This slideshow takes a look at some of the top kidney cancer news of 2016, including FDA approvals, survival disparities, surgical approaches, and more.
Cabozantinib Receives FDA Approval for Treating Advanced RCC:
The US Food and Drug Administration (FDA) approved cabozantinib (Cabometyx) tablets for treating patients with advanced renal cell carcinoma (RCC). The phase III METEOR trial, which led to the approval, included 658 RCC patients who had become refractory to at least one prior vascular endothelial growth factor receptor tyrosine kinase inhibitor. Patients on cabozantinib had a median overall survival of 21.4 months compared with 16.5 months for everolimus.
Image courtesy of Exelixis.
Lenvatinib Receives Approval for Advanced RCC:
The FDA approved lenvatinib (Lenvima) in combination with everolimus for the treatment of advanced RCC. The approval is for patients who were previously treated with an anti-angiogenic therapy. That study included a lenvatinib/everolimus group (51 patients), a lenvatinib monotherapy group (52 patients), and an everolimus monotherapy group (50 patients). The median progression-free survival with the combination was 14.6 months compared with only 5.5 months with everolimus alone, for a hazard ratio of 0.37 (95% CI, 0.22â0.62).
Image courtesy of Eisai.
Survival Improves in African-American RCC Patients, but Disadvantage Persists:
Researchers used the National Cancer Data Base to assess the changes to survival in RCC patients by race over time and found that the median overall survival in the 1998–2004 period was 6.9 months for Caucasians and 5.6 months for African-American patients. These both improved significantly in the 2006–2011 period, to 8.3 months and 6.4 months, respectively. Still, African-American patients maintained a survival disadvantage over the course of the period studied. The unadjusted hazard ratio for death for African-American vs Caucasian patients was 1.13 in the earlier era, and 1.18 in the targeted therapy era. Adjustments for a variety of factors did not dramatically change those ratios.
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Active Surveillance May Be Possible for Some With Metastatic RCC:
Certain patients with metastatic RCC safely underwent active surveillance of their disease prior to undergoing systemic therapy in a phase II study. Researchers identified two prognostic groups through use of a recursive partitioning algorithm-a favorable group consisting of patients with no or one International Metastatic Renal Cell Carcinoma Database Consortium risk factors and two or fewer organs with metastatic disease, and an unfavorable group consisting of all other patients. The favorable group comprised 29 (60%) patients and had an estimated median surveillance time of 22.2 months, whereas the 19 (40%) patients in the unfavorable group had an estimated median surveillance time of 8.4 months. This demonstrated that patients can be offered a period of close surveillance with the potential for prolonged survival before disease progression and the initiation of systemic therapies.
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Metabolic Factors Linked to Treatment Resistance in RCC:
Investigators reported that intrinsic metabolic factors within tumor cells may contribute to treatment resistance in RCC and may even be predictive markers for treatment outcomes. In the study, researchers found that PD-L1–positive RCC patients who did not respond to treatment with the anti–PD-1 therapy nivolumab had significantly higher expression of genes associated with metabolism when compared with PD-L1–positive patients who did respond to nivolumab. The findings may point the way toward potential new targets for combination regimens with anti–PD-1 therapies.
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Functional Status Affected Kidney Cancer Care, Survival:
Patients with kidney cancer who are considered to be in poor functional health were less likely to receive cancer-directed surgery to treat their disease and were at a greater risk of death from something other than kidney cancer. Kidney cancer mortality, other-cause mortality, and receipt of cancer-directed surgery according to functional health status were compared in a group of 28,326 elderly patients with primary kidney cancer taken from SEER-Medicare data from 2000 to 2009. Adjusting for patient characteristics, investigators found that patients with at least one function-related indicator (such as falls, fractures, home oxygen use, pressure ulcers, use of mobility-assist devices, or evidence of overall dysfunction or disability) and those with two or more indicators had a higher risk of other-cause mortality compared with patients without any function-related indicators.
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Despite Preclinical Findings, ‘Much More Work’ Needed for RCC Biomarkers:
Despite treatment advances for RCC, biomarkers are urgently needed for earlier diagnosis and treatment, and quicker assessment of treatment efficacy. Early preclinical studies of circulating VEGF-A and inflammatory cytokine biomarkers, microRNA, and tumor cells have been encouraging for RCC-but “much more needs to be understood about circulating biomarkers” before they can be employed clinically to predict tumor responses to immune checkpoint blockade therapies, cautioned researchers, in a review of liquid RCC biomarkers for selecting antiangiogenic agents and immunotherapies.
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Nephrectomy, Hepatic Resection May Be a Safe Aggressive Approach for RCC:
Patients with RCC who underwent simultaneous nephrectomy and hepatic resection had similar postoperative mortality, long-term survival, and cancer-specific survival as those patients who underwent metastasectomy or en bloc resection of neighboring non-hepatic organs. The study compared 34 patients who underwent nephrectomy with hepatic resection for direct hepatic invasion (50%; n = 17) or metastatic RCC (62%; n = 21) with 68 patients who underwent nephrectomy and resection of non-hepatic locally invasive metastatic disease. Patients undergoing hepatic resection had higher intraoperative blood loss and higher rates of postoperative deep vein thromboses. There were no significant differences in Clavien grade 3/4 complications or in perioperative mortality between the two groups.
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Bevacizumab/Everolimus Active in Certain Non–Clear Cell RCC Histologies:
The combination of the VEGF-directed bevacizumab plus the mTOR-directed everolimus had efficacy in patients with unclassified non–clear cell RCC characterized by papillary features, resulting in an objective response rate of 43% compared with 11% among patients without these features. Researchers conducted a single-center phase II trial testing everolimus 10 mg once daily plus bevacizumab 10 mg/kg every 2 weeks in 35 patients with treatment-naive non–clear cell RCC and found that progression-free survival varied by disease histology. Specifically, those patients whose disease had significant papillary or chromophobe features had higher objective response rates compared with other histologies.
. Image © Roche.
High BMI Linked With Improved Metastatic RCC Survival:
Patients with metastatic RCC and a body mass index (BMI) of ≥ 25 had significantly longer overall survival compared with patients with a BMI < 25. Researchers examined associations between BMI and RCC survival by looking at the underlying biologic mechanisms. They looked at BMI in 1,975 patients from the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) and in an external validation cohort of 4,657 patients. In the IMDC cohort, the median overall survival was 25.6 months in patients with a high BMI compared with 17.1 months in patients with a low BMI.
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Sunitinib Potential New Option for Adjuvant Treatment in RCC:
Patients with RCC at high risk for recurrence had prolonged disease-free survival when treated with sunitinib compared with placebo, according to the results of a phase III trial, which included 615 patients with previously untreated locoregional RCC. All patients had undergone nephrectomy and were randomly assigned to daily 50-mg sunitinib or placebo with a schedule of 4 weeks on, 2 weeks off for 1 year. The median disease-free survival was 6.8 years for sunitinib compared with 5.6 years for placebo.
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First-Line Vaccine Did Not Improve Survival in Metastatic RCC:
The addition of the IMA901 vaccine to sunitinib for the first-line treatment of metastatic RCC did not improve overall survival compared with sunitinib alone, according to results from the IMPRINT study. This is despite encouraging results from a phase II trial that showed an association between overall survival and T-cell response against IMA901. The researchers suggested several explanations for the absence of an overall survival benefit for combined therapy in this trial, including the weakened immune response seen in patients assigned to IMA901.
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