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Japanese Journal of Clinical Oncology Advance Access published online on June 10, 2009
Japanese Journal of Clinical Oncology, doi:10.1093/jjco/hyp059
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© The Author (2009). Published by Oxford University Press. All rights reserved

Dose-escalating and Pharmacokinetic Study of a Weekly Combination of Paclitaxel and Carboplatin for Inoperable Non-small Cell Lung Cancer: JCOG 9910-DI

Katsuhiko Naoki, Hiroshi Kunikane, Tomoki Fujii, Shuko Tsujimura, Naoya Hida, Hiroaki Okamoto and Koshiro Watanabe

Yokohama Municipal Citizen's Hospital, Yokohama, Japan

For reprints and all correspondence: Katsuhiko Naoki, Department of Respiratory Medicine/Comprehensive and Advanced Medicine, School of Medicine, Keio University, 35 Shinanomachi, Shinjuku, Tokyo 160-8582, Japan. E-mail: knaoki{at}pg7.so-net.ne.jp

Received April 5, 2009; accepted May 11, 2009

Objective: Combined paclitaxel and carboplatin is a standard regimen for inoperable non-small cell lung cancer (NSCLC). Although an every-3-week schedule is common, weekly paclitaxel is clinically effective for various cancers. A Phase I clinical trial was conducted to determine maximum-tolerated doses (MTDs) for weekly combined paclitaxel and carboplatin, and to evaluate anti-tumor response, toxicity and pharmacokinetics of paclitaxel in patients with inoperable NSCLC.

Methods: Twenty patients with inoperable NSCLC received weekly carboplatin at area under the curve (AUC) = 2 mg/ml min and paclitaxel. Paclitaxel was escalated if MTD was not reached. Three patients each were entered at levels 1 and 2 (level 1, paclitaxel 50 mg/m2 and carboplatin AUC = 2 mg/ml min; level 2, 60/2), six at level 3 (70/2), five at level 4 (80/2) and three at level 5 (90/2).

Results: One patient had grade 4 (G4) neutropenia at level 2, one had G3 hepatic toxicity at level 3 and one had G3 cardiac toxicity at level 4. MTD was not reached for all dose levels. Response rate (RR) was 35% (7/20) and median survival was 11.1 months. Severe neutropenia (G3 and G4) was seen in seven patients associated with greater AUC, peak concentration (Cmax) and the duration of plasma concentration >50 ng/ml of paclitaxel.

Conclusions: Weekly combined paclitaxel (up to 90 mg/m2) and carboplatin (AUC = 2 mg/ml min) was well tolerated. A higher dose intensity of paclitaxel can be given, and RR and survival are not less than the every-3-week protocol. The weekly regimen is an alternative for untreated inoperable NSCLC patients.

Key Words: carboplatin • non-small cell lung cancer • paclitaxel • Phase I • weekly chemotherapy


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