title: [Safety profiles of gemcitabine hydrochloride(GEMZAR®)in Japanese clinical studies].
abstract: To elucidate the detailed profiles of major adverse events associated with gemcitabine hydrochloride, such as myelosuppression and interstitial pneumonitis (IP), we reanalyzed the results from Japanese clinical studies conducted by Eli Lilly Japan K. K. in patients with various types of cancer. Myelosuppression was clearly apparent after starting therapy at 2-3 weeks in the 28- day course monotherapy group, and at 2 weeks in the 21-day course combination therapy group with paclitaxel, cisplatin, or docetaxel. Increases in the number of courses did not necessarily lead to worsening of myelosuppression. IP possibly related to gemcitabine was seen in 6 out of 5 23 monotherapy patients and 5 out of 233 combination therapy patients. Five of these 11 patients were diagnosed in the first course; however, another patient was diagnosed with IP in Course 6. Two of these patients died of IP, one of whom had a past history of interstitial lung disease. These results indicate that ample attention should be paid to myelosuppression 2-3 weeks after the start of therapy, and to IP during the entire course of therapy.
authors.affiliation: Medical Science, LRL DCOE-J, Eli Lilly Japan K. K.
authors.forename: Masami
authors.initials: M
authors.lastname: Ishii
authors.forename: Soshi
authors.initials: S
authors.lastname: Nagaoka
authors.forename: Masumi
authors.initials: M
authors.lastname: Tatsumi
authors.forename: Natsuko
authors.initials: N
authors.lastname: Kitagawa
authors.forename: Masanori
authors.initials: M
authors.lastname: Taketsuna
authors.forename: Sumiko
authors.initials: S
authors.lastname: Okubo
authors.forename: Kaijiro
authors.initials: K
authors.lastname: Maeda
authors.forename: Kohji
authors.initials: K
authors.lastname: Takeuchi
mesh_terms: D000964:Antimetabolites, Antineoplastic / Q000009:adverse effects* / Q000627:therapeutic use; D049109:Cell Proliferation / Q000187:drug effects; D002986:Clinical Trials as Topic; D003841:Deoxycytidine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006801:Humans; D007564:Japan; D017563:Lung Diseases, Interstitial / Q000139:chemically induced; D022423:Myeloid Cells / Q000187:drug effects; D009369:Neoplasms / Q000188:drug therapy; D000093542:Gemcitabine
chemical_list: D000964:Antimetabolites, Antineoplastic; D003841:Deoxycytidine; D000093542:Gemcitabine