دانلود مقاله ترجمه شده کارآزمایی بالینی لنفادنکتومی در بیماران دچار نئوپلاسم‌های تخمدان پیشرفته

Abstract

BACKGROUND

Systematic  pelvic  and  paraaortic  lymphadenectomy  has  been  widely  used  in  the surgical treatment of patients with advanced ovarian cancer, although supporting evidence from randomized clinical trials has been limited.

METHODS

We  intraoperatively  randomly  assigned  patients  with  newly  diagnosed  advanced  ovarian cancer (International Federation of Gynecology and Obstetrics stage IIB through IV) who had undergone macroscopically complete resection and had normal lymph nodes both before and during surgery to either undergo or not undergo lymphadenectomy. All centers had to qualify with regard to surgical skills before participation in the trial. The primary end point was overall survival.

RESULTS

A  total  of  647  patients  underwent  randomization  from  December  2008  through January  2012,  were  assigned  to  undergo  lymphadenectomy  (323  patients)  or  not undergo  lymphadenectomy  (324),  and  were  included  in  the  analysis.  Among  patients  who  underwent  lymphadenectomy,  the  median  number  of  removed  nodes was 57 (35 pelvic and 22 paraaortic nodes). The median overall survival was 69.2 months in the no-lymphadenectomy group and 65.5 months in the lymphadenectomy  group  (hazard  ratio  for  death  in  the  lymphadenectomy  group,  1.06;  95% 

confidence interval [CI], 0.83 to 1.34; P = 0.65), and median progression-free survival was 25.5 months in both groups (hazard ratio for progression or death in the lymphadenectomy group, 1.11; 95% CI, 0.92 to 1.34; P = 0.29). Serious postoperative complications occurred more frequently in the lymphadenectomy group (e.g., incidence of repeat laparotomy, 12.4% vs. 6.5% [P = 0.01]; mortality within 60 days after surgery, 3.1% vs. 0.9% [P = 0.049]).

CONCLUSIONS

Systematic pelvic and paraaortic lymphadenectomy in patients with advanced ovarian cancer who had undergone intraabdominal macroscopically complete resection and had normal lymph nodes both before and during surgery was not associated with longer overall or progression-free survival than no lymphadenectomy and was associated with a higher incidence of postoperative complications. (Funded by Deutsche Forschungsgemeinschaft and the Austrian Science Fund; LION ClinicalTrials.gov number, NCT00712218.)