Roychowdhury Debasish F, Cassidy Catherine A, Peterson Patrick, Arning Michael
Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 46285, USA.
Invest New Drugs. 2002 Aug;20(3):311-5. doi: 10.1023/a:1016214032272.
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.
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.
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.
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.
近期已注意到基于吉西他滨的治疗方案（G）会引发严重肺部毒性（SPT）。然而，SPT的发生率尚未得到充分评估。本回顾性研究评估了G引发SPT的发生率及相关影响因素。
肺部毒性定义为呼吸困难、间质性肺炎、肺部疾病、肺水肿、肺纤维化、肺炎、呼吸紊乱及呼吸窘迫综合征。患者来自礼来公司全球2个数据库——临床试验数据库（CTD）和安全数据库（SD）。由主治医生认定为严重且可能/很可能与治疗相关的事件，由独立评审进行评估和确认。严重肺部毒性事件分为呼吸困难或其他SPT事件。
在CTD中，研究者认定91例患者发生了与G相关的SPT，经独立评审，其中32例符合。基于CTD中接受G治疗的4448例患者，呼吸困难和其他SPT事件的发生率分别为0.45%和0.27%。在SD中，研究者认定295例患者发生了与G相关的SPT，经独立评审，其中167例符合。基于全球接受G治疗的约217,400例患者，呼吸困难和其他SPT事件的粗略发生率分别为0.02%和0.06%。
与G相关的SPT并不常见。CTD中呼吸困难和其他SPT的发生率分别为0.45%和0.27%。SD中呼吸困难和其他SPT的发生率分别为0.02%和0.06%。其他因素（如抗癌治疗）对这些发生率的影响有待进一步明确。
