Docetaxel administered every two weeks as second-line chemotherapy for advanced non-small cell lung cancer: a phase II study.
BACKGROUND
The aim of this phase II study was to evaluate efficacy and toxicity of single-agent docetaxel, administered every two weeks as second-line treatment for patients with recurrent non-small cell lung cancer (NSCLC).


METHODS
Forty-eight patients with confirmed NSCLC were enrolled in this trial The median age was 56.5 years (range 43-76), median PS was 1, and the main histology type was adenocarcinoma (54%). Only 8% of patients had previously received paclitaxel. Patients received docetaxel i.v., 50 mg/m2 over 1 hour, on day 1 every 2 weeks.


RESULTS
The overall response rate was 8.3% (95% Confidence Interval 0.5-161%). The median time to disease progression, median survival time and 1-year survival rate were 3 months, 6 months and 21%, respectively. Grade 3-4 neutropenia was registered in 47% of patients, with only 1 patient (2%) experiencing febrile neutropenia. Nonhematological toxicity was mild (grade 1-2) and consisted mainly of asthenia (19%o) and diarrhea (10%).


CONCLUSIONS
The bi-weekly schedule of docetaxel showed an activity comparable to the standard tri-weekly 75 mg/m2 schedule as second-line treatment for recurrent NSCLC. Though non-hematological toxicity is significantly reduced, myelosuppression is still a matter of concern.
De Petris
Luigi
L
5th Pneumo-Oncology Unit, Department of Oncology, S. Camillo-Forlanini Hospitals, V. Portuense 332, 00149 Rome, Italy.
Migliorino
Maria Rita
MR
Ceribelli
Anna
A
Martelli
Olga
O
Di Molfetta
Michele
M
Mancuso
Andrea
A
De Santis
Stefano
S
Di Salvia
Roberto
R
De Marinis
Filippo
F
D000328:Adult; D000368:Aged; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage* / Q000009:adverse effects; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D018572:Disease-Free Survival; D000077143:Docetaxel; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D043823:Taxoids / Q000008:administration & dosage* / Q000009:adverse effects
D000972:Antineoplastic Agents, Phytogenic; D043823:Taxoids; D000077143:Docetaxel