Sex differences in fluorouracil-induced stomatitis

Purpose: A meta-analysis of six North Central Cancer Treatment Group (NCCTG ) trials involving patients receiving their first ever fluorouracil (5-FU)- based chemotherapy was undertaken to explore the association of sex with re ports of the incidence and severity of stomatitis. Patients and Methods: Data were obtained on a total of 731 patients (402 me n and 329 women). Comparisons of incidence and severity rates and average s tomatitis across sex were performed using standard binomial testing and t t ests, respectively. Logistic regression analysis and a weighted analysis us ing data summarized to study level served as evidence of cross-validation, Results: Women reported stomatitis both more often and with greater severit y than did men. The incidence of any stomatitis far women was 63% versus 52 % for men (P = .002). The incidence of severe or very severe stomatitis for men and women was 22% and 12%, respectively (P = .0006), On average, women reported stomatitis of roughly 0.4 points higher than men on a 0 to 4 ordi nal scale (P < .00001). Comparison of results across treatment and placebo arms was carried out to validate the initial findings. Logistic regression modelling further confirmed the results conditional on the presence of a nu mber of potentially confounding covariates. Women were also 11% more likely than men ta experience leukopenia of:common toxicity criteria grade greate r than or equal to 1, (70% v 59%, respectively; P < .00001) and grade 3 + ( 18% v 11%, respectively; P = .004). Conclusion: More women than men reported 5-FU-induced stomatitis. The preci se mechanism resulting in different degrees of stomatitis across sex is not evident. (C) 2000 by American Society of Clinical Oncology.