Abstract
We assessed the safety of combination chemotherapy with carboplatin and paclitaxel (TJ therapy) by comparing the occurrence of adverse events and treatment completion before and after switching from brand-name to generic drugs. Thirty-four respiratory surgical patients underwent TJ therapy as preoperative chemotherapy (n = 1), for cancer recurrence (n = 13), and as postoperative adjuvant chemotherapy (n = 20) at the outpatient chemotherapy unit of our hospital between April 2006 and August 2010. Twelve of these 34 patients underwent treatment using generic products. Intergroup comparison of the incidence of adverse events revealed that grade 3 or more severe adverse events occurred in 2 of the 22 patients treated with the brand-name drugs, and 4 of the 12 patients treated with the generic drugs. As for treatment course, treatment withdrawal and dose reduction were necessary in 3 and 2 patients, respectively, in the groups of patients treated with the brand-name or generic drugs. No statistically significant differences were observed in the incidence of adverse events or the treatment course between the two groups. The results indicate that the brand-name drugs and generic drugs are equivalent in terms of safety; however, long-term outcomes need to be carefully followed up.
