Randomized phase II study with two gemcitabine- and docetaxel-based combinations as first-line chemotherapy for metastatic non-small cell lung cancer.
BACKGROUND
Docetaxel and gemcitabine combinations have proven active for the treatment of non-small cell lung cancer (NSCLC). The aim of the present study was to evaluate and compare two treatment schedules, one based on our own preclinical data and the other selected from the literature.


METHODS
Patients with stage IV NSCLC and at least one bidimensionally-measurable lesion were eligible. Adequate bone marrow reserve, normal hepatic and renal function, and an ECOG performance status of 0 to 2 were required. No prior chemotherapy was permitted. Patients were randomized to arm A (docetaxel 70 mg/m2 on day 1 and gemcitabine 900 mg/m2 on days 3-8, every 3 weeks) or B (gemcitabine 900 mg/m2 on days 1 and 8, and docetaxel 70 mg/m2 on day 8, every 3 weeks).


RESULTS
The objective response rate was 20% (95% CI:10.0-35.9) and 18% (95% CI:8.6-33.9) in arms A and B, respectively. Disease control rates were very similar (54% in arm A and 53% in arm B). No differences were noted in median survival (32 vs. 33 weeks) or 1-year survival (33% vs. 35%). Toxicity was mild in both treatment arms.


CONCLUSIONS
Our results highlighted acceptable activity and survival outcomes for both experimental and empirical schedules as first-line treatment of NSCLC, suggesting the potential usefulness of drug sequencing based on preclinical models.


BACKGROUND
IOR 162 02.
Passardi
Alessandro
A
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola, Italy. sandropass@libero.it
Cecconetto
Lorenzo
L
Dall'agata
Monia
M
Dazzi
Claudio
C
Pasquini
Enzo
E
Oliverio
Giovanni
G
Zumaglini
Federica
F
Zoli
Wainer
W
Nanni
Oriana
O
Milandri
Carlo
C
Frassineti
Giovanni Luca
GL
Amadori
Dino
D
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology*; D003841:Deoxycytidine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D018450:Disease Progression; D000077143:Docetaxel; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis / Q000188:drug therapy / Q000473:pathology; D043823:Taxoids / Q000009:adverse effects / Q000627:therapeutic use*; D000093542:Gemcitabine
D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D000093542:Gemcitabine