Skin toxicity as a risk factor for major infections in breast cancer patients treated with docetaxel.

Docetaxel-related skin toxicity, oral and gastrointestinal mucosal toxicity, and changes in blood cell counts were investigated as predictive factors for major infections in 143 women treated with 3-weekly docetaxel (100 mg/m2) as second-line therapy for metastatic breast cancer in a randomized trial. Each patient with a major infection (n = 37) was compared with two controls. Skin toxicity (odds ratio 2.97, 95% CI 1.37-6.47), oral mucositis (1.98, CI 1.30-3.04), and the leukocyte nadir (0.12, CI 0.02-0.51) were significantly associated with a major infection in a univariate logistic regression analysis. In a multivariate analysis, skin toxicity was the only independent factor predictive for grade 3 to 4 infection (2.75, CI 1.00-7.58). A major infection was diagnosed in 62% (8 out of 13) of the docetaxel cycles in severely (grade 4) leukopenic patients who had grade 2 to 4 skin toxicity. Major infections are common in leukopenic patients who develop docetaxel-associated skin toxicity, and leukopenic patients presenting with docetaxel-induced skin toxicity may be candidates for prophylactic anti-infection measures such as prophylactic therapy with hematopoietic growth factors.

RCT Entities:   Population Interventions Outcomes