Salvage treatment with paclitaxel and gemcitabine for patients with non-small-cell lung cancer after cisplatin- or docetaxel-based chemotherapy: a multicenter phase II study.
BACKGROUND
To evaluate the tolerance and efficacy of the combination of paclitaxel and gemcitabine as salvage treatment in patients with advanced non-small-cell lung cancer (NSCLC).


METHODS
Forty-nine patients with measurable NSCLC (PS 0-1: 80%; stage IV: 84%) who progressed or failed first-line chemotherapy were enrolled. Prior chemotherapy was cisplatin-based with (n = 20) or without (n = 22) docetaxel and docetaxel-vinorelbine (n = 7). Patients received gemcitabine (900 mg/m2 i.v.; days 1 and 8) and paclitaxel (175 mg/m2; day 8) every three weeks: G-CSF (150 micrograms/m2/day s.c.; days 9-15) was given prophylactically to all patients.


RESULTS
One (2%) complete and eight (16%) partial responses were achieved (overall response 18%; 95% CI: 4%-24%); 14 patients (29%) had stable disease and 26 (53%) progressive disease. Six responses were observed in 17 patients who responded to first-line chemotherapy. The median duration of response was seven months, the median TTP eight months and the median survival 11 months. The one-year survival rate was 37%. Grade 3-4 neutropenia occured in six (12%) patients, grade 2-3 neurotoxicity in 16 (32%) and grade 2-3 asthenia in 25 (51%). Other toxicities were mild.


CONCLUSIONS
The paclitaxel-gemcitabine combination is a well-tolerated and relatively active salvage regimen in patients with NSCLC and it merits further investigation.
Androulakis
N
N
Department of Medical Oncology, School of Medicine, University of Crete, Greece.
Kouroussis
C
C
Kakolyris
S
S
Tzannes
S
S
Papadakis
E
E
Papadimitriou
C
C
Geroyianni
A
A
Georgopoulou
T
T
Dimopoulou
I
I
Souglakos
J
J
Kotsakis
A
A
Vardakis
N
N
Hatzidaki
D
D
Georgoulias
V
V
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage; D016879:Salvage Therapy; D016019:Survival Analysis; D000093542:Gemcitabine
D003841:Deoxycytidine; D017239:Paclitaxel; D000093542:Gemcitabine