Cisplatin and weekly docetaxel as first-line therapy in patients with advanced non-small cell lung cancer a phase II study.
BACKGROUND
Based on the results of previous phase I studies, in the current phase II trial we evaluated the efficacy and toxicity of cisplatin plus weekly docetaxel in the treatment of advanced non-small cell lung cancer (NSCLC).


METHODS
The eligibility criteria for the study included newly diagnosed stage IIIB/IV NSCLC, age < or = 75 years, Eastern Cooperative Oncology Group performance status of 0-2, adequate organ functions, and signed informed consent. The chemotherapy regimen consisted of cisplatin, 80 mg/m2 on day 1, and docetaxel, 25 mg/m2 on days 1, 8 and 15 every 4 weeks.


RESULTS
Between January 2002 and December 2003, 31 patients with NSCLC were enrolled in the study. An objective response rate of 40% (95% CI, 21-60) was obtained in 27 assessable patients. The median time to progression was 6.4 months (range, 2.5-26.3) and median overall survival was 10.01 months (range, 5-28.3). The regimen was well tolerated with no grade 4 toxicity.


CONCLUSIONS
Cisplatin plus weekly docetaxel is an effective and well-tolerated regimen in chemo-naive patients with advanced NSCLC. A phase III study of weekly versus the conventional regimen of every three weeks should be conducted to compare the survival benefits, toxicity profile and quality of life.
Tartarone
Alfredo
A
Division of Medical Oncology and Hematology, Centro di Riferimento Oncologico della Basilicata (CROB), Rionero in Vulture (PZ), Italy. tarta1@virgilio.it
Romano
Gianpiero
G
Iodice
Giovanni
G
Capobianco
Alba
A
Coccaro
Mariarosa
M
Bochicchio
Annamaria
A
Di Leo
Pasquale
P
Ardito
Raffaele
R
Di Renzo
Nicola
N
D000368:Aged; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology*; D002945:Cisplatin / Q000009:adverse effects / Q000627:therapeutic use*; D018450:Disease Progression; D000077143:Docetaxel; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D015996:Survival Rate; D043823:Taxoids / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors
D043823:Taxoids; D000077143:Docetaxel; D002945:Cisplatin