Phase II study of carboplatin combined with weekly docetaxel in patients with advanced non-small cell lung cancer.
OBJECTIVE
This phase II study is performed to evaluate the safety, efficacy and tolerability of carboplatin combined with weekly docetaxel in patients with advanced non-small cell lung cancer (NSCLC).


METHODS
All patients were treated with the combination of docetaxel 35 mg/m(2) by IV infusion over 30-60 min weekly, on days 1, 8, and 15, for 3 weeks followed by 1 week of rest, with intravenous carboplatin (AUC 6) administered immediately afterward on day 1. Cycles were repeated every 28 days.


RESULTS
Forty-seven (95.9%) of the 49 patients were assessable for response, one case of complete response and 17 cases of partial response were confirmed, giving an overall response rate of 36.7% (95% CI 23.2-50.2%). The median time to progression and overall survival (OS) for all patients were 5.2 months (95% CI 4.1-6.3 months) and 10.4 months (95% CI 7.3-13.5 months), respectively. The estimate of OS at 12 months was 37.6% (95% CI 24.0-51.2%). The most severe hematologic adverse event was anemia, which occurred with grade 3/4 intensity in 7 (14.9%) patients. Neutropenia occurred with grade 3 intensity in 4 (8.5%) patients. However, no grade 4 neutropenia was observed. Grade 3 nausea/vomiting, diarrhea, asthenia, nail changes, and skin reaction were observed in 6 (12.8%), 3 (6.4%), 2 (4.3%), 2 (4.3%) and 1 (2.1%) patients. Yet, no grade 4 non-hematologic toxicity was observed.


CONCLUSIONS
The combination of carboplatin with weekly docetaxel is a tolerated treatment modality with encouraging activity and survival outcome in previously untreated patients with advanced NSCLC.
Jiang
Lian
L
Department of Respiratory Medicine, Jiangyin People's Hospital, Nantong University, No. 163, Shoushan Rd, 214400, Jiangyin, Jiangsu, People's Republic of China. drlian.jiang@gmail.com
Wang
Dao-yuan
DY
Zhu
Zhi-hua
ZH
Tang
Liang-fa
LF
Hou
Xin-heng
XH
Zhao
Hong-da
HD
Xie
Zheng
Z
Wang
Dan-feng
DF
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality; D018450:Disease Progression; D000077143:Docetaxel; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007262:Infusions, Intravenous; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D015996:Survival Rate; D043823:Taxoids / Q000008:administration & dosage; D016896:Treatment Outcome
D043823:Taxoids; D000077143:Docetaxel; D016190:Carboplatin