A report on serious pulmonary toxicity associated with gemcitabine-based therapy

Background: Serious pulmonary toxicity (SPT) has recently been noted with gemcitabine-based therapy (G). However, the incidence of SPT has not been fully evaluated. This retrospective review estimates the incidence of, and the factors influencing, SPT with G. Patients and methods: Pulmonary toxicity was defined as dyspnea, interstitial pneumonitis, lung disorder, lung edema, lung fibrosis, pneumonia, respiratory disorder, and respiratory distress syndrome. Patients were identified from 2 worldwide Lilly databases-the clinical trial database (CTD) and the safety database (SD). Events designated as serious and possibly/probably related to therapy by the primary physician were independently evaluated and confirmed. Serious pulmonary toxicity events were categorized as dyspnea or other SPT events. Results: Of the 91 patients identified by the investigator in the CTD as having G-related SPT, 32 had G-related SPT per the independent reviewers. Based on the 4448 patients treated with G in the CTD, the incidences of dyspnea and other SPT events were 0.45% and 0.27%, respectively. Of the 295 patients identified by the investigator in the SD as having G-related SPT, 167 had G-related SPT per the independent reviewers. Based on an estimated 217,400 patients treated with commercial G worldwide, the crude incidences of dyspnea and other SPT events were 0.02% and 0.06%, respectively. Conclusions: SPT associated with G is uncommon. Incidences from the CTD for dyspnea and other SPT are 0.45% and 0.27%, respectively. Incidences from the SD for dyspnea and other SPT are 0.02% and 0.06%, respectively. The influence of other factors, such as anticancer therapies, on these incidences needs to be better understood.