Abstract 218P
Background
Adjuvant chemotherapy improved disease-free survival (DFS) among MIUC patients (pts). CheckMate 274 study demonstrated adjuvant immunotherapy improved DFS in MIUC pts. However, few studies explored the efficacy of adjuvant chemotherapy plus immunotherapy in MIUC pts. Our real-world study aimed to evaluate the effectiveness of adjuvant chemoimmunotherapy versus chemotherapy in high-risk MIUC pts.
Methods
Clinical data of high-risk MIUC pts between October 2016 and March 2023 were retrospectively collected from Sun Yat-sen University Cancer Center. After radical surgery, pT3/4 and pN+ MIUC pts without prior neoadjuvant therapy received adjuvant tislelizumab combined with GC (T+GC) or GC. In T+GC group, pts firstly received cisplatin 70 mg/m2 D2, and gemcitabine 1000 mg/m2 D1 and D8 every 3 weeks for 2-6 cycles, then received tislelizumab 200 mg every 3 weeks for 2-17 cycles. In GC group, pts received cisplatin 70 mg/m2 D2, and gemcitabine 1000 mg/m2 D1 and D8 every 3 weeks for 2-6 cycles. The primary outcome was DFS, and secondary outcomes were OS and safety.
Results
The median follow-up was 17.7(2.1-38.3) months, totally 117 MIUC pts were analyzed, with a median age of 64 (34-85) years. 75.2% were male, 46.2% were UTUC, 20.5% were variant histology; pT3=58.9%, pT4=17.1%; pN+=52.1%. In T+GC group (n=68), the mean number of tislelizumab cycles was 4 and GC cycles was 2.7. In GC group (n=49), the mean number of GC cycles was 2.9. The T+GC group (n=68) had a significantly longer DFS compared with the GC group (n=49) (median DFS (95% CI): 19.1 (6.0-32.5) vs 8.4 (1.0-39.4) months, HR=0.172, P<0.001). While lymphovascular invasion pts had a lower probability of DFS (HR=22.1 (2.8-173.5), P=0.003). The OS was longer in the T+GC group (n=68) (median OS (95% CI): 20.1(6.0-32.5) vs 12.2(1.5-39.4) months, P=0.186). Longer follow-up was required to determine the OS benefits in T+GC group. Grade 1-2 immune related adverse events including pruritus (n=10), ALT/AST increased (n=8), hyperthyroidism (n=5) and hyperglycaemia (n=3).
Conclusions
Our data demonstrated effectiveness of tislelizumab combined with GC as adjuvant therapy for pT3/4 and pN+ MIUC pts in real world.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Sun Yat-sen University Cancer Center.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
143P - Ablation combined with tislelizumab in treating hepatocellular carcinoma: A phase II trial
Presenter: Yangxun Pan
Session: Poster Display
Resources:
Abstract
144P - Integrated clinical and genomic models using machine-learning methods to predict the efficacy of paclitaxel-based chemotherapy in patients with advanced gastric cancer from K-MASTER project
Presenter: Jwa Hoon Kim
Session: Poster Display
Resources:
Abstract
145P - Tislelizumab (TIS) + chemotherapy (Chemo)/chemoradiotherapy (CRT) as neoadjuvant treatment for resectable esophageal squamous cell carcinoma (R-ESCC)
Presenter: Longqi Chen
Session: Poster Display
Resources:
Abstract
146P - Phase (ph) Ib results of bemarituzumab (BEMA) added to capecitabine/oxaliplatin (CAPOX) or S-1/oxaliplatin (SOX) with or without nivolumab (NIVO) for previously untreated advanced gastric/gastroesophageal junction cancer (G/GEJC): FORTITUDE-103 study
Presenter: Keun-Wook Lee
Session: Poster Display
Resources:
Abstract
147P - Four-year overall survival (OS) update from the phase III HIMALAYA study of tremelimumab plus durvalumab in unresectable hepatocellular carcinoma (uHCC)
Presenter: Stephen Chan
Session: Poster Display
Resources:
Abstract
148P - Safety and efficacy of atezolizumab (Atezo) + bevacizumab (Bev) in Japanese patients (pts) with unresectable hepatocellular carcinoma (uHCC): Preliminary analysis of a prospective, multicenter, observational study (ELIXIR)
Presenter: Teiji Kuzuya
Session: Poster Display
Resources:
Abstract
149P - A prospective observational study of MSI screening in unresectable chemotherapy-naïve advanced gastric cancer/gastroesophageal junction cancer: WJOG13320GPS
Presenter: Yukiya Narita
Session: Poster Display
Resources:
Abstract
150P - Anlotinib plus chemotherapy as first-line therapy for gastrointestinal tumor patients with unresectable liver metastasis: Updated results from a multi-cohort, multi-center phase II trial ALTER-G-001-cohort C
Presenter: Junwei Wu
Session: Poster Display
Resources:
Abstract
151P - Relationship between depth of response and early tumor shrinkage with overall survival in advanced pancreatic cancer
Presenter: EMIKA KUROKI
Session: Poster Display
Resources:
Abstract
152P - Interim analysis of the NAPOLEON-2 study: Safety evaluation of nanoliposomal irinotecan with fluorouracil and folinic acid for unresectable pancreatic cancer patients with prior biliary drainage
Presenter: Futa Koga
Session: Poster Display
Resources:
Abstract