Back to:  List of Articles

Gemcitabine is one of the most promising newer cytotoxic drugs. A claim that is not only based on efficacy, but also on tolerability. A new study has now confirmed that gemcitabine is an important treatment option when combined with cisplatin in patients with invasive bladder cancer.

Rationale

Invasive bladder cancer is among the most frequent malignant tumours, with a rather poor outcome as far as longterm survival is concerned. Chemotherapy is a very important treatment option, but far from being optimal when overall survival is taken into consideration. Given that chemotherapy can hardly cure patients with invasive bladder cancer, tolerability and quality of life play a major role when it comes to treatment selection. One of the most widely used therapy regimens is the MVAC scheme that provides considerable efficacy but is associated with considerable toxicity as well. Based on phase I/II studies the combination of gemcitabine and cisplatin was deemed to be a promising alternative that should be further evaluated in a randomized comparative trial against the MVAC regimen. This was done by a European study group, chaired by Prof. Dr. H. van der Maase, Aarhus, Denmark, who presented the results of this very important study at the CECOG meeting.

A landmark study

The European bladder cancer trial included more than 400 patients with invasive bladder cancer who were randomized to receive gemcitabine + cisplatin or the MVAC scheme. Gemcitabine was administered at 1.000 mg/m² on days 1, 8 and 15, while cisplatin was given on day 2 at a dosage of 70 mg/m². MVAC was applied as usual and repeated every 28 days, as was the combination of gemcitabine + cisplatin.

With regard to efficacy both therapeutic regimens yielded comparable results. Some 50% of the patients presented with a response and in 12% a complete remission could be achieved. As far as time to progression (7,4 months) and overall survival (13,8 versus 14,8 months) is concerned, there was also no significant difference between the two groups. But there were major differences in favour of gemcitabine + cis-platin as to tolerability (table 1). This was due primarily to a reduced risk for
neutropenia, resulting in less neutropenic fever, septic neutropenia, hospital admissions and hospital days in the gemcitabine + cisplatin group.

Furthermore there was a significant advantage of gemcitabine + cisplatin with regard to quality of life on the EORTC-QLQ-C30 score. While patients in the MVAC group experienced a remarkable worsening of the fatigue item compared to baseline,
therapy with gemcitabine + cisplatin did not induce a significant change. Another important finding is that patients treated with gemcitabine + cis-platin presented more often with weight gain (12% versus 3%) and less often with weight loss (8% versus 16%). Summarizing these data suggests, that gemcitabine + cisplatin can preserve quality of life much better than does standard therapy with MVAC.

Conclusion

Overall the present study leads to the conclusion that therapy with gemcitabine + cisplatin is as effective as the MVAC regimen. With regard to side effects and quality of life the gemcitabine-based treatment scheme shows some important features that might justify the use of this regimen as therapy of choice.

CECOG meeting, June 16th 2000, Vienna

 top