Clinical and pharmacokinetic study of docetaxel in elderly non-small-cell lung cancer patients

Nagio Takigawa, Yoshihiko Segawa, Daizo Kishino, Keiichi Fujiwara, Yoshiyuki Tokuda, Nobuhiko Seki, Tetsu Shinkai, Yoichi Watanabe, Shunkichi Hiraki, Toshiyuki Kozuki, Kenichi Gemba, Masahiro Tabata, Katsuyuki Kiura, Hiroshi Ueoka, Mitsune Tanimoto

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Abstract

Purpose: To evaluate the usefulness and pharmacokinetics of docetaxel in the treatment of elderly patients with advanced non-small-cell lung cancer. Patients and methods: Chemotherapy-naive elderly patients (aged at least 76 years) with locally advanced or metastatic non-small-cell lung cancer were accrued. Eligible patients received at least two cycles of docetaxel at a dose of 60 mg/m2 on day 1 over 1 h every 3 weeks. Patients who were considered ineligible for this study were also registered. Symptom control was assessed using a questionnaire during the treatment period. The pharmacokinetics of docetaxel were evaluated in the first cycle of chemotherapy. Results: Of 35 elderly patients, 15 (43%) met the study eligibility criteria. The reasons for ineligibility consisted mainly of poor performance status, poor bone marrow function, and hypoxemia (six patients each). A total of 49 cycles of chemotherapy (median 2 cycles, range 1-12 cycles) were administered to the eligible patients, six of whom achieved a partial response (overall response rate 40%, 95% confidence interval 15-65%). The major toxicity was hematologic, with grade 3 or greater neutropenia and grade 3 neutropenic fever developing in 13 patients (87%) and five patients (33%), respectively. Symptoms, as assessed in terms of the symptom control score, did not clearly decline during the treatment period. The values (mean ± SD) of Cmax, AUC 0 → inf, and t1/2 were 1.35 ± 0.32 μg/ml, 1.79 ± 0.52 μg h/ml, and 4.1 ± 2.3 h, respectively. Conclusions: Although the validity of the results of this study is limited due to the small sample size, docetaxel appears effective in selected elderly patients with advanced non-small-cell lung cancer.

Original languageEnglish
Pages (from-to)230-236
Number of pages7
JournalCancer Chemotherapy and Pharmacology
Volume54
Issue number3
Publication statusPublished - Sep 2004

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docetaxel
Pharmacokinetics
Non-Small Cell Lung Carcinoma
Chemotherapy
Cells
Toxicity
Bone
Drug Therapy
Clinical Studies

Keywords

  • Docetaxel
  • Elderly
  • Non-small-cell lung cancer
  • Pharmacokinetics
  • Symptom control assessment

ASJC Scopus subject areas

  • Cancer Research
  • Pharmacology
  • Oncology

Cite this

Takigawa, N., Segawa, Y., Kishino, D., Fujiwara, K., Tokuda, Y., Seki, N., ... Tanimoto, M. (2004). Clinical and pharmacokinetic study of docetaxel in elderly non-small-cell lung cancer patients. Cancer Chemotherapy and Pharmacology, 54(3), 230-236.

Clinical and pharmacokinetic study of docetaxel in elderly non-small-cell lung cancer patients. / Takigawa, Nagio; Segawa, Yoshihiko; Kishino, Daizo; Fujiwara, Keiichi; Tokuda, Yoshiyuki; Seki, Nobuhiko; Shinkai, Tetsu; Watanabe, Yoichi; Hiraki, Shunkichi; Kozuki, Toshiyuki; Gemba, Kenichi; Tabata, Masahiro; Kiura, Katsuyuki; Ueoka, Hiroshi; Tanimoto, Mitsune.

In: Cancer Chemotherapy and Pharmacology, Vol. 54, No. 3, 09.2004, p. 230-236.

Research output: Contribution to journalArticle

Takigawa, N, Segawa, Y, Kishino, D, Fujiwara, K, Tokuda, Y, Seki, N, Shinkai, T, Watanabe, Y, Hiraki, S, Kozuki, T, Gemba, K, Tabata, M, Kiura, K, Ueoka, H & Tanimoto, M 2004, 'Clinical and pharmacokinetic study of docetaxel in elderly non-small-cell lung cancer patients', Cancer Chemotherapy and Pharmacology, vol. 54, no. 3, pp. 230-236.
Takigawa N, Segawa Y, Kishino D, Fujiwara K, Tokuda Y, Seki N et al. Clinical and pharmacokinetic study of docetaxel in elderly non-small-cell lung cancer patients. Cancer Chemotherapy and Pharmacology. 2004 Sep;54(3):230-236.
Takigawa, Nagio ; Segawa, Yoshihiko ; Kishino, Daizo ; Fujiwara, Keiichi ; Tokuda, Yoshiyuki ; Seki, Nobuhiko ; Shinkai, Tetsu ; Watanabe, Yoichi ; Hiraki, Shunkichi ; Kozuki, Toshiyuki ; Gemba, Kenichi ; Tabata, Masahiro ; Kiura, Katsuyuki ; Ueoka, Hiroshi ; Tanimoto, Mitsune. / Clinical and pharmacokinetic study of docetaxel in elderly non-small-cell lung cancer patients. In: Cancer Chemotherapy and Pharmacology. 2004 ; Vol. 54, No. 3. pp. 230-236.
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abstract = "Purpose: To evaluate the usefulness and pharmacokinetics of docetaxel in the treatment of elderly patients with advanced non-small-cell lung cancer. Patients and methods: Chemotherapy-naive elderly patients (aged at least 76 years) with locally advanced or metastatic non-small-cell lung cancer were accrued. Eligible patients received at least two cycles of docetaxel at a dose of 60 mg/m2 on day 1 over 1 h every 3 weeks. Patients who were considered ineligible for this study were also registered. Symptom control was assessed using a questionnaire during the treatment period. The pharmacokinetics of docetaxel were evaluated in the first cycle of chemotherapy. Results: Of 35 elderly patients, 15 (43{\%}) met the study eligibility criteria. The reasons for ineligibility consisted mainly of poor performance status, poor bone marrow function, and hypoxemia (six patients each). A total of 49 cycles of chemotherapy (median 2 cycles, range 1-12 cycles) were administered to the eligible patients, six of whom achieved a partial response (overall response rate 40{\%}, 95{\%} confidence interval 15-65{\%}). The major toxicity was hematologic, with grade 3 or greater neutropenia and grade 3 neutropenic fever developing in 13 patients (87{\%}) and five patients (33{\%}), respectively. Symptoms, as assessed in terms of the symptom control score, did not clearly decline during the treatment period. The values (mean ± SD) of Cmax, AUC 0 → inf, and t1/2 were 1.35 ± 0.32 μg/ml, 1.79 ± 0.52 μg h/ml, and 4.1 ± 2.3 h, respectively. Conclusions: Although the validity of the results of this study is limited due to the small sample size, docetaxel appears effective in selected elderly patients with advanced non-small-cell lung cancer.",
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AU - Kishino, Daizo

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AU - Tokuda, Yoshiyuki

AU - Seki, Nobuhiko

AU - Shinkai, Tetsu

AU - Watanabe, Yoichi

AU - Hiraki, Shunkichi

AU - Kozuki, Toshiyuki

AU - Gemba, Kenichi

AU - Tabata, Masahiro

AU - Kiura, Katsuyuki

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N2 - Purpose: To evaluate the usefulness and pharmacokinetics of docetaxel in the treatment of elderly patients with advanced non-small-cell lung cancer. Patients and methods: Chemotherapy-naive elderly patients (aged at least 76 years) with locally advanced or metastatic non-small-cell lung cancer were accrued. Eligible patients received at least two cycles of docetaxel at a dose of 60 mg/m2 on day 1 over 1 h every 3 weeks. Patients who were considered ineligible for this study were also registered. Symptom control was assessed using a questionnaire during the treatment period. The pharmacokinetics of docetaxel were evaluated in the first cycle of chemotherapy. Results: Of 35 elderly patients, 15 (43%) met the study eligibility criteria. The reasons for ineligibility consisted mainly of poor performance status, poor bone marrow function, and hypoxemia (six patients each). A total of 49 cycles of chemotherapy (median 2 cycles, range 1-12 cycles) were administered to the eligible patients, six of whom achieved a partial response (overall response rate 40%, 95% confidence interval 15-65%). The major toxicity was hematologic, with grade 3 or greater neutropenia and grade 3 neutropenic fever developing in 13 patients (87%) and five patients (33%), respectively. Symptoms, as assessed in terms of the symptom control score, did not clearly decline during the treatment period. The values (mean ± SD) of Cmax, AUC 0 → inf, and t1/2 were 1.35 ± 0.32 μg/ml, 1.79 ± 0.52 μg h/ml, and 4.1 ± 2.3 h, respectively. Conclusions: Although the validity of the results of this study is limited due to the small sample size, docetaxel appears effective in selected elderly patients with advanced non-small-cell lung cancer.

AB - Purpose: To evaluate the usefulness and pharmacokinetics of docetaxel in the treatment of elderly patients with advanced non-small-cell lung cancer. Patients and methods: Chemotherapy-naive elderly patients (aged at least 76 years) with locally advanced or metastatic non-small-cell lung cancer were accrued. Eligible patients received at least two cycles of docetaxel at a dose of 60 mg/m2 on day 1 over 1 h every 3 weeks. Patients who were considered ineligible for this study were also registered. Symptom control was assessed using a questionnaire during the treatment period. The pharmacokinetics of docetaxel were evaluated in the first cycle of chemotherapy. Results: Of 35 elderly patients, 15 (43%) met the study eligibility criteria. The reasons for ineligibility consisted mainly of poor performance status, poor bone marrow function, and hypoxemia (six patients each). A total of 49 cycles of chemotherapy (median 2 cycles, range 1-12 cycles) were administered to the eligible patients, six of whom achieved a partial response (overall response rate 40%, 95% confidence interval 15-65%). The major toxicity was hematologic, with grade 3 or greater neutropenia and grade 3 neutropenic fever developing in 13 patients (87%) and five patients (33%), respectively. Symptoms, as assessed in terms of the symptom control score, did not clearly decline during the treatment period. The values (mean ± SD) of Cmax, AUC 0 → inf, and t1/2 were 1.35 ± 0.32 μg/ml, 1.79 ± 0.52 μg h/ml, and 4.1 ± 2.3 h, respectively. Conclusions: Although the validity of the results of this study is limited due to the small sample size, docetaxel appears effective in selected elderly patients with advanced non-small-cell lung cancer.

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KW - Pharmacokinetics

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