Gemcitabine-associated interstitial pneumonitis: Comprehensiveness and clinical characteristics of FDA and medical literature cases

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7229 Background: A debate exists over the extent to which gemcitabine is associated with potentially fatal pulmonary toxicities, namely interstitial pneumonitis. Methods: Herein, The Research on Adverse Drug reactions And Reports (RADAR) program evaluated 1) the quality and clinical characteristics of serious gemcitabine-associated pulmonary ADRs reported to the FDA (1997-present) and 2) reviewed medical literature cases (2001-present). Results: Completeness depending on whether reports were from the clinical trial (n=55) or routine care setting (n=95). Significantly more clinical trial reports reported the date of ADR onset (87% vs. 56%); days until onset (71% vs. 56%); pulmonary clinical signs such as dyspnea or hypoxia (82% vs. 69%), suspected drug relatedness (84% vs. 71%); and confirmed cause of death (83% vs. 67%) [p<.05 for all]. RADAR attributes better reporting in the clinical trial setting to prospective case reports forms mandated by IRBs and clinical trial sponsors. Gemcitabine was used for NSCLC (33%), pancreatic cancer (17%) and unspecified lung cancer (14%) and concomitant chemotherapy was used often (80% vs. 53%, clinical trial vs. not). These severe toxicities [pneumonitis (85%) & pneumonia (15%)] were diagnosed by CT or ultrasound (47%), more than one radiological exam (10%) or clinical means alone (43%); the median days until onset were 41 versus 55 days (clinical trial vs. not); 61% of patients were male; and 36 % of patients died. The medical literature indicates that concomitant chemotherapy significantly raises the risk of pulmonary toxicity. Conclusions: The lack of completeness in non-clinical trial versus clinical trial reports indicates that health professionals should strive to prospectively monitor and better report gemcitabine- associated pulmonary complications. No significant financial relationships to disclose.