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There are a lot of options available to manage small (<4cm) tumors that are limited to the kidney

-       cut it out via surgery

-       ablate it via freezing (cryo) or heating (RFA)

-       watch it

In selecting an approach, the surgeon’s goal is to maximize disease free survival and minimize negative side effects…Selection is often based on the surgeon’s training/comfort level with each option and his/her evaluation of the trade-offs associated with each approach. Relative to an open partial nephrectomy (Nx), there is   

 - increased risk of chronic kidney disease w/ a radical Nx (removal of entire kidney)

 - increased complication rate w/ laparoscopic Nx (minimally invasive or small incision)

 - no long term efficacy data on thermal ablation…and ability to salvage (patient advocate perspective: if it doesn’t work, next step is not clear as scarring from cryo/RFA makes subsequent surgery more difficult)

 - increased patient anxiety w/ surveillance and no biomarkers or predictors of growth

 

To help make option selection more objective, Fox Chase Cancer Center has documented a surgeon friendly system which can be found at www.nephrometry.com

 

AUA small renal mass guidelines:

-       cancer control is top priority

-       preservation of renal function is high priority (take out part vs. all of kidney when possible)

-       minimally invasive surgery is encouraged when appropriate

 

 

O = Open

L = Laparascopic

* Ablation date is early w/ RFA and cryo treating smaller tumors with shorter follow-up

 

 

Chronic kidney disease (CKD) is a progressive loss of kidney function over a period of months/years. CKD is

-       increasing in prevalence due to increasing obesity, high blood pressure and diabetes. 

-       Bad as it is an independent risk factor for cardiovascular disease, hospitalization and death. 

Surgeons are questioning whether over-use of radical nephrectomy is negatively impacting survival by causing CKD. Preserving renal function is important so partial nephrectomies should be considered for small renal masses as this approach is thought to be protective of kidney function.

 

In management of small renal masses, for the right patient partial nephrectomy is a good approach as it is nephron-sparing and provides excellent local cancer control. It is important to recognize that with a partial nephrectomy comes complications and recovery. Also, pre-surgical biopsies are important to make sure tumor is not benign…you don’t want to do an unnecessary surgery on a benign tumor.

 

An alternative to partial nephrectomy in the management of small renal masses is thermal ablation.

Ablation refers to a local method that destroys the tumor without removing it. Cryoablation is a freezing technique and Radio Frequency Ablation is a heating technique. Advantages of ablation relative to a partial nephrectomy are that ablation has less complications and can be done on an outpatient basis or w/ 1 day hospital stay. Disadvantages are less competitive/no long tem efficacy data on ablation and ability to salvage. Initial data suggests that RFA is similar to partial nephrectomy as a preserver of renal function. Radiographic follow-up is required. Dr. Cadeddu suggests annual imaging after the 1^st year vs. images every 6 months for active surveillance. Another advantage of ablation relative to active surveillance is that patient drop out rate from the surveillance program can be as high as 40%. It is important to have an experienced doctor perform the ablation procedure. 

 

 

The most common presentation of renal cell carcinoma is the small renal mass (< 4 cm) which is usually detected incidentally and without metastatic disease.

 

Not all renal masses are kidney cancer.  Biopsy is recommended to determine if tumor is benign. Twenty percent of tumors < 4 cm are benign. Belief is that the smaller the mass, the less the metastatic rate and the greater the survival. Experience is showing that small tumors initially grow at a negligible rate even if biopsy proves the tumor is renal cell carcinoma.

 

There is a growing body of Canadian and U.S. data that suggests active surveillance of the small renal mass with delayed treatment for progression appears to be a reasonable initial management option in selected patients (older or infirm)…this approach is not yet recommended for young and fit. 

 

Active surveillance requires regular imaging and careful measurement of tumor size/volume. The optimal surveillance protocol is unknown. The progression trigger(s) for metastatic disease is not yet defined.

In Canadian and U.S. studies there is a notable 1.5-2% risk of progression to metastatic disease even though the renal mass is still of small size (~2.5cm) suggesting that an additional prognostic factor besides tumor size needs to be identified and monitored.

 

 

The TMN staging system is a common language/basis to communicate the extent of disease and assists in evaluating a treatment path. TMN stage T1 and T2 tumors are limited to the kidney. T3 and T4 tumors are locally advanced if there is lymph node disease in a single region and no distant mets.

 

 

Risk of disease progression/recurrence and consequently decreased survival increases with increasing TMN stage and increases with increasing tumor grade (runs from 0 to 4). For small renal masses, median survival for grade 4 tumors is only 11 months. Another factor known as the ECOG score which is a measure of a patient’s general well-being is also important in considering the risk of disease progression/recurrence. An ECOG score of 0 denotes perfect health and 5 denotes death. Directionally, patients with higher ECOG scores do not do as well as patients with lower ECOG scores.

 

 

For patients without distant mets, 5/10 yr survival is 48/32%. Patients with distant mets have a 5 yr survival of 7%

 

Whether to cut out lymph nodes during a nephrectomy is controversial. The CT scan sensitivity for nodes > 1 cm is 95%...only about 42% of these nodes are disease positive.

 PRO: Lymph node dissection (LND) offers

-       improved staging and prognostication (a doctor's prediction about a disease path)

-       improved survival in patients with confirmed advanced kidney cancer whose nodes are positive but do not have distant mets

CON: Lack of proven survival benefit studies

 

In the overall management of kidney cancer, he recommends:

T 1a/1b: No LND

T2-4, N0, M0: LND based on pathological features @ surgery if possible/Mayo/MSK pre-op nomogram

cT2-4, N+, M0: LND is standard of care

cTany, N+/-, M+: cytoreductive surgery then LND

 

 

Neoadjuvant therapy refers to systemic drug treatment given to people with cancer prior to surgery. For local control of the primary tumor, an optimal neoadjuvant therapy:

1. Is safe

2. Decreases size of primary tumor

3. Results in tumor downstaging to potentially permit resection of a technically difficult to remove tumor or allow for partial nephrectomy (ie retraction of IVC thrombus, or decreased invasion into adjacent organs).

 

Local control of primary tumor: summary table of neoadjuvant trials results -

 

There is a learning curve to use these drugs safely and effectively. The current neoadjuvant therapy approaches were safe only in the hands of experienced clinicians…an example is that some patients had incomplete wound healing and had to have their treatment approach altered “on the run”.

 

Did current neoadjuvant therapy:

1. Decrease size of primary mass? YES

2. Convert complete to partial nephrectomy? IN SOME CASES

3. Result in retraction of IVC thrombus, or decreased invasion into adjacent organs? NOT TOO OFTEN.

4. Change biology of primary tumor from invasive to noninvasive. UNPROVEN

However, we need better drugs.

 

Conclusions on Optimal Systemic Control For High Risk Patients:

  - Anti-angiogenic agents are capable of reducing primary tumors, but not consistently.

 - There is no evidence that anti-angiogenic agents are anti-metastatic

 - Monitoring tools/markers need to be developed that can measure efficacy of anti-metastatic drugs

 

AS a patient advocate I point out that in the summary table of neoadjuvant trials results for local control: There is a learning curve to use these drugs safely and effectively. The current neoadjuvant therapy approaches were safe in the hands of experienced clinicians... an example is that some patients had incomplete wound healing and had to have their treatment approach altered "on the run."