TY - JOUR
T1 - Study of paclitaxel and dose escalation of cisplatin in patients with advanced non-small cell lung cancer
AU - Watanabe, Hirokazu
AU - Yamamoto, Noboru
AU - Tamura, Tomohide
AU - Shimoyama, Tatsu
AU - Hotta, Katsuyuki
AU - Inoue, Akira
AU - Sawada, Masahiro
AU - Akiyama, Yoshiko
AU - Kusaba, Hitoshi
AU - Nokihara, Hiroshi
AU - Sekine, Ikuo
AU - Kunitoh, Hideo
AU - Ohe, Yuichiro
AU - Kodama, Tetsuro
AU - Saijo, Nagahiro
PY - 2003/12/1
Y1 - 2003/12/1
N2 - Background: We conducted a dose-finding and feasibility study in which we administered a fixed dose 3-h infusion of paclitaxel and an escalating dose of cisplatin in Japanese patients with advanced non-small cell lung cancer. Methods: Chemotherapy consisted of fixed dose (210 mg/m2) paclitaxel given over 3 h on day 1 and an escalating dose of cisplatin on day 2, every 3-4 weeks. The dose of cisplatin was 40 mg/m2 at level 1, 60 mg/m2 at level 2 and 80 mg/m2 at level 3. Results: Between October 1999 and February 2001, 24 patients were enrolled and 58 cycles were administered. The major hematological toxicities were leukopenia and neutropenia. Grade 4 neutropenia developed in 83.3%, 66.7% and 83.3% of patients at the dose levels of 1, 2 and 3, respectively. The major non-hematological toxicities consisted of alanine aminotransferase (ALT) elevation and peripheral neuropathy. Grade 3 ALT elevation was observed in two of the 12 patients at level 3, but both recovered within 3 days. The peripheral neuropathy was sensory-dominant and frequent, and it was almost tolerable. The maximum tolerated dose was not identified even at the highest dose of paclitaxel (210 mg/m2) and cisplatin (80 mg/m2) administered in the study. The recommended dose was determined to be paclitaxel 210 mg/m2 on day 1 and cisplatin 80 mg/m2 on day 2, every 3-4 weeks. Seven partial responses were observed in the 24 patients. Conclusions: The combination of paclitaxel 210 mg/m2 and cisplatin 80 mg/m2 was found to be a well-tolerated active regimen in Japanese patients with advanced non-small cell lung cancer.
AB - Background: We conducted a dose-finding and feasibility study in which we administered a fixed dose 3-h infusion of paclitaxel and an escalating dose of cisplatin in Japanese patients with advanced non-small cell lung cancer. Methods: Chemotherapy consisted of fixed dose (210 mg/m2) paclitaxel given over 3 h on day 1 and an escalating dose of cisplatin on day 2, every 3-4 weeks. The dose of cisplatin was 40 mg/m2 at level 1, 60 mg/m2 at level 2 and 80 mg/m2 at level 3. Results: Between October 1999 and February 2001, 24 patients were enrolled and 58 cycles were administered. The major hematological toxicities were leukopenia and neutropenia. Grade 4 neutropenia developed in 83.3%, 66.7% and 83.3% of patients at the dose levels of 1, 2 and 3, respectively. The major non-hematological toxicities consisted of alanine aminotransferase (ALT) elevation and peripheral neuropathy. Grade 3 ALT elevation was observed in two of the 12 patients at level 3, but both recovered within 3 days. The peripheral neuropathy was sensory-dominant and frequent, and it was almost tolerable. The maximum tolerated dose was not identified even at the highest dose of paclitaxel (210 mg/m2) and cisplatin (80 mg/m2) administered in the study. The recommended dose was determined to be paclitaxel 210 mg/m2 on day 1 and cisplatin 80 mg/m2 on day 2, every 3-4 weeks. Seven partial responses were observed in the 24 patients. Conclusions: The combination of paclitaxel 210 mg/m2 and cisplatin 80 mg/m2 was found to be a well-tolerated active regimen in Japanese patients with advanced non-small cell lung cancer.
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U2 - 10.1093/jjco/hyg116
DO - 10.1093/jjco/hyg116
M3 - Article
C2 - 14769840
AN - SCOPUS:18544398263
SN - 0368-2811
VL - 33
SP - 626
EP - 630
JO - Japanese Journal of Clinical Oncology
JF - Japanese Journal of Clinical Oncology
IS - 12
ER -
