Abstract 419P
Background
Saci is FDA approved for mTNBC and metastatic HR-positive BC based on ASCENT (Bardia et al., NEJM 2022) and TROPiCS-02 (Rugo et al., JCO 2022). In ASCENT, patients with heavily pre-treated mTNBC, including CNS metastases, had improved PFS and OS with Saci. It remains to be seen whether clincial trial results are uniformly applicable to real-world patients. The objectives of this study are to examine patients treated with Saci for mTNBC at our institution and to determine if clinical trial results can be replicated in the real-world setting.
Methods
We retrospectively identified all patients treated with Saci at our institution. Patient demographics, tumor characteristics, response and outcomes were assessed. Statistics are reported descriptively.
Results
From July 2018-June 2022, 188 patients with MBC were treated with Saci at our institution. Of those, 126 patients with mTNBC received at least one dose of Saci. Patients received a median of 2 lines (0-8) of therapy for metastatic disease prior to Saci. At commencement of Saci, 69.8% of patients had visceral metastases and 23% had CNS metastases. The median PFS with Saci was 3 months (0-13). The clinical benefit rate (CR/PR/SD) with Saci was 59.5% and 15% of patients remained on Saci at the time of reporting. The median OS was 21 months (2-50) and the median survival from Saci to death was 6 months (0-33). Table: 419P
Patient and tumor characteristics (n=126)
Characteristics | n (%) | |
Median age at diagnosis: Years (range) | 52 (27-86) | |
BRCA1/2 mutation status | PositiveNoneUnknown/Not tested | 7 (6%)90 (71%)29 (23%) |
Tumor stage at Dx | T1T2T3T4TxUnknown | 22 (18%)58 (46%)15 (12%)3 (2%)23 (18%)5 (4%) |
Nodal status at Dx | N0N1N2N3NxUnknown | 38 (30%)37 (29%)15 (12%)8 (6.5%)23 (18.5%)5 (4%) |
Metastatic disease at Dx | M0M1Unknown | 101 (80%)20 (16%)5 (4%) |
Prior systemic therapy | TaxaneAnthracyclineCapecitabinePlatinumImmunotherapyPARPi | 119 (94%)92 (73%)77 (61%)75 (60%)55 (44%)19 (15%) |
Conclusions
In this real-world series, we report on a patient population similar to that studied in the ASCENT trial. The median PFS was numerically shorter in this series compared to the ASCENT study (3.0 vs 4.8 months) despite our patients being less heavily pre-treated (median 2 vs 4 prior lines). The median OS was numerically longer in this series (21 vs 11.8 months). Further work is ongoing to evaluate real-world outcomes of patients treated with Saci for HR-positive disease and translational work seeks to establish biomarkers of resistance to Saci and other ADCs.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
E. M. Walsh.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
402P - First-line ribociclib (RIB) + endocrine therapy (ET) vs combination chemotherapy (combo CT) in aggressive HR+/HER2− advanced breast cancer (ABC): A subgroup analysis of patients (pts) with or without visceral crisis from the phase II RIGHT choice study
Presenter: Hamdy Azim
Session: Poster session 03
403P - Breast cancer specific survival (BCSS) in HR+/HER2- metastatic breast cancer (mBC) from 2010 to 2019
Presenter: Adam Brufsky
Session: Poster session 03
404P - A multicenter, single-arm, open-label trial of birociclib, a CDK4/6 inhibitor, as a single agent, in patients with refractory HR+/HER2- metastatic breast cancer
Presenter: Jiayu Wang
Session: Poster session 03
405P - E7389-LF as a first-line (1L) chemotherapy for patients (pts) with metastatic/advanced HER2-negative breast cancer (HER2− BC): Results from a phase I study dose-expansion part
Presenter: Kan Yonemori
Session: Poster session 03
406P - Phase Ib safety and efficacy of nadunolimab/gemcitabine/carboplatin in mTNBC
Presenter: Sara Lopez-Tarruella Cobo
Session: Poster session 03
407P - Palbociclib plus endocrine therapy in HR+/HER2- advanced breast cancer patients: Interim results of the PERFORM study
Presenter: Julia C. Radosa
Session: Poster session 03
408P - Proxalutamide plus endocrine therapy as a combination therapy in women with HR+/HER2-/AR+ metastatic breast cancer: A phase I study
Presenter: Huiping Li
Session: Poster session 03
410P - Patients treated with pertuzumab followed by T-DM1 for breast cancer in France from 2014 to 2021: A survival analysis of 10,408 patients from the French National Hospital discharge summary database (PMSI)
Presenter: Josephine Lemaitre
Session: Poster session 03
411P - Therapy management and safety of 1st-line ribociclib (RIB) + aromatase inhibitor (AI)/fulvestrant (FUL) in clinical routine: Real-world data from the RIBANNA study (5th interim analysis (IA))
Presenter: Frederik Marmé
Session: Poster session 03