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Randomized trials of colony-stimulating factors in febrile patients with neutropenia after chemotherapy have not consistently shown clinical benefit. Nevertheless, the use of colony-stimulating factors to treat patients with chemotherapy-induced neutropenia is widespread.We performed a randomized, double-blind, placebo-controlled trial of granulocyte colony-stimulating factor (G-CSF) in afebrile outpatients with severe chemotherapy-induced neutropenia. We measured the number of days of neutropenia, rate of hospitalization, number of days in the hospital, number of days the patient received parenteral antibiotics, and number of culture-positive infections.We randomly assigned 138 patients to receive G-CSF (n=71) or placebo (n=67). The median time to an absolute neutrophil count of at least 500 per cubic millimeter was significantly shorter for patients who received G-CSF (two days, vs. four days for the patients given placebo). However, there was no effect on the rate of hospitalization, number of days in the hospital, duration of treatment with parenteral antibiotics, or number of culture-positive infections.Routine therapeutic application of G-CSF in afebrile patients with severe neutropenia can reduce the duration of neutropenia, but this does not appear to provide practical clinical benefit.

Publisher Summary This chapter describes the application of nonparametric statistics to cancer data. The approach of the chapter is to present data sets and to use nonparametric statistics in the analysis of the data, giving considerable detail when computations are involved. A single data set consisting only of times to “failure”' or “censor” for patients with high-grade ovarian carcinoma is analyzed in the chapter. The Kaplan–Meier-estimated survival curve is used to obtain estimates of the mean, median and cumulative hazard function. The actuarial approach is also considered in the chapter. The chapter presents the data for a second set of patients with low-grade carcinoma and tests are performed to see if difference in grade is associated with time to progression of disease. The chapter provides special attention to the Cox proportional hazards model and stratified Mantel–Haenszel statistics. The importance of identifying important covariates before comparing treatments is also demonstrated in the chapter.