SPAZO2 (SOGUG): Comparative effectiveness of everolimus (Ev) vs axitinib (Ax) as second-line after first-line pazopanib (1stPz) in metastatic renal carcinoma (mRC)

Arija, J.A. Arranz; Pérez-Valderrama, Begoña; Sánchez, Ángel Rodríguez; Álvarez, Javier; Marín, Álvaro Pinto; Alonso, C. Maximiano; Guzmán, José Carlos Villa; Parra, E.M. Fernandez; Díaz, Enrique; Gonzalez-Larriba, J.; García, J. Tafalla; Lambea, J.; Figueiras, Manuel Constenla; Vidal, M.; Echaburu, Juan Antonio Virizuela; Mazon, F.J. Vazquez; Ulazia, O. Etxaniz; Villar, M.T. Abad; Cassinello, Javier; García, José M.

doi:10.1093/annonc/mdx371.040

Cited by 2 publications

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“…The observational studies included in the OS and PFS sensitivity analyses are at a higher risk of bias than the RCTs. Overall ROBINS-I ratings were at best moderate, for OS,19 29 31 and serious risk of bias for PFS. One study was at critical risk of bias for both PFS and OS,33 which was excluded from the sensitivity analyses.…”

Section: Resultsmentioning

confidence: 94%

“…Five of these studies have been excluded from this review because of the update of the scope excluding sunitinib as it is not recommended at second line in the most up-to-date ESMO guidance for RCC 12. Five new studies, one RCT and four retrospective chart reviews were identified in the update and extension searches (including terms for lenvatinib with everolimus) run in January 2018, making a total of 12 included studies 13–15 19 20 27–33…”

Section: Resultsmentioning

confidence: 99%

“…Twelve studies (n=5144) met the inclusion criteria (table 1): five RCTs (one double-blind28 and four open-label13 15 20 28) and seven observational studies19 27 29–33 (retrospective cohort studies). Sample sizes varied from 101 (HOPE 205)15 to 821 (CheckMate 025)14 participants.…”

Section: Resultsmentioning

confidence: 99%

“…AXIS20 also included people who had not received prior anti-VEGF treatment, but OS and PFS data were available for the subset who had. In eight of the included studies, people had only received one prior VEGF-targeted treatment14 19 29–34; the remaining five studies allowed one or more prior treatments 13 14 27 35. Populations were predominantly male and Caucasian, and mean age was generally between 55 and 65 years.…”

Section: Resultsmentioning

confidence: 99%

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Targeted therapies for previously treated advanced or metastatic renal cell carcinoma: systematic review and network meta-analysis

et al. 2019

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ObjectiveTo compare the effectiveness and safety of treatments for advanced or metastatic renal cell carcinoma (amRCC) after treatment with vascular endothelial growth factor (VEGF)-targeted treatment.DesignSystematic review and network meta-analysis of randomised controlled trials (RCTs) and comparative observational studies. MEDLINE, EMBASE and Cochrane Library were searched up to January 2018.ParticipantsPeople with amRCC requiring treatment after VEGF-targeted treatment.InterventionsAxitinib, cabozantinib, everolimus, lenvatinib with everolimus, nivolumab, sorafenib and best supportive care (BSC).OutcomesPrimary outcomes were overall survival (OS) and progression-free survival (PFS); secondary outcomes were objective response rate (ORR), adverse events, and health-related quality of life (HRQoL).ResultsTwelve studies were included (n=5144): five RCTs and seven observational studies. Lenvatinib with everolimus significantly increased OS and PFS over everolimus (HR 0.61, 95% Credible Interval [95%CrI]: 0.36 to 0.96 and 0.47, 95%CrI: 0.26 to 0.77, respectively) as did cabozantinib (HR 0.66, 95%CrI: 0.53 to 0.82 and 0.51, 95%CrI: 0.41 to 0.63, respectively). This remained the case when observational evidence was included. Nivolumab also significantly improved OS versus everolimus (HR 0.74, 95%CrI: 0.57 to 0.93). OS sensitivity analysis, including observational studies, indicates everolimus being more effective than axitinib and sorafenib. However, inconsistency was identified in the OS sensitivity analysis. PFS sensitivity analysis suggests axitinib is more effective than everolimus, which may be more effective than sorafenib. The results for ORR supported the OS and PFS analyses. Nivolumab is associated with fewer grade 3 or grade 4 adverse events than lenvatinib with everolimus or cabozantinib. HRQoL could not be analysed due to differences in tools used.ConclusionsLenvatinib with everolimus, cabozantinib and nivolumab are effective in prolonging the survival for people with amRCC subsequent to VEGF-targeted treatment, but there is considerable uncertainty about how they compare to each other and how much better they are than axitinib and sorafenib.PROSPERO registrationnumberCRD42017071540.

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Section: Resultsmentioning

confidence: 94%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

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Targeted therapies for previously treated advanced or metastatic renal cell carcinoma: systematic review and network meta-analysis

et al. 2019

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“…The percentage of patients who receive a second-line treatment is similar between sunitinib (59%) sorafenib (52%) and bevacizumab (79%) [ 10 ] treated patients. Majority of patients in SL are treated with everolimus (40–60%) or sorafenib (up to 30%) [ 11 , 12 ].…”

Section: Introductionmentioning

confidence: 99%

Biomarkers defining probability of receiving second-line targeted therapy in metastatic renal cell carcinoma

et al. 2018

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In order to facilitate long-term treatment decisions, we aimed to define biomarkers defining the probability of receiving second-line (SL) targeted therapy (TT) in patients with metastatic renal cell carcinoma (mRCC) based on their characteristics present at first-line TT initiation. We analysed 152 consecutive mRCC patients treated and used multivariable binominal logistic regression to identify factors contributing to the probability of receiving SL TT. Final model was assessed with bias-corrected indices (Nagelkerke’s R2 and area under receiver operating characteristic curve [AUC]) and two bootstrap procedures were used for internal validation. Factors associated with the probability of SL TT eligibility were the presence of brain metastases (odds ratio [OR] 0.084, 95% confidence interval [CI] 0.010–0.707), number of metastatic sites (OR 0.740, 95% CI 0.575–0.953 per each site), platelet count (OR 0.971, 95% CI 0.947–0.997, per 104/ml), lactate dehydrogenase level (OR 0.952, 95% CI 0.910–0.997 per 10 units/l), and albumin concentration (OR 1.924, 95% CI 1.057–3.503 per 1 g/dl). We developed on-line calculator that enables practicing clinicians to estimate SL treatment probability (http://www.r-calc.com).

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SPAZO2 (SOGUG): Comparative effectiveness of everolimus (Ev) vs axitinib (Ax) as second-line after first-line pazopanib (1stPz) in metastatic renal carcinoma (mRC)

Cited by 2 publications

References 0 publications

Targeted therapies for previously treated advanced or metastatic renal cell carcinoma: systematic review and network meta-analysis

Targeted therapies for previously treated advanced or metastatic renal cell carcinoma: systematic review and network meta-analysis

Biomarkers defining probability of receiving second-line targeted therapy in metastatic renal cell carcinoma

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