Weekly Docetaxel in Minimally Pretreated Cancer Patients: A Dose-Escalation Study Focused on Feasibility and Cumulative Toxicity of Long-Term Administration

In a study involving 26 cancer patients, weekly doses of docetaxel were administered to evaluate the long-term feasibility and cumulative toxicity. The study, conducted between October 1996 and January 1998, determined that a maximum tolerated dose was 50 mg/m², with myelosuppression and diarrhea as dose-limiting toxicities. Cumulative toxicities included mild fluid retention, dacryorrhea, and grade 2 alopecia and fatigue at doses of 45 mg/m² and higher. The study concluded that weekly administration of docetaxel up to 45 mg/m² is feasible with acceptable toxicity, but a dose of 40 mg/m²/week was recommended for phase II studies due to minimal toxicity and observed activity at all dose levels. Myelosuppression was the main dose-limiting toxicity, with two out of four patients at 50 mg/m² experiencing dose-limiting leukopenia. The weekly regimen allowed for higher dose intensity with minimal hematological cost compared to traditional every-three-weeks administration. Other observed cumulative toxicities were mild alopecia, fluid retention, dacryorrhea, neurotoxicity, and fatigue, with peripheral edema being insignificant. The study supported further evaluation of docetaxel at 40 mg/m²/week in phase II clinical trials.