scholarly journals Follow-up guidelines after radical or partial nephrectomy for localized and locally advanced renal cell carcinoma

2013 ◽  
Vol 3 (1) ◽  
pp. 73 ◽  
Author(s):  
Wassim Kassouf ◽  
Robert Siemens ◽  
Christopher Morash ◽  
Louis Lacombe ◽  
Michael Jewett ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Cell Carcinoma ◽  
Partial Nephrectomy ◽  
Renal Cell ◽  
Locally Advanced ◽  
Advanced Renal Cell Carcinoma

scholarly journals Randomized Phase III Trial of Adjuvant Pazopanib Versus Placebo After Nephrectomy in Patients With Localized or Locally Advanced Renal Cell Carcinoma

2017 ◽  
Vol 35 (35) ◽  
pp. 3916-3923 ◽  
Author(s):  
Robert J. Motzer ◽  
Naomi B. Haas ◽  
Frede Donskov ◽  
Marine Gross-Goupil ◽  
Sergei Varlamov ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Cell Carcinoma ◽  
Renal Cell ◽  
Locally Advanced ◽  
Phase Iii ◽  
Advanced Renal Cell Carcinoma ◽  
Primary Analysis ◽  
Phase Iii Trial ◽  
Starting Dose

Purpose This phase III trial evaluated the efficacy and safety of pazopanib versus placebo in patients with locally advanced renal cell carcinoma (RCC) at high risk for relapse after nephrectomy. Patients and Methods A total of 1,538 patients with resected pT2 (high grade) or ≥ pT3, including N1, clear cell RCC were randomly assigned to pazopanib or placebo for 1 year; 403 patients received a starting dose of 800 mg or placebo. To address toxicity attrition, the 800-mg starting dose was lowered to 600 mg, and the primary end point analysis was changed to disease-free survival (DFS) for pazopanib 600 mg versus placebo (n = 1,135). Primary analysis was performed after 350 DFS events in the intent-to-treat (ITT) pazopanib 600 mg group (ITT600mg), and DFS follow-up analysis was performed 12 months later. Secondary end point analyses included DFS with ITT pazopanib 800 mg (ITT800mg) and safety. Results The primary analysis results of DFS ITT600mg favored pazopanib but did not show a significant improvement over placebo (hazard ratio [HR], 0.86; 95% CI, 0.70 to 1.06; P = .165). The secondary analysis of DFS in ITT800mg (n = 403) yielded an HR of 0.69 (95% CI, 0.51 to 0.94). Follow-up analysis in ITT600mg yielded an HR of 0.94 (95% CI, 0.77 to 1.14). Increased ALT and AST were common adverse events leading to treatment discontinuation in the pazopanib 600 mg (ALT, 16%; AST, 5%) and 800 mg (ALT, 18%; AST, 7%) groups. Conclusion The results of the primary DFS analysis of pazopanib 600 mg showed no benefit over placebo in the adjuvant setting.

Randomized phase III trial of adjuvant pazopanib versus placebo after nephrectomy in patients with locally advanced renal cell carcinoma (RCC) (PROTECT).

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 4507-4507 ◽  
Author(s):  
Robert J. Motzer ◽  
Naomi B. Haas ◽  
Frede Donskov ◽  
Marine Gross-Goupil ◽  
Sergei Varlamov ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Cell Carcinoma ◽  
Renal Cell ◽  
Locally Advanced ◽  
Disease Free Survival ◽  
Phase Iii ◽  
Advanced Renal Cell Carcinoma ◽  
Primary Analysis ◽  
Intent To Treat

4507 Background: PROTECT (NCT01235962) evaluated the efficacy and safety of pazopanib (PAZ) versus placebo in patients (pts) with locally advanced renal cell carcinoma (RCC) post nephrectomy. Methods: 1538 pts with resected pT2 (high grade), pT3 or greater clear cell RCC were randomly assigned to PAZ or placebo for 1 year. The starting dose (800 mg) following treatment of 403 pts was lowered to 600 mg to improve tolerability and primary endpoint was changed to disease-free survival (DFS) with PAZ 600 (N = 1135). Primary analysis was performed after 350 DFS events in intent-to-treat (ITT) PAZ 600, and DFS follow-up analysis was performed after an additional 12 months. Secondary endpoints included DFS with ITT PAZ 800 and ITT ALL, and safety. Results: Disease characteristics were similar between arms. The primary analysis results of DFS ITT 600 were not significant [HR: 0.862; 95% CI, 0.699, 1.063; p = 0.165] (Table). The secondary endpoint of DFS in ITT PAZ 800 and ITT ALL yielded 31% and 20% risk reduction, respectively. Updated DFS analysis in ITT 600 showed a higher HR with longer follow up. Increased ALT and AST were the most common adverse events leading to treatment discontinuation in the PAZ 600 (ALT 16% and AST 5%) and PAZ 800 (ALT 18% and AST 7%) groups. Conclusions: The study did not meet the primary DFS endpoint in ITT 600; however, a 31% decrease in the risk of recurrence was observed in ITT 800. The safety profiles in the 600 mg and 800 mg groups were similar and consistent with PAZ prior experience. Clinical trial information: NCT01235962. [Table: see text]

scholarly journals Safety and oncological outcomes for large (stage ≥T2b) and locally advanced renal cell carcinoma: comparison between laparoscopic and modified hand-assisted laparoscopic radical nephrectomy

2020 ◽  
Vol 48 (10) ◽  
pp. 030006052096123
Author(s):  
Xudong Guo ◽  
Hanbo Wang ◽  
Yuzhu Xiang ◽  
Xunbo Jin ◽  
Shaobo Jiang
Keyword(s):  
Renal Cell Carcinoma ◽  
Cell Carcinoma ◽  
Renal Cell ◽  
Radical Nephrectomy ◽  
Locally Advanced ◽  
Survival Rates ◽  
Renal Tumors ◽  
Advanced Renal Cell Carcinoma ◽  
Operative Duration ◽  
Laparoscopic Radical Nephrectomy

Objective To compare the operative and oncologic outcomes between hand-assisted laparoscopic radical nephrectomy (HALRN) and laparoscopic radical nephrectomy (LRN) for large (stage ≥T2b) and locally advanced renal cell carcinoma. Methods We retrospectively collected data from patients who underwent HALRN or LRN for stage ≥T2b renal cell carcinoma from January 2011 to January 2018 in our institution. The patients’ demographics, perioperative parameters, and postoperative follow-up data were compared between the two groups. The survival outcome was estimated using the Kaplan–Meier method. Results The HALRN group comprised 78 patients, and the LRN group comprised 63 patients. The median operative duration was significantly shorter in the HALRN than LRN group. The two groups were equivalent in terms of the incision length, blood loss, complication rate, and duration of hospitalization. In the HALRN and LRN groups, the 5-year overall survival rates were 69.4% and 73.1%, the 5-year cancer-specific survival rates were 80.0% and 83.3%, and the 5-year progression-free survival rates were 66.4% and 74.7%, respectively, with no significant differences. Conclusions Compared with LRN, HALRN may offer a shorter operative duration and equivalent surgical outcomes without sacrificing oncological efficacy. In addition, HALRN has specific advantages for extremely large and complicated renal tumors.

Subcutaneous Interleukin-2 in the Treatment of Renal Cell Carcinoma. Preliminary Report

1993 ◽  
Vol 60 (4) ◽  
pp. 305-306
Author(s):  
S. Benvenuti ◽  
E. Gastaldi ◽  
B. Mennini ◽  
M. Iacoviello ◽  
M. Caviguone ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Adverse Effects ◽  
Cell Carcinoma ◽  
Metastatic Renal Cell Carcinoma ◽  
Renal Cell ◽  
Preliminary Report ◽  
Locally Advanced ◽  
Interleukin 2 ◽  
Advanced Renal Cell Carcinoma

10 patients with locally advanced renal cell carcinoma and 5 patients with metastatic renal cell carcinoma were treated with IL-2 subcutaneously. Adverse effects were not important. This study shows that IL-2 alone given subcutaneously is an effective and well-tolerated treatment for renal cell carcinoma.

scholarly journals Nivolumab versus everolimus in patients with advanced renal cell carcinoma: Updated results with long‐term follow‐up of the randomized, open‐label, phase 3 CheckMate 025 trial

Cancer ◽  
2020 ◽  
Vol 126 (18) ◽  
pp. 4156-4167 ◽  
Author(s):  
Robert J. Motzer ◽  
Bernard Escudier ◽  
Saby George ◽  
Hans J. Hammers ◽  
Sandhya Srinivas ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Cell Carcinoma ◽  
Renal Cell ◽  
Advanced Renal Cell Carcinoma ◽  
Open Label ◽  
Phase 3 ◽  
Open Label Phase ◽  
Long Term Follow Up
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