In an expanded cohort of a European trial reported in the Journal of Clinical Oncology, Alessandro Gronchi, MD, and colleagues found that histology-tailored neoadjuvant chemotherapy with trabectedin was noninferior in terms of disease-free survival to standard neoadjuvant anthracycline/ifosfamide in patients with high-grade myxoid liposarcoma.
Alessandro Gronchi, MD
Study Details
A randomized trial performed by the Italian, Spanish, French, and Polish Sarcoma Groups compared the standard neoadjuvant regimen with a histology-tailored regimen in patients with selected localized high-risk soft-tissue sarcoma. The results of the trial showed superiority of standard treatment in disease-free survival in all soft-tissue sarcoma histologies except high-grade myxoid liposarcoma, in which the standard regimen and histology-tailored regimen (trabectedin) appeared to be equivalent.
In the current analysis, the high-grade myxoid liposarcoma cohort was expanded. The trial used a noninferiority Bayesian design, in which the histology-tailored regimen of trabectedin would be considered noninferior to the standard regimen if the posterior probability of the true hazard ratio being > 1.25 was < 5%.
Key Findings
The expanded cohort consisted of 101 patients with high-grade myxoid liposarcoma of the extremities or trunk who were randomly assigned between May 2011 and June 2020 to receive trabectedin (n = 45) or the standard anthracycline/ifosfamide regimen (n = 56). Median follow-up was 66 months (interquartile range = 37–89 months).
At 60 months, the probability of disease-free survival was 0.86 in the trabectedin group vs 0.73 in the standard group (hazard ratio [HR] = 0.60, 95% confidence interval [CI] = 0.24–1.46, P = .26). The posterior probability of the hazard ratio being > 1.25 for disease-free survival met the Bayesian monitoring cutoff of < 5% (4.93%); the finding indicated the noninferiority of trabectedin to anthracycline/ifosfamide.
Also at 60 months, overall survival probabilities were 0.88 in the trabectedin group vs 0.90 in the standard group (HR = 1.20, 95% CI = 0.37–3.93, P =.77).
The investigators concluded, “Trabectedin may be an alternative to standard anthracycline/ifosfamide in high-grade myxoid liposarcoma of the extremities or trunk when neoadjuvant treatment is a consideration.”
Dr. Gronchi, of the Department of Surgery, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, is the corresponding author for the Journal of Clinical Oncology article.
Disclosure: The study was supported by a European Union grant and others. For full disclosures of the study authors, visit ascopubs.org.
