Jonathan C. Trent, MD, PhD: Clinical Data Supporting the Use of Trabectedin

What clinical data support the use of trabectedin in patients with myxoid liposarcoma?

From our clinical experience, patients with mixoid liposarcoma have been known for many years to benefit from therapy with trabectedin. This has been based on a number of trials performed in Europe, from our experience on a large patient access trial in the United States, as well as our experience on the phase III randomized trial of trabectedin compared to dacarbazine which resulted in a median progression-free survival improvement.

CASE: Soft-Tissue Sarcoma Case 2

Michael C is a 59-year-old social worker from Los Angeles California; his medical history is notable for obesity, COPD, and mild hypertension.

• In January of 2014, he presents to his PCP with complaints of right lower leg pain of several weeks’ duration
• Physical exam was unremarkable except for swelling of the lower right calf; x-ray of the affected leg was negative for fracture
• MRI scan of the lower right calf showed a 20 cm well defined lobular mass arising between the gastrocnemius and soleus
• Biopsy of the mass showed myxoid liposarcoma with round cell component. Patient underwent en bloc resection of the tumor following preoperative radiotherapy
• Gross examination showed the tumor to be 10 × 8 × 15 cm with gelatinous brownish appearance

In September of 2014, Michael returns for follow up and his CT scan shows a 4 cm posterior mediastinal mass, and a 6 cm perinephric mass suspicious for metastatic disease. He initiates treatment with anthracycline and ifosfamide chemotherapy (6 cycles) for recurrent disease and shows a partial response.

• In May of 2015, he returns for follow up with intermittent chest and lower back pain; CT scan is consistent with progression of the mediastinal and perinephric masses, and bone scan shows new lesions occurring in the L2 and L3 lumbar vertebrae
• At recurrence, liver and renal function and CBC are within normal limits, and his ECOG performance status is 1
• He received treatment with trabectedin (1.5 mg/m2 24-hr infusion given every 3 week)
• At the 2nd cycle he develops febrile neutropenia (ANC< 500 cells/mm3) requiring hospitalization
• The oncologist reduces his trabectedin dose to 1.2 mg/m2; he continues therapy
• Within 1 week, he shows clinical improvement and CT scan shows slight improvement