Sarcoma Alliance Examines Failure of Promising New Drug

Sarcoma specialists mourn the loss of palifosfamide, which might have improved the quality of life for their patients.

Atlanta, Ga. (PRWEB) April 18, 2013

In a news release, Ziopharm reported that palifosfamide, in combination with doxorubicin, didn't show any significant difference from doxorubicin alone in a phase 3 clinical trial called PICASSO. In further statements, the company said FDA approval for sarcoma now appeared impossible.

"It is such a shame that a great drug will not be approved," said Dr. D'Amato, a sarcoma medical oncologist at Georgia Cancer Specialists in Atlanta.

Sarcoma patients have gotten the chemotherapy drug ifosfamide for years, often combined with doxorubicin (also known by its brand name Adriamycin). Palifosfamide was developed to be as effective as ifosfamide, but not as toxic, Dr. D'Amato said.

In the randomized PICASSO trial, doctors didn't know if they were giving patients palifosfamide or a placebo, said Charles Forscher, MD, medical director of Cedars-Sinai Medical Center's sarcoma program in Los Angeles.

Sometimes side effects give clues as to which patients are getting which drugs. But palifosfamide caused so few side effects that doctors couldn't tell which patients got the drug and which got saline injections, said Scott Schuetze, MD, PhD, director of the Connective Tissue Oncology Program and medical director of the Clinical Trials Office at the University of Michigan Comprehensive Cancer Center in Ann Arbor.

He and other sarcoma oncologists say they await the full study results.

"The provisional results ... add to the evidence that doxorubicin alone could be considered standard systemic treatment for metastatic soft-tissue sarcoma," said Robin Jones, MD, who directs the Gilman Sarcoma Research Program at the Fred Hutchinson Cancer Research Center in Seattle.

Last year, he said, a "European trial of doxorubicin versus doxorubicin and ifosfamide showed NO significant difference in overall survival. However, the combination of doxorubicin and ifosfamide had significantly longer progression-free survival and higher response rate compared to doxorubicin alone."

Originally posted here:
Sarcoma Alliance Examines Failure of Promising New Drug