2024-03-22 10:36:18
(Vienna, March 22, 2024) Since 1999, the standard therapy for locally advanced cervical cancer has consisted of external radiation therapy with simultaneous chemotherapy and subsequent brachytherapy. Since the prognosis for patients is still poor in many cases despite these measures, intensive research is being carried out into new options. An international team including MedUni Vienna has shown in a large-scale clinical study that the immunotherapeutic agent pembrolizumab in combination with chemoradiotherapy leads to a statistically significant improvement compared to chemoradiotherapy alone. The study results were recently published in the top journal “The Lancet”.
The randomized, double-blind and placebo-controlled clinical phase 3 study was carried out at 176 medical centers in 30 countries, including the Vienna General Hospital under the coordination of study co-author Stephan Polterauer (University Clinic for Gynecology at MedUni Vienna, Gynecologic Cancer Unit/CCC and Gynecological Oncology Working Group) in cooperation with the University Clinic for Radiation Oncology. Adults with newly diagnosed, locally advanced, high-risk cervical cancer were randomly selected as subjects. The 1,060 participants were also randomly assigned to treatment between June 2020 and December 2022, including 529 to the pembrolizumab chemoradiotherapy group and 531 to the placebo chemoradiotherapy group. As the researchers’ observations showed, the combination of pembrolizumab and chemoradiotherapy significantly improved progression-free survival in patients. Overall survival also increased with the addition of the monoclonal antibody and was 87 percent in the pembrolizumab chemoradiotherapy group (versus 81 percent in the placebo chemoradiotherapy group).
“There is an urgent need for effective, targeted therapy options for patients with locally advanced cervical cancer. “All data indicate that the effect of chemoradiotherapy can be enhanced by the immune-stimulating properties of pembrolizumab,” reports Stephan Polterauer about the central result from one of the largest studies in patients with cervical cancer. The research, says Polterauer, will most likely change the current standard of care. “Approval of the new combination therapy is expected.”
Publikation: The Lancet
Pembrolizumab or placebo with chemoradiotherapy followed by pembrolizumab or placebo for newly diagnosed, high-risk, locally advanced cervical cancer (ENGOT-cx11/GOG-3047/KEYNOTE-A18): a randomised, double-blind, phase 3 clinical trial
Domenica Lorusso, Yang Xiang, Kosei Hasegawa, Giovanni Scambia, Manuel Leiva, Pier Ramos-Elias, Alexander Acevedo, Vladyslav Sukhin, Noelle Cloven, Andrea J Pereira of Santana Gomes, Fernando Contreras Mejia, Ari Reiss, Ali Ayhan, Jung-Yun Lee , Valeria Saevets, Flora Zagouri, Lucy Gilbert, Jalid Sehouli, Ekkasit Tharavichitkul, Christina Lindemann, Roberta Lazzari, Chih-Long Chang, Rudolf Lampe, Hong Zhu, Ana Oaknin, Melissa Christiaens, Stephan PolterauerTomoka Usami, Kan Li, PhD, Karin Yamada, Sarper Toker, Stephen M Keefe, Sandro Pignata, Linda R Duska on behalf of theENGOT-cx11/GOG-3047/KEYNOTE-A18 investigators
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