Encouraging news on Temodar

A new study finds decent news for Temodar with unresectable and metastatic leiomyosarcoma. Although one can't simply extrapolate results from one sarcoma subtype to another, I thought this was worth mentioning because I found very little encouraging news about Temodar/temozolomide for sarcoma earlier this year. (I eventually took the drug anyway and had stable disease for four months or so, which qualified me for the deforolimus trial.)

The protocol used thalidomide as well, but the investigators believe that the temozolomide was the active agent. A quarter of the patients achieved stable disease for at least six months, which I count as a significant achievement given that these folks were pretty sick.

The abstract:

We assessed the efficacy of combined temozolomide and thalidomide in patients with unresectable or metastatic leiomyosarcoma in a phase II single-institution trial. Twenty-four patients were enrolled. Temozolomide (150 mg/m2/day for 7 days every other week) was administered with concomitant thalidomide (200 mg/day), and continued until unacceptable toxicity or disease progression. There were no complete responses and two (10%) partial responses. Five patients (24%) had stable disease for at least six months. Fourteen patients (67%) progressed after a median of two-month treatment. The median overall survival (twenty-two assessable patients) was 9.5 months [95% CI 7–28 months]. There were no treatment-related deaths or CTC grade 4 toxicities. Thirteen patients were dose-reduced or discontinued thalidomide due to toxicity. In conclusion, this combination of temozolomide and thalidomide provided disease stabilization in a subset of patients with advanced leiomyosarcoma. We hypothesize that temozolomide is the active agent in this regimen, and should be further studied.