Study of paclitaxel and dose escalation of cisplatin in patients with advanced non-small cell lung cancer

Hirokazu Watanabe, Noboru Yamamoto, Tomohide Tamura, Tatsu Shimoyama, Katsuyuki Hotta, Akira Inoue, Masahiro Sawada, Yoshiko Akiyama, Hitoshi Kusaba, Hiroshi Nokihara, Ikuo Sekine, Hideo Kunitoh, Yuichiro Ohe, Tetsuro Kodama, Nagahiro Saijo

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)626-630
Number of pages5
JournalJapanese Journal of Clinical Oncology
Volume33
Issue number12
DOIs
Publication statusPublished - Dec 1 2003
Externally publishedYes

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Paclitaxel
Non-Small Cell Lung Carcinoma
Cisplatin
Peripheral Nervous System Diseases
Neutropenia
Alanine Transaminase
Maximum Tolerated Dose
Leukopenia
Feasibility Studies
Drug Therapy

Keywords

  • Cisplatin
  • DLT
  • MTD
  • Non-small cell lung cancer
  • Paclitaxel

ASJC Scopus subject areas

  • Oncology

Cite this

Study of paclitaxel and dose escalation of cisplatin in patients with advanced non-small cell lung cancer. / Watanabe, Hirokazu; Yamamoto, Noboru; Tamura, Tomohide; Shimoyama, Tatsu; Hotta, Katsuyuki; Inoue, Akira; Sawada, Masahiro; Akiyama, Yoshiko; Kusaba, Hitoshi; Nokihara, Hiroshi; Sekine, Ikuo; Kunitoh, Hideo; Ohe, Yuichiro; Kodama, Tetsuro; Saijo, Nagahiro.

In: Japanese Journal of Clinical Oncology, Vol. 33, No. 12, 01.12.2003, p. 626-630.

Research output: Contribution to journalArticle

Watanabe, H, Yamamoto, N, Tamura, T, Shimoyama, T, Hotta, K, Inoue, A, Sawada, M, Akiyama, Y, Kusaba, H, Nokihara, H, Sekine, I, Kunitoh, H, Ohe, Y, Kodama, T & Saijo, N 2003, 'Study of paclitaxel and dose escalation of cisplatin in patients with advanced non-small cell lung cancer', Japanese Journal of Clinical Oncology, vol. 33, no. 12, pp. 626-630. https://doi.org/10.1093/jjco/hyg116
Watanabe, Hirokazu ; Yamamoto, Noboru ; Tamura, Tomohide ; Shimoyama, Tatsu ; Hotta, Katsuyuki ; Inoue, Akira ; Sawada, Masahiro ; Akiyama, Yoshiko ; Kusaba, Hitoshi ; Nokihara, Hiroshi ; Sekine, Ikuo ; Kunitoh, Hideo ; Ohe, Yuichiro ; Kodama, Tetsuro ; Saijo, Nagahiro. / Study of paclitaxel and dose escalation of cisplatin in patients with advanced non-small cell lung cancer. In: Japanese Journal of Clinical Oncology. 2003 ; Vol. 33, No. 12. pp. 626-630.
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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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KW - DLT

KW - MTD

KW - Non-small cell lung cancer

KW - Paclitaxel

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