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In recent years, the incidence of this disease has been on the rise. The primary focus of this review is the systemic treatment of metastatic renal-cell carcinoma RCC. Traditional cytotoxic chemotherapy is not routinely used for the treatment of metastatic RCC. In the mids, the approval of several anti-VEGF therapies provided patients and clinicians with additional treatment options. Oncologists can now choose from several first-line options for the management of patients with metastatic RCC.
Sunitinib, pazopanib, axitinib, sorafenib, and bevacizumab plus interferon IFN -alpha are considered first-line treatment options based on the current National Comprehensive Cancer Network version 1. However, for patients with a good performance status, high-dose IL-2 remains an appropriate treatment option.
Any agent not used in the first-line setting remains a valid second-line treatment option. Patients receiving the high-dose therapy had more side effects including hypotension, central nervous system disorientation, and thrombocytopenia than patients receiving low-dose therapy. There were no significant differences in overall survival OS between the groups, although patients in the high-dose group who had complete responses did have longer survival.
Patient monitoring during intravenous IV administration of IL-2 is of utmost importance, because of the risk for capillary leak syndrome, which can manifest as hypotension, mental status changes, and edema. Nivolumab was the first PD-1 inhibitor to receive FDA approval for the treatment of patients with metastatic RCC, based on promising results in phase 3 clinical trials. Nivolumab and other PD-1 inhibitors block the interaction between PD-1 and PD-L1, which allows for increased anti-tumor immune response. The primary end point was median OS: the median OS was 25 months in the nivolumab group and The median progression-free survival PFS was similar in both groups—4.
The benefit of nivolumab was seen regardless of PD-L1 expression. This study demonstrated that in patients with previously treated advanced metastatic RCC, nivolumab provided longer OS with fewer side effects when compared with everolimus. At the first interim analysis, the median OS was A second analysis 6 months later showed a median OS of The median PFS was 5. Patients received sorafenib for a median of 23 weeks or placebo for 12 weeks. The most common side effects with sorafenib were diarrhea, rash, fatigue, hand—foot skin reactions, alopecia, and nausea.
The investigators concluded that sorafenib increases PFS versus placebo in patients with advanced clear-cell RCC who did not respond to first-line therapy. Motzer and colleagues compared sunitinib with the then standard-of-care, IFN-alpha, in the treatment of metastatic RCC. The study enrolled patients, with patients in each treatment group. Side effects that were more common with sunitinib than with IFN-alpha included grade 3 diarrhea, vomiting, hypertension, and hand-foot syndrome. Laboratory abnormalities seen more often with sunitinib than with IFN-alpha were leukopenia, neutropenia, thrombocytopenia, increased lipase, and increased amylase.
Side effects seen more often with IFN-alpha than with sunitinib included grade 3 or 4 fatigue, pyrexia, chills, myalgia, and influenzalike symptoms; lymphopenia was the only significant laboratory abnormality in the IFN-alpha group. The median OS was The median PFS was The adverse events with bevacizumab included proteinuria, hypertension, and bleeding.
This trial demonstrated the efficacy of bevacizumab plus IFN-alpha-2a as first-line therapy for the treatment of metastatic RCC. Results showed a median OS of The median PFS was 8. The ORR was also improved with the combination, at This trial showed that bevacizumab plus IFN-alpha improved OS, but not significantly, and the combination therapy resulted in more side effects.
The FDA approved pazopanib for the treatment of patients with metastatic RCC based on a study that compared it with placebo. The goal was to show the noninferiority of pazopanib to sunitinib. The primary end point was median PFS, which was 8. Side effects seen more frequently with pazopanib were hair-color changes, weight loss, alopecia, increased alanine aminotransferase levels, and increased bilirubin.
In contrast, sunitinib was associated with more hand-foot syndrome, mucosal inflammation, stomatitis, hypothyroidism, dysgeusia, dyspepsia, epistaxis, fatigue, leukopenia, thrombocytopenia, neutropenia, and anemia than was pazopanib. The study also assessed health-related quality of life, and found that patients reported significantly less fatigue and foot soreness with pazopanib than with sunitinib. The investigators were able to demonstrate the noninferiority of pazopanib to sunitinib as first-line treatment for metastatic RCC, with a more favorable safety and side-effect profile for pazopanib.
The second-generation VEGF receptor inhibitor axitinib has high affinity for VEGF and low off-target effects, which led to its evaluation against sorafenib for the second-line treatment of metastatic RCC. The median PFS was 6. Based on the IRC review, the median duration of response was 11 months with axitinib and At follow-up, the median OS was Side effects seen more frequently with axitinib than with sorafenib were diarrhea, hypertension, hypothyroidism, fatigue, decreased appetite, nausea, and dysphonia.
Side effects seen more frequently in the sorafenib group than in the axitinib group were alopecia, rash, and palmar-plantar erythrodysesthesia. This study demonstrated that axitinib significantly improved PFS compared with sorafenib, and, as such, axitinib should be considered as second-line therapy for the treatment of patients with metastatic RCC.
Hutson and colleagues evaluated axitinib versus sorafenib as first-line therapy in patients with metastatic RCC. The median duration of response was not different between axitinib and sorafenib, at Side effects more common with axitinib than with sorafenib were diarrhea, hypertension, weight decrease, decreased appetite, dysphonia, hypothyroidism, and upper abdominal pain. In contrast, side effects more common with sorafenib than with axitinib were palmar-plantar erythrodysesthesia, rash, alopecia, and erythema.
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The median PFS was 7. The median OS was significantly longer in the cabozantinib group versus the everolimus group at Two studies had an average age of 56 and 81, respectively. Additionally, two studies showed an average tumor size of 7 cm or more. Three studies had a male to female ratio of 1. The radiographic diagnostic study most frequently utilized was CT. Similar to previous meta-analyses, the proportion of metastasis was 1 per patients, whereas the overall mortality was 16 per patients, further verifying the heterogeneity of this population.
The meta-analysis for Table 4 is the product of the data summarized in Appendix E. All are retrospective cohorts. The rate of metastasis is 1 per patients followed. The overall mortality, or death from any cause, is 16 per patients; however, there was significant heterogeneity noted in the estimates depending on whether the interval between subsequent imaging evaluations was three or six months as per study design. When the interval is three months only one death was reported, but when imaging scans were six months apart, the mortality rate raises to an average of 34 per patients.
Since the deaths averted by a more intense follow-up were not kidney-related, it is unclear whether it was the imaging itself, or just the more frequent contact with a health care provider that led to a reduction of death by detecting other life-threatening issues, thus allowing corresponding life-preserving measures to be taken. Of note, the rate of tumor growth in the current meta-analysis is similar to that reported by Chawla et al. This indicates that the newer studies examining active surveillance have similar findings to those performed in the late s.
Corresponding Forest plots are displayed in Appendix F. In addition, none of the studies reported the intra-observer variability or intra-observer evaluations in tumor measurements and how that might impact observed growth rates. The quality score Appendix G implemented for this question has a maximum of 11 points. All items were scored between 0 desirable property not present and 1 point desirable property present. One property was given an additional point to studies that satisfied the particular item beyond the minimum requirement i. The average quality was 4. The main deficiencies in methodological quality were noted in the study design component retrospective, small sizes, not clear whether individuals were included consecutively , follow-up, and handling of potential confounding factors.
The latter is probably motivated by the small number of individuals that makes difficult any multivariable modeling approach. The precise growth rate or absolute tumor size that would trigger intervention is controversial given the limited available data. Some would propose that because the normal growth rate is approximately 0.
The intervention would primarily involve local treatment as outlined in the AUA Renal Mass Guideline, although a biopsy in the case of biopsy-unproven renal masses or a change to more frequent imaging could also be incorporated. Groups appropriate for active surveillance have already been defined in The Renal Mass Guideline. The accuracy of percutaneous biopsy has improved substantially over the past several years due to further refinements in CT- and MRI-guided techniques. Several systematic reviews have addressed this specific diagnostic procedure, 58,59 focusing on several key issues.
Renal mass biopsy is not indicated, however, for comorbid patients who may consider only conservative management options regardless of biopsy results or who have higher risks of biopsy related complications due to comorbid conditions. Clinical characteristics of the renal neoplasm, such as location, cystic nature and hemorrhagic necrosis, may diminish the possible contribution of renal biopsy and should be considered as well.
Only a limited number of studies have specifically examined long-term growth patterns; however, the published studies do not suggest logarithmic growth but rather linear growth patterns. This would include patients with indeterminate renal biopsy with a radiographically identifiable neoplasm, due to the risk of a false negative biopsy. A physician may choose to discontinue chest imaging and only proceed with yearly ultrasounds to watch for growth that may require intervention.
CT and MRI tend to be used more often for surveillance because they provides higher quality information over US, especially for neoplasms under 3cm; however, there may be benefits in reducing the risks of contrast and radiation exposure by employing alternative imaging. Few studies have examined the correlation between the different imaging modalities, but one study by Mucksavage and colleagues, retrospectively reviewed the clinicopathological data of patients who underwent radical or partial nephrectomy and correlated the ability of CT, MRI and US to predict pathologic maximum tumor diameter.
One limitation of this study was that the mean tumor diameter was approximately 4. The lack of inferiority of ultrasonography in predicting pathological tumor size affords opportunities for the reduction of ionizing radiation exposure, reduced need for IV contrast and reduced dependence on adequate renal function to administer contrasts. If a biopsy is performed, the findings of the biopsy and subsequent neoplasm growth rate should dictate follow-up.
Patients with renal carcinoma, oncocytoma or oncocytic neoplasms and indeterminate histology should be followed with the same imaging protocols for untreated, low risk cT1, N0, Nx renal cancer patients for two primary reasons. First, oncocytomas, while benign, can exhibit substantial growth patterns over time that may threaten the renal unit. Second, while the accuracy of percutaneous biopsy has improved substantially in the past several years, as previously mentioned see renal biopsy background section , the differentiation between oncocytoma and oncocytic neoplasms e.
The chromophobe renal cell carcinoma entity is generally associated with more indolent natural history, although it falls within the spectrum of low-risk renal cell carcinoma, and, as such, most investigators have correspondingly adjusted the associated surveillance protocol. However, the Panel believes that these findings need to be considered carefully. There is very likely an ascertainment bias introduced by lack of chest imaging, not only in the surveillance series, but also in the surgical series of T1 disease.
For example, CT imaging was abdominal only in the early surveillance series, except in four studies where the type of CT imaging was not specified. Similarly, the surgical series was dominated by either abdominal only CT imaging or with the addition of imaging at the pelvic or unspecified site. Only one report specifically noted chest imaging. As early distant disease is often asymptomatic, and most series had limited follow-up duration, one potential explanation for the low metastatic rate lies in the lack of chest imaging to capture these metastases.
Historically, chest imaging has been recommended in surveillance series, although the ideal recommended frequency is unknown and should thus be individualized depending on clinical and radiologic characteristics. Conversely, if the tumor is biopsy-proven benign parenchyma, , chest imaging may be omitted. As outlined previously, patients with biopsy-proven oncocytoma or tumor with oncocytic features should be followed like patients with low risk clinical T1, N0, Nx renal cell carcinoma. Thermal ablative modalities, specifically cryoablation and radiofrequency ablation RFA , currently represent accepted minimally invasive treatment options for clinical T1a renal masses in select patients with appropriate informed consent and counseling.
The majority of neoplasms selected for ablative procedures are less than 4 cm and exophytic, as markedly higher incomplete ablation rates have been noted for endophytic, central and larger neoplasms. Thermal ablative techniques are associated with an increased risk of local recurrence compared to extirpritive surgery in the early clinical experience literature and current meta-analysis of the available literature. For the purposes of this document and to maintain consistency with the AUA Guidelines on Management of the Clinical T1 Renal Mass, and the recommendations of the Working Group of Image-guided Tumor Ablation, "local recurrence" was defined as any localized disease remaining in the treated kidney at any point after the first ablation, as determined by a tumor with contrast enhancement after ablation or a visually enlarging lesion in the same area of treatment with or without the presence of contrast enhancement.
Now that there are more intermediate data available on risks of local recurrence following ablative procedures we are taking this further step in defining the term "local recurrence" to include "the failure of an ablated lesion to regress in size over time, and or the development of new satellite or port site soft tissue nodules.
Modern cryoablative technology involves small and medium caliber needle s systems. Post-procedurally, the cryoablation zone is largest on imaging post-operative day one, but then typically steadily decreases. Failure is typically defined as persistence or development of enhancement within the ablated region.
However, at least one study has noted that persistent contrast enhancement may continue for up to nine months after the procedure. A recent meta-analysis summarized 47 studies assessing the efficacy of ablative interventions in 1, kidney neoplasms. Studies were similar in patient demographics and tumor size, and the majority exhibited short-term follow-up for the two ablative modalities. The majority of studies were non-comparative, retrospective, and of small cohort size.
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Similar to the overall ablative cohorts, cryoablation series have tended to intervene on smaller neoplasms and have had a shorter length of follow-up compared to surgical series. Additionally, many of these series have significant numbers of neoplasms with either no pathologic biopsy or a non-diagnostic biopsy. Lack of definitive ability to assess benign pathology should result in a reduced rate of development of metastatic disease and increased cancer specific survival compared with studies looking at surgical extirpative procedures where definitive pathology is obtained.
However, the impact of staging inaccuracy, which is inherent to non-extirpative procedures, may produce the opposite bias resulting in higher levels of development of metastatic disease and reduced cancer specific survival. At present, there is no imaging, molecular marker or methodology to eliminate this inaccuracy.
Radiofrequency Ablation. The meta-analysis conducted as part of the AUA Clinical T1 Renal Mass Guideline Panel demonstrated similar limitations with respect to the quality of the literature, lack of histologic confirmation and short-term follow-up as cryoablation.
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The population treated with ablation is older mean Post Ablation Imaging. Patients who have undergone ablative treatment of renal tumors are subsequently followed with radiologic imaging, using CT or MRI. Immediate post-procedural imaging of the ablated tumor generally shows the tumor to be larger than its pre-treatment size for RFA due to ablation of a peripheral margin of normal tissue, and for cryoablation due to extension of the iceball beyond the original tumor margin.
Radiological evolution of cryoablated tumors is characterized by significant decrease in size and loss of contrast enhancement on CT. Rim enhancement, believed to represent reactive change, may occasionally be seen at early postprocedural MR imaging after RFA or cryoablation, which later resolves and is not considered ablation failure. Cryoablated or RF-ablated renal tumors generally appear relatively hypointense on T2-weighted images as compared to the intermediate or high signal intensity tumor seen on pre-ablation images.
Ablation zones exhibit somewhat varied signal intensity on T1-weighted images following RFA or cryoablation. Renal tumors that have been successfully treated with cryoablation demonstrate reduction in size, complete resolution or scar formation. Several reports have questioned whether the absence of contrast enhancement in the ablated tumor is a reliable indicator of successful tumor ablation after RFA, although the reliability of the histopathologic "gold standard" used to determine presence of viable tumor in these studies has been subject to criticism. A study by Weight et al.
The study included a total of renal neoplasms in 88 patients treated with percutaneous RFA and a total of renal neoplasms in patients treated with laparoscopic cryoablation. All patients scheduled for ablative therapy underwent initial biopsy. The post-ablation protocol included radiographic imaging with CT or MRI on post-operative day 1, at 3, 6 and 12 months and then annually. Biopsy of the ablated site was performed immediately after the six-month abdominal imaging. There were significantly more centrally-located tumors in the RFA group, half as many in the RFA group had a normal contralateral kidney as did those in the cryoablation group, and there were 17 times more solitary renal remnants in the RFA group.
Centrally located neoplasms within kidneys that in some cases may have demonstrated architectural distortion on imaging may have shown limited conspicuity as distinct from the surrounding renal parenchyma. Also, as was true in the study by Rendon, only hematoxylin H and eosin E staining was used for histopathologic evaluation, and the accuracy of routine staining in the evaluation of post RFA treated tissue for viable cells is unknown.
A study by Raman et al. Nineteen patients with 20 neoplasms underwent RFA in the study. Pre-procedure biopsy confirmed renal cell carcinoma in 17 of the 20 tumors and oncocytoma in the remaining three. All 20 of the neoplasms remained radiographically negative stable in size and without contrast enhancement on CT on surveillance studies carried out to over one year.
Tru-Cut core biopsies of the ablative zone one year or more following the treatment was performed on all 20 neoplasms. Histopathological examination using H and E staining showed "unequivocal tumor eradication" in all cases, with coagulative necrosis, hyalinization, inflammatory cell infiltration and residual ghost cells.
Comparing their more promising results with several prior papers that reported both higher frequencies of viable tumor on post-treatment biopsies and failure of imaging to detect these tumors, researchers attributed differences as likely related to false-positive biopsies performed too early in the post-treatment period; tissue " A report by Javadi et al.
In one of the cases, soft tissue that was initially felt to represent post-procedure hematoma persisted on a six-month follow-up CT. Despite the absence of contrast enhancement, a CT-guided biopsy yielded minute fragments of renal cell cancer. In one of the other two cases the ablation zone tissue abruptly enlarged with some enhancement that was not the typical crescentic or nodular pattern seen in viable tumor, and in the other case the perinephric fat began to demonstrate an infiltrated appearance containing soft tissue strands, but percutaneous biopsy did not yield viable tumor in either of these cases.
In summary, given the findings of the preceding studies close attention to overall radiographic pattern and morphology of the treated lesion over time, pretreatment verification of tumor, careful reporting of outcomes following ablative procedures, careful description of patient and pretreatment tumor characteristics and further assessment of post treatment biopsy accuracy are needed.
Based on what we know today, findings of concern are growth of the lesion with or without enhancement, new nodularity, failure of regression in size of the treated lesion over time, satellite soft tissue nodules, port site nodularity or enhancement beyond three months from ablation.
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Further data to clarify both the histopathologic methodology for detecting viable tumor cells in ablated renal tissue as well as the accuracy of contrast-enhancement or lack thereof on CT or MRI as an indicator of persistent or completely eradicated tumor after renal ablative procedures will be helpful to validate the reliability of post procedural radiologic imaging surveillance protocols. Needle biopsy post ablation. Please refer back to the background on needle biopsy post-ablation for an in-depth discussion.
The Panel considers urologists to be the experts in the evaluation, management and follow-up of both the small renal mass as well as renal cancer and the treatment associated complications. Urologists should be involved in the care of the patient whether or not they perform the actual procedure.
They should be active partners of interventional radiologists, and participation in the percutaneous procedure is encouraged. The Panel considers renal mass biopsy to be of benefit in post-procedure risk stratification and counseling of the ablation patient. A diagnostic biopsy whether benign or malignant will help refine the post-operative follow-up, may allow reduction of the burden of surveillance imaging in patients with benign tumor histology and prevent empirically labeling a patient as having renal cancer.
Conversely, patients who do not undergo biopsy or have indeterminate results on biopsy should be followed as a renal cell cancer patient, which carries the potential burdens of unnecessary surveillance. Percutaneous biopsy carries minimal risk for post procedure complications and tumor spillage and metastatic disease.
This should be further clarified to include a visually enlarging neoplasm or new nodularity in the same area of treatment whether determined by enhancement of the neoplasm on post-treatment contrast imaging, or failure of regression in size of the treated lesion over time, new satellite or port site soft tissue nodules or biopsy proven recurrence. Utilization of a standardized definition of failure may reduce delivery of inappropriate follow-up care, help with future comparative outcomes studies and support new knowledge in the understanding of response to ablative treatments.
Patients who cannot receive IV contrast for imaging related to renal dysfunction or allergies should still undergo cross sectional MRI or CT to assess for regression of the treated lesion and to monitor for nodularity or growth. As previously stated any growth in size of the treated lesion, lack of regression in size of the lesion over time, new nodularity, satellite soft tissue nodules, port site nodularity or enhancement beyond three months from ablation would be concerning and should prompt a biopsy. Further data to clarify both the histopathologic methodology for detecting viable tumor cells in RFA-treated renal tissue as well as the accuracy of contrast-enhancement or lack thereof on CT or MRI as an indicator of persistent or completely eradicated tumor after renal RFA will be helpful to validate the reliability of post procedural radiologic scanning surveillance protocols.
Until there is long-term data showing equivalence to surgery in terms of efficacy, a five-year follow-up period is warranted for patients undergoing ablative therapy. Patients who have undergone ablative treatment of renal tumors are subsequently followed with radiologic scanning using CT or MRI.
Radiological evolution of cryoablated tumors is characterized by significant shrinkage and loss of contrast enhancement on CT. On MRI, the imaging hallmark of successful renal tumor ablation is lack of tumor enhancement at gadolinium-enhanced imaging. Rim enhancement, believed to represent reactive change, may occasionally be seen at early postprocedural MR scanning after RFA or cryoablation, which later resolves.
A limitation of the current ablative literature is the dearth of long term outcomes studies with confirmed histology. Initial ablative series mostly focused on elderly patients with poor surgical risk and multiple medical co-morbidities.
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However, with increasing utilization of ablative modalities on younger patients, longer term follow up will likely become a more significant issue. Patients undergoing ablative procedures who have either biopsy proven low risk renal cell carcinoma, oncocytoma, a tumor with oncocytic features, nondiagnostic biopsies or no prior biopsy should undergo annual chest x-ray CXR to assess for pulmonary metastases for five years. Although the potential burdens and risks of over-surveillance should be borne in mind, it was the Panel's opinion that these patients should be followed with the assumption that the tumor is renal cell carcinoma, given the risk of metastatic progression even in Clinical T1a renal masses and the yet unknown long term five years and beyond oncologic efficacy for ablative procedures.
Given the low biological potential of benign renal masses, routine follow-up scanning after the six month postprocedural mark other than to confirm treatment success or to monitor complications should be avoided. Salvage therapy in ablative failures may be complex, and depending on the size and location of the area of recurrence, options including re-ablation, salvage partial and radical nephrectomy may be considered when feasible.
Salvage partial nephrectomy may be particularly challenging in the post ablative setting, and reports of this in the literature are rare. Given the dearth of long term five year and beyond oncologic efficacy of ablative procedures and the slow natural history of renal cell cancer in terms of growth rate, findings such as increasing size, new nodularity, satellite lesions, or failure of the treated lesion to regress over time even in the absence of enhancement should prompt lesion biopsy.
The Panel has chosen to include non-contrast enhanced imaging findings based on reports of recurrence even in the absence of imaging enhancement, and in recognition of the fact that in circumstances of declining renal function, contrast enhanced studies are contraindicated, and, therefore, non-contrast enhanced imaging is the only form of radiologic surveillance available. In this clinical practice guideline document, the Panel applied the AUA's rigorous and systematic approach to guideline development.
This approach pairs a systematic review of the current best evidence with the Panel members' clinical judgment to address the most pertinent questions relating to the appropriate extent and timing of follow-up in patients with a history of a renal mass. Addressing these questions in this context required an integration of different study types related to diagnosis, prognosis and therapy.
In addition, it required the Panel members to make judgments about the appropriate level of certainty by which we hope to rule in or rule out a given condition, for example local or distant recurrence, to ultimately arrive at measured recommendations about an appropriate follow-up regimen. Additional considerations were concerns about the potential long-term risk of cumulative radiation posed by frequent imaging. Most of the guideline statements in this document are based on low quality evidence, which is reflective of the literature and the need for continuing high quality and transparent research that will have an important impact in the follow-up of patients with renal neoplasms.
We have identified the following areas of priority:. Website Tip! While viewing Guideline Statements on a desktop computer, use the left navigation to jump to different parts of the page. For more educational resources, patient brochures and algorithms, click Tools and Resources on the left sidebar desktop computers only. Standard Operating Procedures Overview.
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Purpose The Panel sought to create evidence-based guidelines for the follow-up and surveillance of clinically localized renal cancers treated with surgery or renal ablative procedures, biopsy-proven untreated clinically localized renal cancers followed on surveillance, and radiographically suspicious but biopsy-unproven renal neoplasms either treated with renal ablative procedures or followed on active surveillance.
Methodology A systematic review was conducted to identify published articles relevant to key questions specified by the Panel related to kidney neoplasms and their follow-up imaging, renal function, markers, biopsy, prognosis. Guideline Statements 1. Clinical Principle 2. Expert Opinion 3. Expert Opinion 4. Grade C 5. Grade C 6. Grade A 7. Grade C Surgery. Low risk patients pT1, N0, Nx : 8. Expert Opinion 9. Grade C Expert Opinion Active Surveillance Grade C Ablation Expert Opinion Clinical Principle Methodology Process for Literature Selection.
Clinical Principle: a statement about a component of clinical care that is widely agreed upon by urologists or other clinicians for which there may or may not be evidence in the medical literature. Expert Opinion: a statement, achieved by consensus of the Panel, that is based on members' clinical training, experience, knowledge, and judgment for which there is no evidence. Table 4. We have identified the following areas of priority: There is a critical need for high quality, prospectively defined cohort studies to better define the prognosis of various renal masses and to establish prognosticators of important patient outcomes, such as overall survival, disease specific survival, cardiovascular and metabolic sequelae and quality of life.
These trials need to include either hypothesis generating or hypothesis testing analyses of laboratory, tissue based or circulating biomarkers. An important first step in these trials is the application of standardized specimen collection algorithms including blood, urine and tumor tissue to create a bank of material that makes future investigation of this patient population possible.
All studies relating to the prognosis and management of renal masses should include a standardized data set of patient and tumor demographics as well as treatment details to allow a meaningful interpretation of its results. When feasible, rates of oncological outcomes for patients with localized and metastatic disease should be provided separately.
Reporting should include measures of estimates' precision i. Given the potential burden of long-term follow-up of renal masses, randomized trials of different surveillance regimens i. Embedded in such trials could be studies that evaluate the impact of new and resource-intense imaging modalities, such as PET. While those trials are not conducted, oncological outcomes by surveillance imaging modalities should be reported in order to assess their detection accuracy and potential utility.
There is a need for better prospectively designed studies to define the diagnostic accuracy of renal biopsies to define the underlying pathology, natural history and need for treatment. There is a need for better prospectively designed studies to define the diagnostic accuracy of renal biopsies following ablative therapies to define the treatment response, natural history and need for further treatment.
In light of the expanding use of ablative therapies for renal masses there is need for a uniform definition of treatment success and failure. For the purposes of this document a local tumor recurrence following ablative therapy was defined as "as any localized disease remaining in the treated kidney at any point after the first ablation, as determined by a tumor with contrast enhancement after ablation, a visually enlarging lesion in the same area of treatment with or without the presence of contrast enhancement, the failure of an ablated lesion to regress in size over time, and or the development of new satellite or port site soft tissue nodules.
There is a need for better prospectively designed studies to define the risk of positive microscopic and gross margins in patients undergoing nephron sparing surgery in terms of the risk of a local or distant recurrence and the timing and pattern of recurrences to guide future surveillance efforts. There is an important need for the stringent application of well-defined criteria for reporting treatment related harm that should be part of any report.
Examples of such systems should include the Martin Criteria, a formal validated grading system such as the Dindo-Clavien grading system for rating complications, and a standardized reporting methodology such as that recommended by the EAU European Association of Urology guideline panel assessment in Brennan MF: Follow up is valuable and effective: true, true and unrelated? Ann Surg Oncol ; 7: 2. CA Cancer J Clin ; Lancet Oncol ; 7: J Urol ; N Engl J Med ; Radiology ; Evaluation of the quality of prognosis studies in systematic reviews. Ann Intern Med ; Controlled Clinical Trials ; 7: BMJ ; 6: Kim SP, Thompson H, Boorjian SA et al: Comparative effectiveness for survival and renal function of partial and radical nephrectomy for localized renal tumors: a systematic review and meta-analysis.
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