Renal cell carcinoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up

Escudier, Bernard; Kataja, Vesa

doi:10.1093/annonc/mdq206

Cited by 383 publications

(591 citation statements)

References 14 publications

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“…Patients with complete or partial response (CR or PR) were considered responders, whereas those with stable or progressive disease (SD or PD) were considered nonresponders. The Memorial Sloan Kettering Cancer Center (MSKCC) prognostic risk scores were calculated according to the presence of six risk factors: a Karnofsky performance status (KPS) of ,80%, anemia, time from diagnosis to treatment of ,1 year, hypercalcemia, thrombocytosis, and neutrophilia [3]. This study was approved by the Institutional Review Board of AMC (S2014-1122-0002).…”

Section: Patientsmentioning

confidence: 99%

“…Tyrosine kinase inhibitors (TKIs) targeting vascular endothelial growth factor (VEGF) signaling, such as sunitinib, sorafenib, and pazopanib, have been approved by the Food and Drug Administration; currently,VEGF-TKI therapy or combining interferon-a immunotherapy with the anti-VEGF monoclonal antibody bevacizumab are recommended as a first-line systemic treatment for patients with mCCRCC [2,3].These therapeutic agents have prolonged the survival of patients with mCCRCC, but 20%-30% of patients derive no benefit from first-line VEGF-TKI treatment [4][5][6]. In addition, patients develop acquired resistance to the VEGF-TKI and occasionally experience adverse effects relating to treatment [4,5,7].…”

Section: Introductionmentioning

confidence: 99%

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The Association Between PD-L1 Expression and the Clinical Outcomes to Vascular Endothelial Growth Factor-Targeted Therapy in Patients With Metastatic Clear Cell Renal Cell Carcinoma

et al. 2015

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Purpose. To evaluate the maximum tolerated regimen (MTR), dose‐limiting toxicities, and pharmacokinetics of pazopanib, an oral small‐molecule tyrosine kinase inhibitor of vascular endothelial growth factor receptor, platelet‐derived growth factor receptor, and c‐Kit, in combination with paclitaxel. Patients and Methods. Pazopanib was given daily with weekly paclitaxel on days 1, 8, and 15 every 28 days. Dose levels of pazopanib (mg/day)/paclitaxel (mg/m2) were 400/15, 800/15, 800/50, and 800/80. An expanded cohort was enrolled at the MTR. Plasma samples were collected to evaluate the effect of pazopanib, an inhibitor of cytochrome P450 (CYP)3A4, on the pharmacokinetics of paclitaxel, a CYP3A4 and CYP2C8 substrate. Results. Of 26 enrolled patients, 17 were treated at the MTR of 800 mg pazopanib and 80 mg/m2 paclitaxel. Dose‐limiting toxicities included a grade 3 abscess and grade 2 hyperbilirubinemia. Other toxicities included elevated liver transaminases and diarrhea. Six patients (23%) had partial responses and 15 patients (58%) had stable disease. Administration of 800 mg pazopanib resulted in a 14% lower paclitaxel clearance and a 31% higher paclitaxel maximal concentration than with administration of paclitaxel alone at 15, 50, and 80 mg/m2. At the MTR, coadministration of 800 mg pazopanib and 80 mg/m2 paclitaxel resulted in a 26% higher geometric mean paclitaxel area under the curve. Conclusion. Pazopanib, at a dose of 800 mg daily, can be safely combined with a therapeutic dose of paclitaxel at 80 mg/m2 when administered on days 1, 8, and 15, every 28 days. The observed greater plasma concentrations of paclitaxel given concurrently with pazopanib suggest that pazopanib is a weak inhibitor of CYP3A4 and CYP2C8.

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Section: Patientsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

The Association Between PD-L1 Expression and the Clinical Outcomes to Vascular Endothelial Growth Factor-Targeted Therapy in Patients With Metastatic Clear Cell Renal Cell Carcinoma

et al. 2015

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“…The CHAARTED [2] and STAMPEDE [3] trials showed that adding docetaxel to the initial treatment of metastatic prostate cancer confers a significant survival advantage of 13.6 [1] and 10 months [2] respectively, compared with endocrine therapy alone. When examined by age category, those aged ≥70 years in the CHAARTED trial had a hazard ratio (HR) for death of 0.43 (95% CI: 0.23-0.78; Fig.…”

Section: Discussionmentioning

confidence: 99%

“…When examined by age category, those aged ≥70 years in the CHAARTED trial had a hazard ratio (HR) for death of 0.43 (95% CI: 0.23-0.78; Fig. 1) [2]. Patients with an Eastern Cooperative Oncology …”

Section: Discussionmentioning

confidence: 99%

First‐line vascular endothelial growth factor inhibitors for advanced renal cell carcinoma and the impact of new agents entering the treatment paradigm

Jain

George

2017

BJU International

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Clinical trials assessing the safety and efficacy of new therapies vs standard of care (SOC) for advanced RCC (aRCC), which includes locally advanced and metastatic RCC, are ongoing. The current first-line SOC for the treatment of aRCC with clear cell histology are the vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitors (TKIs) sunitinib and pazopanib [1,2]. Because sunitinib and pazopanib have similar efficacy based on non-inferiority clinical findings, treatment guidelines do not provide information about which agent should be used over the other; clinicians must weigh the risks and benefits for each agent and decide between the two. Thus, it is critical that clinicians are familiar with study results with these drugs, as well as any comparator trial data that might inform clinical decisionmaking and treatment. Clinicians must also remain vigilant and informed about more recent clinical trial data that aim to supplant pazopanib and sunitinib in the first-line setting, as it is likely that treatments with improved efficacy and safety will inevitably become available. To effectively do this, an understanding of exactly what each clinical trial is evaluating and concluding in the context of the SOC is critical.Efficacy is almost always a primary endpoint of clinical trials that aim to evaluate the SOC against new or novel agents. Although the USA Food and Drug Administration and European Medicines Agency consider overall survival (OS) the most reliable endpoint in oncology trials, sunitinib and pazopanib were approved for first-line therapy of aRCC based on improved progression-free survival (PFS). PFS may be a preferable endpoint for first-line studies, as it is not confounded by post-study treatments, and can be assessed earlier than OS. By comparison, the determination of OS requires a long follow-up period in a large patient population, and is potentially confounded by post-study treatments. Of the ongoing phase III studies of first-line agents in aRCC, the primary endpoint is OS in one study [NCT01582672, International Phase Comments use of one endpoint alone (PFS or OS) may not be sufficient to elucidate true drug effects, particularly with immune checkpoint inhibitors. Furthermore, studies suggest that the immune-related response criteria may be more appropriate for measuring tumour response with immunotherapeutic agents than traditional Response Evaluation Criteria In Solid Tumors (RECIST) measures, which in turn may pose an additional challenge when comparing the efficacy of immunotherapeutics with the SOC sunitinib and pazopanib. Indeed, evaluating efficacy can be quite challenging. In clinical practice, treatment response with targeted agents may best be measured by RECIST, and alternative therapeutic regimens implemented after disease progression. Immunerelated response criteria are probably more appropriate for immunotherapeutic agents, as two consecutive measurements ≥4 weeks apart are typical to demonstrate disease progression, reflecting the different mechanism of acti...

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“…В настоящее время эверолимус входит в пере-чень основных рекомендаций по лечению мПКР: европейской ассоциации урологов EAU (European Association of Urology) [14]; европейского общества медицинских онкологов ESMO (European Society for Medical Oncology) [31]; европейской организации по изучению и лечению рака EORTC-GU (European Organisation for Research and Treatment of Cancer Genitourinary Group) [32] и аме-риканской национальной противораковой сети NCCN (National Comprehensive Cancer Network) [15] как препарат второй и тре-тьей линии для лечения мПКР при резистентности к другим тар-гетным препаратам. Рекомендуемая дозировка для лечения дис-семинированного ПКР составляет 10 мг перорально ежедневно, до тех пор, пока препарат эффективен и больной хорошо пере-носит его прием [14,15,31,32].…”

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Long-term use of targeted afinitor therapy for metastatic renal cell carcinoma

Сундуй¹,

Krasheninnikov²,

Sundui³

et al. 2015

Onkol. Z. im. P.A. Gercena

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Представлено клиническое наблюдение больного, получившего три линии таргетной терапии, описаны профиль токсич-ности препарата и методы купирования нежелательных побочных явлений. Наиболее продолжительную стабилизацию опухолевого процесса зарегистрировали при применении препарата афинитор. На примере клинического случая про-демонстрирована целесообразность и оправданность последовательного применения таргетных препаратов, что обеспе-чивает контроль заболевания при удовлетворительной переносимости. Ключевые слова: метастатический почечно-клеточный рак, таргетная терапия, ингибиторы ангиогенеза, ингибиторы тирозинкиназ, афинитор, эверолимус.The paper describes a case of a patient receiving three lines of targeted therapy for metastatic renal cell carcinoma, the drug toxicity profile, and methods for abolishing adverse events. Afinitor has been recorded to provide the longest stabilization of a tumor process. This clinical case has been used as an example to demonstrate that it is expediency and appropriate to sequentially use targeted drugs, which ensures the disease to be monitored if the patient satisfactorily tolerates the drug.

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Renal cell carcinoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up

Cited by 383 publications

References 14 publications

The Association Between PD-L1 Expression and the Clinical Outcomes to Vascular Endothelial Growth Factor-Targeted Therapy in Patients With Metastatic Clear Cell Renal Cell Carcinoma

The Association Between PD-L1 Expression and the Clinical Outcomes to Vascular Endothelial Growth Factor-Targeted Therapy in Patients With Metastatic Clear Cell Renal Cell Carcinoma

First‐line vascular endothelial growth factor inhibitors for advanced renal cell carcinoma and the impact of new agents entering the treatment paradigm

Long-term use of targeted afinitor therapy for metastatic renal cell carcinoma

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