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A randomized double-blind phase II study to evaluate same-day vs next-day administration of pegfilgrastim with carboplatin and docetaxel in patients with NSCLC.

7110 Background: Combination therapy with carboplatin and docetaxel has demonstrated activity against non-small cell lung cancer (NSCLC), but is associated with at least a moderate risk of febrile neutropenia (FN). Though pegfilgrastim is given only once-per-cycle 24 hours after chemotherapy (CT), administering pegfilgrastim on the same day as CT would be convenient for patients (pts).


METHODS
Pts ≥18 years with previously untreated stage IIIB or IV NSCLC and ECOG ≤2 who were candidates for carboplatin AUC 6 and docetaxel 75 mg/m2 were randomized 1:1 to receive pegfilgrastim 6 mg within 4 hours or approximately 24 hours after CT. The primary endpoint was the duration of grade 4 neutropenia (DSN) in cycle 1. Same-day administration was considered noninferior to next-day if the upper 95% confidence interval (CI) limit for the difference in DSN between groups in cycle 1 was <2 days.


RESULTS
As planned, 90 pts were enrolled. 88 pts received blinded study drug. Pts in the same-day and next-day groups had comparable mean baseline ANC and similar proportions of pts completed the study (43% vs 45%). In cycle 1, only 5% of pts in both groups experienced grade 4 neutropenia; resulting in a mean DSN of 0 days. Similarly in cycle 4, 10% (lasting for 1 day only) and 0% of pts in the same-day and next-day groups experienced grade 4 neutropenia. No pts experienced FN during the study. 44% of pts in the same-day and 33% of pts in the next-day group experienced serious adverse events.


CONCLUSIONS
In this study of lung cancer patients receiving carboplatin and docetaxel, use of pegfilgrastim from the first cycle was well-tolerated in both treatment groups. Although the incidence of grade 3/4 neutropenia was lower than previously reported for this regimen, DSN appeared to be similar for patients in the same-day and next-day groups. Additionally, few patients experienced reductions or delays in CT delivery. [Table: see text] [Table: see text].