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Paul Russo

Publications and source records attributed to Paul Russo.

At least 55 records · Page 3Linked to original sources
PubMed2004

Multifocal renal cortical tumors: frequency, associated clinicopathological features and impact on survival.

PURPOSE: We determined the frequency of tumor multifocality in patients with renal cortical tumors, characterized clinical and pathological features associated with multifocality and evaluated its effect on patient survival. MATERIALS AND METHODS: Between July 1989 and July 2002, 1,071 radical nephrectomies were performed at our institution. Specimens were examined grossly and microscopically for multifocal tumors. Preoperative imaging was reviewed to determine whether multifocality was suspected prior to operation. Multivariate analysis was performed to identify clinical and pathological factors associated with multifocality. RESULTS: Of 1,071 radical nephrectomy specimens 57 (5.3%) had pathological evidence of tumor multifocality. Bilateral synchronous renal cortical tumors were present in 6 of the 57 multifocal cases (11%). A total of 19 cases (33%) had evidence of multifocality on preoperative imaging and, therefore, occult multifocality undetected on preoperative imaging was present in 3.5% of radical nephrectomies (38 of 1,071). Primary tumors in the multifocal group were most commonly conventional clear cell carcinoma, followed by papillary carcinoma. Of multifocal cases 74% had the same histological subtype in all tumors. Multivariate analysis demonstrated that bilaterality, papillary subtype, advanced tumor stage and lymph node metastasis were associated with multifocality. At a median follow up of 40.5 months overall survival, disease-free survival, and disease-free probability were not significantly different between the multifocal and unifocal groups. CONCLUSIONS: We report a 5.3% frequency of multifocal renal cortical tumors and a 3.5% frequency of clinically unsuspected multifocal tumors. Multifocality had no apparent effect on recurrence or survival in patients who underwent radical nephrectomy.

Adolescent↗
PubMed2004

Feasibility of radical prostatectomy after neoadjuvant chemohormonal therapy for patients with high risk or locally advanced prostate cancer: results of a phase I/II study.

PURPOSE: We determined the feasibility of radical prostatectomy after neoadjuvant chemohormonal therapy in locally advanced (stage T3 or greater) and/or high risk tumors (Gleason 8 to 10 and/or serum prostate specific antigen (PSA) greater than 20 ng/ml). MATERIALS AND METHODS: Enrollment criteria included clinical stage T1 to 2 with any Gleason grade and PSA greater than 20 ng/ml, clinical stage T3 to 4 with any serum PSA or Gleason grade, or any clinical stage with biopsy Gleason grade of 8 to 10 and any serum PSA. All patients received neoadjuvant hormonal therapy during chemotherapy (4 cycles of paclitaxel and carboplatin and estramustine) followed by radical prostatectomy. Nerve sparing was decided on an individual basis and a nerve graft was offered to those who underwent unilateral or bilateral nerve resection. Perioperative morbidity, mortality and delayed complications were assessed. RESULTS: A total of 36 patients were enrolled. After chemohormonal therapy clinical stage was less in 39% of patients and greater in 36%. Bilateral nerve sparing was performed in 3 patients and the remaining 33 underwent either unilateral or bilateral neurovascular bundle resection with nerve grafts performed in 17 (52%). Deep vein thrombosis (22%) was the most frequent complication of chemotherapy. Minor postoperative complications occurred in 6 patients. At a median followup of 29 months (range 5 to 51) after radical prostatectomy 32 (89%) were continent and 5 (15%) preoperatively potent men remained potent. The positive surgical margin rate was 22%. Of all subjects 45% remain free from biochemical recurrence. CONCLUSIONS: Neoadjuvant chemohormonal therapy followed by radical prostatectomy can be performed with low morbidity. Positive surgical margin rates are low. This approach yielded good local control of disease, however impact on tumor recurrence and survival is not known.

Adult↗
PubMed2004

Ketorolac: safe and effective analgesia for the management of renal cortical tumors with partial nephrectomy.

PURPOSE: Ketorolac has demonstrated advantages as a supplement to opioid based analgesia in several surgical settings, including donor nephrectomy. To our knowledge there has been no published data to date on the use of ketorolac in patients undergoing partial nephrectomy. We compared analgesia with ketorolac and opioids to analgesia with opioids alone with regard to pain control, postoperative recovery and effects on renal function in patients with renal cortical tumors surgically managed by partial nephrectomy. MATERIALS AND METHODS: Records for 154 patients treated with partial nephrectomy for renal cortical tumors were retrospectively analyzed. Clinicopathological variables examined were age, gender, medication use, comorbidity profile, operation side, estimated blood loss, hospital stay, operative duration, American Society of Anesthesiologists class, histopathology results, perioperative transfusion status, ischemia type (warm vs cold vs none), duration of renal artery cross clamping, tumor size and intraparenchymal location, pathological stage and perioperative complications. Postoperative duration to the initiation of solid diet, discontinuation of patient controlled analgesia and overall pain control were assessed. Serum creatinine was measured during the preoperative period, and at 1, 3 or greater and 30 or greater days postoperatively. RESULTS: Patients who received ketorolac demonstrated superior postoperative recovery with an earlier return to solid diet and earlier discontinuation of patient controlled analgesia. Treatment groups were similar with respect to changes in serum creatinine, blood loss, transfusion rates and complication rates. Ketorolac was not associated with an increased risk of acute renal failure. CONCLUSIONS: Ketorolac is a safe and effective supplement to opioid based analgesia for pain control after partial nephrectomy.

Adult↗
PubMed2004

Renal vein or inferior vena caval extension in patients with renal cortical tumors: impact of tumor histology.

PURPOSE: We determined the prognostic significance of renal vein or inferior vena caval (IVC) extension in patients with nonmetastatic renal cell carcinoma (RCC) or oncocytoma undergoing surgery. MATERIALS AND METHODS: The charts of patients undergoing radical or partial nephrectomy from 1989 to 2001 for nonmetastatic RCC or oncocytoma were retrospectively reviewed. A total of 1082 patients (1120 renal units) underwent radical (850 renal units) or partial (270 renal units) nephrectomy. RESULTS: Renal vein extension was present in 60 patients (65.9%) and IVC extension was present in 31 (34.1%). The histological type associated with an increased risk of renal vein/IVC extension was conventional (80 of 702 cases, p <0.0001) and histological types with a decreased risk were oncocytoma (0 of 117, p = 0.00052) and papillary histology (0 of 146, p <0.0001). The 5-year actuarial recurrence-free probability was 59%, 65% and 91% in patients with IVC extension, renal vein extension and no renal vein or IVC extension, respectively. Larger tumor size, nodal metastases and conventional histology were associated with an increased risk of recurrence (RR = 3.38, 95% CI 2.53 to 4.51 for a doubling in size, RR = 9.97, 95% CI 5.51 to 18.1 and RR 3.78, 95% CI 2.15 to 6.65) as well as death (RR = 1.44, 95% CI 1.20 to 1.74 for a doubling in size, RR = 5.39, 95% CI 2.86 to 10.2 and RR = 1.56, 95% CI 1.09 to 2.24, respectively). CONCLUSIONS: Conventional RCC is associated with an increased risk, and oncocytoma and papillary histology are associated with a decreased risk of renal vein or IVC extension. Renal vein or IVC extension alone does not impart a worse prognosis independent of tumor size, nodal status and histology.

Adenoma, Oxyphilic↗
PubMed2004

Impact of unnecessary exploratory laparotomy on the treatment of patients with metastatic germ cell tumor.

PURPOSE: Patients with testicular germ cell tumors (GCTs) may undergo unnecessary diagnostic or surgical procedures when this diagnosis is not considered. In a cohort of patients who underwent exploratory laparotomy for unsuspected metastatic GCT we determined the impact of this surgery on morbidity, therapeutic delay and cancer therapy. MATERIALS AND METHODS: Between 1980 and 2001, 40 patients who underwent exploratory laparotomy for unsuspected metastatic GCT were later referred to our department for management. Patient records were reviewed retrospectively. RESULTS: Mean patient age at exploratory laparotomy was 34 years. All patients had a midline retroperitoneal mass and 14 had disease at other sites. At the time of evaluation at our institution abnormalities on physical examination and testicular sonogram were identified in 8 (20%) and 22 (55%) patients, respectively. Elevated serum alpha-fetoprotein and/or beta-human chorionic gonadotropin were identified in 26 patients (65%). Eight patients (22%) experienced complications from exploratory surgery. The median interval from laparotomy to chemotherapy was 29 days and in 48% of patients the delay in therapy was 30 days or greater. Of patients with a delay of 30 days or greater 60% required intensive chemotherapy (multiple regimens, or high dose or salvage chemotherapy) compared to 26% with a delay of less than 30 days (p = 0.01). CONCLUSIONS: Exploratory laparotomy contributes to therapeutic delay in a substantial number of patients and it complicates cancer therapy. At presentation evidence to suggest GCT was present in all patients, which highlights the importance of physician awareness in making a prompt diagnosis.

Adolescent↗
PubMed2004

Partial cystectomy: a contemporary review of the Memorial Sloan-Kettering Cancer Center experience and recommendations for patient selection.

PURPOSE: Partial cystectomy is a bladder sparing procedure that has been used to treat invasive bladder cancer in highly selected patients. This study analyzes the outcomes of partial cystectomy in a contemporary cohort of patients to identify appropriate selection criteria for the procedure. MATERIALS AND METHODS: Records were reviewed for 58 patients with a primary bladder tumor who had undergone partial cystectomy at Memorial Sloan-Kettering Cancer Center from 1995 to 2001. Information was collected on tumor size, histology, location, presence of carcinoma in situ (CIS), multifocality, neoadjuvant treatment, clinical stage, pathological stage and disease status. RESULTS: For the 58 patients analyzed, overall 5-year survival was 69% with a mean followup of 33 months (range 1 to 83). Of the patients 43 (74%) are alive with an intact bladder, 39 (67%) are currently disease-free with an intact bladder and 32 (55%) have been continuously disease-free with an intact bladder. Seven patients experienced a superficial recurrence and were treated successfully while 15 patients experienced an advanced recurrence. On univariate analysis CIS and multifocality were related to superficial recurrence, and lymph node involvement and positive surgical margin were related to advanced recurrence. On multivariate analysis concomitant CIS (odds ratio 7.05, p = 0.004) and lymph node involvement (odds ratio 4.38, p = 0.031) were predictors of advanced recurrence. CONCLUSIONS: In highly selected patients with invasive bladder cancer, partial cystectomy offers acceptable outcomes. Concomitant CIS and presence of metastases to regional lymph nodes predict advanced recurrence.

Adolescent↗
PubMed2004

Bladder cancer as a prognostic factor for upper tract transitional cell carcinoma.

PURPOSE: Upper tract transitional cell carcinoma (UTTCC) is a relatively rare tumor. Overall 5-year disease specific survival is in the range of 16.5% to 95% depending on stage. In this study we evaluated predictors associated with disease recurrence and disease specific survival. MATERIALS AND METHODS: We report on 129 patients with a median age of 68 years who underwent nephroureterectomy for UTTCC between July 1989 and June 2002. A total of 67 patients had primary UTTCC and 62 had previous (52) or synchronous (10) transitional cell carcinoma of the bladder (BTCC). Medical records were reviewed and analyzed for possible prognostic predictors (primary tumor stage, grade, multifocality, carcinoma in situ, symptoms and signs at presentation, sex, and history of smoking). Disease specific survival and freedom from bladder recurrence were assessed with the Kaplan-Meier method, and differences between the groups were compared using the log rank test. The Cox proportional hazards regression model was used to assess the significance of each predictor. RESULTS: Disease specific death was reported for 44 patients. In a multivariate analysis using previous BTCC as a predictor (categorized as superficial, invasive or none), primary disease stage and history of BTCC were associated with disease specific survival (p = 0.001 and p = 0.018). History of BTCC grouped the patients into distinct populations in terms of disease specific survival and freedom from bladder recurrence. CONCLUSIONS: This study demonstrates that a history of BTCC (invasive or superficial) has an adverse effect on the prognosis of patients diagnosed with UTTCC independent of primary tumor stage.

Adult↗
PubMed2004

Partial nephrectomy for patients with a solitary kidney: the Memorial Sloan-Kettering experience.

OBJECTIVE: To report the experience of partial nephrectomy in patients with a solitary kidney at one institution, with analysis of renal function, complications, oncological efficacy and survival. PATIENTS AND METHODS: We identified 54 consecutive patients with a solitary kidney who had a partial nephrectomy between December 1989 and July 2003. Variables examined included patient age and gender, renal function, renal ischaemia time, surgical margin status and complications. Pathological features, e.g. tumour size, histological subtype and tumour stage, were also assessed. Disease-free probability and overall and cancer-specific survivals were determined. RESULTS: The histological subtype was clear cell in 35 cases (65%), papillary in 10 (19%), oncocytoma in four (7%), chromophobe in two (4%), unclassified in one (2%) and multiple subtypes in two (2%). The median creatinine level before surgery was 14 mg/L, which increased to 16 mg/L 6 months afterward, and at 1 and 2 years after surgery it was 15 mg/L. Two patients developed end-stage renal disease requiring haemodialysis, one soon after surgery and another 8 years after nephron-sparing surgery. In all, 26% of patients developed at least one perioperative complication, with acute renal failure and urinary fistula being the most common. At 5 years the overall and cancer-specific survival, and disease-free probability were 68%, 88% and 73%, respectively. CONCLUSIONS: Partial nephrectomy is safe in patients with a solitary kidney, with an acceptable decline in renal function and low likelihood of requiring temporary or permanent haemodialysis. After an initial decline, renal function appears to stabilize during the first year.

Adult↗
PubMed2003

The evolving role of partial nephrectomy in the management of renal cell carcinoma.

The surgical management of renal cell carcinoma has undergone critical review over the past decade. Initially treated with radical nephrectomy, renal cell carcinoma is now approached with nephron-sparing surgical techniques. Improved imaging modalities have substantially increased the number of incidental renal tumors detected, and with the increasing number of incidentally detected kidney tumors, a size and stage migration has occurred in renal cell carcinoma. Early studies showed that disease-free survival rates were similar between cancers treated with radical and partial nephrectomy. The standard now is to offer partial nephrectomy as a surgical option to all patients with renal lesions measuring 4.0 cm or smaller in the setting of a normal contralateral kidney. More recent issues regarding partial nephrectomy concern complication rates and management, renal cell carcinoma multifocality, margin status and distance to normal renal parenchyma, cost analysis, and the development of laparoscopic techniques that duplicate open partial nephrectomy. The purpose of this review is to outline and analyze these more recent concerns regarding partial nephrectomy.

Carcinoma, Renal Cell↗
PubMed2003

Orthotopic urinary diversion after cystectomy for bladder cancer: implications for cancer control and patterns of disease recurrence.

PURPOSE: The impact of orthotopic urinary diversion on the quality of cystectomy and ensuing cancer control has not been adequately studied. We analyzed our experience with this clinical problem. MATERIALS AND METHODS: The records of 214 patients who underwent cystectomy and orthotopic diversion for bladder cancer were retrospectively evaluated and compared with those of 269 treated with an ileal conduit. Analyzed end points included overall and cancer specific survival. We specifically assessed the patterns of relapse and their association with pathological findings at cystectomy in the neobladder group. RESULTS: No cancer specific survival difference was identified in the neobladder and ileal conduit cohorts when adjusting for pathological stage. Patterns of relapse in 62 of the 214 patients with a neobladder (29%) included local recurrence in 23 (11%), distant recurrence in 19 (9%), and combined local and distant recurrence in 18 (8%). Urethral recurrence was rare (2%). Of 10 patients (4.6%) diagnosed with upper tract recurrence 6 and 4 initially had relapse in the ureteroenteric anastomosis and renal pelvis, respectively. Five of the 6 patients with anastomotic relapse had evidence of disease in the intramural or juxtavesical ureter that was removed en bloc with the cystectomy specimen. Only 1 patient required neobladder takedown after such anastomotic recurrence. CONCLUSIONS: These results indicate that neobladders do not compromise the quality of preceding cystectomy or interfere with management in the presence of local or distant disease relapse. Our data suggest that involvement of the intramural or juxtavesical ureteral segment at cystectomy irrespective of surgical margin status may identify patients at higher risk for anastomotic recurrence, which is associated with an ominous prognosis.

Aged↗
PubMed2003

Long-term follow-up of bilateral sporadic renal tumors.

OBJECTIVES: To assess the clinical characteristics, pathology, and long-term follow-up of patients with bilateral nonfamilial renal tumors (BNFRTs). METHODS: Patients with BNFRTs and unilateral tumors were identified from a prospective surgery database. The Mann-Whitney U test, Cox proportional hazards regression analysis, and the log-rank test were used to compare groups. RESULTS: From a database of 1082 patients with nonmetastatic renal tumors, 46 were identified with BNFRTs (4.25%). Thirty-three had synchronous tumors and 13 had asynchronous tumors. The median patient age of BNFRT patients was 61 years. Of the 92 renal tumors in these 46 patients, 42% were managed with radical nephrectomy (RN) and 58% with partial nephrectomy (PN); 7 underwent bilateral PN. The tumors were conventional clear cell carcinoma in 66% (n = 61), papillary carcinoma in 14% (n = 13), and the remaining 20% were of varied histologic origin. A 76.2% concordance was noted between the histologic subtypes of the two renal tumors in each patient. Median follow-up was 74 months. Thirty-three patients (72%) were disease-free and 7 patients had recurrence (2 local, 5 metastatic). Compared with patients having unilateral disease, BNFRT patients had an equivalent disease-free survival (DFS) (bilateral: 3-year DFS 90%, 5-year DFS 83%; unilateral: 3-year DFS 92%, 5-year DFS 82% [P = 0.449]). No difference in DFS was observed between synchronous and asynchronous tumors. CONCLUSIONS: BNFRTs were present in 4.25% of patients with sporadic renal tumors. Conventional clear cell histology was the most common histologic subtype; concordance among tumors was found to be 76%. DFS rates comparable to those of unilateral tumors can be obtained by using combinations of PN and RN.

Brain Neoplasms↗
PubMed2003

Phase II trial of ZD1839 (IRESSA) in patients with advanced renal cell carcinoma.

Eighteen patients with advanced renal cell carcinoma (RCC) were treated on a phase II trial with ZD1839 (IRESSA). Treatment efficacy was determined using the endpoint of improvement in time to progression (TTP) compared to TTP in patients who received interferon-alpha therapy. The Memorial Sloan Kettering Cancer Center database of renal cell patients shows that patients receiving therapy with interferon-alpha had a median TTP of 4.7 months, with 40% of patients having disease progression at 4 months. To show efficacy in this trial, 60% of evaluable patients would have to remain progression free at 4 months. Treatment with ZD1839 did not result in any complete or partial responses, and 13 patients (81%) had progression of disease within 4 months of start of therapy. At the dose and schedule used in this trial, the lack of antitumor activity associated with ZD1839 does not support further study in patients with metastatic RCC.

Adult↗
PubMed2003

Adult spermatic cord sarcomas: management and results.

BACKGROUND: We present a 20-year surgical experience with spermatic cord sarcoma, describe prognostic features, and evaluate the results of surgical and adjunctive treatments. METHODS: Forty-seven patients were identified from an institutional database. Disease-free survival was calculated, and prognostic factors such as tumor grade, size, extent of operation, and adjuvant therapy were analyzed. RESULTS: The median patient age was 58 years (range, 16-83 years), and the median follow-up was 51 months (range,.5-226 months). The most common tumor types included liposarcoma (51%), leiomyosarcoma (19%), embryonal rhabdomyosarcoma (13%), and malignant fibrous histiocytoma (11%). Twenty-nine (62%) patients had high-grade tumors, 21 (45%) were treated with adjuvant radiation, and 9 (19%) received chemotherapy. The overall 5- and 10-year disease-specific survival was 75% and 55%, respectively. No specific prognostic factors were identified for recurrence or disease-free survival. In 21 patients who underwent reoperative wide resection after a prior incomplete resection, a trend toward improved disease-free survival was noted (P <.059). Of these, six (29%) had residual viable sarcoma. We could not demonstrate a therapeutic effect of adjuvant radiation or chemotherapy. CONCLUSIONS: We demonstrated that aggressive surgical strategies, including reoperative wide resection, significantly decrease local recurrence and may improve disease free-survival in select patients with spermatic cord sarcoma.

Adolescent↗
PubMed2002

Phase I trial of intravesical gemcitabine in bacillus Calmette-Guérin-refractory transitional-cell carcinoma of the bladder.

PURPOSE: The aim of this phase I study was to determine the safety and toxicity profile of gemcitabine administered as an intravesical agent in patients with transitional-cell carcinoma (TCC) of the bladder. PATIENTS AND METHODS: Patients with superficial bladder cancer refractory to intravesical bacillus Calmette-Guérin (BCG) therapy and refusing a cystectomy were considered eligible for the trial. Gemcitabine was given in the bladder for 1 hour twice weekly in 100 mL sodium chloride for a total of six treatments. After a 1-week break, a second course of six treatments over 3 weeks was given, followed by response assessment. Four dose levels were explored: 500 mg, 1,000 mg, 1,500 mg, and 2,000 mg. RESULTS: Eighteen patients completed therapy: three at 500 mg, six at 1,000 mg, three at 1,500 mg, and six at 2,000 mg. No grade 3 or 4 toxicity was observed at 500 mg. At 1,000 mg, three patients developed hematuria and one had a skin reaction resembling grade 3 hand-foot syndrome. Three patients at 1,500 mg had no grade 3 or 4 toxicity. Of six patients at 2,000 mg, one had grade 3 thrombocytopenia and neutropenia without infection. Seven patients had a complete response (negative cytology and posttreatment biopsy), and four patients had a mixed response (negative bladder biopsy but positive cytology). CONCLUSION: Gemcitabine has substantial activity as an intravesical agent in BCG-refractory TCC and warrants further investigation. Therapy given twice weekly was associated with minimal bladder irritation and tolerable myelosuppression. The recommended phase II dose for twice-weekly therapy is 2,000 mg.

Administration, Intravesical↗
PubMed2002

Temporal change in risk of metachronous contralateral renal cell carcinoma: influence of tumor characteristics and demographic factors.

PURPOSE: To determine the relative risk (RR) of developing a metachronous contralateral renal tumor after an initial diagnosis of renal cell carcinoma (RCC), with stratification by renal tumor characteristics, demographic factors, and follow-up duration, in order to develop an improved risk-based surveillance strategy. PATIENTS AND METHODS: The 1973 to 1997 Surveillance, Epidemiology, and End Results database was used to determine the observed and expected number of metachronous contralateral renal tumors developing after an initial diagnosis of RCC. RESULTS: A total of 43,483 patients had a first diagnosis of RCC. Contralateral RCC developed subsequently in 155 (0.4%) of 40,049 patients with follow-up who had no synchronous diagnosis of RCC, with 10.81 expected cases (RR, 14.3; 95% CI, 12.2 to 16.8). The respective RRs (and 95% CIs) for contralateral RCC for white men and women were 16.0 (11.1 to 22.3) and 13.7 (7.7 to 22.6) at less than 2 years, 8.8 (5.0 to 14.3) and 10.5 (5.0 to 19.3) at 2 to 5 years, 13.5 (8.1 to 21.0) and 5.1 (1.4 to 13.2) at 5 to 10 years, and 13.0 (6.2 to 23.9) and 13.7 (5.0 to 29.9) at > or = 10 years, respectively. The RRs were significantly higher in black compared with white men for the first 5 years, with the RRs (and 95% CIs) in the former group of 95.3 (58.2 to 146.7) at less than 2 years and 41.9 (16.8 to 86.3) at 2 to 5 years. CONCLUSION: The incidence of metachronous contralateral RCC is stable on long-term follow-up, suggesting that surveillance of the contralateral kidney should remain rigorous on extended follow-up. Black men are at a significantly higher risk of developing contralateral RCC in the first 5 years of follow-up.

Adult↗
PubMed2002

Treatment outcome and survival associated with metastatic renal cell carcinoma of non-clear-cell histology.

PURPOSE: To define outcome data for patients with metastatic renal cell carcinoma (RCC) with histology other than clear-cell type, including collecting duct (or medullary carcinoma), papillary, chromophobe, and unclassified histologies. PATIENTS AND METHODS: Sixty-four patients with metastatic non-clear-cell RCC histology were the subjects of this retrospective review. Included in the analysis were 22 (8%) of 286 patients from a clinical trials database, 19 of 1,166 patients from a surgery database, and 23 of 357 patients from a pathology database. RESULTS: The prevalent histology was collecting duct, present in 26 (41%) patients. The number of patients with chromophobe and papillary histologies was 12 (19%) and 18 (28%), respectively. Eight (12%) of the patients had tumors that could not be classified for specific tumor histology. Among the 43 patients treated with 86 systemic therapies, including 37 cytokine therapies, two patients (5%) were observed to have a partial response. The median overall survival time was 9.4 months (95% confidence interval, 8 to 14 months). The survival was longer for patients with chromophobe tumors compared with collecting duct or papillary histology, and this group included four patients with survival of greater than 3 years. CONCLUSION: RCC consists of a heterogeneous group of tumors including clear-cell, papillary, chromophobe, collecting duct, and unclassified cell types. Non-clear-cell histologies constitute less than 10% of patients in general populations of patients with advanced RCC treated on clinical trials. Metastatic non-clear-cell RCC is characterized by a resistance to systemic therapy and poor survival, with the survival for patients with chromophobe tumors longer than that for patients with metastatic collecting duct or papillary RCC. Treatment with novel agents on clinical trials is warranted.

Adolescent↗
PubMed2002

Interferon-alfa as a comparative treatment for clinical trials of new therapies against advanced renal cell carcinoma.

PURPOSE: To define outcome data and prognostic criteria for patients with metastatic renal cell carcinoma (RCC) treated with interferon-alfa as initial systemic therapy. The data can be applied to design and interpretation of clinical trials of new agents and treatment programs against this refractory malignancy. PATIENTS AND METHODS: Four hundred sixty-three patients with advanced RCC administered interferon-alpha as first-line systemic therapy on six prospective clinical trials were the subjects of this retrospective analysis. Three risk categories for predicting survival were identified on the basis of five pretreatment clinical features by a stratified Cox proportional hazards model. RESULTS: The median overall survival time was 13 months. The median time to progression was 4.7 months. Five variables were used as risk factors for short survival: low Karnofsky performance status, high lactate dehydrogenase, low serum hemoglobin, high corrected serum calcium, and time from initial RCC diagnosis to start of interferon-alpha therapy of less than one year. Each patient was assigned to one of three risk groups: those with zero risk factors (favorable risk), those with one or two (intermediate risk), and those with three or more (poor risk). The median time to death of patients deemed favorable risk was 30 months. Median survival time in the intermediate-risk group was 14 months. In contrast, the poor-risk group had a median survival time of 5 months. CONCLUSION: Progression-free and overall survival with interferon-alpha treatment can be compared with new therapies in phase II and III clinical investigations. The prognostic model is suitable for risk stratification of phase III trials using interferon-alpha as the comparative treatment arm.

Adult↗