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Latest Research on
Renal Cell Carcinoma
     
Urol Oncol. 2008 Jan-Feb;26(1):102.
Intermediate comparison of partial nephrectomy and radiofrequency ablation for clinical T1a renal tumors.
Stern JM, Svatek R, Park S, Hermann M, Lotan Y, Sagalowsky AI, Cadeddu JA, Department of Urology, University of Texas, Southwestern Medical Center, Dallas, TX.Boorjian SA, Blute ML.

OBJECTIVE: To compare the intermediate term outcomes of patients with clinical T1a renal tumors who were treated with nephron-sparing surgery by partial nephrectomy (PN), the preferred approach for small (cT1a) renal tumors, or radiofrequency ablation (RFA), recently offered to selected patients as an alternative, less morbid technique. PATIENTS AND METHODS: We identified patients with stage T1a renal masses who had >/=2 years of follow-up; those with bilateral synchronous or metachronous tumors, metastatic disease at presentation, or a family history of renal cell carcinoma were excluded. From July 1996 to January 2004, 110 PNs were identified in our database; 37 patients who fulfilled the inclusion criteria had either open (30) or laparoscopic PN (7), and 40 had either percutaneous (26) or laparoscopic (14) RFA. RESULTS: The mean (range) follow-up for the RFA and PN groups was 30 (18-42) and 47 (24-93) months, respectively; the respective mean tumor size was 2.41 and 2.43 c
m. There was 1 incomplete ablation and 2 local recurrences in the RFA group, and 2 recurrences in the PN group (1 local and 1 in the contralateral kidney). There were no disease-specific deaths. The overall actuarial disease-free probability for the PN and RFA groups, respectively, was 95.8% and 93.4% (P = 0.67). CONCLUSIONS: This initial 3-year actuarial analysis showed that RFA for cT1a renal tumors has comparable oncological outcomes to PN; however, longer term data are still needed.

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Urol Oncol. 2008 Jan-Feb;26(1):102-3.
Renal cell carcinoma clinically involving adjacent organs: Experience with aggressive surgical management.
Margulis V, Sánchez-Ortiz RF, Tamboli P, Cohen DD, Swanson DA, Wood CG, Department of Urology, University of Texas, M.D. Anderson Cancer Center, Houston, TX.Russo P.

BACKGROUND: Historically, patients with nonmetastatic renal cell carcinoma (RCC) involving adjacent organs have been considered inoperable and incurable. The oncologic efficacy of an aggressive surgical approach was evaluated in a selected subpopulation of RCC patients. Further, an attempt was made to define the clinical and pathologic characteristics predictive of surgical failure. METHODS: With Institutional Review Board approval, the institutional nephrectomy database of 3,470 patients treated at M. D. Anderson Cancer Center from 1990 to 2006 was searched for RCC patients treated with radical nephrectomy and resection of at least 1 adjacent organ thought to be directly involved by RCC. Patients with nonmetastatic RCC and a minimum follow-up of 6 months were included in the analysis. RESULTS: In all, 30 patients with clinical T4NxM0 RCC and median follow-up of 32.3 months (range, 8.5-140.1) met the study inclusion criteria and comprise the dataset for the analysis. On pathologic evaluation 60% of patients were clinically overstaged, as only 12 (40%) of 30 patients demonstrated direct invasion into adjacent organs resected. None of the clinical tumor characteristics predicted a finding of pathologic T4 RCC. Nodal involvement and pathologic T stage were significant independent predictors of disease recurrence (hazard ratio [HR] 3.726, P = 0.043, and HR 2.414, P = 0.045, respectively) and cancer-specific survival (HR 17.145, P = 0.002, and HR 3.791, P = 0.024, respectively). Disease recurred in 11 of 18 (61.1%) of <pT4 patients and in 10 of 12 (83.3%) of pT4 patients at a median 13.3 and 2.3 months, respectively; 13 (73.3%) <pT4 patients and 5 (41.7%) pT4 patients were alive at the time of analysis. CONCLUSIONS: True pathologic involvement of adjacent organs by RCC cannot be predicted from pre- or intraoperative parameters. A significant proportion of patients clinically suspected of having T4 RCC are downstaged, and benefit from aggressive surgical resection with en bloc removal of involved organs.

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Urol Oncol. 2008 Jan-Feb;26(1):101-2.
A prospective randomized EORTC intergroup Phase 3 study comparing the complications of elective nephron-sparing surgery and radical nephrectomy for low-stage renal cell carcinoma.
Van Poppel H, Da Pozzo L, Albrecht W, Matveev V, Bono A, Borkowski A, Marechal JM, Klotz L, Skinner E, Keane T, Claessens I, Sylvester R, European Organization for Research and Treatment of Cancer (EORTC); National Cancer Institute of Canada Clinical Trials Group (NCIC CTG); Southwest Oncology Group (SWOG); Eastern Cooperative Oncology Group (ECOG). Department of Urology, University Hospital Gasthuisberg, Katholieke Universiteit Leuven, Leuven, Belgium.Boorjian SA, Blute ML.

OBJECTIVES: This study compared the complications and the cancer control of elective nephron-sparing surgery (NSS) and radical nephrectomy (RN) in patients with a small (</=5 cm), solitary, low-stage N0 M0 tumor suspicious for renal cell carcinoma (RCC), and a normal contralateral kidney. METHODS: Five hundred forty-one patients were randomized in a prospective, multicenter, Phase 3 trial to undergo NSS (n = 268) or RN (n = 273) together with a limited lymph node dissection. RESULTS: This publication reports only on the complications reported for both surgical methods. The rate of perioperative blood loss was slightly higher after RN (96.0% vs. 87.2%) and the rate of severe hemorrhage was slightly higher after NSS (3.1% vs. 1.2%). Ten patients (4.4%), all of whom were treated with NSS, developed urinary fistulas. Pleural damage (11.5% for NSS vs. 9.3% for RN) and spleen damage (0.4% for NSS and 0.4% for RN) were observed with similar rates in both groups. Postoperative computed tomography scanning abnormalities were seen in 5.8% of NSS and 2.0% of RN patients. Reoperation for complications was necessary in 4.4% of NSS and 2.4% of RN patients. CONCLUSIONS: NSS for small, easily resectable, incidentally discovered RCC in the presence of a normal contralateral kidney can be performed safely with slightly higher complication rates than after RN. The oncologic results are eagerly awaited to confirm that NSS is an acceptable approach for small asymptomatic RCC.

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J Clin Oncol. 2008 Jan 1;26(1):127-31.
Efficacy of sunitinib and sorafenib in metastatic papillary and chromophobe renal cell carcinoma.
Choueiri TK, Plantade A, Elson P, Negrier S, Ravaud A, Oudard S, Zhou M, Rini BI, Bukowski RM, Escudier B.
Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA 02115, USA. Toni_Choueiri@dfci.harvard.edu

PURPOSE: Sunitinib and sorafenib are novel tyrosine kinase inhibitors (TKIs) that have shown significant clinical activity in metastatic clear cell renal cell carcinoma (RCC). The activity of sunitinib and sorafenib in non-clear cell histologies has not been evaluated. PATIENTS AND METHODS: Clinical features at study entry and treatment outcomes were evaluated in patients with metastatic papillary RCC (PRCC) and chromophobe RCC (ChRCC) who received either sunitinib or sorafenib as their initial TKI treatment in five US and French institutions. Response rate and survival were documented. Fisher's exact test was used for categoric variables, and the Kaplan-Meier method was used to estimate survival. RESULTS: Fifty-three patients were included. The number of patients with papillary and chromophobe histologies was 41 (77%) and 12 (23%), respectively. Response rate, progression-free survival (PFS) time, and overall survival time for the entire cohort were 10%, 8.6 months, and 19.6
months, respectively. Three (25%) of 12 ChRCC patients achieved a response (two patients treated with sorafenib and one treated with sunitinib), and PFS was 10.6 months. Two (4.8%) of 41 PRCC patients achieved a response (both patients were treated with sunitinib). PFS for the whole cohort was 7.6 months. Sunitinib-treated PRCC patients had a PFS of 11.9 months compared with 5.1 months for sorafenib-treated patients (P < .001). CONCLUSION: Patients with PRCC and ChRCC may have prolonged PFS from sunitinib and sorafenib, although clinical responses remain overall low in PRCC. Additional prospective trials with these agents in non-clear cell RCC will further clarify their use in the future.

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Lancet. 2007 Dec 22;370(9605):2103-11. Comment in: Lancet. 2007 Dec 22;370(9605):2071-3.
Bevacizumab plus interferon alfa-2a for treatment of metastatic renal cell carcinoma: a randomised, double-blind phase III trial.
Escudier B, Pluzanska A, Koralewski P, Ravaud A, Bracarda S, Szczylik C, Chevreau C, Filipek M, Melichar B, Bajetta E, Gorbunova V, Bay JO, Bodrogi I, Jagiello-Gruszfeld A, Moore N; AVOREN Trial investigators.
Department of Medicine, Institut Gustave Roussy, Villejuif, France. escudier@igr.fr

BACKGROUND: Vascular endothelial growth factor (VEGF) inhibition is a valid therapeutic approach in renal cell carcinoma. Therefore, an investigation of the combination treatment of the humanised anti-VEGF monoclonal antibody bevacizumab with interferon alfa was warranted. METHODS: In a multicentre, randomised, double-blind, phase III trial, 649 patients with previously untreated metastatic renal cell carcinoma were randomised to receive interferon alfa-2a (9 MIU subcutaneously three times weekly) and bevacizumab (10 mg/kg every 2 weeks; n=327) or placebo and interferon alfa-2a (n=322). The primary endpoint was overall survival. Secondary endpoints included progression-free survival and safety. An interim analysis of overall survival was prespecified after 250 deaths. On the basis of new second-line therapies that became available while the trial was in progress, which could have confounded analyses of overall survival data, we agreed with regulatory agencies that the pre-planned final analysis of progression-free survival would be acceptable for regulatory submission. The protocol was amended to allow the study to be unblinded at this point. The final analysis of progression-free survival is reported here. Efficacy analyses were done by intention to treat. This trial is registered with centerwatch.com, number BO17705E. FINDINGS: 325 patients in the bevacizumab plus interferon alfa group and 316 in the placebo plus interferon alfa group received at least one dose of study treatment. At the time of unblinding, 230 progression events had occurred in the bevacizumab plus interferon alfa group and 275 in the control group; there were 114 deaths in the bevacizumab plus interferon alfa group and 137 in the control group. Median duration of progression-free survival was significantly longer in the bevacizumab plus interferon alfa group than it was in the control group (10.2 months vs 5.4 months; HR 0.63, 95% CI 0.52-0.75; p=0.0001). Increases in progression-free survival were seen with bevacizumab plus interferon alfa irrespective of risk group or whether reduced-dose interferon alfa was received. Deaths due to adverse events were reported in eight (2%) patients who received one or more doses of bevacizumab and seven (2%) of those who did not receive the drug. Only three deaths in the bevacizumab arm were considered by investigators to be possibly related to bevacizumab. The most commonly reported grade 3 or worse adverse events were fatigue (40 [12%] patients in the bevacizumab group vs 25 [8%] in the control group) and asthenia (34 [10%] vs 20 [7%]). INTERPRETATION: The combination of bevacizumab with interferon alfa as first-line treatment in patients with metastatic renal cell carcinoma results in a significant improvement in progression-free survival, compared with interferon alfa alone.

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Expert Rev Anticancer Ther. 2007 Dec;7(12):1749-61.
Current status of cytoreductive nephrectomy in metastatic renal cell carcinoma.
Harshman LC, Srinivas S.
Fellow, Medical Oncology, Stanford University School of Medicine, Division of Medical Oncology, 875 Blake Wilbur Drive, Stanford, CA 94305, USA. laurenhs@stanford.edu

The incidence of metastatic renal cell carcinoma (mRCC) continues to rise. While treatment options have increased dramatically in the last few years, few patients achieve a cure. The standard of care for mRCC in cytokine-eligible candidates is nephrectomy followed by high-dose IL-2. High-dose IL-2 can induce durable complete remissions, but only select patients can enjoy its benefits owing to toxicities. While not curative, the newer targeted therapies offer a broader patient population the chance for treatment response and prolonged survival. This review highlights the historical background of cytoreductive nephrectomy in mRCC, discusses the available treatment options and considers alternative treatment paradigms, such as the integration of the targeted agents with nephrectomy and the use of systemic therapy as medical selection for determining appropriate nephrectomy candidates.

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Urology. 2007 Nov;70(5):900-4; discussion 904.
Surgical resection provides excellent outcomes for patients with cystic clear cell renal cell carcinoma.
Webster WS, Thompson RH, Cheville JC, Lohse CM, Blute ML, Leibovich BC.
Department of Urology, Mayo Clinic, Rochester, Minnesota 55905, USA.

OBJECTIVES: Previous observations suggest that cystic clear cell renal cell carcinoma (RCC) is cured with surgical resection. However, long-term outcome data are lacking. We reviewed our experience with RCC and report on pathologic features and patient outcome associated with the cystic variant. METHODS: We identified 2431 patients treated with nephrectomy for unilateral, sporadic clear cell RCC between 1970 and 2002. A single urologic pathologist (J.C.C.) reviewed all of the microscopic slides without knowledge of patient outcome. Cystic clear cell RCC was characterized by numerous confluent cysts lined by clear cells, and containing nests of clear cells within the cyst walls. RESULTS: There were 85 (3.5%) patients with cystic RCC. Among these patients, 22 died during follow-up, although no patient died of RCC. The median follow-up for the remaining 63 patients was 5 years. The estimated cancer-specific survival rate at 5 years after surgery for patients with noncystic clear cell RCC was 70.6% compared with 100% for patients with the cystic variant (P <0.001). This difference persisted even when comparing patients with cystic RCC to the subset with noncystic RCC who had pT1, pNx/pN0, and no clinical evidence of metastases (cM0). No patient with cystic clear cell RCC had extrarenal disease at time of nephrectomy with the exception of 1 patient who had perinephric fat invasion. CONCLUSIONS: Cystic RCC is a distinct pathologic entity and should be assessed routinely during pathologic evaluation. Furthermore, we present data supporting that cystic RCC patients should expect to be cured after surgical extirpation.

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Eur Urol. 2007 Nov 20 [Epub ahead of print]
Nephron-Sparing Surgery versus Radical Nephrectomy in the Treatment of Intracapsular Renal Cell Carcinoma up to 7cm.
Antonelli A, Cozzoli A, Nicolai M, Zani D, Zanotelli T, Perucchini L, Cunico SC, Simeone C.
Department of Urology, University of Brescia, Brescia, Italy.

OBJECTIVE: To compare the oncologic outcomes of nephron-sparing surgery versus radical nephrectomy in intracapsular renal cell carcinoma (RCC) up to 7cm by reviewing surgical experience retrospectively. METHODS: Data from 1290 consecutive patients who had surgery for RCC have been stored in a dedicated database since 1983. We selected and reviewed those related to disease-free patients who had been treated for unilateral pT1a/pT1b pN0/Nx M0 carcinomas up to 7cm and later followed for a minimum of 12 mo. RESULTS: A total of 642 patients with mean follow-up of 72.9 mo were selected; 313 had been treated for tumours <4cm in diameter (176 nephron-sparing surgery, 137 nephrectomy), whereas 329 had been treated for tumours measuring >/=4cm (52 nephron-sparing surgery, 277 nephrectomy). The comparison between tumours <4cm or >/=4cm in diameter showed worse progression and disease-free survival rates for the latter, but the type of surgery (nephron-sparing or radical) seemed to have no significant impact. CONCLUSIONS: Conservative management can be cautiously suggested for RCC up to 7cm because the worsening of prognosis as diameter increases shows no statistical differences for either nephron-sparing or radical surgery. The agreement of our results with those of similar studies available in the literature may suggest designing a prospective study to compare conservative and more radical surgery in the management of RCC up to 7cm.

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Curr Treat Options Oncol. 2007 Aug 22; [Epub ahead of print]
Tyrosine Kinase Inhibitors and Anti-Angiogenic Therapies in Kidney Cancer.
Haas NB, Uzzo RG.
The Department of Medical Oncology, Fox Chase Cancer Center, Temple University School of Medicine, 333 Cottman Avenue, Philadelphia, PA, 19111, USA.

OPINION STATEMENTS: Renal cell carcinoma (RCC) is a heterogeneous disease as reflected in its presentation and clinical course, pathological subtypes, nuclear grades and molecular biology. Emerging data indicate that renal tumors express a variety of molecular tumor markers and unique patterns of gene expression. Clinically the disease behaves quite heterogeneously, with courses ranging from indolent to highly aggressive. Surgical monotherapy or as part of a multimodal approach remains the standard of care for most cases of RCC. Radical or partial nephrectomy is associated with a 5-year cancer specific survival (CSS) of 85-97% for pT1 tumors. Unfortunately, 20% of patients have either locally advanced or node positive (N+) RCC while another 22% have metastatic RCC (mRCC) at presentation. Unlike the outcomes in early localized disease, survival rates for N+ patients are poor and patients with mRCC are rarely cured despite aggressive multimodal therapy. Classic cytotoxic chemo therapy has repeatedly been shown to have little effect and only 5-20% of patients with mRCC respond to immunologic agents such as interferon and/or interleukin. Cytoreductive nephrectomy with systemic immunotherapy is associated with few cures with median survivals of 12-24 months. Recent advances in our understanding of the molecular origins and pathways of RCC have led to the development of more effective targeted therapies. Here we review the molecular pathways that define the pertinent therapeutic targets in RCC and the clinical data for these new and promising agents.

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Nat Clin Pract Oncol. 2007 Aug;4(8):470-9.
Drug insight: advances in renal cell carcinoma and the role of targeted therapies.
Larkin JM, Chowdhury S, Gore ME.
Royal Marsden Hospital, London, UK.

In metastatic renal cell carcinoma (RCC) immunotherapy results in a small but important improvement in overall survival, but a need exists to develop more-effective systemic therapies. Recent developments in our understanding of the molecular biology of RCC have identified several pathways associated with the development of the disease. A number of strategies designed specifically to target these pathways have resulted. Initial studies have shown marked clinical benefits of so-called 'targeted therapies'. Sunitinib, sorafenib and axitinib are kinase inhibitors that inhibit the VEGF, platelet-derived growth factor and c-kit receptor tyrosine kinases. Bevacizumab is a monoclonal antibody that is directed against VEGF. Temsirolimus inhibits the mammalian target of rapamycin. These agents have all shown considerable activity with manageable toxicity in phase II and III studies in both previously treated and untreated patients. In phase III studies, sorafenib and bevacizumab have been associated with prolonged progression-free survival compared with placebo. Phase III data have shown improvements in progression-free and overall survival with sunitinib and temsirolimus, respectively, compared with interferon alfa. Additional studies are needed to determine the optimum utilization of these agents at the appropriate stage of disease and in the best combinations for maximal clinical benefit.

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Anticancer Res. 2007 Jul-Aug;27(4C):2985-8.
Efficacy of IL-2 immunotherapy in metastatic renal cell carcinoma in relation to the psychic profile as evaluated using the Rorschach test.
Messina G, Lissoni P, Bartolacelli E, Fumagalli L, Brivio F, Colombo E, Gardani GS.
Division of Radiation Oncology, San Gerardo Hospital, 20052 Monza, Milan, Italy. giusy.messina@libero.it

BACKGROUND: Despite the well-documented importance of the psycho-emotional status in modulating the anticancer immunity, at present no study has been performed to analyse the influence of the psychological condition on the efficacy of IL-2 cancer immunotherapy. Previous clinical studies have already suggested that the evidence of anxiety may negatively affect the therapeutic efficacy of IL-2 immunotherapy of cancer. Moreover, previous psycho-oncological investigations showed that the suppression of sexual pleasure and sexual identity would represent one of the most frequent psychological profiles in cancer patients. On this basis, a study was planned in an attempt to evaluate relations existing between psychological status, analysed using the Rorschach test and efficacy of IL-2 immunotherapy in the treatment of metastatic renal cell cancer patients. PATIENTS AND METHODS: The study included 30 consecutive metastatic RCC patients. IL-2 was injected s.c. at a dose of 3 million IU twice/day 5 days/week for 4 consecutive weeks, corresponding to one complete immunotherapeutic cycle, followed by a second cycle after a 21-day rest period. RESULTS: A complete response (CR) was achieved in only 1/30 (3%) patients; a partial response (PR) was obtained in 6/30 (20%) patients. The tumor response rate (CR +PR) was 7/30 (23%) patients. The performance of a psychological analysis was accepted by 24/30 (80%) patients. A normal sexual identity was present in 7/24 (29%) patients. The tumor response rate achieved in patients with sexual identity was significantly higher compared to these who had no sexual identity or who refused the psychological investigation (p<0.05 and p<0.01, respectively). In the same way, the increase in mean lymphocyte number obtained in patients with sexual identity was significantly higher compared to that found in the other two groups of patients. CONCLUSION: This study demonstrated that the psychological status prior to treatment may be associated with the clinical response to IL-2 cancer immunotherapy.

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J Endourol. 2007 Jul;21(7):709-13.
Nephron-Sparing Surgery and Percutaneous Biopsies in Renal-Cell Carcinoma: A Global Impression among Endourologists.
Kümmerlin IP, Borrego J, Wink MH, Van Dijk MM, Wijkstra H, de la Rosette JJ, Laguna MP.
Department of Urology, Academic Medical Center, University of Amsterdam, The Netherlands.

Background and Purpose: On the one hand, nephron-sparing surgery (NSS) in small renal tumors is a safe and effective alternative to radical nephrectomy. On the other hand, the role of preoperative percutaneous needle biopsies (PNB) remains controversial. The purpose of this study was to evaluate the global current use of NSS in the treatment of renal-cell carcinoma (RCC) and the use of PNB among endourologists. Materials and Methods: One thousand questionnaires were distributed during the 23rd World Congress of Endourology and SWL. Six questions regarding NSS and two questions regarding PNB were presented. Two hundred twenty-two questionnaires were returned. Results: Of the respondents, 86.6% perform NSS for small renal tumors, whereas 13.4% perform only radical nephrectomies; 7.5% will consider NSS only in patients with a solitary kidney, and 0.5% will never consider NSS. The techniques for NSS, in descending order of preference, are partial nephrectomy, enucleation, cryoablation, radiofrequency ablation, and high-intensity focused ultrasound. The mean and maximum diameter of the tumor in patients with a normal contralateral kidney for which the urologists perform NSS is 4.0 cm. For a centrally located tumor, NSS is an option for 27.2% of the respondents. Regarding PNB in patients with suspicion of RCC, 55.9% of respondents never obtain renal biopsies in the preoperative assessment and 41.8% obtain them only in rare cases. The majority (90%) prefer histologic over cytologic biopsies. Conclusions: Nephron-sparing surgery is evolving to a global worldwide standard treatment for small renal tumors. Percutaneous needle biopsy remains a highly debated procedure.

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Urology. 2007 Jul;70(1):43-6.
Laparoscopic radical nephrectomy with hilar lymph node dissection in patients with advanced renal cell carcinoma.
Simmons MN, Kaouk J, Gill IS, Fergany A.
Section of Laparoscopic and Robotic Surgery, Glickman Urological Institute, Cleveland Clinic Foundation, Cleveland, Ohio 44195, USA.

OBJECTIVES: Lymph node dissection (LND) may improve accuracy of staging, decrease recurrence rates, and improve survival in patients with advanced renal cell carcinoma (RCC). Here we assess the feasibility and safety of laparoscopic LND. METHODS: Data were analyzed for patients who underwent combined laparoscopic radical nephrectomy (LRN) with LND between July 1997 and September 2006. Demographics, operative data, pathologic data, outcomes, and complications were assessed. RESULTS: In a cohort of 700 patients who underwent LRN, 14 (13 male, 1 female) underwent LND. Transperitoneal LRN was conducted in 12 patients (86%). Retroperitoneal LRN and laparoscopic partial nephrectomy were conducted in 1 patient each (7%). Lymph node dissection yielded an average of 2.7 lymph nodes. Median tumor size was 9.5 cm (range, 1.5 to 13 cm), and median node size was 2.3 cm (range, 0.8 to 11 cm). Tumor stage was T2 or higher in 9 cases (64%), and distant metastasis was present in 7 patients (50%). One elective hand-assist and one open conversion were performed. Median estimated blood loss was 250 mL (range, 100 to 2100 mL). Median length of hospital stay was 2.5 days (range, 2 to 5 days). Median operative time was 199 minutes (range, 152 to 260 minutes). There was a single grade 1 complication (7%). CONCLUSIONS: Patients with advanced or metastatic RCC may require cytoreductive nephrectomy for staging and tumor debulking before secondary therapy. Laparoscopic LND is both feasible and safe in select patients. Decreased morbidity associated with the laparoscopic approach is beneficial to patients with advanced disease.

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Proc (Bayl Univ Med Cent). 2007 Jul;20(3):244-8.
Targeted therapy for renal cell carcinoma: a new treatment paradigm.
Hutson TE.
Genitourinary Oncology Program, Department of Oncology, Baylor Charles A. Sammons Cancer Center, Dallas, Texas.

Metastatic clear cell renal cell cancer has traditionally been treated with cytokines (interferon or interleukin-2). Improved understanding of biology has engendered novel targeted therapeutic agents that have altered the natural history of this disease. The vascular endothelial growth factor and its related receptor and the mTOR signal transduction pathway have particularly been exploited. Sunitinib malate, sorafenib tosylate, temsirolimus, and bevacizumab have improved clinical outcomes in randomized trials. Other multitargeted tyrosine kinase inhibitors (lapatinib, axitinib, pazopanib) and antiangiogenic agents (VEGF Trap, lenalidomide) have also demonstrated activity in early studies. Combinations of these agents are being evaluated. The future of the therapy of renal cancer appears promising owing to the efficacy of these novel agents.

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ScientificWorldJournal. 2007 Apr 9;7:837-49.
Cytokine-based immunotherapy for advanced kidney cancer: past results and future perspectives in the era of molecularly targeted agents.
Porta C, Paglino C, Imarisio I, Bonomi L.
Medical Oncology, I.R.C.C.S. San Matteo University Hospital Foundation, Pavia, Italy. c.porta@smatteo.pv.it

Until recently, immunotherapy has been the only therapeutic option available for patients with advanced kidney cancer, even though different choices were often made on the two sides of the Atlantic Ocean. The absence of alternatives made different immunotherapeutic approaches common practice, even with few adequate randomized studies that addressed key questions, such as the best treatment and schedule, and so on. The recent registration of the first two, molecularly targeted, agents Sorafenib and Sunitinib could (and will) render many therapeutic approaches, e.g., single-agent Interferon, obsolete. In this review, we shall cover the past achievements obtained so far with cytokine-based immunotherapy and discuss the present role of immunotherapy in the era of molecularly targeted agents. In particular, specific indications for immunotherapy are emerging (e.g., the use of Interleukin-2 in patients with high CAIX expression), while new trials are ongoing to test immunotherapy i
n combination with molecularly targeted agents, such as Sorafenib, Sunitinib, or Bevacizumab.

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Urology. 2007 Apr;69(4):642-5; discussion 645-6.
Superselective embolization as first step of laparoscopic partial nephrectomy.
Gallucci M, Guaglianone S, Carpanese L, Papalia R, Simone G, Forestiere E, Leonardo C.
Department of Urology, Regina Elena Cancer Institute, Rome, Italy. gallucci@ifo.it

OBJECTIVES: Laparoscopic partial nephrectomy is currently very hard to perform because of the great difficulty in obtaining renal parenchymal hemostasis during tumor excision and the consequent high risk of bleeding. The aim of this study was to propose a method to decrease the risk of bleeding, consisting of the superselective embolization of tumor vessels before performing the laparoscopic partial nephrectomy. METHODS: Fifty patients with small, solitary, enhancing, predominantly exophytic renal tumors underwent a superselective radiographically guided embolization of tumor vessels. An average of 6 hours after embolization, the patients underwent partial laparoscopic nephrectomy, with transperitoneal access and three trocars placed, under balanced general anesthesia. The mean operative time was measured, as was the mean estimated blood loss. RESULTS: The mean operative time was 90 minutes, the mean estimated blood loss was 200 mL, and the average hospital stay was 6 days. Complications were reported in only 2 patients. The final pathologic evaluation confirmed the diagnosis of renal cell carcinoma in 43 cases. The median follow-up was 11 months and, to date, the examinations have revealed no recurrences in any of the cases. CONCLUSIONS: Superselective embolization is a valid option for laparoscopic partial nephrectomy. The procedure does not require any regional vascular control or clamping, reduces the estimated blood loss, and reduces the operative time.

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Clin Orthop Relat Res. 2007 Apr 12; [Epub ahead of print]
Radiotherapy to Bone Has Utility in Multifocal Metastatic Renal Carcinoma.
Reichel LM, Pohar S, Heiner J, Buzaianu EM, Damron TA.
>From the *Department of Orthopedics and Radiation Oncology, Upstate Medical University, State University of New York, Syracuse, NY; the daggerDepartment of Orthopedics, University of Wisconsin, Madison, WI; and the double daggerDept. of Mathematics and Statistics, University of North Florida, Jacksonville, FL.

Renal cell carcinoma metastases to bone are classically considered radioresistant. We reviewed 28 patients who underwent irradiation for metastatic renal cell carcinomas to bone to test the hypothesis that irradiation of renal metastases to bone provides adequate palliation in carefully selected patients. Metastases were multifocal in all patients. All patients were followed until death. Overall, 36 index radiotherapy treatments were given as palliative initial treatment for 36 osseous metastatic sites. Twenty-five of 36 sites (69.5%) had no subsequent radiotherapy. Eight sites (22.2%) underwent repeat radiotherapy at a mean 28.9 weeks after treatment. Two (5.6%) additional sites underwent surgery at the site at an average 74 weeks later, and a pathologic fracture occurred at one (2.8%) site 3 weeks after irradiation. Overall, 33 of 36 (91.7%) sites had only radiotherapy as their source of palliation. Median times to return to pretreatment pain and functional levels, however, were 2 months and 1 month, respectively. Radiotherapy to osseous sites appears to control pain for the short term and generally prevents fractures and avoids the need for surgery in renal cell carcinoma patients with multiple bone metastases.Level of Evidence: Level IV, therapeutic study. See the Guidelines for Authors for a complete description of levels of evidence.

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Cancer. 2007 Apr 9; [Epub ahead of print]
Renal cell carcinoma clinically involving adjacent organs: experience with aggressive surgical management.
Margulis V, Sanchez-Ortiz RF, Tamboli P, Cohen DD, Swanson DA, Wood CG.
Department of Urology, University of Texas M. D. Anderson Cancer Center, Houston, Texas.

BACKGROUND.: Historically, patients with nonmetastatic renal cell carcinoma (RCC) involving adjacent organs have been considered inoperable and incurable. The oncologic efficacy of an aggressive surgical approach was evaluated in a selected subpopulation of RCC patients. Further, an attempt was made to define the clinical and pathologic characteristics predictive of surgical failure. METHODS.: With Institutional Review Board approval, the institutional nephrectomy database of 3470 patients treated at MD Anderson Cancer Center from 1990 to 2006 was searched for RCC patients treated with radical nephrectomy and resection of at least 1 adjacent organ thought to be directly involved by RCC. Patients with nonmetastatic RCC and a minimum follow-up of 6 months were included in the analysis. RESULTS.: In all, 30 patients with clinical T4NxM0 RCC and median follow-up of 32.3 months (range, 8.5-140.1) met the study inclusion criteria and comprise the dataset for the analysis. On pathologic evaluation 60% of patients were clinically overstaged, as only 12 (40%) of 30 patients demonstrated direct invasion into adjacent organs resected. None of the clinical tumor characteristics predicted a finding of pathologic T4 RCC. Nodal involvement and pathologic T stage were significant independent predictors of disease recurrence (hazard ratio [HR] 3.726, P = .043, and HR 2.414, P = .045, respectively) and cancer-specific survival (HR 17.145, P = .002, and HR 3.791, P = .024, respectively). Disease recurred in 11 of 18 (61.1%) of <pT4 patients and in 10 of 12 (83.3%) of pT4 patients at a median 13.3 and 2.3 months, respectively; 13 (73.3%) <pT4 patients and 5 (41.7%) pT4 patients were alive at the time of analysis. CONCLUSIONS.: True pathologic involvement of adjacent organs by RCC cannot be predicted from pre- or intraoperative parameters. A significant proportion of patients clinically suspected of having T4 RCC are downstaged, and benefit from aggressive surgical resection with en bloc removal of involved organs. Cancer 2007. (c) 2007 American Cancer Society.

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CA Cancer J Clin. 2007 Mar-Apr;57(2):112-25.
Recent progress in the management of advanced renal cell carcinoma.
Garcia JA, Rini BI.
Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, Cleveland, OH.

A better understanding of the molecular biology of renal cell carcinoma (RCC) has led to a dramatic paradigm shift in the treatment of patients with metastatic disease. Historically, a nonspecific immune approach using cytokines was employed, but recently this has transitioned to a molecularly-targeted approach against vascular endothelial growth factor (VEGF) and related pathways. Several anti-VEGF agents, including ligand-binding agents such as bevacizumab and the small molecule inhibitors of VEGF and related receptors such as sunitinib and sorafenib, have demonstrated clinical activity in patients with metastatic RCC. Other agents that inhibit alternative targets such as the mammalian target of rapamycin (mTOR) have also demonstrated activity. This generation of novel molecular targeted therapies continues to show great promise. The purpose of this review is to summarize the current management and to discuss potential future directions in the management of metastatic RCC.

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Invest New Drugs. 2007 Mar 28; [Epub ahead of print]
Phase II study of Triapine(R) in patients with metastatic renal cell carcinoma: a trial of the National Cancer Institute of Canada Clinical Trials Group (NCIC IND.161).
Knox JJ, Hotte SJ, Kollmannsberger C, Winquist E, Fisher B, Eisenhauer EA.
Department of Medical Oncology, University Health Network-OCI/Princess Margaret Hospital, 610 University Avenue, Toronto, ON, M5G 2M9, Canada, jennifer.knox@uhn.on.ca.

Triapine(R) is a novel small molecule ribonucleotide reductase inhibitor that showed activity in renal cell carcinoma (RCC) cell lines. Evaluating new agents with novel mechanisms remains of interest for patients with incurable RCC. This was a single-arm, multicentre phase II trial where Triapine was given at a schedule of 96 mg/m(2) 2-h infusion daily x 4 repeated every 2 weeks in patients with recurrent RCC. A median of four cycles of Triapine was administered to 19 eligible patients. One response was seen (7%.) Median time to progression was 3.6 months. Common adverse events (AEs) were grade 1-2, with fatigue in 74%, nausea in 68% and vomiting in 58%. However grade 3/4 neutropenia was seen in 79% and acute reactions of hypoxia, hypotension, methemoglobinemia were seen. Dose reductions/delays due to AEs were common with only 47% of patients receiving > 90% of planned dose intensity. The study closed, at the end of stage 1 as it did not meet the minimal efficacy criteria to proceed. Further evaluation of Triapine at this dose and schedule in patients with advanced kidney cancer is not recommended.

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Urology. 2007 Mar;69(3):462-4.
Renal cell carcinoma in renal transplant patients.
Ianhez LE, Lucon M, Nahas WC, Sabbaga E, Saldanha LB, Lucon AM, Srougi M.
Department of Urology, Sao Paulo University Medical School, Sao Paulo, Sao Paulo, Brazil.

OBJECTIVES: To report our experience with renal cell carcinoma in patients with end-stage renal failure receiving dialysis at two institutions that perform a large number of transplantations. Renal cell carcinoma is more frequent in patients with end-stage renal failure treated with dialysis and in renal transplant patients than in the population at large. METHODS: We reviewed the case histories of 1375 consecutive patients who had transplanted kidneys functioning for more than 1 year. RESULTS: Eleven renal tumors were found in 10 patients (1.37%); 10 of the tumors (90%) were in the native kidney (9 unilateral and 1 bilateral) and 1 (10%) was in the transplanted kidney. The tumors in the native kidneys were discovered incidentally. Three were in organs removed for treatment of arterial hypertension and the other seven were found by ultrasonography. The tumor in the transplanted kidney was found after nephrectomy for the treatment of hematuria. The tumor types were clear cell in six, papillary in four, and chromophobe in one. Of the 9 patients who were treated with radical nephrectomy, 7 were alive with no evidence of the disease and 2 had died of other causes, also with no evidence of the disease. One patient who already had metastases at the diagnosis did not undergo surgery and died 4 months later. CONCLUSIONS: The native kidneys of renal transplant patients should be examined by ultrasonography annually because they are at greater risk of renal cell carcinoma. Radical nephrectomy cures those cases in which the tumors are clinically localized and 6 cm or less in size.

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Scand J Urol Nephrol. 2007;41(1):10-3.
Nephron-sparing surgery for renal cell carcinoma in the solitary kidney.
Berdjis N, Hakenberg OW, Novotny V, Manseck A, Oehlschlager S, Wirth MP.
Department of Urology, University Hospital Carl Gustav Carus, Technical University Dresden, Dresden, Germany.

OBJECTIVE: Partial nephrectomy in solitary kidneys carries the risk of tumour progression as well as loss of renal function. We evaluated complications and outcome in patients with renal cell cancer in solitary kidneys who were treated by means of nephron-sparing surgery. MATERIAL AND METHODS: Between 1993 and 2003, 38 patients with renal cell carcinoma in a solitary kidney underwent nephron-sparing surgery (partial nephrectomy, n = 37; work-bench resection, n = 1). Of these patients, 21 had asynchronous and eight had synchronous bilateral tumours and underwent contralateral radical nephrectomy. The variables examined were tumour size, disease progression, pre- and postoperative renal function and early (within 30 days of nephron-sparing surgery) and late complications. RESULTS: After a mean follow-up period of 41.7 months (range 8-93 months) the mean serum creatinine level had increased from 1.25 mg/dl preoperatively to 1.62 mg/dl postoperatively. Seventeen patients retained normal renal function and 21 developed some degree of renal insufficiency. New-onset chronic renal insufficiency after nephron-sparing surgery with creatinine levels >2 mg/dl was the only late complication observed, occurring in 10 cases. None of the patients required dialysis. Transient urinary leakage was the most frequent early complication, occurring in four cases. Recurrence and/or progression were seen in six patients: four with local recurrence (three of whom also had distant metastases) and two with pure metastatic progression. Nephron-sparing surgery was repeated for the patient with isolated local tumour recurrence. The mean tumour size was 3.8 cm (range 0.7-9.9 cm). Tumour size was markedly greater in patients who developed disease progression (6.2 vs 3.5 cm) and in those who developed renal insufficiency (5.2 vs 3.3 cm). CONCLUSIONS: Nephron-sparing surgery for renal cell carcinoma involving a solitary kidney provides effective curative treatment for small tumours, with preservation of renal function. However, patients who undergo partial nephrectomy for locally extensive tumours are at high risk of disease progression.

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J Endourol. 2007 Jan;21(1):71-4.
Laparoscopic partial nephrectomy: experience in 60 cases.
Brown GA, Matin SF.
Department of Urology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas.

Purpose: To identify the factors associated with better outcomes in patients undergoing laparoscopic partial nephrectomy (LPN). Patients and Methods: We retrospectively analyzed the medical records of 36 men and 24 women aged 31 to 80 years (mean 60 years) in whom LPN was attempted at our institution over a 3.5-year period. Baseline patient characteristics and operative, pathologic, and postoperative outcomes were analyzed. The median duration of follow-up was 14.2 months (range 1-38 months). Results: The median pathologic tumor size was 2.1 cm (range 0.7-6.0 cm). Final pathologic review revealed renal-cell carcinoma in 73% of patients. Six patients (10%) required conversion to either an open partial nephrectomy or a laparoscopic radical nephrectomy. Dense perinephric adipose tissue in the setting of a small renal tumor and unanticipated multifocal disease were factors associated with surgical conversion. The median overall estimated blood loss was 112 mL, and the median warm-ischemia time was 30 minutes. Blood loss was greater in patients who did not undergo hilar clamping (467 v 65 mL; P = 0.008). Conclusion: Factors influencing successful LPN outcomes include selecting a tumor commensurate with the surgeon's laparoscopic experience, performing routine hilar clamping, adjunctive use of hemostatic agents, and renal-parenchymal suture ligation. The presence of thick, fibrotic perinephric fat overlying a small tumor increases the technical difficulty.

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Clin Cancer Res. 2007 Jan 15;13(2):747s-52s.
Sorafenib in renal cell carcinoma.
Flaherty KT.
Author's Affiliation: Abramson Cancer Center, University of Pennsylvania, Philadelphia, Pennsylvania.

Sorafenib is an orally available inhibitor of vascular endothelial growth factor receptors, platelet-derived growth factor receptor-beta, and RAF kinases. A dose of 400 mg twice daily administered continuously was selected for phase 2 testing, although 600 mg twice daily formally met criteria for a maximum tolerated dose. It is well tolerated compared with cytokine therapy. Antitumor activity was shown clearly in the context of a randomized discontinuation phase 2 trial. In this setting, even disease stabilization was established as a treatment-related phenomenon. A phase 3 trial with sorafenib confirmed a benefit of therapy across the vast majority of patients treated with sorafenib as opposed to placebo. Limited investigations into the mechanism of action of sorafenib in renal cell carcinoma support vascular endothelial growth factor receptor antagonism as the primary mediator of effect. The toxicity profile of sorafenib allows for its use in combination regimens. The focus of efforts to improve on the efficacy of sorafenib is on use with IFN, bevacizumab, or temsirolimus. Preliminary evidence with this approach is promising and will be the subject of the next generation of randomized trials in renal cell carcinoma.

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Clin Cancer Res. 2007 Jan 15;13(2):716s-20s.
Update on the application of interleukin-2 in the treatment of renal cell carcinoma.
McDermott DF.
Author's Affiliation: Beth Israel Deaconess Medical Center and the Dana-Farber/Harvard Cancer Center Renal Cancer Program, Boston, Massachusetts.

High-dose bolus interleukin 2 (IL-2) was granted Food and Drug Administration approval based on its ability to produce durable complete responses in a small number of patients with metastatic renal cell carcinoma. Results from randomized phase 3 trials suggest that regimens involving lower doses of IL-2, either alone or in combination with IFN, produce fewer tumor regressions of less overall quality. Given the toxicity, expense, and limited efficacy of this treatment, recent studies have focused on identifying predictors of response (or resistance) to IL-2 therapy. This year, investigators launched a clinical trial designed to prospectively determine if patients who are more likely to respond to high-dose IL-2 can be identified before starting therapy. As the list of effective therapies for metastatic renal cell carcinoma grows, improvements in patient selection will be necessary to ensure that patients who might attain a durable remission with IL-2 will not miss this opportunity.

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Clin Cancer Res. 2007 Jan 15;13(2):697s-702s.
Multimodal approaches in the management of locally advanced and metastatic renal cell carcinoma: combining surgery and systemic therapies to improve patient outcome.
Wood CG.
Author's Affiliation: The University of Texas M. D. Anderson Cancer Center, Houston, Texas.

Patients with locally advanced renal cell carcinoma are at high risk of metastatic relapse following surgery. Patients with metastatic disease have a poor prognosis and few systemic therapy options. Radiation, chemotherapy, hormonal therapy, vaccines, and immunotherapy have all been tested as adjuvant therapy without benefit. Neoadjuvant therapy in the metastatic setting holds promise as a new treatment paradigm. It can serve as a litmus test to allow proper patient selection for aggressive surgical intervention and may provide limited downstaging of primary tumors in selected cases. It can also provide a histologic assessment of the effect of targeted therapy. Application of this paradigm may have merit in the locally advanced setting as well. Effective adjuvant therapy for renal cell carcinoma remains elusive. The benefit of new targeted therapies has yet to be tested in this setting. Neoadjuvant strategies that integrate aggressive surgical intervention with systemic therapy may hold promise as a treatment paradigm.

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Clin Cancer Res. 2007 Jan 15;13(2):693s-6s.
Cytoreductive nephrectomy for metastatic renal cell carcinoma: is it still imperative in the era of targeted therapy?
Pantuck AJ, Belldegrun AS, Figlin RA.
Authors' Affiliation: Departments of Urology and Medicine, David Geffen School of Medicine at University of California at Los Angeles, Los Angeles, California.

In the era before cytokine therapy, controversy existed about the need for cytoreductive nephrectomy in treating patients with metastatic renal cell carcinoma. In 1978, Dekernion showed that nephrectomy alone had no effect on survival. During this period, removal of the malignant kidney was confined to palliative therapy in some settings of metastatic RCC, such as pain related to the kidney mass, intractable hematuria, erythrocytosis, uncontrolled hypertension, or poorly controlled hypercalcemia. When interleukin-2 was approved by the Food and Drug Administration in 1992, the role of nephrectomy was reexamined. After a decade of controversy, two randomized controlled studies established that cytoreductive surgery has a role in properly selected patients and offers a survival advantage when done before cytokine therapy. Unfortunately, the mechanisms underlying this benefit remain poorly understood. Immunotherapy may work best when there is a small volume of cancer present, and removing a large primary tumor may prevent the seeding of additional metastases. Data have also suggested that primary tumors were capable of producing immunosuppressive compounds that might decrease the efficacy of immunotherapy. Another hypothesis suggested that removing the kidney altered the acid/base status of the patient to such an extent that the growth of the tumor was hindered. With the emergence in 2006 of two targeted agents for advanced renal cell carcinoma, the role of cytoreductive nephrectomy has reemerged as a source of controversy. Although evidence-based medical practice suggests a role for nephrectomy before the use of targeted agents, the arguments for and against this practice will be weighed.

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Curr Urol Rep. 2007 Jan;8(1):19-30.
Adjuvant therapy for high-risk renal cell carcinoma patients.
Kunkle DA, Haas NB, Uzzo RG.
Department of Urologic Oncology, Fox Chase Cancer Center, 333 Cottman Avenue, Philadelphia, PA 19111, USA. R_Uzzo@FCCC.edu

For most cases of renal cell carcinoma (RCC), the standard of care is surgical resection as monotherapy or as part of a multimodal approach. In patients with early localized disease, radical nephrectomy is associated with a favorable prognosis, whereas patients with advanced disease are rarely cured. A significant number of patients undergoing surgery for localized RCC experience recurrence, suggesting that there are some individuals in whom surgical excision is necessary but insufficient. In these patients, the development of effective adjuvant strategies is imperative. In this article, we review the prognostic variables and comprehensive staging algorithms for identifying patients at high risk for disease recurrence. Additionally, we review data from completed adjuvant RCC trials and highlight relevant ongoing trials.

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Oncology (Williston Park). 2006 Dec;20(14):1745-53; discussion 1756.
Novel targets and therapies for metastatic renal cell carcinoma.
Feldman DR, Motzer RJ.
Division of Medical Oncology and Hematology, Department of Internal Medicine, Memorial Sloan-Kettering Cancer Center, New York, New York, USA.

For the past 20 years, the systemic treatment of metastatic renal cell carcinoma (RCC) has been limited primarily to cytokines, with few patients showing benefit. However, recent advances in understanding the pathobiology of RCC have led to the identification of novel therapeutic targets for this disease. Drugs specifically designed to inhibit these targets have been developed, with several showing superior efficacy over traditional cytokine therapy. Moreover, these agents are well tolerated and have improved the span of progression-free, and in some cases, overall survival. As a result, between December 2005 and January 2006, two of these targeted therapies--sunitinib (Sutent) and sorafenib (Nexavar)--were approved by the U.S. Food and Drug Administration for the treatment of advanced RCC. The authors review the clinical trials that have focused on these two drugs as well as those concentrating on two other promising agents, bevacizumab (Avastin) and temsirolimus. The ways in which these novel drugs are changing the standard of care for metastatic RCC and the future directions of RCC clinical trials are also discussed.

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Clin Genitourin Cancer. 2006 Dec;5 Suppl 1:S24-30.
Improving outcomes with novel therapies for patients with newly diagnosed renal cell carcinoma.
Speca J, Yenser S, Creel P, George D.
Division of Medical Oncology, Department of Medicine, Duke University Medical Center, Durham, NC.

With the approval of sunitinib and sorafenib, 2 new multitargeted tyrosine kinase inhibitors, for the treatment of advanced renal cell carcinoma (RCC), the natural history and prognosis of patients with this disease has significantly improved. These drugs were approved based upon clinical data demonstrating robust, unprecedented response rates in one case and dramatic prolongation of progression-free survival in the other. In both cases, these results were seen in study patients in whom standard therapy had failed and who, on average, carried substantial disease burden. Important challenges today include integrating these therapies with other standard therapeutic options and into other advanced-stage RCC patient populations. This article addresses current data and practice patterns regarding the clinical use of tyrosine kinase inhibitors in patients with advanced-stage RCC, including dose modifications and alternative dosing, the current role of debulking nephrectomy, and use in patients with indolent disease. Finally, a summary of the more common side effects and management strategies for these is also discussed. Ultimately, more clinical data is needed to address the chronic use of these agents alone, in combination with other agents, with radiation therapy, and in sequence.

   

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