. Ashraf, S.A. Bamias, A. Barone, C. Bella, S.R. Belz, H. Companario, E.B. Bolling, C. Bono, P. Bothe, K. Carteni, G. Espinosa, J.C. Clausse, M. Confente, C. Coskun, H. Herrero, G.C. Demey, W. D'hondt, R. Santasusana, M.D. Doshi, G. Elkiran, E. Facchini, G. Fein, L. Calvo, O.F. Flaherty, A. Fountzilas, G. Fruehauf, J. Díaz, E.G. Garcia, R. Domínguez, R.G. Ghosn, M. Glorieux, P. Goebell, P.J. Gutierrez, L.G.-A. Gonzalez, M. Green, N.B. Arnau, M.G. Harich, H.-D. Hawkins, R. Hegele, A. Pérez, C.H. Herrmann, E. Horniniger, W.J. Hutson, T.E. Janetschek, G. Kalantari, H. Kalofonos, H. Klausmann, M. Kolin, M. Krause, S. Kroening, H. Sorrosal, J.J.L. Lázaro, M. Lema, M. Lema, M.L. Lin, J. Lueck, A. Lybaert, W. Magi, A. Marina, V.A. Rey, J.P.M. Matus, G. Melear, J. Gonzalez, B.M. Milella, M. Montalar, J. Ferrandis, J.M. Nathan, P. Nechushtan, H. Nusch, A. Ojamaa, K. Oksuzoglu, B. Ozkan, M. Papazisis, K. Passalacqua, R. Pe'er, A. Gracia, J.L.P. Pichler, A. Pokker, H. Porta, C. Rauchenwald, M. Richardet, M.E. Richey, S.L. Garcia, J.M.R. Sánchez, A.R. Rudolph, R. Sabbatini, R. Salmon, J.-P. Lobera, C.S. Sarid, D.L. Saylors, G.B. Schmidinger, M. Schrijvers, D. Schulze, M. Sevilay, A. Shumaker, G.G. Siemer, S. de Prado y Otero, D.S. Srihari, N. Stoiber, F. Rodriguez, C.S. Varela, M.S. Vasanthan, S. Estevez, S.V. Vehling-Kaiser, U. Vogelzang, N. Weiss, H. Whenham, N. Wyendaele, W. Yildiz, R. Yucel, I. Zarba, J.J. Zarkar, A. Zhong, W. Ziem, P. the PRINCIPAL Study Group

Abstract

Background: Real-world data are essential to accurately assessing efficacy and toxicity of approved agents in everyday practice. PRINCIPAL, a prospective, observational study, was designed to confirm the real-world safety and efficacy of pazopanib in patients with advanced renal cell carcinoma (RCC). Subjects, Materials, and Methods: Patients with clear cell advanced/metastatic RCC and a clinical decision to initiate pazopanib treatment within 30 days of enrollment were eligible. Primary objectives included progression-free survival (PFS), overall survival (OS), objective response rate (ORR), relative dose intensity (RDI) and its effect on treatment outcomes, change in health-related quality of life (HRQoL), and safety. We also compared characteristics and outcomes of clinical-trial-eligible (CTE) patients, defined using COMPARZ trial eligibility criteria, with those of non-clinical-trial-eligible (NCTE) patients. Secondary study objectives were to evaluate clinical efficacy, safety, and RDI in patient subgroups. Results: Six hundred fifty-seven patients were enrolled and received ≥1 dose of pazopanib. Median PFS and OS were 10.3 months (95% confidence interval [CI], 9.2–12.0) and 29.9 months (95% CI, 24.7 to not reached), respectively, and the ORR was 30.3%. HRQoL showed no or little deterioration over time. Treatment-related serious adverse events (AEs) and AEs of special interest occurred in 64 (9.7%), and 399 (60.7%) patients, respectively. More patients were classified NCTE than CTE (85.2% vs. 14.8%). Efficacy of pazopanib was similar between the two groups. Conclusion: PRINCIPAL confirms the efficacy and safety of pazopanib in patients with advanced/metastatic RCC in a real-world clinical setting. Implications for Practice: PRINCIPAL is the largest (n = 657) prospective, observational study of pazopanib in patients with advanced/metastatic renal cell carcinoma, to the authors’ knowledge. Consistent with clinical trial results that often contain specific patient types, the PRINCIPAL study demonstrated that the effectiveness and safety of pazopanib is similarly safe and effective in patients with advanced kidney cancer in a real-world clinical setting. The PRINCIPAL study showed that patients with advanced kidney cancer who are treated with first-line pazopanib generally do not show disease progression for approximately 10 months and generally survive for nearly 30 months. © AlphaMed Press 2019

Published
2019

47. PL02.09 Nintedanib + Pemetrexed/Cisplatin in Patients with Unresectable MPM: Phase III Results from the LUME-Meso Trial

Author

Scagliotti, G., primary, Gaafar, R., additional, Nowak, A., additional, Nakano, T., additional, Van Meerbeeck, J., additional, Popat, S., additional, Vogelzang, N., additional, Grosso, F., additional, Aboelhassan, R., additional, Jakopovic, M., additional, Ceresoli, G., additional, Taylor, P., additional, Orlandi, F., additional, Fennell, D., additional, Novello, S., additional, Scherpereel, A., additional, Von Wangenheim, U., additional, Kim, M., additional, Barrueco, J., additional, and Tsao, A., additional

Published
2018
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