Abstract 62P
Background
First line endocrine therapy is the gold standard for advanced ER- positive, HER2 -negative breast cancer. Adding CDK4/6 inhibitors has improved PFS with several challenges to adopt for all patients. Metronomic Capecitabine has proven to be safe to combine with endocrine therapy with promising efficacy.
Methods
We conducted a phase II randomised, open label, single centre clinical trial on patients with metastatic ER- positive, HER -2 negative breast cancer. Eligible patients were randomised (1:1) to arm A: metronomic dose of capecitabine (500mg/m2 BID) with letrozole (2.5mg OD) or arm B: letrozole alone. The primary endpoint was progression free survival. The study was terminated early due to poor accrual and 60 eligible patients out of the planned 204 were randomized.
Results
Between February 2019 and April 2022, 60 patients were randomized. This is the first report of the study, after a median follow-up of 18.6 months. The median age at diagnosis was 47 years with only 41.7% of patients post-menopausal. Half of our patients had bone-only disease, 45% had visceral metastasis (liver and lung) and 63% presented with endocrine sensitive disease. The estimated median PFS for the whole population was 16.2 months. Median PFS for capecitabine arm was 17.7 months versus 14.6 months for letrozole alone (p = 0.078). Overall response rate was 70% for capecitabine/letrozole arm and 56.6% for letrozole only. Clinical benefit rate was 90% in the capecitabine/letrozole arm versus 73.3% in the letrozole arm. Overall survival data is still immature after this short follow up duration. Adverse event assessment showed acceptable all grade and high grade toxicity profile consistent with the established adverse events of both capecitabine and letrozole. Anaemia (28.3%) and hand & foot syndrome (43.8%) were significantly more common in the capecitabine/letrozole arm.
Conclusions
Capecitabine combined with letrozole have showed a trend towards improvement in progression free survival with potential more benefit to certain sub-groups and the combination showed acceptable safety profile consistent with the established known safety profile of both letrozole and capecitabine.
Clinical trial identification
MD-127-2019, NCT04571437.
Editorial acknowledgement
Legal entity responsible for the study
Ethics committee at the Faculty of Medicine, Cairo University.
Funding
Has not received any funding.
Disclosure
L. Kassem, H.A. Azim: Financial Interests, Personal, Other, Honoraria: Roche, AstraZeneca, Novartis, Janssen, Pfizer, Eva, Sandoz, Hikma, MSD. All other authors have declared no conflicts of interest.
Resources from the same session
592P - Treatment patterns and outcomes in patients with advanced non-small cell lung cancer with MET exon 14 skipping alterations in China
Presenter: Hanxiao Chen
Session: Poster Display
Resources:
Abstract
593P - MET TKIs in Asian patients (pts) with MET exon 14 skipping NSCLC: A matching-adjusted indirect comparison (MAIC)
Presenter: E-e Ke
Session: Poster Display
Resources:
Abstract
594P - The treatment pattern and clinical outcome in NSCLC patients with MET alteration: A retrospective real-world analysis in China
Presenter: Yongfeng Yu
Session: Poster Display
Resources:
Abstract
595P - Durable efficacy of zenocutuzumab, a HER2 x HER3 bispecific antibody, in advanced NRG1 fusion-positive (NRG1+) non-small cell lung cancer (NSCLC)
Presenter: Koichi Goto
Session: Poster Display
Resources:
Abstract
596P - Repotrectinib in patients (pts) from Asia and China with ROS1 fusion-positive (ROS1+) non-small cell lung cancer (NSCLC): Results from the phase I/II TRIDENT-1 trial
Presenter: Ross Soo
Session: Poster Display
Resources:
Abstract
597TiP - A phase I/II study to evaluate the safety and anti-tumor activity of JIN-A02 in patients with EGFR TKI-refractory, EGFR-mutant advanced NSCLC
Presenter: Sun Min Lim
Session: Poster Display
Resources:
Abstract
598TiP - Exploration of aumolertinib in first-line treatment for advanced non-small cell lung cancer patients of performance status 3 with EGFR mutations (19del and L858R)
Presenter: Haiyi Deng
Session: Poster Display
Resources:
Abstract
599TiP - A prospective study of savolitinib plus docetaxel in pretreated EGFR/ALK/ROS1/METex14m-wildtype advanced NSCLC patients with MET overexpression (FirstMET)
Presenter: Shuting Zhan
Session: Poster Display
Resources:
Abstract
600TiP - Phase III study of telisotuzumab vedotin (Teliso-V) vs docetaxel in pretreated c-Met overexpressing EGFR wildtype (WT) non-squamous (NSQ) locally advanced/metastatic non-small cell lung cancer (a/mNSCLC)
Presenter: Junko Tanizaki
Session: Poster Display
Resources:
Abstract
601P - Pembrolizumab in patients of Chinese descent with microsatellite instability-high/mismatch repair deficient advanced solid tumors: KEYNOTE-158
Presenter: Xiaohua Wu
Session: Poster Display
Resources:
Abstract