15 agosto 2018

Yondelis para el Tratamiento de LipoSarcomas y LeiomyoSarcomas . Demuestra tener Igual Eficacia en la Población Joven como en la Anciana .



Author :

1.- Seattle Cancer Care Alliance, Seattle, USA; currently at Royal Marsden Hospital/Institute of Cancer Research, London, UK.
2.- Center for Sarcoma and Bone Oncology, Dana Farber Cancer Institute; Ludwig Center at Harvard; Boston, USA.
3.- University of Michigan Health System, Ann Arbor, USA.
4.- University of Iowa Hospitals and Clinics, Iowa City, USA.
5.- University of Colorado Cancer Center, Aurora, USA.
6.- Division of Oncology, Washington University in St. Louis, St. Louis, USA.
7.- Norton Cancer Institute, Louisville, USA.
8.- Clinical Oncology, Janssen Research and Development, Raritan, USA.
9.- Clinical Biostatistics, Janssen Research and Development, Raritan, USA.
10.- Memorial Sloan Kettering Cancer Center, New York, USA.
11.- Monter Cancer Center, Northwell Health, Lake Success, USA, and Cold Spring Harbor Laboratory, Cold Spring Harbor, USA.
12.- Department of Sarcoma Medical Oncology, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston, USA.
13.- Department of Hematology and Medical Oncology, Fox Chase Cancer Center, Philadelphia, USA.



Efficacy and Tolerability of Trabectedin in Elderly Patients with Sarcoma : Subgroup Analysis from a Phase 3, Randomized Controlled Study of Trabectedin or Dacarbazine in Patients with Advanced Liposarcoma or Leiomyosarcoma.

Abstract



BACKGROUND:

Treatment options for soft tissue sarcoma patients aged ≥65 years (elderly) can be limited by concerns regarding the increased risk of toxicity associated with standard systemic therapies. Trabectedin has demonstrated improved disease control in a phase 3 trial (ET743-SAR-3007) of patients with advanced liposarcoma or leiomyosarcoma (LPS/LMS) after failure of anthracycline-based chemotherapy. Since previous retrospective analyses have suggested that trabectedin has similar safety and efficacy outcomes regardless of patient age, we performed a subgroup analysis of the safety and efficacy observed in elderly patients enrolled in this trial.

PATIENTS AND METHODS:

Patients were randomized 2:1 to trabectedin (n = 384) or dacarbazine (n = 193) administered intravenously every-3-weeks. The primary endpoint was overall survival (OS); secondary endpoints were progression-free survival (PFS), time-to-progression, objective response rate (ORR), duration of response, symptom severity, and safety. A post hoc analysis was conducted in the elderly patient subgroup.

RESULTS:

Among 131 (trabectedin=94; dacarbazine=37) elderly patients, disease characteristics were well-balanced and consistent with those of the total study population. Treatment exposure was longer in patients treated with trabectedin versus dacarbazine (median 4 versus 2 cycles, respectively), with a significantly higher proportion receiving prolonged therapy (≥6 cycles) in the trabectedin arm (43% versus 23%, respectively; p=0.04). Elderly patients treated with trabectedin showed significantly improved PFS (4.9 versus 1.5 months, respectively; hazard ratio [HR]=0.40; p=0.0002) but no statistically significant improvement in OS (15.1 versus 8.0 months, respectively; HR = 0.72; p=0.18) or ORR (9% versus 3%, respectively; p=0.43). The safety profile for elderly trabectedin-treated patients was comparable to that of the overall trabectedin-treated study population.

CONCLUSIONS:

This subgroup analysis of the elderly population of ET743-SAR-3007 suggests that elderly patients with soft tissue sarcoma and good performance status can expect clinical benefit from trabectedin similar to that observed in younger patients.