Domenica Lorusso, MD, PhD, discusses the rationale behind the phase 3 ENGOT-cx11/GOG-3047/KEYNOTE-A18 study.
Domenica Lorusso, MD, PhD, director of the Gynaecological Oncology Unit at Humanitas Hospital San Pio X, Milan, and full professor of Obstetrics and Gynaecology, Humanitas University, Rozzano, discusses the rationale behind the phase 3 ENGOT-cx11/GOG-3047/KEYNOTE-A18 study (NCT04221945).
ENGOT-cx11 is a randomized, double-blind, placebo-controlled trial that enrolled patients aged 18 years or older diagnosed with locally advanced cervical cancer characterized by specific high-risk histological features, including squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma.
Lorusso also discusses the patient population evaluated in this study, and explains how it reflects the broad demographic of those with this condition.
Transcription:
0:09 | For more than 25 years, the treatment of locally advanced cervical cancer has been represented by concurrent chemoradiation plus brachytherapy. But there were several preclinical and clinical data suggesting that when we combine immunotherapy [with] radiation treatment, radiation treatment may work as a primer and enhance the efficacy of immunotherapy. Immunotherapy does work in cervical cancer because cervical cancer is a [human papillomavirus (HPV)]-related disease. So, immunotherapy works in cervical cancer. Radiotherapy may work better in combination with immunotherapy, and that is the reason why we moved in the treatment of [patients with] locally advanced cervical cancer.
0:53 | We chose the setting of locally advanced disease, and we chose to enroll patients with the locally advanced disease. We chose a 2014 classification FIGO and, in order to be enrolled in the trial, patients had to have FIGO stage IB to IIB and node positive [disease], or FIGO stage IIIA and IVA, regardless of nodal status.
1:19 | The incidence of locally advanced disease varies across the world and reflects the implementation of primary or secondary preventive strategies. In Europe, up to 35 patients are diagnosed with locally advanced disease, but in [areas] like Asia or Africa where there is no screening, this diagnosis involves up to 100% of patients.
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