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Article: Can individualized sunitinib dose and schedule changes optimize outcomes for kidney cancer patients?

Bjarnason, Georg A

Canadian Urological Association journal = Journal de l'Association des urologues du Canada

2016 Volume 10, Issue 11-12Suppl7, Page(s) S252–S255

Abstract: The recommended starting dose and schedule for sunitinib is 50 mg daily for 28 days, followed by a 14-day break with significant dose reductions to 37.5 mg (75% of starting dose), and then 25 mg (50% of starting dose) on the same schedule (four/two ... ...

Abstract	The recommended starting dose and schedule for sunitinib is 50 mg daily for 28 days, followed by a 14-day break with significant dose reductions to 37.5 mg (75% of starting dose), and then 25 mg (50% of starting dose) on the same schedule (four/two schedule). There are several reasons why these dose and scheduling recommendations may not be optimal for most patients, as outlined below.
Language	English
Publishing date	2016-12-21
Publishing country	Canada
Document type	Review ; Journal Article
ZDB-ID	2431403-1
ISSN	1911-6470
ISSN	1911-6470
DOI	10.5489/cuaj.4293
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Article ; Online: TimeTeller: A tool to probe the circadian clock as a multigene dynamical system.

Vlachou, Denise / Veretennikova, Maria / Usselmann, Laura / Vasilyev, Vadim / Ott, Sascha / Bjarnason, Georg A / Dallmann, Robert / Levi, Francis / Rand, David A

PLoS computational biology

2024 Volume 20, Issue 2, Page(s) e1011779

Abstract: Recent studies have established that the circadian clock influences onset, progression and therapeutic outcomes in a number of diseases including cancer and heart diseases. Therefore, there is a need for tools to measure the functional state of the ... ...

Abstract	Recent studies have established that the circadian clock influences onset, progression and therapeutic outcomes in a number of diseases including cancer and heart diseases. Therefore, there is a need for tools to measure the functional state of the molecular circadian clock and its downstream targets in patients. Moreover, the clock is a multi-dimensional stochastic oscillator and there are few tools for analysing it as a noisy multigene dynamical system. In this paper we consider the methodology behind TimeTeller, a machine learning tool that analyses the clock as a noisy multigene dynamical system and aims to estimate circadian clock function from a single transcriptome by modelling the multi-dimensional state of the clock. We demonstrate its potential for clock systems assessment by applying it to mouse, baboon and human microarray and RNA-seq data and show how to visualise and quantify the global structure of the clock, quantitatively stratify individual transcriptomic samples by clock dysfunction and globally compare clocks across individuals, conditions and tissues thus highlighting its potential relevance for advancing circadian medicine.
MeSH term(s)	Humans ; Mice ; Animals ; Circadian Clocks/genetics ; Transcriptome/genetics ; Gene Expression Profiling ; Circadian Rhythm/genetics
Language	English
Publishing date	2024-02-29
Publishing country	United States
Document type	Journal Article
ZDB-ID	2193340-6
ISSN	1553-7358 ; 1553-734X
ISSN (online)	1553-7358
ISSN	1553-734X
DOI	10.1371/journal.pcbi.1011779
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Article ; Online: Cabozantinib after prior checkpoint inhibitor therapy in patients with solid tumors: A systematic literature review.

Graham, Jeffrey / Vogel, Arndt / Cheng, Ann-Lii / Bjarnason, Georg A / Neal, Joel W

Cancer treatment reviews

2022 Volume 110, Page(s) 102453

Abstract: Introduction: We conducted a systematic literature review to identify evidence for cabozantinib activity in patients with solid tumors after prior checkpoint inhibitor (CPI) therapy.: Methods: The review was conducted according to PRISMA guidelines ... ...

Abstract	Introduction: We conducted a systematic literature review to identify evidence for cabozantinib activity in patients with solid tumors after prior checkpoint inhibitor (CPI) therapy. Methods: The review was conducted according to PRISMA guidelines and registered with PROSPERO (CRD42021259873). MEDLINE®, Embase, and the Cochrane Library were searched on 19 May 2021 to identify publications reporting the efficacy/effectiveness and safety/tolerability of cabozantinib in patients with solid tumors who had received prior CPI-based therapy. Publications were screened by one reviewer with uncertainties resolved by a second and/or the full author group. Risk of bias was assessed using Gradingof Recommendations Assessment, Development and Evaluation (GRADE) for clinical trials and the Newcastle-Ottawa Scale (NOS) for observational studies. Results: Of 669 publications screened, 21 were eligible: 18 reported data on renal cell carcinoma, and one each for hepatocellular carcinoma, metastatic urothelial carcinoma, and non-small cell lung cancer. Of six trial publications, three reported moderate-quality evidence and three low-quality evidence. Of 15 observational studies, NOS scores ranged from 3 to 6, suggesting a high potential for uncertainty. The studies consistently reported clinical activity for cabozantinib after CPI therapy, across treatment lines and tumor types, with no new safety signals. The findings were limited by the quality and quantity of available data. Conclusion: Cabozantinib appears to have anti-tumor activity after prior CPI therapy in patients with solid tumors. Our results are driven largely by studies in renal cell carcinoma. Evidence from ongoing phase 3 trials is required to establish further the role of cabozantinib after CPI therapy.
MeSH term(s)	Humans ; Anilides/adverse effects ; Carcinoma, Non-Small-Cell Lung/drug therapy ; Carcinoma, Renal Cell/drug therapy ; Carcinoma, Transitional Cell/drug therapy ; Kidney Neoplasms/drug therapy ; Kidney Neoplasms/pathology ; Lung Neoplasms/drug therapy ; Pyridines ; Urinary Bladder Neoplasms/drug therapy
Chemical Substances	Anilides ; cabozantinib (1C39JW444G) ; Pyridines
Language	English
Publishing date	2022-08-10
Publishing country	Netherlands
Document type	Journal Article ; Review ; Systematic Review
ZDB-ID	125102-8
ISSN	1532-1967 ; 0305-7372
ISSN (online)	1532-1967
ISSN	0305-7372
DOI	10.1016/j.ctrv.2022.102453
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Article ; Online: The future of precise cancer chronotherapeutics.

Innominato, Pasquale F / Karaboué, Abdoulaye / Bouchahda, Mohammed / Bjarnason, Georg A / Lévi, Francis A

The Lancet. Oncology

2022 Volume 23, Issue 6, Page(s) e242

MeSH term(s)	Data Collection ; Drug Chronotherapy ; Humans ; Neoplasms/drug therapy ; Neoplasms/epidemiology
Language	English
Publishing date	2022-06-22
Publishing country	England
Document type	Letter ; Comment
ZDB-ID	2049730-1
ISSN	1474-5488 ; 1470-2045
ISSN (online)	1474-5488
ISSN	1470-2045
DOI	10.1016/S1470-2045(22)00188-7
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Article ; Online: Erratum to: Extended Disease Control with Unconventional Cabozantinib Dose Increase in Metastatic Renal Cell Carcinoma.

Sharma, Akanksha / Elias, Roy / Christie, Alana / Williams, Noelle S / Pedrosa, Ivan / Bjarnason, Georg A / Brugarolas, James

Kidney cancer (Clifton, Va.)

2023 Volume 7, Issue 1, Page(s) 15

Abstract: This corrects the article DOI: 10.3233/KCA-210117.]. ...

Abstract	[This corrects the article DOI: 10.3233/KCA-210117.].
Language	English
Publishing date	2023-03-23
Publishing country	United States
Document type	Published Erratum
ZDB-ID	2961890-3
ISSN	2468-4570 ; 2468-4562
ISSN (online)	2468-4570
ISSN	2468-4562
DOI	10.3233/KCA-229030
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Article ; Online: Towards Comprehensive Clinical Trial Reporting: The Value of Unpublished Data to Inform Therapeutic Decision-Making in Metastatic Renal Cell Carcinoma.

Parmar, Ambica / Bjarnason, Georg A / Vera-Badillo, Francisco E

Clinical genitourinary cancer

2019 Volume 17, Issue 6, Page(s) e1181–e1184

MeSH term(s)	Carcinoma, Renal Cell/drug therapy ; Clinical Decision-Making ; Clinical Trials as Topic ; Endpoint Determination ; Humans ; Kidney Neoplasms/drug therapy ; Molecular Targeted Therapy ; Practice Guidelines as Topic ; Publishing ; Research Design
Language	English
Publishing date	2019-08-20
Publishing country	United States
Document type	Journal Article
ZDB-ID	2225121-2
ISSN	1938-0682 ; 1558-7673
ISSN (online)	1938-0682
ISSN	1558-7673
DOI	10.1016/j.clgc.2019.08.004
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Article ; Online: Systemic therapy in metastatic renal cell carcinoma: Emerging challenges in therapeutic choice.

Parmar, Ambica / Sander, Beate / Bjarnason, Georg A / Chan, Kelvin K W

Critical reviews in oncology/hematology

2020 Volume 152, Page(s) 102971

Abstract: The treatment landscape for metastatic renal cell carcinoma (mRCC) has undergone a substantial evolution in the past decade, with a dramatic increase in the number of available systemic therapies. Although this offers promise for improved patient ... ...

Abstract	The treatment landscape for metastatic renal cell carcinoma (mRCC) has undergone a substantial evolution in the past decade, with a dramatic increase in the number of available systemic therapies. Although this offers promise for improved patient outcomes, this rapid pace in development has led to new challenges in therapeutic choice. For instance, the absence of direct comparative evidence across all therapeutic options has led to a critical gap in evidence to clearly define preferred systemic therapy choice. Additionally, the rising cost of systemic therapies being evaluated for mRCC necessitates demonstration of cost-effectiveness prior to widespread adoption. This review provides an overview of the current treatment landscape in mRCC to highlight the emerging challenges faced by clinicians and health policy-makers. In addition, this review summarizes the currently available evidence that aims to address the above challenges.
MeSH term(s)	Antineoplastic Agents ; Carcinoma, Renal Cell/secondary ; Carcinoma, Renal Cell/therapy ; Humans ; Immunotherapy ; Kidney Neoplasms/therapy ; Molecular Targeted Therapy ; Neoplasm Metastasis
Chemical Substances	Antineoplastic Agents
Language	English
Publishing date	2020-06-01
Publishing country	Netherlands
Document type	Journal Article ; Review
ZDB-ID	605680-5
ISSN	1879-0461 ; 0737-9587 ; 1040-8428
ISSN (online)	1879-0461
ISSN	0737-9587 ; 1040-8428
DOI	10.1016/j.critrevonc.2020.102971
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Article ; Online: Sunitinib dose-escalation after disease progression in metastatic renal cell carcinoma.

Raphael, Jacques / Thawer, Alia / Bjarnason, Georg A

Urologic oncology

2018 Volume 36, Issue 1, Page(s) 12.e1–12.e6

Abstract: Purpose: Previous pharmacologic studies demonstrated that higher sunitinib exposure is associated with improved clinical outcomes in patients with metastatic renal cell carcinoma (mRCC). We aimed to assess the efficacy and toxicity of sunitinib dose- ... ...

Abstract	Purpose: Previous pharmacologic studies demonstrated that higher sunitinib exposure is associated with improved clinical outcomes in patients with metastatic renal cell carcinoma (mRCC). We aimed to assess the efficacy and toxicity of sunitinib dose-escalation in mRCC patients progressing on the standard 50mg dose. Methods: A single-institution retrospective review was conducted on mRCC patients, treated outside trials with a 50mg sunitinib dose given on an individualized schedule between October 2009 and January 2016, who subsequently progressed on imaging. All progressing patients who were dose-escalated to 62.5 and 75mg on an individualized schedule if toxicity permitted were eligible for this analysis. Median progression-free survival (PFS) and overall survival (OS) were analyzed using the Kaplan-Meier method. PFS1 and 2 were defined as the time between the start of sunitinib and first progression and the time between dose-escalation and second progression respectively. Results: A total of 25 eligible patients were identified with a median follow-up of 40.3 months (Q1-Q3: 11.1-66.6) and a mean age of 54 years (standard deviation: 12.4). Most of the patients underwent cytoreductive surgery (92%) and were men (88%). In total 32%, 44%, and 24% had a good, intermediate, and poor prognostic Heng Score, respectively. At standard doses, 60% and 16% of patients had a partial response (PR) and a stable disease (SD) as best response respectively for a median duration of 11.4 months (95% CI: 3-20.7). A total of 6 patients (24%) had progressive disease as best response. After progression, 36% and 28% had PR and SD on higher doses of sunitinib respectively for a median duration of 7.8 months (95% CI: 6.3-12.4). The median PFS1, PFS2 and OS were 6.1 months (95% CI: 2.3-19.4), 6.7 months (95% CI: 3.1-8.4) and 63.7 months (95% CI: 26-NR) respectively. The most common adverse events after dose-escalation were fatigue (56%), diarrhea (40%) and skin toxicity (28%). Conclusion: Patients with mRCC who progress on 50mg sunitinib dose, may derive a clinical benefit and prolonged survival from dose-escalation with acceptable toxicity profiles. These results need to be confirmed in prospective studies with the aim to overcome drug resistance and delay the change in systemic therapy at progression.
MeSH term(s)	Antineoplastic Agents/pharmacology ; Antineoplastic Agents/therapeutic use ; Carcinoma, Renal Cell/drug therapy ; Carcinoma, Renal Cell/mortality ; Carcinoma, Renal Cell/pathology ; Disease Progression ; Female ; Humans ; Indoles/pharmacology ; Indoles/therapeutic use ; Male ; Middle Aged ; Pyrroles/pharmacology ; Pyrroles/therapeutic use ; Retrospective Studies ; Survival Analysis ; Treatment Outcome
Chemical Substances	Antineoplastic Agents ; Indoles ; Pyrroles ; sunitinib (V99T50803M)
Language	English
Publishing date	2018
Publishing country	United States
Document type	Journal Article
ZDB-ID	1336505-8
ISSN	1873-2496 ; 1078-1439
ISSN (online)	1873-2496
ISSN	1078-1439
DOI	10.1016/j.urolonc.2017.09.004
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Article ; Online: Extended disease control with unconventional cabozantinib dose increase in metastatic renal cell carcinoma.

Sharma, Akanksha / Elias, Roy / Christie, Alana / Williams, Noelle S / Pedrosa, Ivan / Bjarnason, Georg A / Brugarolas, James

Kidney cancer (Clifton, Va.)

2022 Volume 6, Issue 1, Page(s) 69–79

Abstract: Background: Cabozantinib is among the most potent tyrosine kinase inhibitors (TKIs) FDA-approved for metastatic renal cell carcinoma (mRCC). Effective treatments after progression on cabozantinib salvage therapy are limited. Dose escalation for other ... ...

Abstract	Background: Cabozantinib is among the most potent tyrosine kinase inhibitors (TKIs) FDA-approved for metastatic renal cell carcinoma (mRCC). Effective treatments after progression on cabozantinib salvage therapy are limited. Dose escalation for other TKIs has been shown to afford added disease control. Objective: We sought to evaluate whether dose escalation of cabozantinib (Cabometyx Methods: We identified patients with mRCC at the University of Texas Southwestern Medical Center who were treated with cabozantinib dose escalation to 80 mg after progressing on conventional cabozantinib 60 mg. We then queried leading kidney cancer investigators across the world to identify additional patients. Finally, we reviewed pharmacokinetic (PK) data to assess how higher doses impacted circulating levels by comparison to other formulations (Cometriq Results: We report six patients treated at two different institutions with cabozantinib-responsive disease and good tolerability, where cabozantinib was dose escalated (typically to 80 mg, but as high as 120 mg) after progression on 60 mg, a strategy that resulted in added disease control (median duration, 14 months; 95% Confidence Interval [CI]: 8 - Not Estimable[NE]). Four patients (66.7%) had disease control lasting at least 1 year. No grade III/IV adverse events were identified in this small, select, cohort. A comparison of PK data to FDA-approved cabozantinib 140 mg capsules suggest that cabozantinib 80 mg tablets results in comparable exposures. Conclusions: mRCC patients with cabozantinib responsive disease and reasonable tolerability may benefit from dose escalation at progression.
Language	English
Publishing date	2022-03-15
Publishing country	United States
Document type	Journal Article
ZDB-ID	2961890-3
ISSN	2468-4570 ; 2468-4562
ISSN (online)	2468-4570
ISSN	2468-4562
DOI	10.3233/kca-210117
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Article ; Online: Characterization of Responses to Lenvatinib plus Pembrolizumab in Patients with Advanced Renal Cell Carcinoma at the Final Prespecified Survival Analysis of the Phase 3 CLEAR Study.

Motzer, Robert J / Choueiri, Toni K / Hutson, Thomas / Young Rha, Sun / Puente, Javier / Lalani, Aly-Khan A / Winquist, Eric / Eto, Masatoshi / Basappa, Naveen S / Tannir, Nizar M / Vaishampayan, Ulka / Bjarnason, Georg A / Oudard, Stéphane / Grünwald, Viktor / Burgents, Joseph / Xie, Ran / McKenzie, Jodi / Powles, Thomas

European urology

2024

Abstract: In the phase 3 CLEAR trial, lenvatinib plus pembrolizumab (L + P) showed superior efficacy versus sunitinib in treatment-naïve patients with advanced renal cell carcinoma (aRCC). The combination treatment was associated with a robust objective response ... ...

Abstract	In the phase 3 CLEAR trial, lenvatinib plus pembrolizumab (L + P) showed superior efficacy versus sunitinib in treatment-naïve patients with advanced renal cell carcinoma (aRCC). The combination treatment was associated with a robust objective response rate of 71%. Here we report tumor responses for patients in the L + P arm in CLEAR, with median follow-up of ∼4 yr at the final prespecified overall survival (OS) analysis. Tumor responses were assessed by independent review using Response Evaluation Criteria in Solid Tumors v1.1. Patients with a complete response (CR; n = 65), partial response (PR) with maximum tumor shrinkage ≥75% (near-CR; n = 59), or PR with maximum tumor shrinkage <75% (other PR; n = 129), were characterized in terms of their baseline characteristics. The median duration of response was 43.7 mo (95% confidence interval [CI] 39.2-not estimable) for the CR group, 30.5 mo (95% CI 22.4-not estimable) for the near-CR group, and 17.2 mo (95% CI 12.5-21.4) for the other PR group. The 36-mo OS rates were consistently high in the CR (97%), near-CR (86%), and other PR (62%) groups. Robust objective response rates were observed across International Metastatic RCC Database Consortium favorable-risk (69%, 95% CI 60-78%), intermediate-risk (73%, 95% CI 67-79%), and poor-risk (70%, 95% CI 54-85%) subgroups. The robust response to L + P supports this combination as a standard-of-care first-line treatment for patients with aRCC. PATIENT SUMMARY: The CLEAR trial enrolled patients with advanced kidney cancer who had not previously received any treatment for their cancer. Here we report results for tumor shrinkage observed in the group that received lenvatinib plus pembrolizumab combination treatment during the trial. Shrinkage of target tumors with this combination was long-lasting and was observed in patients irrespective of their disease severity. This trial is registered on ClinicalTrials.gov as NCT02811861.
Language	English
Publishing date	2024-04-05
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	193790-x
ISSN	1873-7560 ; 1421-993X ; 0302-2838
ISSN (online)	1873-7560 ; 1421-993X
ISSN	0302-2838
DOI	10.1016/j.eururo.2024.03.015
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