Le Cesne A, et al. Eur J Cancer /// March 13, 2015 .Patients with soft tissue sarcoma who received trabectedin until disease progression demonstrated significantly improved PFS and OS compared with patients who only received six cycles of treatment, according to study results.
“This retrospective analysis consistently confirms that trabectedin is an effective treatment for patients with advanced sarcoma of multiple histologies following relapse or disease progression after standard-of-care front-line chemotherapy,” Axel Le Cesne, MD, of the department of medicine at the Institut Gustave Roussy in Villejuif, France, and colleagues of the French Sarcoma Group wrote.
Le Cesne and colleagues evaluated data from 885 patients with soft tissue sarcoma from 25 French centers. The median patient age was 54 years, and 54.8% were women. The most common histological types of sarcoma in the population were leiomyosarcoma (36.3%), liposarcoma (18.2%) and synovial sarcoma (11.1%).
Patients received a median of four cycles (range, 1-28) of trabectedin (Yondelis; PharmaMar and Johnson & Johnson). Median treatment duration was 2.4 months (range, 0.3-40.3).
Median follow-up was 22 months (range, 0.03-54.8).
The efficacy analysis included 804 evaluable patients. Half of the patients (50.1%; n = 403) had stable disease, six patients (0.7%) achieved a complete response and 127 (15.8%) achieved a partial response.
Median PFS in the overall population was 4.4 months (95% CI, 3.9-4.9) and median OS was 12.2 months (95% CI, 11-13.3). More than one third of the population (31.3%; n = 277) were alive at the end of the follow-up period, and 8% were alive after 4 years.
Patients who achieved stable disease or an objective response after six cycles of treatment were able to continue treatment with trabectedin until disease progression. Overall, 304 patients met these criteria, and 227 went on to receive prolonged treatment. The other 77 patients stopped treatment at their physician’s discretion.
Patients who received long-term treatment with trabectedin demonstrated significantly improved median PFS (11.7 months vs. 7.6 months; P < .003) and median OS (24.9 months vs. 16.9 months; P < .001) compared with patients who ceased trabectedin treatment after six cycles.
Four patients (0.5%) died due to a drug-related adverse event, and 9.4% were hospitalized due to an adverse event.
Further study into the effectiveness of trabectedin treatment is warranted, the researchers concluded.
“Such a [treatment] approach may allow patients to benefit from a long-term treatment and to achieve longer disease control with respect to patients who are treated later in the course of their disease,” Le Cesne and colleagues wrote. “Still, in order to finally demonstrate the superiority of continued long-term therapy with trabectedin versus treatment interruption an additional prospective and controlled comparison is needed to assess not only the efficacy outcomes but also the impacts on quality of life and cost-effectiveness of both approaches.” – by Cameron Kelsall .