High incidence of local venous reactions to esorubicin

A retrospective analysis was performed on the medical charts of 160 cancer patients who received esorubicin (ESO or 4′ deoxydoxorubicin) in a Phase I clinical trial. The purpose of the review was to characterize the incidence of local venous reactions to this investigational doxorubicin (DOX) analog. The impact of prophy lactic pretreatments or post-treatment using antihistamines and glucocorticosteroids was also assessed. There were 58 episodes of local reactions to ESO injections (14.3%). These reactions were characterized by local swelling, itching and erythema. Like DOX-induced venous reactions, ESO complications resolved spontane ously after several hours and did not predispose patients to skin ulceration or subsequent general hypersensiti vity reactions. Indeed, ESO reactions were more common with initial treatments at low drug doses of only 10-15 mg/M² (p <.05 by Chi-square analysis). One case of ESO extravasation (about 5mg) was successful ly managed with topical cooling. The use of antihistamines and corticosteroids was ineffective at preventing local reactions. However, when these drugs were administered after a reaction had ensued, symptoms were lessened significantly in half of the patients treated (p <.05). The results of this review suggest that ESO causes a four-fold greater incidence of local venous reactions than with the parent DOX.