Background: The combination of paclitaxel (225 mg/m(2), 3-h infusion) and c
arboplatin (area under the curve 6) is widely used for non-small cell lung
cancer in the USA. In Japan, however, the recommended dose for single-use p
aclitaxel in 3-h infusion is 210 mg/m(2) and the optimal dose of this agent
in combination with carboplatin has not been established. This dose escala
tion study was designed to determine the maximum tolerated dose of paclitax
el in 3-h infusion plus carboplatin at a fixed dose of area under the curve
6 for Japanese patients with advanced, untreated non-small cell lung cance
Methods: Between October 1999 and May 2000, 19 patients were enrolled and 1
8 of these patients were evaluable for toxicity. Chemotherapy consisted of
carboplatin area under the curve 6 and an escalated dose of paclitaxel on d
ay 1 every 3-4 weeks. The initial dose of paclitaxel was 175 mg/m(2) and wa
s increased by 25 mg/m(2) at each dose level.
Results: Neutropenia was the major toxicity observed, but was not dose rela
ted. Febrile neutropenia was not observed. No grade 3 or more peripheral ne
uropathy, myalgia or arthralgia was reported. The maximum tolerated dose wa
s not determined even at the highest paclitaxel dose level (225 mg/m(2)) in
this study. Partial responses were observed in six of the 19 patients (31.
Conclusion: We conclude that paclitaxel at 225 mg/m(2) in 3-h infusion and
carboplatin area under the curve 6 can safely be given to Japanese patients
with non-small cell lung cancer.