Response: Re: Systematic Pelvic Lymphadenectomy vs No Lymphadenectomy in Early-Stage Endometrial Carcinoma: Randomized Clinical Trial

Extract

In their correspondence, the Mayo Clinic group expressed concern that our randomized study could be misinterpreted and commented on three study limitations that we addressed in the article ( 1 ). Patients with early-stage endometrial carcinoma are inherently a low-risk population, but our trial was powered to detect differences in survival consistent with a therapeutic intervention not devoid of important side effects.

The prevalence of lymph node metastases in our trial (ie, 13.3%) was similar to that found in the Mayo Clinic series of patients undergoing systematic pelvic and aortic lymphadenectomy (ie, 14.7%–16%), suggesting that our inclusion criteria were adequate ( 1 , 2 ). Furthermore, pelvic lymphadenectomy failed to play a therapeutic role also in the women with poorly differentiated cancer, who constitute the subgroup with the highest risk of lymph node metastases ( 1 ).

In our trial, after a complete pelvic lymphadenectomy, surgeons selected the patients (the majority of whom had grade 3 cancers or bulky or suspicious or positive pelvic and/or aortic lymph nodes) who should receive aortic lymphadenectomy; 26% of the patients in our trial were candidates for this procedure. The rate of isolated aortic metastases or pelvic plus aortic metastases in our trial was in keeping with other reports ( 3 , 4 ), including those from the Mayo Clinic (ie, 2.8% and 7.2%, respectively, in our trial vs 2.8% and 6.7% in Mayo Clinic experience) ( 1 , 2 ). Mariani et al. ( 2 ) maintained that the optimal surgical treatment should include systematic lymphadenectomy up to renal vessels in two-thirds of patients with endometrial cancer because “a surgical procedure may be therapeutic if it helps eradicate metastatic disease” and because up to 10% of women could potentially benefit from aortic lymph node dissection.