Lenograstim as support for ACE chemotherapy of small-cell lung cancer - A phase III, multicenter, randomized study

This phase III study was conducted to evaluate the usefulness of lenograsti m as support for ACE (doxorubicin, cyclophosphamide, and etoposide) chemoth erapy in previously untreated patients with small-cell lung cancer. Patient s were randomized to receive up to six 3-week cycles of either ACE alone (n = 139) or ACE with lenograstim support (150 mu g/m(2)/day subcutaneously, days 4-13, n = 141). Compared with the chemotherapy-alone group, the lenogr astim support group was more likely to achieve neutrophil recovery (absolut e neutrophil count, greater than or equal to 1.5 X 10(9) cells/l) by day 14 (95.8-100% vs. 14.3-24.1% across the cycles) and less likely to experience at least one infectious episode (36.7 vs. 54.0%; p = 0.004), chemotherapy delay (51.8 vs. 56.2%; NS), or dose reduction (17.3 vs. 27.7%; p = 0.037). Objective response and event-free and overall survival rates were similar. Lenograstim was well tolerated. Lenograstim may allow the interval between cycles of ACE to be reduced to 2 weeks; such dose intensification may lead to more favorable objective response and survival rates.