A French study proves the therapeutic effectiveness of the doxorubicin-trabectedin combination, followed by maintenance treatment with this new molecule, against one of the most common types of soft tissue sarcoma.
- Leiomyosarcomas, which arise in smooth muscle, are one of the most common histological subgroups of soft tissue sarcomas.
- The combination of doxorubicin and trabectedin, followed by maintenance treatment with trabectedin, is linked to an improvement in overall survival, amounting to 33 months compared to 24 months with standard treatment.
- Survival without progression of the disease also increases from 6 months in the doxorubicin alone group, to 12 months in the doxorubicin-trabectedin then trabectedin maintenance group.
Around 3,000. This is the number of so-called “soft tissue” sarcomas detected each year in France. These attack cells present in muscles, fat (adipose tissue), or even nerves. They include several histological subtypes of tumors. One of the most common are leiomyosarcomas, which develop from smooth muscles found in the limbs or uterine wall. Regardless of their location, when these sarcomas are diagnosed at an advanced or metastatic stage, they present an unfavorable prognosis. Thus, it is essential to identify new therapeutic avenues, as the available options are limited.
Patients with advanced leiomyosarcoma received six cycles of doxorubicin plus trabectedin
Currently, and for decades, the standard treatment of the vast majority of soft tissue sarcomas is based on chemotherapy based on anthracyclines (doxorubicin), administered as monotherapy. If this fails, a second mono-chemotherapy with a molecule synthesized from a marine sponge, called “trabectedin”, is administered. In a study, French researchers, led by Dr. Patricia Pautier, head of the gynecological oncology committee at the Gustave Roussy Institute, wanted to determine whether the doxorubicin-trabectedin combination was effective against leiomyosarcomas.
To find out, scientists, as part of the phase 3 trial, recruited 150 people suffering from advanced leiomyosarcoma who had not previously received chemotherapy. The participants were divided and divided into two groups. The first received six cycles of doxorubicin. The other volunteers received six cycles of doxorubicin combined with trabectedin, followed by maintenance treatment with trabectedin for those whose disease did not progress. “Surgical intervention to remove residual disease was permitted in each group after six treatment cycles. Analyzes of progression-free survival (primary endpoint) and overall survival (secondary endpoint) were adjusted for two factors stratification: the site of origin of the tumor (uterine versus soft tissue) and the stage of the disease (locally advanced versus metastatic)”, can we read in the works.
Leiomyosarcoma: overall survival increasing from 24 to 33 months
According to the research, published in the journal The New England Journal of Medicine107 patients died, more precisely 47 adults in the doxorubicin-trabectedin group and 60 people in the doxorubicin group, after a follow-up period of 55 months. The authors noted that the overall survival of patients who benefited from the doxorubicin-trabectedin combination, followed by maintenance treatment with this new molecule, was 33 months, compared to 24 months in participants who received only the treatment. standard. Another encouraging result: progression-free survival was longer in the doxorubicin-trabectedin group (12 months) than in the doxorubicin group (6 months).
“The incidence of adverse reactions and the percentage of patients who underwent dose reductions were higher with the combination of doxorubicin and trabectedin than with doxorubicin alone,” indicated the team, estimating that this study will make it possible to modify the management on a global scale of all patients suffering from advanced leiomyosarcoma. “A new European phase III trial led by the French Sarcoma Group will begin in uterine leiomyosarcomas at high risk of recurrence after surgery, which will compare monitoring alone to 4 cycles of chemotherapy with doxorubicin-trabectedin”, said Dr. Patricia Pautier.
