Randomised Phase III Trial of gemcitabine and vinorelbine (GV) verses gemcitabine, vinorelbine and cisplatin (GVP) in metastatic non-small cell lung cancer

The following is an abstract taken from the 27th ESMO Congress.

Purpose

To evaluate whether cisplatin based chemotherapy (GVP) prolongs overall survival in comparison to cisplatin free chemotherapy (GV) as first line therapy.

Patients and methods

From 9/99 to 6/01 300 patients (pts) (aged 18 to 75 years, Karnofsky performance status (KPS) > 70%) with NSCLC stage IIIB with malignant pleural effusion of stage IV disease were randomised to receive GV (gemcitabine 1000mg/m2 and vinorelbine 25mg/m2 d 1, 8 q 3 weeks) or GVP (gemcitabine 1000mg/m2 plus vinorelbine 25mg/m2 d 1, 8 plus cisplatin 75mg/m2 d 2 q 3 weeks).

Results

287 patients (GV 143/GVP 144) were eligible. The study was well balanced between the two treatment arms for stage, gender, age, histologic type, grading, KPS and second-line chemotherapy. At the time of analysis 209 (GV 103/GVP 106) of 287 pts had died (73%). No statistically significant difference was observed in overall survival (p=0.73) (median survival 35.9 vs. 32.4 weeks, 1 year survival rate 33.6 vs 27.5%) as well as in progression-free survival (p=0.35) between GV and GVP. 214 pts were evaluable for best response (GV: 0 CR, 14 PR, 63 SD, 31 PD; GVP: 4 CR, 26 PR, 60 SD, 16PD). The overall response rates were 13% for GV vs. 28.3% of GVP (p= 0.004). Grade III/IV toxicity was lower in the GV treatment arm compared to GVP (anemia 3 vs 23%; neutropenia 27 vs 66%, thrombocytopenia 4 vs 48%, alopecia 1 vs 9% of pts).

The administered total dose and average dose per cycle of gemcitabine and vinorelbine were similar in both treatment arms.

Conclusions

The GVP regimen showed no survival benefit in comparison to the GV regimen, which was substantially better tolerated. The results indicate, that cisplatin does not play an important role in the era of new cytotoxic agents for the palliative care of pts with NSCLC.

For more information on gemcitabine, cisplatin and vinorelbine, please go to the treatment section of virtual cancer centre.