Short-course intravenous prophylaxis for paclitaxel-related hypersensitivity reactions

Abstract

To estimate the incidence of hypersensitivity reactions using a short-course intravenous prophylactic regimen in patients receiving outpatient therapy with paclitaxel. Patients were identified from a retrospective search of a computerized pharmacy database covering a two-year period from January 1994 through December 1995. Eligible outpatients received paclitaxel as a one- to three-hour infusion 30 minutes after intravenous dexamethasone (10 or 20 mg), diphenhydramine (50 mg), and cimetidine (300 mg) or ranitidine (50 mg). Charts from all patients were then manually reviewed to verify drug administration and to record any evidence of hypersensitivity reactions during the first two cycles of therapy. A total of 283 outpatients were identified from the pharmacy database and all charts reviewed. All patients received intravenous dexamethasone (5 to 20 mg) 30 minutes prior to paclitaxel without prior oral dexamethasone. Hypersensitivity reactions were documented in 13 patients (4.6%) during the first or second cycle with a 95% confidence interval (CI) of 2.2% to 7.0%. Reactions resolved rapidly without sequelae and did not require hospitalization. Only two reactions (0.7%) were graded as serious with a 95% CI of 0.2% to 1.2%, based on the use of bronchodilators and presence of angioedema. Therapy was continued with modification in 10 patients without recurrent hypersensitivity reaction. Therapy was discontinued in two patients without rechallenge and discontinued in one patient after rechallenge with a recurrent hypersensitivity reaction. A short-course single-dose regimen of intravenous dexamethasone, diphenhydramine, and cimetidine (or ranitidine) offers a safe and convenient alternative for prevention of hypersensitivity reactions associated with outpatient paclitaxel administration.