Trastuzumab tolerability in the treatment of advanced (stage III-IV) or recurrent uterine serous carcinomas that overexpress HER2/neu

Joan Tymon-Rosario, Eric R. Siegel, Stefania Bellone, Justin Harold, Naomi Adjei, Burak Zeybek, Dennis Mauricio, Gary Altwerger, Gulden Menderes, Elena Ratner, Mitchell Clark, Vaagn Andikyan, Gloria S. Huang, Masoud Azodi, Peter E. Schwartz, Amanda N. Fader, Alessandro D. Santin

Research output: Contribution to journalArticlepeer-review


Objective: Due to previously reported trastuzumab safety concerns and the scant data available in endometrial cancer patients, we sought to assess the safety, tolerability and toxicity profile of trastuzumab in patients with advanced/recurrent uterine serous carcinoma (USC) that overexpress HER2/neu in our multicenter randomized phase II trial. Methods: Patients were randomized 1:1 to receive carboplatin/paclitaxel (C/P) for 6 cycles ± trastuzumab (T) with the experimental arm continuing to receive single agent trastuzumab maintenance treatment until disease progression/toxicity. Progression-free-survival was the primary endpoint; overall-survival and toxicity were secondary endpoints. Adverse events (AEs) were compared between treatment arms. Results: There were 28 patients in the C/P arm and 32 patients in the experimental (C/P + T) arm. Fifty-eight patients (97%) experienced 977 treatment-related AEs of which 875 (89.6%) were low-grade (grade 1–2) and 102 (10.4%) were high-grade (grade 3–5). The mean ± standard deviation of AEs per patient was 15.5 ± 16.3 in the C/P arm and 17.0 ± 16.0 in the C/P + T arm. Gastrointestinal AEs were the most common in both arms (n = 155, 15.7%) of which 94.2% were low-grade (n = 146). Importantly, no significant difference between treatment arms was detected in any system-organ class of AE including cardiac AE. Five (17%) of 29 patients who received prolonged trastuzumab maintenance therapy had no sign of cumulative toxicity after an average (range) of 5.1 (4.2–6.3) years. Conclusions: Trastuzumab appears to be safe and has a manageable toxicity profile both when used in combination with chemotherapy and when used for single agent maintenance in patients with HER2/neu positive USC. This safety profile is reassuring given the proven efficacy of trastuzumab in advanced/recurrent HER2/neu positive USC.

Original languageEnglish (US)
Pages (from-to)93-99
Number of pages7
JournalGynecologic oncology
Issue number1
StatePublished - Oct 2021


  • HER2/neu
  • Side effects
  • Tolerability
  • Trastuzumab
  • Uterine serous carcinomas

ASJC Scopus subject areas

  • Oncology
  • Obstetrics and Gynecology


Dive into the research topics of 'Trastuzumab tolerability in the treatment of advanced (stage III-IV) or recurrent uterine serous carcinomas that overexpress HER2/neu'. Together they form a unique fingerprint.

Cite this