Clinical and pharmacokinetic study of docetaxel in elderly non-small-cell lung cancer patients.
OBJECTIVE
To evaluate the usefulness and pharmacokinetics of docetaxel in the treatment of elderly patients with advanced non-small-cell lung cancer.


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.
Takigawa
Nagio
N
Department of Internal Medicine, National Shikoku Cancer Center, 13 Horinouchi, Matsuyama, Ehime, 790-0007, Japan.
Segawa
Yoshihiko
Y
Kishino
Daizo
D
Fujiwara
Keiichi
K
Tokuda
Yoshiyuki
Y
Seki
Nobuhiko
N
Shinkai
Tetsu
T
Watanabe
Yoichi
Y
Hiraki
Shunkichi
S
Kozuki
Toshiyuki
T
Gemba
Kenichi
K
Tabata
Masahiro
M
Kiura
Katsuyuki
K
Ueoka
Hiroshi
H
Tanimoto
Mitsune
M
D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics*; D019540:Area Under Curve; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D000077143:Docetaxel; D005260:Female; D005334:Fever / Q000139:chemically induced; D006304:Health Status; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D009503:Neutropenia / Q000139:chemically induced; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics*; D016896:Treatment Outcome
D000972:Antineoplastic Agents, Phytogenic; D043823:Taxoids; D000077143:Docetaxel