Adding Palifosfamide to Doxorubicin Fails to Improve PFS in Sarcoma

The addition of palifosfamide to doxorubicin did not significantly improve progression-free or overall survival, compared with doxorubicin plus placebo, among patients with metastatic soft tissue sarcoma, according to a study published in the Journal of Clinical Oncology.¹

Palifosfamide, the active metabolite of ifosfamide, does not require prodrug formation, thereby bypassing the formation of toxic metabolites observed with the metabolism of ifosfamide and cyclophosphamide.

For the international, phase 3 PICASSO trial, investigators enrolled 447 patients with metastatic soft tissue sarcoma who had received no prior systemic therapy, and randomly assigned them 1:1 to receive doxorubicin plus palifosfamide or placebo.

Median progression-free survival was 6.0 months with palifosfamide and 5.2 months with doxorubicin (hazard ratio, 0.86; 95% CI, 0.68-1.08; P = .19).

Median overall survival was 15.9 months for doxorubicin plus palifosfamide, versus 16.9 months for doxorubicin plus placebo (hazard ratio, 1.05; 95% CI, 0.79-1.39; P = .74).

Palifosfamide treatment was associated with a higher rate of grade 3 to 4 adverse events, including a higher rate of febrile neutropenia.                    

Reference

1. Ryan CW, Merimsky O, Agulnik M, et al. PICASSO III: A phase III, placebo-controlled study of doxorubicin with or without palifosfamide in patients with metastatic soft tissue sarcoma. J Clin Oncol. 2016 Sep 12. doi: 10.1200/JCO.2016.67.6684 [Epub ahead of print]