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Secondary analyses from a randomized clinical trial: age as the key prognostic factor in endometrial carcinoma - 27/03/14

Doi : 10.1016/j.ajog.2013.12.025 
Pierluigi Benedetti Panici, MD a, Stefano Basile, MD d, , Maria Giovanna Salerno, MD d, Violante Di Donato, MD a, Claudia Marchetti, MD a, Giorgia Perniola, MD a, Antonio Palagiano, MD a, Alessandra Perutelli, MD d, Francesco Maneschi, MD e, Andrea Alberto Lissoni, MD f, Mauro Signorelli, MD f, Giovanni Scambia, MD b, Saverio Tateo, MD g, Giorgia Mangili, MD h, Dionyssios Katsaros, MD k, Elio Campagnutta, MD l, Nicoletta Donadello, MD m, Stefano Greggi, MD n, Mauro Melpignano, MD o, Francesco Raspagliesi, MD i, Gennaro Cormio, MD p, Roberto Grassi, MD q, Massimo Franchi, MD r, Diana Giannarelli, MD c, Roldano Fossati, MD j, Valter Torri, MD j, Clara Crocè, MD s, Costantino Mangioni, MD f
a Department of Obstetrics and Gynecology, Sapienza University Hospital, Rome, Italy 
b Department of Obstetrics and Gynecology, Gemelli Hospital, Rome, Italy 
c Department of Obstetrics and Gynecology, IFO–Istituto Regina Elena, Rome, Italy 
d Department of Obstetrics and Gynecology, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy 
e Department of Obstetrics and Gynecology, S. Maria Goretti Hospital, Latina, Italy 
f Department of Obstetrics and Gynecology, S. Gerardo Hospital, Monza, Italy 
g Department of Obstetrics and Gynecology, Fondazione Policlinico S. Matteo Pavia, Milan, Italy 
h Department of Obstetrics and Gynecology, S. Raffaele Hospital, Milan, Italy 
i Department of Obstetrics and Gynecology, Istituto Nazionale Tumori, Milan, Italy 
j Department of Obstetrics and Gynecology, Mario Negri Institute, Milan, Italy 
k Department of Obstetrics and Gynecology, S. Anna Hospital, Turin, Italy 
l Department of Obstetrics and Gynecology, Aviano Hospital, Aviano, Italy 
m Department of Obstetrics and Gynecology, University of Varese, Varese, Italy 
n Department of Obstetrics and Gynecology, Istituto Nazionale Tumori, Fondazione G. Pascale, Naples, Italy 
o Department of Obstetrics and Gynecology, Parma University Hospital, Parma, Italy 
p Department of Obstetrics and Gynecology, University of Bari, Bari, Italy 
q Department of Obstetrics and Gynecology, Treviglio Hospital, Treviglio, Italy 
r Department of Obstetrics and Gynecology, University of Verona, Verona, Italy 
s Department of Obstetrics and Gynecology, Northeast Women's Health and Obstetrics, Concord, NC 

Reprints: Stefano Basile, MD, Department of Obstetrics and Gynecology II, Azienda Ospedaliero-Universitaria Pisana, Via Roma, 67, 56126 Pisa, Italy.

Abstract

Objective

The purpose of this study was to explore in greater depth the outcomes of the Italian randomized trial investigating the role of pelvic lymphadenectomy in clinical early stage endometrial cancer. In the attempt to identify the patients with poorer prognosis, the impact of age and body mass index were also thoroughly investigated by cancer-specific survival (CSS) analyses.

Study Design

Survival outcomes of trial patients were analyzed in relation to age (≤65 years and >65 years) in the 2 arms (lymphadenectomy and no lymphadenectomy) and in the whole population of the trial.

Results

Univariate and multivariable analyses of CSS and overall survival (OS) of patients showed that age >65 years is a strong independent poor prognostic factor (5-y OS 92.1% and 78.4% in ≤65 years and >65 years patients, respectively, P < .0001; 5-y CSS 93.8% and 83.5% in ≤65 years and >65 years patients, respectively, P = .003). Among women ≤65 years, node negative patients had 94.4% 5-y OS and 96.3% 5-y CSS vs 74.3% 5-y OS and 74.3% 5-y CSS for node positive patients (P = .009 and P = .002, respectively), while among women >65 y, node negative patients had 75.7% 5-y OS and 83.6% 5-y CSS vs 74.1% 5-y OS and 83.3% 5-y CSS for node positive patients (P = .55 and P = .58, respectively). Univariate and multivariable survival analyses in the whole trial population showed that older age, and higher tumor grade and stage were significantly associated to a worse prognosis.

Conclusion

Older women faced an intrinsic poorer survival whether or not they underwent lymphadenectomy, and, unexpectedly, irrespective of the presence of nodal metastasis. Only in older patients was obesity (body mass index >30) significantly associated with scarce prognosis.

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Key words : age, body mass index, endometrial carcinoma, prognostic factors


Mappa


 The original trial was partially funded by grants from Università di Roma La Sapienza, Rome, and the Mario Negri Institute, Milan, as reported in the original published paper. There was no financial support for these secondary analyses.
 The authors report no conflict of interest.
 Cite this article as: Benedetti Panici P, Basile S, Salerno MG, et al. Secondary analyses from a randomized clinical trial: age as the key prognostic factor in endometrial carcinoma. Am J Obstet Gynecol 2014;210:363.e1-10.


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