Axitinib treatment in patients with cytokine-refractory metastatic renal-cell cancer: a phase II study

Rixe, Olivier; Bukowski, Ronald M.; Michaelson, M. Dror; Wilding, George; Hudes, Gary R.; Bolte, Oliver; Motzer, Robert J.; Bycott, Paul; Liau, Katherine; Freddo, James L.; Trask, Peter C.; Kim, Sinil; Rini, Brian I.

doi:10.1016/s1470-2045(07)70285-1

Cited by 411 publications

(290 citation statements)

References 15 publications

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“…[56,58] Results from this study demonstrated an ORR of , [55] with permission. Best response Cytokine refractory (n = 52) [56] Sorafenib refractory (n = 62) [57] Objective response rate 23 (44) Maximum percentage decrease in target lesion size, based on RECIST is shown in figure 4a. The second phase II study evaluated axitinib in 62 patients with advanced and refractory RCC who had not responded to sorafenib-based therapy.…”

Section: Efficacymentioning

confidence: 64%

“…[57] In this study, prior therapies were not limited to sorafenib, but could also include cytotoxic therapies, cytokines and other targeted therapies such as sunitinib, bevacizumab, and temsirolimus. PR was observed in 14 patients giving an ORR of 22.6%, (95% CI 12.9, 35.0), SD [57] and (b) Rixe et al, [56] with permission bid = twice daily; CR = complete response; PR = partial response. in 11 patients (18%), and progressive disease in 25 patients (40%).…”

Section: Efficacymentioning

confidence: 93%

“…[56,57] These AEs are an expected class effect due to the known mechanism of action of the drug. The majority of AEs are manageable with dose modification and supportive care; hypertension is generally easily managed with standard antihypertensive drugs.…”

Section: Safety and Tolerabilitymentioning

confidence: 99%

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Axitinib for the Management of Metastatic Renal Cell Carcinoma

Escudier

Gore

2011

Drugs R D

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Section: Efficacymentioning

confidence: 64%

Section: Efficacymentioning

confidence: 93%

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Axitinib for the Management of Metastatic Renal Cell Carcinoma

Escudier

Gore

2011

Drugs R D

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“…Axitinib is an oral inhibitor of VEGF receptors (VEGFRs) 1, 2, and 3 that achieved an overall response rate (ORR) of 44.2% (2 CR, 21 partial responses [PR]) in 52 patients with cytokine-refractory mRCC in a single-arm, open-label phase II trial [35]. HRQOL was assessed with the EORTC QLQ-C30 at baseline, day 29, day 57, and every 8 weeks thereafter to a maximum of 144 weeks of treatment, and at follow-up [36].…”

Section: Axitinibmentioning

confidence: 99%

“…The rate of AE-related treatment discontinuation was 19.2% (10 patients) due to nonfatal events (specific AEs not reported). The dose reduction rate was 28.8% (15 patients) due to grade 3 AEs (diarrhea, fatigue, gastrointestinal upset, dehydration, myalgia, and gout) in 8 patients and multiple grade 2 AEs including hypertension in 7 patients [35].…”

Section: Axitinibmentioning

confidence: 99%

Beyond Traditional Outcomes: Improving Quality of Life in Patients with Renal Cell Carcinoma

Cella

2011

The Oncologist

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Vascular Endothelial Growth Factor Receptor Inhibitors for Recurrent or Metastatic Adenoid Cystic Carcinoma

Hoff,

Manzi,

Lazar Neto

et al. 2024

JAMA Otolaryngol Head Neck Surg

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ImportanceThere is no systemic therapy for recurrent or metastatic adenoid cystic carcinoma (ACC) approved by the US Food and Drug Administration.ObjectiveTo examine the efficacy, safety, and tolerability of vascular endothelial growth factor receptor (VEGFR) inhibitors in recurrent or metastatic ACC.Data SourcesPubMed, Embase, and Cochrane Library were systematically searched for studies of VEGFR inhibitors in recurrent or metastatic ACC from database inception to August 31, 2023.Study SelectionInclusion criteria were prospective clinical trials of recurrent or metastatic ACC treated with VEGFR inhibitors, reporting at least 1 outcome of interest specifically for ACC. Of 1963 identified studies, 17 (0.9%) met inclusion criteria.Data Extraction and SynthesisThe Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) reporting guideline was followed to extract data. Data were pooled using a random-effects generalized linear mixed model with 95% CIs.Main Outcomes and MeasuresThe primary efficacy outcome was best overall response to VEGFR inhibitors, including objective response, stable disease, or progressive disease (PD). Safety and tolerability outcomes included incidence of grade 3 or higher adverse events, rates of exit from trial due to PD or drug-related toxic effects, and dose reduction rate (DRR).ResultsA total of 17 studies comprising 560 patients with recurrent or metastatic ACC treated with 10 VEGFR inhibitors were included. The objective response rate was 6% (95% CI, 3%-12%; I2 = 71%) and stable disease was the most frequent best overall response (82%; 95% CI, 74%-87%; I2 = 67%). The 6-month disease control (defined as objective response and stable disease) rate was 54% (95% CI, 45%-62%; I2 = 52%). The rate of grade 3 or higher adverse events was 53% (95% CI, 42%-64%; I2 = 81%) and of DRR was 59% (95% CI, 40%-76%). Most patients (57%; 95% CI, 44%-70%; I2 = 83%) continued therapy until PD; 21% (95% CI, 15%-28%; I2 = 62%) of patients suspended therapy for toxic effects. In subgroup analysis by specific VEGFR inhibitor, the objective response rate was 14% (95% CI, 7%-25%; I2 = 0%), stable disease rate was 76% (95% CI, 63%-85%; I2 = 0%), proportion treated until PD was 61% (95% CI, 14%-94%; I2 = 94%), and DRR was 78% (95% CI, 66%-87%; I2 = 39%) with lenvatinib. Corresponding axitinib results were objective response rate of 8% (95% CI, 4%-15%; I2 = 0%) and stable disease rate of 85% (95% CI, 72%-92%; I2 = 69%), with 73% (95% CI, 63%-82%; I2 = 0%) of patients treated until PD, and the DRR was 22% (95% CI, 12%-38%; I2 = 77%). Rivoceranib had the highest objective response rate (24%; 95% CI, 7%-57%) but high heterogeneity among studies (I2 = 95%) and the lowest rate of patients who continued therapy until PD (35%; 95% CI, 20%-55%; I2 = 90%).Conclusions and RelevanceThis systematic review and meta-analysis found that VEGFR inhibitors were associated with high rates of disease stabilization in recurrent or metastatic ACC. Of 10 included VEGFR inhibitors, lenvatinib and axitinib were associated with the best combined and consistent efficacy, safety, and tolerability profiles, substantiating their inclusion in treatment guidelines.

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Axitinib treatment in patients with cytokine-refractory metastatic renal-cell cancer: a phase II study

Cited by 411 publications

References 15 publications

Axitinib for the Management of Metastatic Renal Cell Carcinoma

Axitinib for the Management of Metastatic Renal Cell Carcinoma

Beyond Traditional Outcomes: Improving Quality of Life in Patients with Renal Cell Carcinoma

Vascular Endothelial Growth Factor Receptor Inhibitors for Recurrent or Metastatic Adenoid Cystic Carcinoma

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