Outcomes and Drug Costs of Sunitinib Regimens for Metastatic Renal Cell Carcinoma: A Provincial Population-Based Study

Suo, Aleksi; Iqbal, Urooj; Lim, June; Lee, Chel; Gesy, Kathy; Iqbal, Nayyer; Abbas, Tahir

doi:10.1016/j.clgc.2017.01.016

Cited by 9 publications

(16 citation statements)

References 19 publications

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“…The efficacy and safety of sunitinib in treatment‐naive patients with advanced clear cell RCC was demonstrated in the pivotal phase III trial, in which sunitinib significantly prolonged median progression‐free survival (mPFS) but not overall survival (OS) versus IFN‐α (Table ). Several real‐world studies confirm the effectiveness of first‐line sunitinib in patients with aRCC . Most large ( n > 150) real‐world studies are retrospective, multicenter analyses with a wide range in mPFS (7.0–20.0 months) and median OS (mOS; 18.7–45.1 months) reported across studies .…”

Section: Introductionmentioning

confidence: 94%

“…Several real‐world studies confirm the effectiveness of first‐line sunitinib in patients with aRCC . Most large ( n > 150) real‐world studies are retrospective, multicenter analyses with a wide range in mPFS (7.0–20.0 months) and median OS (mOS; 18.7–45.1 months) reported across studies . In one of the larger real‐world sunitinib studies that provided information about the effectiveness in patient subgroups often excluded from clinical trials, an expanded‐access trial in 4,543 patients with metastatic RCC demonstrated that the objective response rate (ORR) was 16% and mPFS and mOS were 9.4 and 18.7 months, respectively .…”

Section: Introductionmentioning

confidence: 99%

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The Current and Evolving Landscape of First-Line Treatments for Advanced Renal Cell Carcinoma

Calvo¹,

Porta

Grünwald

et al. 2018

The Oncologist

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Vascular endothelial growth factor receptor tyrosine kinase inhibitors are approved by the U.S. Food and Drug Administration as first-line treatment options for advanced renal cell carcinoma; however, the treatment paradigm is rapidly evolving. The combination of nivolumab plus ipilimumab was recently approved for intermediate- and poor-risk patients, and other combination strategies and novel first-line agents will likely be introduced soon.

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Section: Introductionmentioning

confidence: 94%

Section: Introductionmentioning

confidence: 99%

The Current and Evolving Landscape of First-Line Treatments for Advanced Renal Cell Carcinoma

Calvo¹,

Porta

Grünwald

et al. 2018

The Oncologist

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“…A total of seven nonrandomized studies [3,[8][9][10][11][12][13] were included in a comparison of oncological outcomes according to dosing schedules. However, two studies [3,8] did not report an analysis of OS; therefore, OS was analyzed using data from the other five studies.…”

Section: Oncological Outcomes; Progression-free Survival and Overall mentioning

confidence: 99%

“…Accordingly, some alternative schedules have been tested in an attempt to improve the safety profile and increase the dose intensity of sunitinib [3][4][5][6][7][8][9][10][11][12][13]. A continuous once daily dosing regimen with 37.5 mg of sunitinib has been proposed as an alternative [14], although the most often attempted strategy is a two weeks on and one week off (2/1) schedule.…”

Section: Introductionmentioning

confidence: 99%

“…A continuous once daily dosing regimen with 37.5 mg of sunitinib has been proposed as an alternative [14], although the most often attempted strategy is a two weeks on and one week off (2/1) schedule. Several researchers have reported the clinical outcomes of the 2/1 schedule, including one phase II randomized controlled trial (RCT) [3,6,[8][9][10][11][12][13]15], however, there has been no phase III RCT comparing 2/1 and 4/2 schedules of sunitinib. Recently, two meta-analysis studies have been published on this topic [16,17].…”

Section: Introductionmentioning

confidence: 99%

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Does an Alternative Sunitinib Dosing Schedule Really Improve Survival Outcomes Over a Conventional Dosing Schedule in Patients with Metastatic Renal Cell Carcinoma? An Updated Systematic Review and Meta-Analysis

Chung

Kang

Kim

et al. 2019

Cancers

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Treatment-related adverse events (AEs) can obfuscate the maintenance of a conventional schedule of sunitinib in patients with metastatic renal cell carcinoma. Accordingly, alternative schedules seeking to improve the safety profile of sunitinib have been tested. Recently, two meta-analyses similarly described improved safety profiles favoring a two weeks on and one week off (2/1) schedule, but with conflicting results for survival outcomes. Therefore, we conducted an updated systematic review and meta-analysis, including all recently published studies and using complementary statistical methods. Endpoints included progression-free survival, overall survival, and AEs of 15 types. Eleven articles were included in this meta-analysis. Using adjusted findings, we noted statistically better results in progression-free survival (hazard ratio, 0.58; 95% confidence interval, 0.39-0.84; p = 0.005), but no difference in overall survival (hazard ratio, 0.66; 95% confidence interval, 0.42-1.04; p = 0.08). Moreover, the 2/1 schedule was beneficial for reducing the incidence of several AEs. Conclusively, our meta-analysis suggests that the 2/1 schedule holds promise as an alternative means of reducing AEs and maintaining patient quality of life. While the survival outcomes of the 2/1 schedule seem also to be favorable, the level of evidence for this was low, and the interpretation of these findings should warrant caution. Large scale randomized trials are needed to support these results.

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Uptake and Survival Outcomes Following Immune Checkpoint Inhibitor Therapy Among Trial-Ineligible Patients With Advanced Solid Cancers

et al. 2021

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Immune checkpoint inhibitors (ICIs) are part of standard of care for patients with many advanced solid tumors. Patients with poor performance status or organ dysfunction are traditionally ineligible to partake in pivotal randomized clinical trials of ICIs.OBJECTIVE To assess ICI use and survival outcomes among patients with advanced cancers who are traditionally trial ineligible based on poor performance status or organ dysfunction. DESIGN, SETTING, AND PARTICIPANTSThis retrospective cohort study was conducted in 280 predominantly community oncology practices in the US and included 34 131 patients (9318 [27.3%] trial ineligible) who initiated first-line systemic therapy from January 2014 through December 2019 for newly diagnosed metastatic or recurrent nontargetable non-small cell lung, urothelial cell, renal cell, or hepatocellular carcinoma. Data analysis was performed from December 1, 2019, to June 1, 2021.EXPOSURES Trial ineligibility (Eastern Cooperative Oncology Group performance status Ն2 or the presence of kidney or liver dysfunction); first-line systemic therapy. MAIN OUTCOMES AND MEASURESThe association between trial ineligibility and ICI monotherapy uptake was assessed using inverse probability-weighted (IPW) logistic regressions. The comparative survival outcomes following ICI and non-ICI therapy among trial-ineligible patients were assessed using treatment IPW survival analyses. Because we observed nonproportional hazards, we reported 12-month and 36-month restricted mean survival times (RMSTs) and time-varying hazard ratios (HRs) of less than 6 months and 6 months or greater. RESULTS Among the overall cohort (n = 34 131), the median (IQR) age was 70 (62-77) years; 23 586 (69%) were White individuals, and 14 478 (42%) were women. Over the study period, the proportion of patients receiving ICI monotherapy increased from 0% to 30.2% among trial-ineligible patients and 0.1% to 19.4% among trial-eligible patients. Trial ineligibility was associated with increased ICI monotherapy use (IPW-adjusted odds ratio compared with non-ICI therapy, 1.8; 95% CI, 1.7-1.9). Among trial-ineligible patients, there were no overall survival differences between ICI monotherapy, ICI combination therapy, and non-ICI therapy at 12 months (RMST, 7.8 vs 7.7 vs 8.1 months) or 36 months (RMST, 15.0 vs 13.9 vs 14.4 months). Compared with non-ICI therapy, ICI monotherapy showed evidence of early harm (IPW-adjusted HR within 6 months, 1.2; 95% CI, 1.1-1.2) but late benefit (adjusted HR among patients who survived 6 months, 0.8; 95% CI, 0.7-0.8). CONCLUSIONS AND RELEVANCEIn this cohort study, compared with trial-eligible patients, trial-ineligible patients with advanced cancers preferentially received first-line ICI therapy. A survival difference was not detected between ICI and non-ICI therapies among trial-ineligible patients. Positive results for ICI in phase 3 trials may not translate to this vulnerable population.

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Outcomes and Drug Costs of Sunitinib Regimens for Metastatic Renal Cell Carcinoma: A Provincial Population-Based Study

Cited by 9 publications

References 19 publications

The Current and Evolving Landscape of First-Line Treatments for Advanced Renal Cell Carcinoma

The Current and Evolving Landscape of First-Line Treatments for Advanced Renal Cell Carcinoma

Does an Alternative Sunitinib Dosing Schedule Really Improve Survival Outcomes Over a Conventional Dosing Schedule in Patients with Metastatic Renal Cell Carcinoma? An Updated Systematic Review and Meta-Analysis

Uptake and Survival Outcomes Following Immune Checkpoint Inhibitor Therapy Among Trial-Ineligible Patients With Advanced Solid Cancers

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