B. Brockstein et al., Phase II studies of bryostatin-1 in patients with advanced sarcoma and advanced head and neck cancer, INV NEW DR, 19(3), 2001, pp. 249-254
Background. Bryostatin 1 is a marine derived macrolactone with antineoplast
ic activity modulated through protein kinase C, and with good activity in i
n vitro and in vivo models. There are few drugs that offer palliation for m
etastatic soft-tissue sarcoma and head and neck cancer, and drugs with new
mechanisms of action warrant detailed disease specific study. Patients and
methods. Two phase II studies for patients with incurable soft tissue sarco
ma (12), or head and neck cancer (12) were conducted. Patients were treated
with bryostatin, 120 mg/m(2)/72 hours every 2 weeks for 3 cycles prior to
re-evaluation. Most patients had received prior chemotherapy. Results. No p
atients had objective responses to therapy. Six patients had brief periods
of disease stabilization. Toxicity was generally mild, with myalgia being p
rominent (n=8). Hyponatremia, not previously described, occurred in 5 patie
nts. The mechanism of this toxicity was unclear. Conclusions. Bryosytatin 1
given as a single agent for advanced adult soft tissue sarcoma and head an
d neck cancer is inactive. Myalgia and hyponatremia were the predominant to
xicities.