Paclitaxel administered by 1‐hour infusion. Preliminary results of a phase 1/11 trial comparing two schedules

摘要: Background. Paclitaxel currently is administered by prolonged intravenous infusion because of the occurrence severe hypersensitivity reactions in patients early clinical trials. However, intensive premedication probably more important eliminating allergic than length infusion. The authors evaluated feasibility two paclitaxel schedules using a 1-hour, outpatient infusion. Methods. Fifty-six with advanced, refractory malignancies were randomized to receive one schedules: 135 mg/m2 as single dose over 1 hour, or divided daily doses for 3 days, each hour. All premedicated dexamethasone, diphenhydramine, and cimetidine. Results. No serious occurred either schedule paclitaxel. In addition, other adverse effects usually mild easily tolerated. Other alopecia, which all patients, myelosuppression was most common toxicity. grade leukopenia only 19% treatment courses, 4 (nadir < 1000/μL) 2%. Nine required hospitalization infection associated neutropenia. significant differences toxicity observed when regimens compared. Although it too assess results adequately, preliminary findings showed that thus far 11 56 patints (20%) had partial complete response therapy. Responses breast, ovarian, lung cancer. Conclusions. can be safely 1-hour an setting, three days. Severe did not occur 162 neutropenia patients. Incorporation this these into combination chemotherapy should feasible. An investigation higher given progress.