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Management

Updated 28 October 2008

Stage I (T1 N0 M0) and Stage II (T2 N0 M0)

Radical nephrectomy with or without regional node dissection.

Partial nephrectomy in select cases of functional solitary kidneys or small polar lesions.

Stage III (T1 N1 M0 - T2 N1 M0 - T3 N0,N1 M0)

Surgery

Radical nephrectomy with or without regional node dissection. Renal vein or vena cava involvement can be surgically evacuated with curative intent. Patients with bilateral primary renal cell carcinoma or only one functioning kidney may undergo partial nephrectomy.

Radiation Therapy

Radiation therapy has no established role as primary definitive therapy of early renal cancers or as an adjuvant to surgery (preoperative or postoperative).

Chemotherapy

Chemotherapy has no role as adjuvant therapy for high risk tumours.

Stage IV (T4 N0 N1 M0 - any T N2 M0 - any T any N any M1) or Recurrent Disease

Surgery - Current Policy

  1. Palliative nephrectomy or angio-infarction may be required for uncontrolled pain and bleeding
  2. Palliative nephrectomy is recommended in combination with interferon for patients in good performance status. This policy is based on two parallel randomized studies with a weighted median survival improvement of approximately six months. These trials selected only the fittest patients and therefore only such patients should be considered for up-front nephrectomy
  3. The role of palliative nephrectomy in combination with Vascular endothelial growth factor (VEGF) receptor inhibitors is currently unknown. However, based on the eligibility criteria of the pivotal phase III trial as well as retrospective data, cytoreductive nephrectomy is recommended in patients with good performance status (ECOG 0,1). An interval of at least three weeks is currently recommended between major surgery and the initiation of anti-angiogenic therapy
  4. Resection of a solitary metastasis or oligo-metastases in a single site, from renal cell carcinoma should be considered for patients in good performance status if the patients has synchronous limited metastatic spread, or if the interval from nephrectomy to the detection of metachronous limited metastases is sufficiently long and the metastatic site is proven to be solitary by adequate restaging (CT of brain, chest and abdomen, bone scan)

Reference:

Tannock IF. Commentary on "cytoreduction nephrectomy in metastatic renal cancer: the results of SWOG 8949". J Clin Oncol 2000; 18(21 Suppl):39S-42S.

Radiation Therapy

Radiation therapy may be used to control bleeding and pain from the primary tumour and to palliate symptoms from metastases.

Chemotherapy and Immunotherapy

  • Chemotherapy, such as vinblastine or other chemotherapy agents, is not recommended
  • Interferon-alpha has proven superiority over medroxyprogesterone acetate within a randomized trial in patients with metastatic RCC. Interferon-alpha provides response rates of 6-15% resulting in a modest survival benefit of three to four months. Single patients with long term survival have been reported. Only good prognosis patients appear to benefit, so generally, only highly selected RCC patients with good prognosis features should be considered for interferon. This includes patients with clear cell histology, good performance status, a progression-free interval following initial diagnosis of more than one year and preferably lung metastases as the sole metastatic site
  • Other cytokines such as interleukin or cytokine combinations such as interferon plus interleukin have not shown significant benefit in randomized trials or have not been validated compared to best supportive care in randomized trials
  • Patients that have had nephrectomy with a good disease-free interval and are found to have asymptomatic recurrence (e.g. small lung metastases) may also be observed without treatment. Such a period of observation can be very prolonged in selected patients. This allows a better knowledge of the tempo of the disease and is associated with a better quality-of-life than any of the systemic treatments. This appears to be a safe alternative to immediately starting treatment as long as patients remain under close observation. Treatment should be initiated upon progression.
  • Small molecule tyrosine kinase inhibitors against VEGF are considered the new reference standard of care in RCC with clear cell component.
  • Sorafenib: a tyrosine kinase inhibitor with activity against Raf kinases, VEGFR-2, and PDGFR. Sorafenib has shown to significantly improve progression-free survival as second-line therapy in patients with metastatic RCC after cytokine failure (HR 0.44).
    Sorafenib is recommended for patients after cytokine failure.
    Although there was no difference in progression-free survival, Sorafenib was associated with better tolerability, less side effects, fewer kidney cancer related symptoms and higher quality of life as compared to interferon within a randomized phase II study in previously untreated patients with advanced RCC.
    Sorafenib may therefore also be considered as an alternative to sunitinib as first-line therapy if patients are unsuitable for sunitinib
  • Sunitinib: a small molecule tyrosine kinase inhibitor with activity against VEGFR, PDGFR, KIT and FLT-3. Sunitinib has demonstrated an objective response rate of approximately 40% and a tumor control rate (CR+PR+SD ≥ 3 months) of approximately 70% as second-line therapy after cytokine failure in two large phase II studies. Sunitinib can therefore serve as an alternative to sorafenib as second-line therapy after cytokine failure.
    A large randomized trial comparing Sunitinib with interferon as first-line therapy including 747 patients with metastatic RCC showed a progression-free survival of 11 months versus 5 months in favour of Sunitinib. Most patients had good or intermediate risk criteria according to the Motzer criteria. Sunitinib is the reference standard for first-line therapy in patients with metastatic RCC
  • Temsirolimus: an inhibitor of the mammalian target of rapamycin (mTOR). Within a large randomized phase III trial, Temsirolimus proved to be significantly superior over Interferon with regards to both progression-free and overall survival in patients with poor prognosis metastatic RCC based on the modified Motzer criteria. Temsirolimus should be considered for patients with metastatic poor risk RCC
  • The role of second line therapy after failure of anti-angiogenesis agents is currently unknown and is being investigated in clinical trials

References:

  1. Escudier B., Eisen T., Stadler W. et al: Sorafenib in Advanced Clear-Cell Renal-Cell Carcinoma. N Engl J Med 356:125-34, 2007

  2. Motzer R., Rini B., Buzkowski R. et al: Sunitinib in Patients With Metastatic Renal Cell Carcinoma. JAMA 295:2516-2524, 2006

  3. Motzer R., Michelson D., Redman B. et al: Activity of SU11248, a Multitargeted Inhibitor of Vascular Endothelial Growth Factor Receptor and Platelet-Derived Growth Factor Receptor, in Patients With Metastatic Renal Cell Carcinoma. J Clin Oncol 24:16-24, 2006

  4. Motzer R., Hutson T., Tomczak P. et al: Sunitinib versus Interferon Alfa in Metastatic Renal-Cell Carcinoma. N Engl J Med 356:115-24, 2007

  5. Hudes G., Carducci M., Tomczak P et al: Temsirolimus, interferon alfa, or both for advanced renal-cell carcinoma. N Engl J Med 356:2271-2281, 2007

  6. Szczylik C., Demkow T., Staehler M., Rolland F., Negrier S., Hutson TE., Bukowski RM, Scheuring UJ., Burk K., Escudier B.: Randomized phase II trial of first-line treatment with sorafenib versus interferon in patients with advanced renal cell carcinoma: Final results. J Clin Oncol ASCO Annual Meeting Proceedings Part I. Vol 25, No. 18S (June 20 Supplement): 5025, 2007

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