Abstract 216P
Background
Trimodal therapy (TMT) has achieved long-term survival and persistent oncologic control in selected muscle-invasive bladder cancer (MIBC) patients, however, tailored treatment using biomarkers based on chemotherapy plus PD-1 inhibitor responses is currently absent. Furthermore, the safety and efficacy of hypo-fractionated radiation in combination with PD-1 inhibitors and concurrent chemotherapy is worth exploring.
Methods
This is a two-stage, single-arm, phase II trial recruiting cT2-4aN0-1M0 MIBC pts. Based on results of cystoscopy, urine cytology, imaging and urine minimal residual disease(MRD)detection after first stage (Tislelizumab (T) 200 mg on D1, Cisplatin (C) 70 mg/m2 on D1 and Gemcitabine (G) 1000 mg/m2 on D1 and D8 Q3W for 3-4 cycles), pts achieving cCR (cT0, cTa) are treated with T, while the other pts receive T and chemoradiotherapy (whole bladder 44Gy/16 fractionation combined with C as radiosensitizer). 1-year bladder intact disease-free survival (BIDFS) rate is the primary endpoint. Secondary endpoints include 2-year metastasis free survival (MFS) rate, 2-year BIDFS rate and safety. Tissue and urine samples will be obtained for genetic profiling and biomarker research.
Results
As of August 15, 2023 (median follow up: 310 (217-377) days, 18 pts with a median age of 64.5 (41-77) years were enrolled and 94.44% are male. 15 pts with cT2 (55.55%), cT3 (33.33%) and cT4 (11.12%) tumors were evaluable. 2 pts were assessed as N1. 12/15 pts (80%) achieved cCR and maintained a sustained response. Based on positive urine cytology and urine MRD, 3 pts were classified as non-cCR (2 pts in cT3N0M0 and 1 pt in cT4N0M0). Due to RC (ypT0N0 and ypT2N0) and incomplete treatment cycles, 3 pts were excluded from the efficacy analysis set. TRAEs were found in 12 of 18 pts (66.67%). The only grade 3-4 TRAE observed (5.56%) was adrenal cortical insufficiency. Hematological AEs (22.22%), pruritus (22.22%), and fatigue (16.67%) are the most common AEs. During hypo-fractionated radiation, no new safety signs were discovered.
Conclusions
The preliminary findings indicate a potential efficacy and manageable toxicity during the two-stage treatment. Enrollment is still ongoing, and long-term efficacy will be proved.
Clinical trial identification
NCT05531123.
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
26P - Subcutaneous trastuzumab versus intravenous trastuzumab for treatment of patients with HER2-positive breast cancer: A time, motion and cost-benefit assessment in a day care oncology unit in China
Presenter: Bei Sun
Session: Poster Display
Resources:
Abstract
27P - The biological characteristics of HER2-low in TNBC using mRNA profiling and molecular subtypes
Presenter: Asako Tsuruga
Session: Poster Display
Resources:
Abstract
28P - One-week ultra-hypofractionated partial breast RT in early breast cancer: 3DCRT vs IMRT
Presenter: Nurilla Zaynutdinov
Session: Poster Display
Resources:
Abstract
30P - Stereotactic body radiotherapy using cyberknife versus interstitial brachytherapy in accelerated partial breast irradiation on left-sided breast: A comparison of preliminary clinical result and dosimetric characteristics
Presenter: Ting-Na Wei
Session: Poster Display
Resources:
Abstract
31P - Prognostic implication of breast edema on preoperative breast MRI in breast cancer
Presenter: Ki-tae Hwang
Session: Poster Display
Resources:
Abstract
32P - Efficacy of olanzapine in the prophylaxis of delayed chemotherapy-induced nausea and vomiting in breast cancer patients receiving dose-dense AC with a steroid-sparing regimen: A single-center pilot study
Presenter: Manami Tada
Session: Poster Display
Resources:
Abstract
34P - Social support as the mediator of the association between unmet needs and happiness among women with early breast cancer
Presenter: Nithiya Sinarajoo
Session: Poster Display
Resources:
Abstract
35P - Prospective study assessing the efficacy and safety of a scalp cooling device for the prevention of alopecia in breast cancer patients undergoing (neo)adjuvant chemotherapy
Presenter: Winnie Yeo
Session: Poster Display
Resources:
Abstract
37P - To excise or not to excise: Preventive management of early breast cancer in atypical ductal hyperplasia patients
Presenter: Clarisse Hing
Session: Poster Display
Resources:
Abstract
38P - Exploring prognostic factors in patients achieving PCR after neoadjuvant therapy for triple-negative breast cancer: A retrospective study based on SEER data
Presenter: Lv Wenjie
Session: Poster Display
Resources:
Abstract