ESMO 2023 - Oral Presentation By Dr. Patricia Pautier

October 22, 2023

ESMO 2023

Oral presentation by Dr. Patricia Pautier

A new combination therapy using doxorubicin and trabectedin improves long-term survival in patients with metastatic leiomyosarcoma

Madrid, October 22, 2023—Each year in France, there are approximately 3,000 new cases of sarcoma, a tumor that develops in the supportive tissue of organs. Nearly 40% of these are leiomyosarcomas, meaning they affect smooth muscle. Furthermore, each year, approximately 600 to 700 cases of these leiomyosarcomas are at the metastatic stage, with a poor prognosis. The Phase III LMS-04 trial, presented in an oral session at ESMO 2023 by Dr. Patricia Pautier, head of the Gynecology Committee at Gustave Roussy, evaluated the efficacy of a new drug, trabectedin, in combination with standard treatment (chemotherapy with doxorubicin). The 5-year results have just shown that this combination significantly improves survival. It could become the standard of care for metastatic leiomyosarcomas.

Leiomyosarcoma most commonly affects women and men over the age of 50–60. In women, in 40% of cases, this leiomyosarcoma involves the smooth muscle of the uterus, with symptoms that are often mistaken for a uterine fibroid. Leiomyosarcoma also affects other smooth muscles in the body and presents as a mass.

Until now, the standard of care for patients with metastatic non-bone (so-called soft tissue) sarcomas, including leiomyosarcomas, has been the same for all sarcomas: doxorubicin. No new drug, either alone or in combination, has outperformed this standard of care. While certain medications have sometimes increased the response rate or duration of response, they have not improved long-term survival. A few years ago, a new chemotherapy drug, trabectedin—derived from a marine sponge—showed encouraging results in the treatment of sarcomas during preliminary trials, primarily for metastatic leiomyosarcomas.

In an effort to improve the initial management of metastatic leiomyosarcomas, a trial launched in 2015 aimed to compare the impact on progression-free survival of a combination of doxorubicin andtrabectedin followed by maintenance therapy with trabectedin alone in patients whose disease had not progressed after 6 cycles of treatment, compared with doxorubicin alone. Initial results in 2021 showed a significant increase in progression-free survival with the combination of the two drugs. The survival results, which were recently presented at ESMO, include 150 patients: 74 received the doxorubicin/trabectedin combination and 76 received doxorubicin alone.

It appears that long-term overall survival, with a median follow-up of 55 months, is higher with the combination of the two drugs than with doxorubicin monotherapy. The median survival was 10 months longer in the doxorubicin/trabectedin group compared to doxorubicin alone. “This is the first time a treatment has significantly improved survival compared to doxorubicin alone for this indication,” explains Dr. Pautier. “This combination could become the standard of care in the future for metastatic leiomyosarcomas. However, it is more toxic than monotherapy, particularly in terms of hematologic toxicity—including a drop in platelet count—which must be properly managed.”

LMS-04 is a Phase III academic study by the French Sarcoma Group, led by Gustave Roussy, which was conducted at 22 French centers.

Dr. Julien Hadoux’s explanations in a video

Play video - https://www.youtube.com/watch?v=Xm1gmEikKV0

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