Vinorelbine versus paclitaxel for patients with advanced non-small cell lung cancer (NSCLC) and a performance status of 2.
OBJECTIVE
The purpose of this study was to compare two single agents paclitaxel (intravenous) versus vinorelbine (oral) in non-small cell lung cancer (NSCLC) patients with performance status (PS):2.


METHODS
The patients were randomized to receive either oral vinorelbine 60 mg/m(2) on days 1, 8, 15 every 4 weeks for 4 cycles (group A) or paclitaxel 90 mg/m(2) intravenously for 1 h on days 1, 8, 15 every 4 weeks for a total of 4 cycles (group B).


RESULTS
Among the 74 eligible patients (36 in arm A and 38 in arm B) in arm A, two (6%) had a partial response (95% CI, 0.7-18.7) and 5 (14%) had stable disease (95% CI, 4.7-29.5). In arm B, five (13%) had a partial response (95% CI, 4.4-28.1) and 7 (18%) had stable disease (95% CI, 7.7-34.3). No significant difference was found in terms of clinical benefit between the two groups after two cycles of treatment except for appetite in favour of paclitaxel (p=0.01). Median survival was 3.1 months (95% CI, 2.2-4.0) for arm A and 5.1 months (95% CI, 2.7-7.6) for arm B (p=0.95). Toxicity was mild and only alopecia was more profound in the patients of arm B (p=0.008).


CONCLUSIONS
No significant difference was found in clinical benefit between PS:2 NSCLC patients treated with either vinorelbine or paclitaxel.
Hygeia Hospital, Tsoha 2 and Vas. Sofias Ave, 11521, Athens, Greece. parkosmi@otenet.gr
Paris A
PA
Kosmidis
Konstantinos
K
Syrigos
Haralampos P
HP
Kalofonos
Meletios-Athanasios
MA
Dimopoulos
Dimosthenis
D
Skarlos
Nicolas
N
Pavlidis
Ioannis
I
Boukovinas
Dimitrios
D
Bafaloukos
Dimitrios
D
Pectasides
Charalampos
C
Bacoyiannis
George
G
Fountzilas
D000230:Adenocarcinoma / Q000188:drug therapy / Q000401:mortality / Q000556:secondary; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001859:Bone Neoplasms / Q000188:drug therapy / Q000401:mortality / Q000556:secondary; D001932:Brain Neoplasms / Q000188:drug therapy / Q000401:mortality / Q000556:secondary; D018287:Carcinoma, Large Cell / Q000175:diagnosis / Q000235:genetics; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality* / Q000556:secondary; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy / Q000401:mortality / Q000556:secondary; D018450:Disease Progression; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008113:Liver Neoplasms / Q000188:drug therapy / Q000401:mortality / Q000556:secondary; D008175:Lung Neoplasms / Q000188:drug therapy / Q000401:mortality / Q000473:pathology; D008207:Lymphatic Metastasis; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000008:administration & dosage; D055752:Small Cell Lung Carcinoma / Q000188:drug therapy / Q000401:mortality / Q000556:secondary; D015996:Survival Rate; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077235:Vinorelbine
D014747:Vinblastine; D017239:Paclitaxel; D000077235:Vinorelbine