Reduction of oral mucositis by filgrastim (r-metHuG-CSF) in patients receiving chemotherapy

Mucositis, the inflammation and necrosis of mucosal membranes, is a serious and debilitating consequence of many cancer therapies. We were interested in the potential role of filgrastim (recombinant methionyl human granulocyt e colony-stimulating factor, r-metHuG-CSF) in the reduction of mucositis. P atients with newly diagnosed small-cell lung cancer (SCLC) were treated wit h CAE chemotherapy (cyclophosphamide, doxorubicin, and etoposide) and place bo or filgrastim. If patients had an episode of febrile neutropenia, they r eceived unblinded filgrastim in subsequent CAP cycles. Oral mucositis was c onsidered to have occurred if a patient reported any clinical sign or sympt om of oral mucositis with or without oral candidiasis. Oral mucositis was a nalyzed using the unadjusted chi-square test, and time to first episode of mucositis was analyzed using the stratified log-rank test as well as the Co x proportional hazards regression model. During cycle 1, placebo-treated pa tients had more episodes of mucositis (47%) compared with those patients ra ndomized to filgrastim (28%). Across all cycles of treatment, 70% of placeb o-treated patients experienced mucositis, compared with 53% of patients ran domized to filgrastim. A significant reduction in the incidence of chemothe rapy-related oral mucositis occurred across multiple cycles of treatment in patients treated with filgrastim.