BACKGROUNDTo observe the efficacy and safety of navelbine (NVB) combined with ifosfamide (IFO) and cisplatin (DDP) (NIP regimen) and IFO plus DDP (IP regimen) for advanced non-small cell lung cancer (NSCLC).

METHODSOne hundred and twenty patients with advanced NSCLC pathologically proved were randomly divided into group A (NIP regimen, n=60) and group B (IP regimen, n=60).

RESULTSIn group A, 58 patients were evaluable. The response rates were 58.62%(34/58), 65.58%(17/26) and 53.12% (17/32) in whole group, untreated patients, and retreated patients, respectively. The median duration of survival was 11.3 months. One-year survival rate was 40.0%. In group B, 59 patients could be evaluated. The response rates were 40.68%(24/59), 63.33%(19/30) and 17.24%(5/29) in whole group, untreated patients, and retreated patients, respectively. The median duration of survival was 9 months and 1-year survival rate was 36.7%. There was no significant difference in objective response rate among all the patients and the patients with no prior treatment between the two groups ( P > 0.05, P > 0.05). However, among retreated patients, the response rate in group A was remarkably higher than that in group B ( P < 0.05). The main dose limiting toxicity was myelosuppression. Leukopenia at grade III+IV was significantly higher in the NIP arm than in the IP arm ( P < 0.05).

CONCLUSIONSNIP yields a higher response rate than IP does in retreated patients, with acceptable toxicity, which can be the first line regimen in the retreatment of advanced NSCLC. IP regimen showes a similar response rate and less toxicity in initial patients, compared with NIP regimen, so it might be considered a relevant regimen in initial patients with advanced NSCLC.