Abstract 66P
Background
Treatment options are limited for patients with advanced or metastatic solid tumors after failure of standard therapies. Utidelone, a genetically engineered epothilone analogue, has demonstrated high activity in clinical studies against a broad range of tumors using regimen of 30mg/m2, iv, d1-5 every 21 day. This study aimed to evaluate the efficacy and safety for solid tumors using 120h continuous intravenous infusion of utidelone.
Methods
This is a prospective, multicenter, single-arm trial. We included patients aged 18 years or older with metastatic solid tumor after failure of standard therapies. Utidelone was administrated at 150 mg/m2 via 120h continuous intravenous infusion, alone or in combination with other anticancer agents every 21 days until disease progression or intolerable toxicity. The primary endpoints were ORR and safety. Secondary endpoints included mPFS, DCR and QoL.
Results
As data cut-off on June 30, 2023, a total of 50 patients were enrolled and analyzed. There were 20 patients with breast cancers,11 with gynecological cancers, 8 with gastrointestinal cancers, 6 with lung cancer and 5 with other solid tumors. The median number of previous systemic therapies was three. 38 (76%) patients had taxane-refractory diseases. The overall ORR and DCR was 20% and 66%, respectively, the mPFS was 4 months. For breast cancer patients, the ORR and DCR was 40% and 75%, respectively, and the mPFS was 6 months. For gynecological cancers, the ORR and DCR was 9% and 64%, respectively. Most of the AEs were grade 1 or 2 and were manageable and reversible. The rate of grade ≥3 AEs including peripheral neuropathy was 4% (2/50). No treatment-related discontinuation or deaths occurred.
Conclusions
This study demonstrated a promising anti-tumor activity of utidelone in patients with metastatic solid tumors after failure of the standard therapies, especially in patients with breast cand gynecological cancers. Moreover, 120h continuous intravenous infusion is a more tolerable administration method than 5 days intermittent infusion, worthy further study.
Clinical trial identification
ChiCTR2300074299.
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
112P - Optimal classification and treatment strategy based on technical and oncological futures in recurrence of colorectal liver metastases
Presenter: Kosuke Kobayashi
Session: Poster Display
Resources:
Abstract
113P - Phase I/II study of capecitabine(C)/oxaliplatin(O)/irinotecan(I) combined with bevacizumab(B) in the first-line treatment of metastatic colorectal cancer (mCRC)
Presenter: Kai Ou
Session: Poster Display
Resources:
Abstract
114P - The prognostic role of LAG-3 expression in metastatic colorectal cancer
Presenter: Yi-Hsuan Huang
Session: Poster Display
Resources:
Abstract
115P - Sidedness and survival of chemo-refractory metastatic colorectal cancer treated with lonsurf or regorafenib: A nationwide population-based study in Taiwan
Presenter: Meng-Che Hsieh
Session: Poster Display
Resources:
Abstract
116P - Burden and trends of colorectal cancer in high income Asia Pacific countries from 1990-2019 and its projections of deaths to 2040: A comparative analysis
Presenter: Monika Chhayani
Session: Poster Display
Resources:
Abstract
117P - Australasian real-world treatment selection and clinical outcomes for patients with left side (LS), RAS wildtype (RASwt) metastatic colorectal cancer (mCRC)
Presenter: Vanessa Wong
Session: Poster Display
Resources:
Abstract
119P - Neoadjuvant chemoradiotherapy in the mode of hypofractionation in locally advanced rectal cancer: Is it time to change standards of care?
Presenter: Abror Abdujapparov
Session: Poster Display
Resources:
Abstract
120P - Improved clinical outcomes with cetuximab maintenance therapy in left-sided RAS/BRAF wild-type metastatic colorectal cancer: A real-world study of Hunan cancer hospital
Presenter: Xiaolin Yang
Session: Poster Display
Resources:
Abstract
121P - Single-cell sequencing reveals the role of Treg cells with high expression of BIRC3 in regulating the progression of colorectal cancer
Presenter: Yuqiu Xu
Session: Poster Display
Resources:
Abstract
122P - Distinct transcriptomic immune profiling and clinicopathological features of cribriform morphology in colorectal adenocarcinomas
Presenter: Abdelhakim Khellaf
Session: Poster Display
Resources:
Abstract