A multicenter phase II study of docetaxel and carboplatin combination as front-line treatment in advanced non-small cell lung cancer.
BACKGROUND
To evaluate the efficacy and safety of docetaxel in combination with carboplatin as first-line treatment of patients with inoperable, locally advanced or metastatic non-small cell lung cancer (NSCLC).


METHODS
Chemotherapy-naive patients with stage IIIB and IV NSCLC, age < 75 years, performance status (WHO) 0-2, were enrolled onto the study. Docetaxel was given at a dose of 100 mg/m2 over an 1-hour i.v. infusion. Carboplatin dosed to an area under the time-concentration curve (AUC) of 6 mg/ml.minute, using the Calvert's formula, was administered over a 30-minute i.v. infusion. The regimen was repeated every 3 weeks.


RESULTS
Thirty-eight patients received a total of 155 chemotherapy cycles (median 4 cycles/patient). All patients were assessable for toxicity and 34 for response. There was one (2.6%) complete and nine (23.7%) partial responses; in an intention-to-treat analysis the overall response rate was 26.6% (95% CI: 12.3%-40.3%). The median duration of response was 7 months (range: 3-29), the median time to tumor progression 7 months (range: 3.5-31), and the median overall survival 9 months (range: 0.5-31.5). The probability for 1-year survival was 44%. Grade 3-4 neutropenia was the main hematological toxicity of the regimen occurring in 19 (50%) patients. Four (10.5%) neutropenic episodes were complicated with fever but there was no septic death. Non-hematological toxicity was generally mild.


CONCLUSIONS
These results indicate that the docetaxel-carboplatin combination is a relatively active and well-tolerated front-line regimen for the treatment of patients with advanced or metastatic NSCLC.
Giannakakis
Theodore
T
Department of Medical Oncology, Agii Anargiri Cancer Hospital, Athens, Greece.
Kakolyris
Stelios
S
Theodoropoulos
Elias
E
Kouroussis
Charalambos
C
Michailakis
Emmanuel
E
Papadouris
Savvakis
S
Tsitoura
Miranda
M
Kalbakis
Kostas
K
Souglakos
John
J
Agelaki
Sohia
S
Vardakis
Nikos
N
Georgoulias
Vassilis
V
D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage / Q000009:adverse effects; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D000077143:Docetaxel; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced; D006402:Hematologic Diseases / Q000139:chemically induced; D006801:Humans; D007262:Infusions, Intravenous; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D043823:Taxoids
D043823:Taxoids; D000077143:Docetaxel; D016190:Carboplatin; D017239:Paclitaxel