A phase II study of combination chemotherapy with docetaxel and carboplatin for patients with advanced or metastatic non-small cell lung cancer.
BACKGROUND
The aim of this phase II study was to evaluate the efficacy of combination chemotherapy consisting of docetaxel and carboplatin in patients with inoperable non-small cell lung cancer (NSCLC).


METHODS
For this multicenter phase II study, the eligibility criteria included histologically or cytologically proven inoperable NSCLC, measurable lesions, Eastern Cooperative Oncology Group performance status (PS) 0-2, adequate organ and bone marrow functions, and written informed consent. Patients received 60 mg/m2 of docetaxel and carboplatin (target AUC 5.5) on day 1 every 3 weeks until disease progression. The primary end-point of this study was response rate and the secondary end-points were toxicities, time to progression and overall survival.


RESULTS
A total of 40 patients were enrolled and 39 patients were eligible. A complete response and partial response were observed in 1 and 13 patients, respectively. An objective response rate was 35.9% (95% confidential interval [CI] 20.8-51.0%). The median time to progression was 5.2 months and the median overall survival was 12.0 months. The 1- and 2-year survival rates were 53.8% and 25.1%, respectively. The major toxicities were leukocytopenia and neutropenia. Grade 3 or 4 thrombocytopenia was rare and non-hematological toxicities were generally mild. Grade 3 non-hematological toxicities were observed in 6 patients (2 with nausea and vomiting, 1 with diarrhea, 1 with elevated transaminase levels, 1 with allergic reaction and 1 with edema). No grade 4 non-hematological toxicities were observed.


CONCLUSIONS
Docetaxel and carboplatin combination chemotherapy was well tolerated and active in Japanese patients with advanced or metastatic NSCLC.
Kasahara
Kazuo
K
Respiratory Medicine, Kanazawa University Hospital, Takara-machi 13-1, Kanazawa, Ishikawa, Japan. kasa1237@med3.m.kanazawa-u.ac.jp
Kimura
Hideharu
H
Shibata
Kazuhiko
K
Araya
Tomoyuki
T
Sone
Takashi
T
Oribe
Yoshitaka
Y
Furusho
Shiho
S
Kita
Toshiyuki
T
Shirasaki
Hiroki
H
Oribe
Yoshitaka
Y
Yoshimi
Yuzo
Y
Ueda
Akihito
A
Tachibana
Hideki
H
Shintani
Hiromoto
H
Mizuguchi
Masayuki
M
Nishi
Kohichi
K
Fujimura
Masaki
M
Nakao
Shinji
S
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D016190:Carboplatin / Q000627:therapeutic use*; D018288:Carcinoma, Small Cell / Q000188:drug therapy* / Q000473:pathology; D018450:Disease Progression; D000077143:Docetaxel; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D043823:Taxoids / Q000627:therapeutic use*
D043823:Taxoids; D000077143:Docetaxel; D016190:Carboplatin