A randomized phase II trial of interleukin-2/interferon-α plus bevacizumab versus interleukin-2/interferon-α in metastatic renal cell carcinoma (mRCC): Results from the Danish Renal Cancer Group (DARENCA) study 1.

Donskov, Frede; Jensen, Niels Viggo; Smidt-Hansen, Torben; Brøndum, Line; Geertsen, Poul F.

doi:10.1200/jco.2016.34.15_suppl.4563

Cited by 8 publications

(6 citation statements)

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“…DARENCA-1 ( ClinicalTrials. gov identifier NCT01274273) 16 was a randomized Phase II clinical trial comparing subcutaneously administered interleukin-2-based immunotherapy with and without the intravenous angiogenesis inhibitor bevacizumab (Avastin; Roche, Basel, Switzerland). AIS is an ongoing cohort study of patients receiving routine first-line angiogenesis inhibitors.…”

Section: Methodsmentioning

confidence: 99%

Use of patient outcome endpoints to identify the best functional CT imaging parameters in metastatic renal cell carcinoma patients

Mains

Donskov

Pedersen

et al. 2017

The British Journal of Radiology

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Patient outcome was used to identify the best functional imaging parameters in patients with metastatic renal cell carcinoma. Taking patient outcome and reproducibility into account, BV, BV and BF provide the most clinically meaningful information, whereas PS seems to be treatment dependent. Standardization of acquisition protocols and post-processing software is necessary for future clinical utilization. Advances in knowledge: Taking patient outcome and reproducibility into account, BV, BV and BF provide the most clinically meaningful information. PS seems to be treatment dependent.

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Section: Methodsmentioning

confidence: 99%

Use of patient outcome endpoints to identify the best functional CT imaging parameters in metastatic renal cell carcinoma patients

Mains

Donskov

Pedersen

et al. 2017

The British Journal of Radiology

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“…19 A recent study of IL-2/IFN versus IL-2/IFN/bevacizumab reported stomatitis in 17% and 32%. 20 Basically, all approved therapies for mRCC have the ability to cause mucosal irritation, stomatitis, and dysgeusia in a substantial number of patients. This might impair daily quality of life and might lead to dose reduction, discontinuation, or treatment shift.…”

Section: Discussionmentioning

confidence: 99%

Folic Acid Reduces Mucositis in Metastatic Renal Cell Carcinoma Patients: A Retrospective Study

Fristrup

Donskov

2019

Clinical Genitourinary Cancer

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Mucositis is a frequent side effect of targeted therapy in metastatic renal cell carcinoma (mRCC) patients, which leads to dose reduction, discontinuation, or treatment shift. In this retrospective study of 77 patients, we found folic acid to significantly reduce mucositis in mRCC patients receiving systemic therapy. Patient outcomes were equal or better than expected. A double-blind, placebo-controlled prospective study is ongoing (NCT03581773) in order to validate this finding. Background: Mucositis is often experienced in metastatic renal cell carcinoma (mRCC) patients treated with targeted therapies. This might impair daily quality of life and lead to dose reduction, discontinuation, or treatment shift. We assessed the effect of folic acid to reduce mucositis. Patients and Methods: Patients treated with systemic therapy for mRCC who developed Grade 2 mucositis according to Common Terminology Criteria for Adverse Events version 4.0 (CTCAE) received oral folic acid to reduce mucositis. The medical charts were retrospectively reviewed. Results: A total of 77 patients had Grade 2 mucositis during therapy with sunitinib (n ¼ 29), pazopanib (n ¼ 24), everolimus (n ¼ 10), axitinib (n ¼ 4), temsirolimus (n ¼ 3), interleukin-2/interferon-a (n ¼ 3), cabozantinib (n ¼ 2), bevacizumab (n ¼ 1), and nivolumab (n ¼ 1). Given in doses of 1 to 5 mg daily, folic acid significantly reduced mucositis, mean CTCAE grade 0.88 (95% confidence interval [CI], 0.74-1.03) versus 2.38 (95% CI, 2.26-2.54; P < .0001). Stratified according to treatment, folic acid significantly reduced mucositis grade for sunitinib (0.97 [95% CI, 0.75-1.18] vs. 2.45 [95% CI, 2.23-2.67], P < .0001), pazopanib (0.96 [95% CI, 0.67-1.25] vs. 2.20 [2.03-2.38], P < .0001), everolimus (0.60 [95% CI, 0.10-1.10] vs. 2.60 [95% CI, 2.23-2.97], P < .0001), and other treatments (0.79 [95% CI, 0.38-1.19] vs. 2.36 [95% CI, 2.07-2.64], P < .0001). Of the 77 patients, 8 (10%) patients received dose reduction. Overall progression-free survival was 14 months and overall survival was 31 months. Conclusion: Folic acid reduced mucositis in mRCC patients receiving systemic therapy. This finding needs prospective validation. A double-blind, placebo-controlled prospective evaluation of folic acid is ongoing (NCT03581773).

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“…Patients in the cohort study AIS (N = 33) were enrolled between January 2012 and September 2016 and were treated with first-line pazopanib (N = 12) (Votrient: Novartis Oncology, before 2015: GlaxoSmithKline), sunitinib (N = 12) (Sutent: Pfizer), or temsirolimus (N = 9) (Torisel: Pfizer Inc). The randomized phase II clinical trial DaRenCa-1 (N = 89) compared the effect of subcutaneously administered Interleukin 2 (IL-2) (aldesleukin, Proleukin: Novartis Vaccines and Diagnostics) and interferon alpha (IFN-α) (IFN-α2b, IntronA: Merck) with or without intravenously administered bevacizumab (N = 45 and N = 44, respectivly) (Avastin: Genentech, Roche) in patients enrolled between October 2009 and November 2014 18 . Treatment in both AIS and DaRenCa-1 cohorts was given until RECIST v1.1-defined progression.…”

Section: Methodsmentioning

confidence: 99%

Blood Volume as a new functional image-based biomarker of progression in metastatic renal cell carcinoma

Drljevic-Nielsen

Rasmussen

Mains

et al. 2021

Sci Rep

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RECIST v1.1 has limitations in evaluating progression. We assessed Dynamic Constrast Enhanced Computed Tomography (DCE-CT) identified Blood Volume (BV) for the evaluation of progressive disease (PD) in patients with metastatic renal cell carcinoma (mRCC). BV was quantified prospectively at baseline, after one month, then every three months until PD. Relative changes (ΔBV) were assessed at each timepoint compared with baseline values. The primary endpoint was Time to PD (TTP), the secondary endpoint was Time to the scan prior to PD (PDminus1). Cox proportional hazard models adjusted ΔBV for treatments and International mRCC Database Consortium factors. A total of 62 patients had analyzable scans at the PD timepoint. Median BV was 23.92 mL × 100 g−1 (range 4.40–399.04) at PD and 26.39 mL × 100 g−1 (range 8.70–77.44) at PDminus1. In the final multivariate analysis higher ΔBV was statistically significantly associated with shorter Time to PD, HR 1.11 (95% CI 1.07–1.15, P < 0.001). Also assessed at PDminus1, higher ΔBV was significantly associated with shorter time to PD, HR 1.14 (95% CI 1.01–1.28, P = 0.031). In conclusion, DCE-CT identified BV is a new image-based biomarker of therapy progression in patients with mRCC.

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A randomized phase II trial of interleukin-2/interferon-α plus bevacizumab versus interleukin-2/interferon-α in metastatic renal cell carcinoma (mRCC): Results from the Danish Renal Cancer Group (DARENCA) study 1.

Cited by 8 publications

References 0 publications

Use of patient outcome endpoints to identify the best functional CT imaging parameters in metastatic renal cell carcinoma patients

Use of patient outcome endpoints to identify the best functional CT imaging parameters in metastatic renal cell carcinoma patients

Folic Acid Reduces Mucositis in Metastatic Renal Cell Carcinoma Patients: A Retrospective Study

Blood Volume as a new functional image-based biomarker of progression in metastatic renal cell carcinoma

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