Duration Of Treatment And Outcomes

The median duration of treatment ranged from 27 to 69 d, representing one treatment course in each of three studies (cervical cancer and two solid tumor) and two treatment courses in the prostate cancer study. Total duration of treatment ranged from 1 to 672 d. Four patients were treated for greater than 1 yr. These include two women with advanced cervical cancer (508 and 652 d), one patient with a fibrous histiocytoma (672 d), and one patient with advanced colon cancer (388 d).

The primary reason that patients were discontinued was disease progression, which occurred in 71.1% (86 of 120) of patients. Adverse events and intercurrent medical events each accounted for 9.1% (11 of 120) of patients' discontinuations. The incidence of all other reasons for termination did not exceed 3.3% for each category: death, personal reasons, lost to follow-up, and so on. Two deaths, both attributed to the patients' diseases, occurred within 10 d of the last dose of TNP-470. One cervical cancer patient discontinued treatment after experiencing and maintaining a complete response for more than 18 mo. Another cervical cancer patient with demonstrated stable disease of greater than 18 mo duration was transferred to an extended-use protocol, and continues treatment with TNP-470.

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