Dr Garcia on the Future of the MELISA Trial in Ovarian Cancer

Núria Agustí Garcia, MD, postdoctoral fellow, The University of Texas MD Anderson Cancer Center, discusses an investigation into the phase 2 mapping sentinel lymph nodes in early-stage ovarian cancer (MELISA) trial, which is evaluating steps toward lymphadenectomy replacement in patients with ovarian cancer.

This study was exploratory in nature, aimed at determining whether the observed sentinel lymph node detection rate would support the feasibility of conducting a phase 3 trial, Garcia begins. Presently, investigators are engaged in a community-centric study using 2 tracers to assess detection rates, she says, adding that it is crucial to ensure that diagnostic accuracy remains consistent throughout these investigations. Garcia shares that she anticipates opening the multicenter study in 2024 or 2025 to validate these findings and pave the way for a successful phase 3 trial.

The technique employed in this study presents unique challenges, distinct from the methods used in cervical and endometrial cancer, she continues. Unlike in these cancers, where tracers are injected directly into the cervix, in ovarian cancer, tracers are injected intraoperatively into the surgical site, followed by further surgical procedures, Garcia reports. This underscores the need to adapt methodologies specifically for ovarian cancer rather than replicating approaches used in other gynecological cancers, according to Garcia. Additionally, although indocyanine green fluorescence is commonly used in cervical and endometrial cancers, its utility may be limited in ovarian cancer, she explains. Therefore, employing 2 tracers becomes vital, Garcia notes. In MELISA, this dual tracer approach demonstrated improved detection rates and outcomes compared with using a single tracer, as seen in other cancer types, Garcia adds.

In summary, challenges lie in tailoring sentinel lymph node detection methods to suit the unique characteristics of ovarian cancer, Garcia continues. The use of 2 tracers represents a step forward in optimizing detection rates and refining diagnostic accuracy in this disease, she notes. This iterative process of refining detection methodologies based on the MELISA study outcomes is vital for ensuring the success of future clinical trials and ultimately improving diagnostic and therapeutic approaches for patients with ovarian cancer, Garcia concludes.

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Núria Agustí Garcia, MD, discusses the mapping of sentinel lymph nodes in early-stage ovarian cancer.

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 

mTc-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.

Núria Agustí Garcia, MD, discusses the MELISA trial, which is evaluating further steps toward lymphadenectomy replacement in ovarian cancer.

Núria Agustí Garcia, MD

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Dr Garcia on the Future of the MELISA Trial in Ovarian Cancer

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