Results of a Prospective Phase 2 Trial
With great interest we read the article by Brown et al, who reported the results of a phase 2 study using gemcitabine and cisplatin in patients with advanced endometrial cancer. 1 Although we recognize the reported impressive activity of this regimen, we believe there are several aspects that should lead to a cautious interpretation of the data. First, the study by Brown et al was a rather small phase 2 study, with dose modifications performed during an ongoing trial. Moreover, despite modification of the protocol, 80% of the evaluable patients still required dose reductions and grade 3/4 hematotoxicity was observed in nearly 50% of the treated women. In total, 18 of 20 patients experienced grade 3/4 toxic effects.
Although the authors viewed the high toxicity rates in the context of the pretreatment of these patients, we do not agree that this is a satisfying argument in the palliative setting. For one, the combination of weekly carboplatin and paclitaxel has also shown remarkable activity but less toxicity. 2 Of course, a combined regimen of gemcitabine and cisplatin may have particular advantages, as stated by the authors. 1 Nevertheless, in our view this regimen does not appear to be appropriate for palliative treatment due to the reported toxicity. Accepting the high antitumoral activity found in these 20 patients, further trials should evaluate a better tolerated schedule (eg, a biweekly application of gemcitabine and cisplatin, potentially combined with a biological agent).