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.


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.
Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 46285, USA. dfr@lilly.com
Debasish F
DF
Roychowdhury
Catherine A
CA
Cassidy
Patrick
P
Peterson
Michael
M
Arning
D000328:Adult; D000964:Antimetabolites, Antineoplastic / Q000009:adverse effects*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects; D016208:Databases, Factual; D003841:Deoxycytidine / Q000009:adverse effects* / Q000031:analogs & derivatives*; D005260:Female; D006801:Humans; D008171:Lung Diseases / Q000139:chemically induced*; D008297:Male; D008875:Middle Aged; D011878:Radiotherapy / Q000009:adverse effects; D012189:Retrospective Studies; D012307:Risk Factors; D000093542:Gemcitabine
D000964:Antimetabolites, Antineoplastic; D003841:Deoxycytidine; D000093542:Gemcitabine