Adding Trastuzumab to Uterine Serous Carcinoma Treatment Extended PFS
Carboplatin in combination with paclitaxel is an established treatment for uterine serous carcinoma.
Adding trastuzumab to carboplatin and paclitaxel is safe and effective among patients with advanced or recurrent uterine serous carcinoma with overexpressed HER2/neu, according to a presentation at the 2018 Society of Gynecologic Oncology Annual Meeting on Women's Cancer in New Orleans.1
Carboplatin/paclitaxel is an established treatment for uterine serous carcinoma, a rare and aggressive subtype of endometrial cancer. For this phase 2 study (ClinicalTrials.gov Identifier: NCT01367002), researchers evaluated whether adding trastuzumab, which inhibits HER2/neu, to this combination would improve outcomes among patients with advanced/recurrent disease with overexpressed HER2/neu. The primary endpoint was progression-free survival (PFS).
Sixty-one patients were randomly assigned to receive carboplatin/paclitaxel or carboplatin/paclitaxel with trastuzumab. All patients had stage III to IV primary or recurrent disease. Fifty-eight patients were evaluable for PFS.
The overall median PFS was 12.6 in the trastuzumab arm vs 8 months in the control arm (hazard ratio [HR], 0.44; P = .005). Patients treated for primary disease (41 patients) had a median PFS of 17.9 months in the trastuzumab arm vs 9.3 in the control arm (HR, 0.40; P = .013); patients with recurrent disease (17 patients) had a median PFS of 9.2 vs 6 months in the experimental vs control arm, respectively (HR, 0.14; P = .003).
Toxicity was similar in both arms.
The authors concluded that adding “trastuzumab to carboplatin-paclitaxel was well-tolerated and increased PFS. This regimen may come to represent the new standard of care for women with advanced or recurrent uterine serous carcinoma who overexpress Her2/neu.”
Santin AD, Fader AN. Randomized phase II trial of carboplatin-paclitaxel compared to carboplatin-paclitaxel-trastuzumab in advanced or recurrent uterine serous carcinomas that overexpress Her2/neu (NCT01367002). Oral presentation at: 2018 Society of Gynecologic Oncology Annual Meeting on Women's Cancer; March 24-27, 2018; New Orleans, LA.