Phase II study of weekly paclitaxel in patients with non-small cell lung cancer who have failed previous treatments.
OBJECTIVE
New effective therapy is desirable for patients with non-small cell lung cancer (NSCLC) who have failed previous treatments. Fractionated administration of paclitaxel may be less toxic and more active against NSCLC. The aim of this study was to evaluate the activity and toxicity of weekly paclitaxel therapy for NSCLC in a second-line setting.


METHODS
Patients with pathological or cytological diagnosis of NSCLC, measurable lesions, and one or more prior therapies were enrolled. We administered weekly infusions of 80 mg/m2 paclitaxel 3 times in a 4-week cycle. In the absence of progressive disease or intolerable toxicity, each patient was treated for a minimum of 4 cycles.


RESULTS
Of 39 patients enrolled, 1 patient achieved complete response and 11 patients achieved partial response (response rate, 31%: 95% confidence interval, 17-48%). The median survival time was 43 weeks (range, 7-128 weeks). Grade 3 or 4 leukopenia occurred in only 7 patients (18%). Neurotoxicity was the most frequent adverse effect (grades 1 and 2.26 and 5%, respectively). Although all patients recovered rapidly with corticosteroid treatment, drug-induced pneumonitis was observed in 3 patients (8%).


CONCLUSIONS
Low-dose weekly paclitaxel is a promising therapy with high effectiveness for advanced NSCLC in patients with NSCLC who have failed previous treatments.
Yasuda
Kazuhito
K
Third Department of Internal Medicine, Faculty of Medicine, Tottori University, Yonago, Japan.
Igishi
Tadashi
T
Kawasaki
Yuji
Y
Kato
Kazuhiro
K
Matsumoto
Shingo
S
Katayama
Satoru
S
Sako
Takanori
T
Shigeoka
Yasushi
Y
Suyama
Hisashi
H
Sugitani
Akinori
A
Yamamoto
Mistunobu
M
Hitsuda
Yutaka
Y
Shimizu
Eiji
E
D000328:Adult; D000368:Aged; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016019:Survival Analysis; D017211:Treatment Failure; D016896:Treatment Outcome
D000972:Antineoplastic Agents, Phytogenic; D017239:Paclitaxel