A comparison of two prophylactic regimens for hypersensitivity reactions to paclitaxel.

OBJECTIVE

The aim of this study was to compare the rates of hypersensitivity reactions to paclitaxel with the conventional prophylactic regimen of two doses of oral corticosteroids and a modified regimen of a single dose of intravenous corticosteroid.

METHODS

This was a retrospective historical cohort study assessing the rates of hypersensitivity reactions in patients receiving paclitaxel for ovarian or primary peritoneal carcinoma at the Hamilton Regional Cancer Centre from 1996 to 2000. Until 1998, all patients received the conventional prophylactic regimen consisting of two doses of oral dexamethasone (20 mg), 12 and 6 h prior to paclitaxel. From 1998 to the present, patients received a single dose of intravenous dexamethasone (20 mg), 30 min prior to paclitaxel. All patients also received an H(1) and H(2) blocker intravenously prior to paclitaxel administration. The analysis was corrected for potential covariates such as dose of paclitaxel and rate of infusion. The primary outcome measure was the rate of hypersensitivity reactions as defined by the National Cancer Institute of Canada-Clinical Trials Group. The Yates-corrected chi(2) test was used to compare the rates of these reactions, and a logistic regression analysis was used to determine whether any of the covariates were significant factors in these reactions.

RESULTS

One hundred seven patients received the conventional corticosteroid prophylaxis prior to paclitaxel, and 110 received the single-dose intravenous corticosteroid prophylaxis. Of the 107 patients in the conventional prophylaxis group, 8 had a hypersensitivity reaction (7.5%), and only 1 of these was severe (0.9%). In contrast, of the 110 patients in the single-dose IV corticosteroid group, 19 had a hypersensitivity reaction (17.3%), and 8 of these were severe (7.3%). The difference in hypersensitivity reaction rates was significant (chi(2), P = 0.047). In the logistic regression analysis, the only significant factor related to hypersensitivity reactions was the type of prophylactic steroid regimen.

CONCLUSIONS

In this series, the single-dose intravenous corticosteroid prophylactic regimen appeared to be associated with a higher rate of hypersensitivity reactions to paclitaxel than the conventional two-dose oral corticosteroid regimen.