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
581P - The associations between afatinib-related adverse events and survival outcomes in patients with lung cancer
Presenter: Wen-Chen Tang
Session: Poster Display
Resources:
Abstract
582P - Furmonertinib treatment in patients with EGFR-mutated non-small cell lung cancer and leptomeningeal metastases: A real-world study
Presenter: Haiyang Chen
Session: Poster Display
Resources:
Abstract
583P - RHBDL2 promotes non-small cell lung cancer metastasis and osimertinib resistance by activating the RAS/MEK/ERK signaling pathway through interaction with FGFR
Presenter: jun Deng
Session: Poster Display
Resources:
Abstract
584P - Upfront aumolertinib for preventing symptomatic central nervous system(CNS) metastases in EGFR-mutant non-small cell lung cancer without baseline CNS metastasis
Presenter: Tangfeng Lv
Session: Poster Display
Resources:
Abstract
585P - Real-world outcomes in patients with non-small cell lung cancer with EGFR exon 20 insertion mutations receiving mobocertinib
Presenter: Tony S.K. Mok
Session: Poster Display
Resources:
Abstract
586P - Clinical validation of a multiplex polymerase chain reaction (mPCR) assay to identify patients (pts) with NSCLC suitable for mobocertinib treatment
Presenter: Caicun Zhou
Session: Poster Display
Resources:
Abstract
587P - Exploring the prevalence and characteristics of human epidermal growth factor receptor 2 (HER2) alterations in non-small cell lung cancer: Analysis from a Malaysian cohort
Presenter: Ning Yi Yap
Session: Poster Display
Resources:
Abstract
588P - First real-world study with HER2 ADC in treating HER2-altered non-small cell lung cancer
Presenter: Kaihua Lu
Session: Poster Display
Resources:
Abstract
590P - A retrospective study of the prevalence and clinical outcomes of KRAS G12C mutated advanced non-small cell lung cancer (NSCLC) in Australian patients (pts)
Presenter: Ben Markman
Session: Poster Display
Resources:
Abstract
591P - The utility of next generation sequencing for KRAS gene variants prevalence in cytological and tissue samples in real-world NSCLC patients: A large single institution real-world study
Presenter: Adam Pluzanski
Session: Poster Display
Resources:
Abstract