These were similar, randomized, double-blind phase II noninferiority studies of patients with
lymphoma or non-small-cell lung (NSCLC), breast, or
ovarian cancer. Each study was analyzed separately. The primary end point in each study was cycle-1 severe
neutropenia duration. Approximately 90 patients per study were to be randomly assigned at a ratio of 1:1 to receive
pegfilgrastim 6 mg once per cycle on the day of
chemotherapy or the day after (with placebo on the alternate day).
RESULTS: In four studies, 272 patients received
chemotherapy and one or more doses of
pegfilgrastim (133 same day, 139 next day). Three studies (breast,
lymphoma, NSCLC) enrolled an adequate number of patients for analysis. However, in the NSCLC study, the neutropenic rate was lower than expected (only two patients per arm experienced grade 4
neutropenia). In the
breast cancer study, the mean cycle-1 severe
neutropenia duration was 1.2 days (95% confidence limit [CL], 0.7 to 1.6) longer in the same-day compared with the next-day group (mean, 2.6 v 1.4 days). In the
lymphoma study, the mean cycle-1 severe
neutropenia duration was 0.9 days (95% CL, 0.3 to 1.4) longer in the same-day compared with the next-day group (mean, 2.1 v 1.2 days). In the breast and
lymphoma studies, the absolute neutrophil count profile for same-day patients was earlier, deeper, and longer compared with that for next-day patients, although the results indicate that same-day administration was statistically noninferior to next-day administration according to
neutropenia duration.
CONCLUSION: