Phase II study of paclitaxel in combination with carboplatin for patients with recurrent or persistent uterine sarcoma

Objective

To evaluate the efficacy and toxicity of combined paclitaxel and carboplatin treatment for persistent or recurrent uterine sarcoma.

Methods

Paclitaxel was administrated at 175?mg/m² intravenously over 3?h plus carboplatin at AUC 5 intravenously over 30?min every 3-week cycle in patients with recurrent or progressive uterine sarcoma, who were unsuitable candidates for curative treatment with either surgery or radiotherapy. The Simon’s two-stage optimal design was chosen for defining the total number of patients required for the phase II study. A total of 13 patients were entered in the study at the first stage of trial. A median of four cycles were administrated per patient, with a range of one to nine cycles. Prior to the study, 4 (30.8?%) of the 13 patients had received radiotherapy or chemotherapy. The response was measured by evaluation of the size of the mass by CT scan.

Results

The overall response rate was 15.4?% (2/13), with two patients exhibiting partial responses. There was 1 (7.7?%) case of stable disease and 9 (69.2?%) cases of progression disease. The median progression free survival was 2.23?months (95?% confidence interval 1.94–3.67). Peripheral neuropathy and hematologic toxicity, including anemia and neutropenia, were the most frequent adverse events. One patient died from treatment-related toxicities.

Conclusions

Paclitaxel in combination with carboplatin demonstrated acceptable levels of toxicity, but it was not active in the treatment of recurrent or progressive uterine sarcoma. This regimen might have limited role for advanced uterine sarcomas.