Oral dexamethasone for the amelioration of the gemcitabine-induced side effects asthenia, edema, and flu-like symptoms: A pilot trial in 35 patients with various malignancies

Flu-like symptoms, asthenia, and edema are common side effects of gemcitabine treatment, occurring in up to 20% of all patients. The pathophysiologic mechanisms is currently unknown. We studied prospectively the efficacy of prophylactically administered oral dexamethasone in patients with different tumor types, who were complaining of gemcitabine-induced side effects. Dexamethasone was given in a dosage of 8 mg prior to the gemcitabine infusion and 12 and 24 h later. The evaluation of the efficacy was performed with a detailed interview, prior to the next gemcitabine infusion. Of 35 patients studied, 27 noticed some side effects during gemcitabine treatment and received dexamethasone for the second or subsequent gemcitabine infusion. 24/27 patients noted a better tolerance of the gemcitabine infusion. In 5 patients, edema diminished, 4 had no rash anymore, and 19 noted an improvement of asthenia and/or their general well-being. In 8/27 patients, omission of dexamethasone led these patients to request the drug routinely. Our results indicate that oral dexamethasone at least ameliorates gemcitabine-induced side effects in the majority of patients. A prospective, randomized, placebo-controlled study has been initiated to unequivocally prove this effect.