A phase II study of weekly paclitaxel in elderly patients with advanced non-small cell lung cancer.
OBJECTIVE
Our aim was to evaluate the efficacy, toxicity, and pharmacokinetic behavior of single-agent paclitaxel given weekly to elderly patients with lung cancer.


METHODS
Previously untreated patients with stage IIIB/IV non-small cell lung cancer were eligible for the study if they were at least 70 years of age and had preserved organ function. Paclitaxel was administered over 1 h at a dose of 90 mg/m(2) for 6 consecutive weeks on an 8-week cycle. The pharmacokinetics of paclitaxel were assessed during the first and sixth week of therapy in a subgroup of eight patients.


RESULTS
A total of 35 patients (median age, 76 years; range, 70-85) were enrolled. The overall response rate was 23%. Median time to failure was 5.2 months, whereas the median survival time was 10.3 months. Survival rates after 1 and 2 years were 45 and 22%, respectively. Grade 3/4 toxicities included neutropenia (5.8%), hyperglycemia (17.6%), neuropathy (5.8%), and infection (8.8%). Two patients died from treatment-related toxicity. There was no significant difference (P = 0.18) between the total body clearance of paclitaxel on the first (17.4 +/- 2.9 liters/h/m(2), mean +/- SD) and sixth (15.8 +/- 4.1 liters/h/m(2)) week of therapy.


CONCLUSIONS
Paclitaxel administered as a weekly 1-h infusion at a dose of 90 mg/m(2) is a safe and effective therapy for elderly patients with advanced non-small cell lung cancer. Its pharmacokinetics in elderly patients do not appear to differ from historical data for younger patients, and there was no suggestion of a change in drug clearance after repeated weekly dosing.
Fidias
P
P
Division of Hematology-Oncology, Massachusetts General Hospital, 100 Blossom Street, Cox 201, Boston, MA 02114, USA. Pfidias2@Partners.org
Supko
J G
JG
Martins
R
R
Boral
A
A
Carey
R
R
Grossbard
M
M
Shapiro
G
G
Ostler
P
P
Lucca
J
J
Johnson
B E
BE
Skarin
A
A
Lynch
T J
TJ
D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000972:Antineoplastic Agents, Phytogenic / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D019540:Area Under Curve; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D006801:Humans; D007262:Infusions, Intravenous; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008657:Metabolic Clearance Rate; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D015996:Survival Rate; D013997:Time Factors
D000972:Antineoplastic Agents, Phytogenic; D017239:Paclitaxel