Abstract
Adding trastuzumab to carboplatin–paclitaxel is well tolerated in patients with uterine serous carcinoma.
Major finding: Adding trastuzumab to carboplatin–paclitaxel is well tolerated in patients with uterine serous carcinoma.
Concept: Trastuzumab increases progression-free survival without added toxicity in a phase II trial.
Impact: Trastuzumab plus carboplatin–paclitaxel warrants further study in HER2/neu+ uterine serous carcinoma.
Uterine serous carcinoma is a rare aggressive type of endometrial cancer characterized by frequent overexpression of HER2/neu, which promotes tumor cell growth and survival. The humanized monoclonal HER2/neu antibody trastuzumab has been approved for the treatment of metastatic breast cancer and gastric adenocarcinomas that overexpress HER2/neu, prompting Fader and colleagues to evaluate trastuzumab in patients with HER2/neu-positive advanced or recurrent uterine serous carcinoma in a randomized phase II trial. A total of 60 patients were enrolled and treated with carboplatin–paclitaxel alone (control group; 28 patients) or carboplatin–paclitaxel plus trastuzumab (experimental group; 32 patients). The primary end point was progression-free survival, and secondary endpoints included safety of trastuzumab. The overall median progression-free survival was 8 months in the control group versus 12.6 months in the experimental group. Of the 41 patients with stage III or IV disease undergoing primary treatment, the median progression-free survival was 9.3 months in the control group and 17.9 months in the experimental group. Of the 17 patients with recurrent disease, the median progression-free survival was 6 months in the control group and 9.2 months in the experimental group. Combination treatment with carboplatin–paclitaxel plus trastuzumab was well tolerated, and there were no significant differences in toxicity between the control and experimental arms, suggesting that the addition of trastuzumab does not increase toxicity. Taken together, the results of this phase II trial indicate that the addition of trastuzumab to carboplatin–paclitaxel treatment is well tolerated and extends progression-free survival in patients with HER2/neu-positive uterine serous carcinoma, supporting further investigation of carboplatin–paclitaxel plus trastuzumab in these patients.
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