NEW ORLEANS – Adding the anti-HER2 antibody trastuzumab to a standard chemotherapy regimen produced markedly improved responses among patients with an advanced stage or recurrent uterine serous carcinoma that also overexpressed the HER2/neu cell receptor protein in a controlled, multicenter, phase 2 study with 58 evaluable patients.
The 30 patients who received trastuzumab along with carboplatin plus paclitaxel had a median progression-free survival of 12.6 months compared with 8.0 months among the 28 control patients who received only carboplatin plus paclitaxel, a hazard reduction of 56% with trastuzumab that was statistically significant (P = .0052),, said at the annual meeting of the Society of Gynecologic Oncology.
In the subgroup of 41 patients with advanced (not recurrent) uterine serous carcinoma (USC) the incremental difference in median progression-free survival among patients treated with trastuzumab was 8.6 months, based on a 17.9-month duration in the 20 patients who received trastuzumab and 9.3 months in 20 control patients on chemotherapy only (P = .013).
“We’ll push to have the trastuzumab, carboplatin, and paclitaxel regimen in the guidelines” for treating patients with USC that overexpresses HER2/neu, agreed, director of gynecologic oncology at Johns Hopkins Medicine in Baltimore and lead author on the study reported by Dr. Santin.
Shortly after Dr. Santin’s report at the meeting, the results appeared inMarch 27 in Journal of Clinical Oncology.
The phase 2