A phase II study of non-platinum based chemotherapy with paclitaxel and vinorelbine in non-small cell lung cancer.
BACKGROUND
Paclitaxel and vinorelbine combination in previous untreated patients with stage IIIb-IV non-small cell lung cancer (NSCLC) as a phase II study.


METHODS
Thirty-four patients (4 patients with stage IIIb, 30 patients in stage IV), with median age 66 and performance status 0-1, were administered paclitaxel, 175 mg/m(2) in a 3-h infusion rate on day 1 and vinorelbine, 25 mg/m(2) in a 10-min infusion rate on days 1, and 8 with G-CSF and EPO support.


RESULTS
Among our 33 evaluable patients for toxicity 16 patients (48.4%) presented leukopenia and 15 patients (45.4%) presented anemia despite G-CSF and EPO administration. Two patients (6%) presented Grade III-IV peripheral neuropathy. The overall response rate was 67.7%; 5 patients (16.1%) showed complete response (2 patients stage IIIb) and 16 patients (51.6%) showed partial response (1 patient stage IIIb). The overall median survival time was 10 months (range 3-18 months) and the median disease-free survival was 9 months (range 3-15 months) with an 1-year survival time of 45.1% (14 patients).


CONCLUSIONS
The results of the combination as 1st line treatment for patients with non-operable NSCLC are promising and should be further investigated.
Ginopoulos
Panagiotis
P
Department of Clinical Oncology, General Hospital of St Andreas, Tsertidou 1, Patras PC 26335, Greece. drginop@mail.otenet.gr
Kontomanolis
Emanuel
E
Kardamakis
Dimitrios
D
Sougleri
Maria
M
Rathosis
Spiros
S
Karana
Afroditi
A
Christias
Helias
H
Mandellos
George
G
D000328:Adult; D000368:Aged; D000740:Anemia / Q000139:chemically induced; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D018572:Disease-Free Survival; D004921:Erythropoietin / Q000008:administration & dosage; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage; D006801:Humans; D007262:Infusions, Intravenous; D007970:Leukopenia / Q000139:chemically induced; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D000077235:Vinorelbine
D004921:Erythropoietin; D016179:Granulocyte Colony-Stimulating Factor; D014747:Vinblastine; D017239:Paclitaxel; D000077235:Vinorelbine