BACKGROUND: Until now the therapeutic value of lymphadenectomy for renal-cell carcinoma has remained controversial. Several studies attempting to solve this controversy have been published, but none of them were set up as prospective randomized trials. OBJECTIVE: To assess whether a complete lymph-node dissection in conjunction with a radical nephrectomy for renal-cell cancer is more effective than a radical nephrectomy alone. DESIGN, SETTING, AND PARTICIPANTS: In 1988, the European Organization for Research and Treatment of Cancer (EORTC) Genitourinary Group started a randomized phase 3 trial comparing radical nephrectomy with a complete lymphadenectomy to radical nephrectomy alone. After the renal-cell carcinoma was judged to be N0M0 and resectable, patients were randomly selected prior to surgery to undergo either a radical nephrectomy with a complete lymph-node dissection or to undergo a radical nephrectomy alone. Postoperatively all patients were followed for progression of disease and mortality. INTERVENTION: All patients underwent a radical nephrectomy with or without a complete lymph-node dissection. MEASUREMENTS: All patients were postoperatively evaluated for time-to-progression, overall survival, and progression-free survival. Time-to-event curves were estimated based on the Kaplan-Meier method and compared using a two-sided log-rank test. RESULTS AND LIMITATIONS: Of the 772 patients selected for randomization, 40 were not eligible for the study. 383 patients were randomly selected to receive a complete lymph-node dissection together with a radical nephrectomy, and 389 patients were randomly selected to undergo a radical nephrectomy alone. The complication rate did not differ significantly between the two groups. Complete lymph-node dissections in 346 patients revealed an absence of lymph-node metastases in 332 patients. The study revealed no significant differences in overall survival, time to progression of disease, or progression-free survival between the two study groups. CONCLUSIONS: This study shows that, after proper preoperative staging, the incidence of unsuspected lymph-node metastases is low (4.0%) and that, notwithstanding a possible relationship to this low incidence rate, no survival advantage of a complete lymph-node dissection in conjunction with a radical nephrectomy could be demonstrated.
RCT Entities:
BACKGROUND: Until now the therapeutic value of lymphadenectomy for renal-cell carcinoma has remained controversial. Several studies attempting to solve this controversy have been published, but none of them were set up as prospective randomized trials. OBJECTIVE: To assess whether a complete lymph-node dissection in conjunction with a radical nephrectomy for renal-cell cancer is more effective than a radical nephrectomy alone. DESIGN, SETTING, AND PARTICIPANTS: In 1988, the European Organization for Research and Treatment of Cancer (EORTC) Genitourinary Group started a randomized phase 3 trial comparing radical nephrectomy with a complete lymphadenectomy to radical nephrectomy alone. After the renal-cell carcinoma was judged to be N0M0 and resectable, patients were randomly selected prior to surgery to undergo either a radical nephrectomy with a complete lymph-node dissection or to undergo a radical nephrectomy alone. Postoperatively all patients were followed for progression of disease and mortality. INTERVENTION: All patients underwent a radical nephrectomy with or without a complete lymph-node dissection. MEASUREMENTS: All patients were postoperatively evaluated for time-to-progression, overall survival, and progression-free survival. Time-to-event curves were estimated based on the Kaplan-Meier method and compared using a two-sided log-rank test. RESULTS AND LIMITATIONS: Of the 772 patients selected for randomization, 40 were not eligible for the study. 383 patients were randomly selected to receive a complete lymph-node dissection together with a radical nephrectomy, and 389 patients were randomly selected to undergo a radical nephrectomy alone. The complication rate did not differ significantly between the two groups. Complete lymph-node dissections in 346 patients revealed an absence of lymph-node metastases in 332 patients. The study revealed no significant differences in overall survival, time to progression of disease, or progression-free survival between the two study groups. CONCLUSIONS: This study shows that, after proper preoperative staging, the incidence of unsuspected lymph-node metastases is low (4.0%) and that, notwithstanding a possible relationship to this low incidence rate, no survival advantage of a complete lymph-node dissection in conjunction with a radical nephrectomy could be demonstrated.
Authors: Mas Jewett; A Finelli; C Kollmannsberger; L Wood; L Legere; J Basiuk; C Canil; D Heng; N Reaume; S Tanguay; M Atkins; G Bjarnason; J Dancey; M Evans; N Fleshner; M Haider; A Kapoor; R Uzzo; D Maskens; D Soulieres; G Yousef; N Basappa; N Bendali; P Black; N Blais; I Cagiannos; M Care; R Chow; H Chung; P Czaykowski; D Derosa; K Durrant; S Ellard; G Farquharson; C Filion-Brulotte; J Gingerich; L Godbout; R Grant; W Hamilton; W Kassouf; G Kurban; K Lane; Jb Lattouf; D Lau; M Leveridge; J McCarthy; R Moore; S North; P O'brien; E Pituskin; P Racine; R Rendon; A So; S Sridhar; K Stubbs; Z Su; L Taylor; T Udall; P Venner; W Vogel; S Yap; P Yau; M Cooper; N Giroux; D Miron; D Mosher; K Ross; J Willacy Journal: Can Urol Assoc J Date: 2012-02 Impact factor: 1.862
Authors: Benjamin T Ristau; Judi Manola; Naomi B Haas; Daniel Y C Heng; Edward M Messing; Christopher G Wood; Christopher J Kane; Robert S DiPaola; Robert G Uzzo Journal: J Urol Date: 2017-07-18 Impact factor: 7.450