Pertuzumab Plus Trastuzumab in Patients With Endometrial Cancer With
JCO Precis Oncol
washington; swedish; swedish cancer; Female; Humans; Trastuzumab; Antineoplastic Combined Chemotherapy Protocols; Endometrial Neoplasms; Mutation; Receptor, ErbB-2
Purpose: The TAPUR Study is a pragmatic basket trial evaluating antitumor activity of commercially available targeted agents in patients with advanced cancers harboring potentially actionable genomic alterations. Data from a cohort of patients with endometrial cancer (EC) with ERBB2 or ERBB3 (ERBB2/3) amplification, overexpression, or mutation treated with pertuzumab plus trastuzumab (P + T) are reported.
Methods: Eligible patients had advanced EC, no standard treatment options, measurable disease (RECIST v1.1), Eastern Cooperative Oncology Group performance status 0-2, adequate organ function, and tumors with ERBB2/3 amplification, overexpression, or mutation. Simon's two-stage design was used with a primary end point of disease control (DC), defined as objective response (OR) or stable disease (SD) of at least 16 weeks (SD16+) duration. Secondary end points include safety, duration of response, duration of SD, progression-free survival (PFS), and overall survival (OS).
Results: Twenty-eight patients were enrolled from March 2017 to November 2019; all patients were evaluable for efficacy and toxicity. Seventeen patients had tumors with ERBB2/3 amplification and/or overexpression, eight with both ERBB2 amplification and ERBB2/3 mutations, and three with only ERBB2 mutations. Ten patients had DC (two partial response and eight SD16+); all 10 had ERBB2 amplification, and 6 of the 10 patients with DC had >1 ERBB2/3 alteration. DC and OR rates were 37% (95% CI, 21 to 50) and 7% (95% CI, 1 to 24), respectively; the median PFS and median OS were 16 weeks (95% CI, 10-28) and 61 weeks (95% CI, 24-105), respectively. One patient experienced a grade 3 serious adverse event (muscle weakness) at least possibly related to P + T.
Conclusion: P + T has antitumor activity in heavily pretreated patients with EC with ERBB2 amplification and warrants additional study.
Trial registration: ClinicalTrials.gov NCT02693535.
Women & Children
Obstetrics & Gynecology
Ahn, Eugene R; Rothe, Michael; Mangat, Pam K; Garrett-Mayer, Elizabeth; Ali-Ahmad, Hussein M; Chan, John; Maitland, Michael L; Patel, Sapna R; Reese, Zachary; Balmanoukian, Ani S; Drescher, Charles W; Li, Rui; Tsimberidou, Apostolia M; Leath, Charles A; O'Lone, Raegan; Grantham, Gina N; Halabi, Susan; and Schilsky, Richard L, "Pertuzumab Plus Trastuzumab in Patients With Endometrial Cancer With" (2023). Articles, Abstracts, and Reports. 7264.