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Depth of remission is a prognostic factor for survival in patients with metastatic renal cell carcinoma.

ABSTRACT: Response remains an important endpoint in clinical cancer trials. However, the prognostic utility of best tumor response in metastatic renal cell carcinoma (mRCC) remains vague.To define the prognostic relevance of the depth of remission in mRCC.Pooled data from the Pfizer database for 2749 patients from phase 2 and 3 clinical trials in mRCC were analyzed. Tumor shrinkage was categorized according to the best percentage change in the sum of the largest diameter of target lesions. Outcome was computed using Kaplan-Meier curves and correlation was assessed via Cox regression, including a 6-mo landmark.Sunitinib, sorafenib, axitinib, temsirolimus, or temsirolimus and interferon-?.Categorized tumor shrinkage, overall survival (OS), progression free survival (PFS).Major tumor shrinkage of 60% or more occurred in approximately 10% of patients and was associated with median OS of 54.5 mo. OS expectations steadily decreased with depth of remission (26.4, 16.6, 10.4, and 7.3 mo). The association was maintained when stratified by type of therapy, line of therapy, and performance status. Cox proportional regression analyses for the 6-mo landmark confirmed the prognostic relevance of major tumor shrinkage (hazard ratio 0.29, 95% confidence interval 0.22-0.39; p<0.001). The major limitation of our study is the variability of imaging intervals among studies.This is the first and largest analysis of best tumor response in mRCC. We demonstrate that depth of remission is an independent prognostic factor in mRCC.It remains unknown whether tumor shrinkage during therapy is needed to achieve clinical activity in metastatic renal cell carcinoma. Our analysis shows that the magnitude of tumor shrinkage correlates with better survival in patients. This observation may be used as a clinical research tool in future trials.NCT00054886, NCT00077974, NCT00267748, NCT00338884, NCT00137423, NCT00083889, NCT00065468, NCT00678392.

SUBMITTER: Grunwald V

PROVIDER: S-EPMC4570832 | biostudies-literature | 2015 May

REPOSITORIES: biostudies-literature

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Depth of remission is a prognostic factor for survival in patients with metastatic renal cell carcinoma.

Grünwald Viktor V McKay Rana R RR Krajewski Katherine M KM Kalanovic Daniel D Lin Xun X Perkins Julia J JJ Simantov Ronit R Choueiri Toni K TK

European urology 20150107 5

<h4>Background</h4>Response remains an important endpoint in clinical cancer trials. However, the prognostic utility of best tumor response in metastatic renal cell carcinoma (mRCC) remains vague.<h4>Objective</h4>To define the prognostic relevance of the depth of remission in mRCC.<h4>Design, setting, and participants</h4>Pooled data from the Pfizer database for 2749 patients from phase 2 and 3 clinical trials in mRCC were analyzed. Tumor shrinkage was categorized according to the best percenta ...[more]

PMID: 25577718

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Project description:Patients with metastatic renal cell cancer (mRCC) for whom surgery is ineffective may experience a poor prognosis. The different sites where cancer has spread, and the different ways to treat it in the immune checkpoint inhibitors era could help clinical decision-making. In this study, individuals with mRCC were selected from the SEER database between 2015 and 2016 based on the Food and Drug Administration (FDA) approval of ICIs. A total of 4011 mRCC patients were studied (2239 with lung metastasis vs. 797 with liver metastasis in the immune checkpoint inhibitors period). The age ≤ 64 years and male were the majority in all cases of mRCC. When the two groups (lung metastasis and liver metastasis) were compared, the liver metastasis group had more bone metastasis than the lung metastasis group (41.8% vs. 34.1%, p < 0.001), but the lung metastasis group had more brain metastasis (8.9% vs. 11.5%) (p = 0.023). In a study of overall survival (OS) in the ICI era for mRCC, we found that lung metastasis was significantly associated with improved survival compared to liver metastasis (p < 0.001: 7 months vs. 4 months). This survival advantage restricted in lung metastasis group of mRCC after adjusting age, sex, race, marital status, histological type, metastasis to bone, and brain, origin, radiotherapy record chemotherapy record, surgery on multivariable using Cox proportional hazard model (HR = 1.407; 95% CI = 1. 269-1.560; p < 0.001). The overall survival difference between the variables of the lung metastasis and liver metastasis was noted among most of the variables, with survival benefits restricted to patients in lung metastasis in the ICI era. Patients who had undergone chemotherapy and surgery were strongly positive predictors for better OS (HR = 0.427; 95% CI = 0.379-0.481; p < 0.001) (HR = 0.371; 95% CI = 0.311-0.444; p=< 0.001), and (HR = 0.313; 95% CI = 0.264-0.372; p < 0.001), (HR = 0.427; 95% CI = 0.320-0.568; p < 0.001) in lung metastasis group and liver metastasis group. The c-index of the prognostic nomogram for OS prediction was 0.74 and 0.73. This study found that patients with lung metastasis who received ICI had better survival than those with liver metastasis. Chemotherapy and surgery enhanced survival in kidney cancer patients, whereas radiation had little impact. We developed a complete and realistic nomogram for mRCC patients based on distant metastases to the lung and liver.

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Depth of remission is a prognostic factor for survival in patients with metastatic renal cell carcinoma.

Publications

Depth of remission is a prognostic factor for survival in patients with metastatic renal cell carcinoma.

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