Docetaxel in combination with gemcitabine plus rhG-CSF support as second-line treatment in non-small cell lung cancer. A multicenter phase II study.
BACKGROUND
Docetaxel in combination with gemcitabine is an active front-line chemotherapy regimen against non-small cell lung cancer (NSCLC) with acceptable toxicity. A multicenter phase II study was conducted in order to determine the toxicity and efficacy of this combination, as salvage treatment in patients progressing after a cisplatin-based front line regimens.


METHODS
Thirty-two patients with histologically confirmed, bidimensionally measurable NSCLC, who failed prior cisplatin-based chemotherapy were enrolled. The patients' median age was 62.5 years, 29 (91%) were male, 23 (72%) had disease stage IV, and 22 (69%) had a performance status (WHO) 0-1. Gemcitabine (900 mg/m(2)) was administered on days 1 and 8 and docetaxel (100 mg/m(2)) on day 8, after appropriate premedication. rhG-CSF (150 microg/m(2)) was given prophylactically from day 9 to 15. Treatment was repeated on an outpatient basis every three weeks.


RESULTS
A total of 127 chemotherapy cycles were administered. In an intention-to-treat analysis five patients (15.6%; 95% CI: 3.04-28.21%) achieved a partial response, 11 (34.4%) stable disease, and 16 (50%) progressive disease. The median duration of response was 9 months, the median TTP 7 months, and the overall median survival 6.5 months; the overall 1-year survival probability was 27.6%. Grade 3/4 neutropenia was observed in five (15.6%) patients and in two of them associated with fever. Grade 3 anemia and thrombocytopenia occurred in three (9%) and two (6.5%) patients, respectively. Non-hematologic toxicity was very mild with only one episode of grade 4 diarrhea and mucositis, respectively; two (6%) patients complained for grade 3 asthenia.


CONCLUSIONS
The combination of gemcitabine and docetaxel with prophylactic use of rhG-CSF is a safe and well-tolerated regimen for the treatment of patients with advanced NSCLC, who failed front-line treatment with cisplatin-based regimens.
Kakolyris
S
S
Department of Medical Oncology, University General Hospital of Heraklion, Heraklion 71110, Crete, Greece
Papadakis
E
E
Tsiafaki
X
X
Kalofonos
C
C
Rapti
A
A
Toubis
M
M
Bania
E
E
Kouroussis
C
C
Chainis
K
K
Androulakis
N
N
Agelaki
S
S
Sarra
E
E
Vardakis
N
N
Georgoulias
V
V
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality; D002945:Cisplatin / Q000494:pharmacology; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D018450:Disease Progression; D018572:Disease-Free Survival; D000077143:Docetaxel; D004334:Drug Administration Schedule; D019008:Drug Resistance, Neoplasm; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use*; D006402:Hematologic Diseases / Q000139:chemically induced / Q000517:prevention & control; D006801:Humans; D015993:Life Tables; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced / Q000517:prevention & control*; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D011994:Recombinant Proteins / Q000627:therapeutic use; D016879:Salvage Therapy; D016019:Survival Analysis; D015996:Survival Rate; D043823:Taxoids; D016896:Treatment Outcome; D000093542:Gemcitabine
D011994:Recombinant Proteins; D043823:Taxoids; D003841:Deoxycytidine; D016179:Granulocyte Colony-Stimulating Factor; D000077143:Docetaxel; D017239:Paclitaxel; D002945:Cisplatin; D000093542:Gemcitabine