SystLymphadenectomy vs. Opti Debulking: Same Survival

Systematic Aortic and Pelvic Lymphadenectomy Versus Resection of Bulky Nodes Only in Optimally Debulked Advanced Ovarian Cancer: A Randomized Clinical Trial

Pierluigi Benedetti Panici, Angelo Maggioni, Neville Hacker, Fabio Landoni, Sven Ackermann, Elio Campagnutta, Karl Tamussino, Raimund Winter, Antonio Pellegrino, Stefano Greggi, Roberto Angioli, Natalina Manci, Giovanni Scambia, Tiziana Dell'Anna, Roldano Fossati, Irene Floriani, Rita S. Rossi, Roberto Grassi, Giuseppe Favalli, Francesco Raspagliesi, Diana Giannarelli, Luca Martella, Costantino Mangioni

Affiliations of authors: Università "La Sapienza," Rome, Italy (PBP, NM); Istituto Europeo di Oncologia, Milan, Italy (AM, FL); Royal Hospital for Women, Randwick, Australia (NH); University of Erlangen-Nuremberg, Erlangen, Germany (SA); Centro di Riferimento Oncologico, Aviano, Italy (EC, LM); Medical University of Graz, Graz, Austria (KT, RW); S. Gerardo Hospital, Monza, Italy (AP, TD, RSR, CM); Istituto Nazionale Tumori, Fondazione G. Pascale, Naples, Italy (SG); Università "Campus Biomedico," Rome, Italy (RA); Università Cattolica del "Sacro Cuore," Rome, Italy (GS); Laboratory of Clinical Cancer Research, Mario Negri Institute, Milan, Italy (RF, IF); Treviglio Hospital, Treviglio, Italy (RG); Spedali Civili di Brescia, Brescia, Italy (GF); Istituto Nazionale Tumori, Milan, Italy (FR); IFO-Istituto Regina Elena, Rome, Italy (DG)

Correspondence to: Roldano Fossati, MD, Istituto Mario Negri, Via Eritrea 62, 20157, Milan, Italy (e-mail: fossati@marionegri.it.

Background: The role of systematic aortic and pelvic lymphadenectomy in patients with optimally debulked advanced ovarian cancer is unclear and has not been addressed by randomized studies.

We conducted a randomized clinical trial to determine whether systematic aortic and pelvic lymphadenectomy improves progression-free and overall survival compared with resection of bulky nodes only.

Methods: From January 1991 through May 2003, 427 eligible patients with International Federation of Gynecology and Obstetrics (FIGO) stage IIIB-C and IV epithelial ovarian carcinoma were randomly assigned to undergo systematic pelvic and para-aortic lymphadenectomy (n = 216) or resection of bulky nodes only (n = 211).

Progression-free survival and overall survival were analyzed using a log-rank statistic and a Cox multivariable regression analysis. All statistical tests were two-sided.

Results: After a median follow-up of 68.4 months, 292 events (i.e., recurrences or deaths) were observed, and 202 patients had died. Sites of first recurrences were similar in both arms.

The adjusted risk for first event was statistically significantly lower in the systematic lymphadenectomy arm (hazard ratio [HR] = .75, 95% confidence interval [CI] = 0.59 to 0.94; P = .01) than in the no-lymphadenectomy arm, corresponding to 5-year progression-free survival rates of 31.2 and 21.6% in the systematic lymphadenectomy and control arms, respectively (difference = 9.6%, 95% CI = 1.5% to 21.6%), and to median progression-free survival of 29.4 and 22.4 months, respectively (difference = 7 months, 95% CI = 1.0 to 14.4 months).

The risk of death was similar in both arms (HR = 0.97, 95% CI = 0.74 to 1.29; P = .85), corresponding to 5-year overall survival rates of 48.5 and 47%, respectively (difference = 1.5%, 95% CI = –8.4% to 10.6%), and to median overall survival of 58.7 and 56.3 months, respectively (difference = 2.4 months, 95% CI = –11.8 to 21.0 months).

Median operating time was longer, and the percentage of patients requiring blood transfusions was higher in the systematic lymphadenectomy arm than in the no-lymphadenectomy arm (300 versus 210 minutes, P<.001, and 72% versus 59%; P = .006, respectively).

Conclusion: Systematic lymphadenectomy improves progression-free but not overall survival in women with optimally debulked advanced ovarian carcinoma.

J Natl Cancer Inst 2005; 97: 560-566.

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