Dr Agustí Garcia on the Rationale for the MELISA Trial in Ovarian Cancer

Núria Agustí Garcia, MD, postdoctoral fellow, The University of Texas MD Anderson Cancer Center, discusses the rationale for and outcomes from the mapping sentinel lymph nodes in early-stage ovarian cancer (MELISA) trial, which is evaluating further steps toward lymphadenectomy replacement in this ovarian cancer population.

The rationale behind this study stems from the ongoing practice of systematic pelvic and para-aortic lymphadenectomy, Agustí Garcia begins, which, though a common treatment approach, often provides no therapeutic value. However, ovarian cancer remains the sole context where full pelvic lymphadenectomy is routinely performed for staging, she explains. The MELISA trial prospectively assessed the sentinel lymph node (SLN) detection rate and the diagnostic accuracy of mapping SLNs in patients with early-stage epithelial ovarian cancer. Consequently, the aim of this study was to explore the feasibility of using SLN detection to mitigate the morbidity associated with pelvic lymphadenectomy, which carries inherent risks of vascular or neural injury, she reports.

Agustí Garcia states that investigators limited the study to patients with malignant ovarian cancer histologies, initially including cases of uncertain malignancy that were ultimately confirmed as malignant upon final analysis. Exclusion criteria comprised patients with prior lymph node dissections or potential factors impacting results, she reports.

This prospective, single-arm study enrolled patients diagnosed with early-stage epithelial ovarian cancer (FIGO stages I and II) who were undergoing either primary surgery or restaging surgery. SLN mapping entailed injecting 0.2 mL of 37-mBq ⁹⁹mTc-nanocoloid albumin and 2 mL of 2.5 mg/mL indocyanine green into the infundibulopelvic and utero-ovarian ligaments. Following SLN removal, a complete systematic pelvic and para-aortic lymphadenectomy was performed. The primary end point was the overall SLN detection rate using either or both tracers.

This study demonstrated a robust 90% detection rate for SLNs with a 0% false negative rate, Agustí Garcia explains. Notably, 7 SLNs exhibited metastatic involvement, with 5 harboring isolated tumor cells—a phenomenon warranting further exploration due to its novelty and lack of existing evidence, she concludes.