Docetaxel plus gemcitabine as front-line chemotherapy in elderly patients with lung adenocarcinomas: a multicenter phase II study.
BACKGROUND
The docetaxel/gemcitabine (DG) combination is an active and well-tolerated regimen against non-small cell lung cancer (NSCLC). A phase II study was conducted in order to evaluate its efficacy in elderly patients with lung adenocarcinomas.


METHODS
Chemotherapy-naive patients, aged > or =70 years, with locally advanced or metastatic lung adenocarcinomas and performance status (PS) < or =2 (ECOG) received gemcitabine 1100 mg/m(2) (days 1+8) and docetaxel 100 mg/m(2) (day 8) with rhG-CSF support.


RESULTS
Seventy-seven patients were enrolled. One (1.3%) complete and 23 (29.9%) partial responses were achieved (intention to treat analysis: ORR 31.2%; 95% CI 20.82-41.51%) whereas tumor growth control was achieved in 53.3% of patients. The median TTP was 4.1 months, the median overall survival 9.4 months and the 1- and 2-year survival rate 37.9% and 10.7%, respectively. Grade 3-4 neutropenia occurred in 18.2% and febrile neutropenia in 3 (3.9%) patients. Non-haematological toxicity was mild with grade 2-3 asthenia occurring in 22.1% patients.


CONCLUSIONS
The DG regimen is an active and well-tolerated front-line chemotherapy for elderly patients with lung adenocarcinomas and merits further evaluation in prospective randomized trials.
Boukovinas
I
I
2nd Department of Medical Oncology, Theagenion Anticancer Hospital, Thessaloniki, Greece. ibouk@otenet.gr
Souglakos
J
J
Hatzidaki
D
D
Kakolyris
S
S
Ziras
N
N
Vamvakas
L
L
Polyzos
A
A
Geroyianni
A
A
Agelidou
A
A
Agelaki
S
S
Kalbakis
K
K
Kotsakis
A
A
Mavroudis
D
D
Georgoulias
V
V
D000230:Adenocarcinoma / Q000188:drug therapy*; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D000077143:Docetaxel; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D009362:Neoplasm Metastasis; D011446:Prospective Studies; D043823:Taxoids / Q000008:administration & dosage*; D013997:Time Factors; D016896:Treatment Outcome; D000093542:Gemcitabine
D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D000093542:Gemcitabine