Japanese Journal of Clinical Oncology 31:482-487 (2001)
© 2001 Foundation for Promotion of Cancer Research
A Dose Escalation Study of Paclitaxel and Carboplatin in Untreated Japanese Patients with Advanced Non-small Cell Lung Cancer
Division of Thoracic Oncology, Department of Internal Medicine, National Cancer Center Hospital, Tokyo, Japan
Background: The combination of paclitaxel (225 mg/m2, 3-h infusion) and carboplatin (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 paclitaxel in 3-h infusion is 210 mg/m2 and the optimal dose of this agent in combination with carboplatin has not been established. This dose escalation study was designed to determine the maximum tolerated dose of paclitaxel 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 cancer.
Methods: Between October 1999 and May 2000, 19 patients were enrolled and 18 of these patients were evaluable for toxicity. Chemotherapy consisted of carboplatin area under the curve 6 and an escalated dose of paclitaxel on day 1 every 3–4 weeks. The initial dose of paclitaxel was 175 mg/m2 and was increased by 25 mg/m2 at each dose level.
Results: Neutropenia was the major toxicity observed, but was not dose related. Febrile neutropenia was not observed. No grade 3 or more peripheral neuropathy, myalgia or arthralgia was reported. The maximum tolerated dose was not determined even at the highest paclitaxel dose level (225 mg/m2) in this study. Partial responses were observed in six of the 19 patients (31.6%).
Conclusion: We conclude that paclitaxel at 225 mg/m2 in 3-h infusion and carboplatin area under the curve 6 can safely be given to Japanese patients with non-small cell lung cancer.
+ For reprints and correspondence: Yoshiko Akiyama, Department of Internal Medicine, National Cancer Center Hospital,1–1 Tsukiji 5-chome, Chuo-ku, Tokyo, 104-0045, Japan
Abbreviations: NSCLC, non-small cell lung cancer; SWOG, Southwest Oncology Group; ECOG, Eastern Cooperative Oncology Group; AUC, area under the concentration–time curve; MST, median survival time; MTD, maximum tolerated dose; CBC, complete blood count; CT, computed tomography; MRI, magnetic resonance imaging; HSR, hypersensitivity reaction; G-CSF, granulocyte colony-stimulating factor; NCI-CTC, National Cancer Institute Common Toxicity Criteria; DLT, dose limiting toxicity; CR, complete response; PR, partial response; SD, stable disease; PD, progressive disease; NE, not evaluable