Safety and Efficacy of Recombinant Human Apo2L/TRAIL in Advanced Cancer Patients

A groundbreaking study has been published, offering new insights into the use of recombinant human Apo2L/TRAIL as a potential cancer therapy. The phase I dose-escalation study, conducted by researchers at the University of Texas M. D. Anderson Cancer Center, assessed the safety, tolerability, pharmacokinetics, and antitumor activity of multiple intravenous doses of rhApo2L/TRAIL in patients with advanced cancer. The study found that the treatment was safe and well-tolerated, with the most common adverse events being fatigue, nausea, vomiting, fever, anemia, and constipation.

Key Takeaways:

• The study involved 71 patients who received a mean of 18.3 doses of rhApo2L/TRAIL, with seven patients completing all eight treatment cycles.
• The most common adverse events reported were fatigue (38%), nausea (28%), vomiting (23%), fever (23%), anemia (18%), and constipation (18%).
• Liver enzyme elevations were concurrent with progressive metastatic liver disease in some patients.
• Two patients with sarcoma experienced serious adverse events associated with rapid tumor necrosis.
• Two patients with chondrosarcoma experienced durable partial responses to rhApo2L/TRAIL.
• Dose escalation achieved peak rhApo2L/TRAIL serum concentrations equivalent to those associated with preclinical antitumor efficacy.

Statistics:

• 71 patients received rhApo2L/TRAIL treatment
• Mean dose: 18.3 doses per patient
• 7 patients completed all 8 treatment cycles
• 38% of patients experienced fatigue
• 28% of patients experienced nausea
• 23% of patients experienced vomiting, fever
• 18% of patients experienced anemia, constipation