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

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 t(1/2) were 1.35+/-0.32 microg/ml, 1.79+/-0.52 microg 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.

• Authors: 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
• Journal: Cancer chemotherapy and pharmacology (Cancer Chemother Pharmacol) Vol. 54 Issue 3 Pg. 230-6 (Sep 2004) ISSN: 0344-5704 [Print] Germany
• PMID: 15127232 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Antineoplastic Agents, Phytogenic
• Taxoids
• Docetaxel

Topics

• Age Factors
• Aged
• Aged, 80 and over
• Antineoplastic Agents, Phytogenic (administration & dosage, adverse effects, pharmacokinetics)
• Area Under Curve
• Carcinoma, Non-Small-Cell Lung (drug therapy)
• Docetaxel
• Female
• Fever (chemically induced)
• Health Status
• Humans
• Lung Neoplasms (drug therapy)
• Male
• Neutropenia (chemically induced)
• Taxoids (administration & dosage, adverse effects, pharmacokinetics)
• Treatment Outcome