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