NCCN Task Force Report: Optimizing Treatment of Advanced Renal Cell Carcinoma With Molecular Targeted Therapy

Hudes, Gary R.; Carducci, Michael A.; Choueiri, Toni K.; Esper, Peg; Jonasch, Eric; Kumar, Rashmi; Margolin, Kim; Michaelson, M. Dror; Motzer, Robert J.; Пили, Роберто; Roethke, Susan K.; Srinivas, Sandy

doi:10.6004/jnccn.2011.0124

Cited by 49 publications

(51 citation statements)

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“…A lack of benefit with conventional chemotherapy led to the use of cytokine therapy with interferon alfa or HDIL-2 for RCC [1]. The past decade witnessed the development of vascular endothelial growth factor receptor (VEGFR)-tyrosine kinase inhibitors (TKI) and mammalian target of rapamycin inhibitors (mTORi) highlighting our increased knowledge of the biology of RCC and allowing for oral administration of therapy [2][3][4][5][6][7][8][9].…”

Section: Introductionmentioning

confidence: 99%

Extension of overall survival beyond objective responses in patients with metastatic renal cell carcinoma treated with high-dose interleukin-2

Stenehjem

Toole

Merriman

et al. 2016

Cancer Immunol Immunother

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Section: Introductionmentioning

confidence: 99%

Extension of overall survival beyond objective responses in patients with metastatic renal cell carcinoma treated with high-dose interleukin-2

Stenehjem

Toole

Merriman

et al. 2016

Cancer Immunol Immunother

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“…At present, drugs that should be used for molecular targeted therapy are usually selected on the basis of the Memorial Sloan-Kettering Cancer Center (MSKCC) risk classification. (1,2) This results from the fact that clinical trials of molecular targeted drugs, such as sunitinib and temsirolimus, have been performed by selecting subjects on the basis of this risk classification and their usefulness has been clarified. (3,4) In Japan, the MSKCC risk classification is widely used not only in clinical trials, but also in daily clinical practice.…”

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confidence: 99%

A new prognostic classification for overall survival in Asian patients with previously untreated metastatic renal cell carcinoma

et al. 2012

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The aims of the present study were to: (i) develop a clinically useful prognostic classification in Asian patients with metastatic renal cell carcinoma (RCC) by combining metastatic features with several pretreatment parameters; and (ii) evaluate the validity of this prognostic classification. Baseline characteristics and outcomes were collected for 361 patients who underwent interferon-a-based therapy between 1995 and 2005. Relationships between overall survival (OS) and potential prognostic factors were assessed using Cox's proportional hazard model. The predictive performance of the model was evaluated using bootstrap resampling procedures and by using an independent dataset obtained from randomly selected institutions. The predictive accuracy was measured using the concordance index (c-index). Four factors were identified as independent prognostic factors: time from initial diagnosis to treatment, anemia, elevated lactate dehydrogenase (LDH), and poor prognostic metastatic group (liver only, bone only, or multiple organ metastases). Each patient was assigned to one of three risk groups: favorable risk (none or one factor; n = 120), in which median OS was 51 months; intermediate risk (two factors; n = 101), in which median OS was 21 months; and poor risk (three or four factors; n = 102), in which median OS was 10 months. The c-index was 0.72 in the original dataset and 0.72 in 500 random bootstrap samples. In the independent dataset for external validation, the c-index was 0.73. Thus, the new prognostic classification is easily applicable for Asian patients with previously untreated metastatic RCC and should be incorporated into patient care, as well as clinical trials performed in Asia. (Cancer Sci 2012; 103: 1695-1700 W ith the advent of molecular targeted therapy, treatment for metastatic renal cell carcinoma (RCC) has changed markedly. At present, drugs that should be used for molecular targeted therapy are usually selected on the basis of the Memorial Sloan-Kettering Cancer Center (MSKCC) risk classification.(1,2) This results from the fact that clinical trials of molecular targeted drugs, such as sunitinib and temsirolimus, have been performed by selecting subjects on the basis of this risk classification and their usefulness has been clarified. (3,4) In Japan, the MSKCC risk classification is widely used not only in clinical trials, but also in daily clinical practice.(5,6) However, whether this risk classification is useful for predicting outcomes in Japanese patients with metastatic RCC is not unclear. Recently, we performed a retrospective study on the MSKCC risk classification in patients with metastatic RCC and reported its applicability to Japanese patients.(7) However, when this risk classification was used in Japanese RCC patients, the percentage of patients in the poor risk group was high compared with that in Western series and the survival period of the poor risk group was twice as long in Japanese patients as that in patients in Western countries. (7,8) This may be because multiple organ me...

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“…However in most cases, clinical benefit remains transitory and patients eventually experience disease progression. 98,99 …”

Section: Issues In Specific Tumor Typesmentioning

confidence: 99%

NCCN Working Group Report: Designing Clinical Trials in the Era of Multiple Biomarkers and Targeted Therapies

Venook¹,

Arcila²,

Benson³

et al. 2014

J Natl Compr Canc Netw

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Defining treatment susceptible or resistant populations of cancer patients through the use of genetically defined biomarkers has revolutionized cancer care in recent years for some disease/patient groups. Research continues to show that histologically defined diseases are diverse in their expression of unique mutations or other genetic alterations, however, which presents both opportunities for the development of personalized cancer treatments, but increased difficulty in testing these therapies because potential patient populations are divided into ever-smaller numbers. To address some of the growing challenges in biomarker development and clinical trial design, NCCN assembled a group of experts across specialties and solid tumor disease types to begin to define the problems and to consider alternate ways of designing clinical trials in the era of multiple biomarkers and targeted therapies. Results from that discussion are presented, focusing on issues of clinical trial design from the perspective of statisticians, clinical researchers, regulators, pathologists and information developers.

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NCCN Task Force Report: Optimizing Treatment of Advanced Renal Cell Carcinoma With Molecular Targeted Therapy

Cited by 49 publications

References 129 publications

Extension of overall survival beyond objective responses in patients with metastatic renal cell carcinoma treated with high-dose interleukin-2

Extension of overall survival beyond objective responses in patients with metastatic renal cell carcinoma treated with high-dose interleukin-2

A new prognostic classification for overall survival in Asian patients with previously untreated metastatic renal cell carcinoma

NCCN Working Group Report: Designing Clinical Trials in the Era of Multiple Biomarkers and Targeted Therapies

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