An evaluation of combination 5-fluorouracil and spirogermanium in the treatment of advanced colorectal carcinoma.

Seventeen patients with advanced colorectal carcinoma were treated with a combination of 5-fluorouracil and spirogermanium, a recently developed azaspiran-germanium compound remarkable for its lack of hematologic, gastrointestinal, renal or hepatic toxicity. Response to treatment and the incidence and severity of toxicity were evaluated. No patient achieved a complete response; there were three partial responses. Toxicity was unexpectedly frequent and severe; one patient was removed from study early due to intractable diarrhea, and there were two toxic deaths, both attributable to neutropenia and sepsis. Significant toxicity occurred in all seventeen patients, including three instances of Grade 3 or 4 hematologic toxicity. Given the low response rate and high incidence of life-threatening toxicity, we do not recommend further evaluation of this schedule of 5-fluorouracil and spirogermanium in the treatment of colorectal carcinoma.