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Purpose: The therapeutic efficacy of metastatic renal cell carcinoma (mRCC) has been significantly enhanced with the advent of immune checkpoint inhibitors (ICIs). However, there are limited data on the efficacy of Tislelizumab in patients with mRCC. This study aimed to assess the effectiveness and safety of Tislelizumab plus tyrosine kinase inhibitor (TKI) for patients with mRCC. Methods: Demographic and clinicopathological data of mRCC patients treated with first-line TKI monotherapy or Tislelizumab plus TKI therapy between March 2019 to February 2023 were collected. Outcome measures included the objective response rate (ORR), median progression-free survival (mPFS). Patient baseline characteristics and adverse events (AEs) were documented. Results: Totally 136 patients were included in the analysis, with a median age of 57 years. Of the patients, 72.1% were male, 78.8% with intermediate/poor-risk disease. For the overall population, the combination group (n = 61) exhibited a longer PFS compared to the TKI monotherapy group (n = 75) (mPFS (95% CI): 15.9 (10.9–20.9) vs. 6.2 (5.4–6.9) months, P < 0.001) and improved ORR (44.3% vs. 18.7%, P = 0.001). In the non-clear cell RCC (nccRCC) subgroup (n = 39), the combination group (n = 20) showed improved PFS (mPFS (95% CI): 11.9 (0.6–23.3) vs. 4.6 (3.4–5.9) months, P < 0.001) and ORR (40.0% vs. 10.5%, P = 0.006) compared to the TKI monotherapy group (n = 19). The incidence of grade three or higher treatment-related AEs are comparable between the groups (47.54% vs. 40.00%). Conclusion: Our data demonstrated the promising efficacy and safety profile of Tislelizumab plus TKI as first-line treatment for both ccRCC and nccRCC. [ABSTRACT FROM AUTHOR]

Monoclonal antibodies (mAbs) have completely changed the face of oncology over the last 50 years, and they have contributed to a major breakthrough in terms of cancer therapy. Esophageal and gastric cancers, the eighth and fifth most commonly diagnosed types of cancer worldwide, respectively, have lately, been managed more effectively, with the introduction of new therapeutic treatment strategies, especially mAbs. Combination treatments and new molecules have changed the face of the disease, while more therapies are getting approved on a daily basis. This review aims to analyse the major up-to-date clinical trials using mAbs and immunotherapy for the treatment of advanced gastro-esophageal cancers. [ABSTRACT FROM AUTHOR]

Background: Tislelizumab has emerged as a promising therapy for unresectable hepatocellular carcinoma (uHCC), although its economic viability across different healthcare systems remains uncertain. Aim: This study compared the cost-effectiveness of tislelizumab versus sorafenib as a first-line treatment for uHCC from the perspectives of the healthcare systems of China, the United States and Europe. Method: A partitioned survival model was developed using data from the RATIONALE-301 trial. Costs and utilities were sourced from local healthcare charges, publicly available databases, and published literature. Total costs, quality-adjusted life years, and incremental cost-effectiveness ratios (ICERs) were assessed. Price simulations were conducted to identify cost-effective pricing within established willingness-to-pay (WTP) thresholds. Sensitivity and scenario analyses were performed to test the robustness of the model. Results: Tislelizumab (priced at $1587.45/100 mg) was cost-effective in the US at a WTP threshold of $150,000, with an ICER of $108,812.52. In Europe, tislelizumab was cost-effective at a WTP threshold of $100,000, with an ICER of $94,880.40. For $186.18/100 mg in China, tislelizumab was cost-effective with an ICER of $14,206.80. Price simulation analyses showed that in the US, tislelizumab was favored when priced below $1438.30/100 mg at a $100,000 WTP threshold and below $2284.56/100 mg at a $150,000 WTP threshold. In Europe, it was favored below $1661.82/100 mg and $2501.93/100 mg for the same thresholds. In China, tislelizumab was cost-effective at a WTP threshold of $38,184 when priced below $582.11/100 mg. Conclusion: Tislelizumab presents a cost-effective first-line treatment option for uHCC, potentially supporting its broader adoption in health policy. Future research should focus on long-term efficacy and real-world data to further validate these findings. [ABSTRACT FROM AUTHOR]

Drug-induced hyponatremia is an adverse reaction with accelerated electrolyte disturbance. This study reported a rare case of delayed hyponatremia in a 68year-old female with recurrent upper tract urothelial carcinoma after Gemcitabine plus Cisplatin (GC) and Tislelizumab treatment. She had left ureter surgery, recurrence a year later with mildly abnormal kidney function (glomerular filtration rate (GFR) was 54.9 ml/min). After the first cycle of GC plus Tislelizumab, severe hyponatremia leading to life-threatening conditions occurred eight days later. Hypothesizing Cisplatin as the cause, its usage was modified in the second cycle (40mg/day for three days). No severe hyponatremia followed. CT showed partial remission. From the third cycle, due to grade IV bone marrow suppression, she had Tislelizumab alone. Now, she is on 21-day Tislelizumab maintenance with a stable tumor status. Low-dose continuous Cisplatin may suit patients with borderline or mildly abnormal renal function (GFR: 40-60mL/min) better than single full-dose use. Tislelizumab alone for maintenance may be an option for those intolerant of chemotherapy. But Na+ decrease may be related to Tirelizumab or Gemcitabine, needing more clinical observation and experiments. [ABSTRACT FROM AUTHOR]

Background: Malignant esophageal mediastinal fistula is a severe complication that occurs in both the advanced stages of esophageal cancer and after radiotherapy for esophageal cancer. Esophageal mediastinal fistula is very susceptible to complications such as mediastinitis and mediastinal abscess, resulting in a significantly elevated mortality rate for patients. We reported a rare case of esophageal mediastinal fistula after immunotherapy for non-small cell lung cancer (NSCLC). Case Presentation: A 74-year-old male patient with NSCLC was hospitalized in July 2023. About one week after Tislelizumab immunotherapy, the patient suddenly developed high fever accompanied by coughing and choking on water, chest tightness, shortness of breath, and hemoptysis. Following the completion of bronchial artery computed tomography angiography (CTA), imaging suggested the presence of esophageal mediastinal fistula. We opted for a conservative medical treatment instead of surgery. The patient was discharged without any complications. Conclusions: This is the first case of NSCLC accompanied by an esophageal mediastinal fistula after treatment with tislelizumab. The occurrence of malignant esophageal mediastinal fistula is very uncommon and poses a high level of hazard. In addition, this paper provides a concise overview of cases of lung cancer complicated with esophageal fistula in the past 10 years. It offers valuable insights for diagnosis and treatment, serving as a resource for clinicians. [ABSTRACT FROM AUTHOR]

Primary small cell neuroendocrine carcinoma of the prostate is extremely rare, highly aggressive, and has a very poor prognosis, with an overall survival typically not exceeding one year. Standard treatment is generally based on the regimen for small cell lung cancer (SCLC), with guidelines recommending etoposide combined with cisplatin (EP regimen) as the first-line treatment. However, their therapeutic effects are limited. For primary small cell neuroendocrine carcinoma of the prostate that has failed the EP regimen treatment, there is currently a lack of relevant treatment methods. Here, we report a case of small cell neuroendocrine carcinoma of the prostate with multiple metastases, whose disease rapidly progressed despite receiving EP and second-line systemic chemotherapy. The patient was then administered a combination of anlotinib and tislelizumab. After treatment, the patient's symptoms were controlled, tumor marker levels decreased, and imaging showed significant improvement. The patient had a progression-free survival time of more than 22 months and continued to receive treatment. This is the first report of the use of anlotinib combined with tislelizumab for the treatment of primary small cell neuroendocrine carcinoma of the prostate, providing a new therapeutic option for patients with this disease. [ABSTRACT FROM AUTHOR]

Background: Since the imported PD-1 inhibitor pembrolizumab was listed in China in 2018, China has opened up the era of immunotherapy for malignant tumors, with several domestically produced PD-1 inhibitors coming onto the market one after another. To find out whether there are differences in the efficacy and safety of domestic and imported PD-1 inhibitors in patients with advanced non-small cell lung cancer, we conducted this retrospective study in two tertiary hospitals in China. Methods: Patients with advanced NSCLC treated with tislelizumab or camrelizumab or pembrolizumab who met the inclusion criteria were screened through the electronic medical record system. A total of 259 patients were screened, but due to the unbalanced baseline, we performed propensity score matching and finally included 149 patients in three groups: pembrolizumab (n = 38), tislelizumab (n = 38), and camrelizumab (n = 73), which had very balanced baseline characteristics in each group after propensity score matching treatment. Results: The results showed that the median progression-free period was 11.3 m vs 10.1 m vs 8.9 m; p = 0.754; and the objective response rate was 63.2% vs 50% vs 57.5%; P = 0.510 for pembrolizumab, tislelizumab, and carrelizumab, respectively. There was no significant difference in median PFS between PD-L1 expression subgroups. In terms of safety, only skin toxicity of any grade of carrelizumab was higher than that of the other two groups (p = 0.034), and the incidence of grade ≥ 3 adverse reactions was not statistically significant among the three groups. Conclusion: In this real-world study, the efficacy and safety of the domestically produced tislelizumab, camrelizumab, and the imported pembrolizumab were comparable. [ABSTRACT FROM AUTHOR]

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Purpose: To assess the activity and toxicity of hepatic arterial infusion chemotherapy (HAIC)+tislelizumab+lenvatinib (HAIC+tisle+len) in hepatocellular carcinoma (HCC) with portal vein tumor thrombus (PVTT) type IV (Vp4 hCC) in a real-world context. Methods: Fifty-five patients, with Vp4 hCC receiving HAIC+tisle+len therapy from April 2021 to December 2022, were analyzed retrospectively. Data on patient characteristics, adverse events (AEs), treatment, and survival were collected. Outcomes were disease control rate (DCR), overall response rate (ORR), overall survival (OS), progression-free survival (PFS), and treatment-related AEs (TRAEs). Results: As of December 20, 2023, the median follow-up was 17.5 months (95% confidence interval [CI]: 14.7– 22.5). The ORR was 52.7% (3 complete response [CR], 26 partial response [PR]) as per RECIST v1.1 and 65.5% (12 CR, 24 PR) as per mRECIST. The DCR was 94.5% using both RECIST v1.1 and mRECIST. The median PFS and the median OS were 8.0 months (95% CI: 6.2– 12.3) and 16.7 months (95% CI: 12.0-not reached), respectively. Additionally, PFS was independently predicted only by the best tumor response. In patients with the best tumor response (PR or CR), the median PFS was 11.7 months (95% CI: 8.02-not reached) by mRECIST and 15.4 months (95% CI: 7.39-not reached) by RECIST v1.1. Hypertension (14.5%), decreased albumin levels (10.9%) and anorexia (9.1%) were the most frequently observed grade 3– 4 TRAEs. Conclusion: HAIC+tisle+len regimen demonstrated a promising efficacy and favorable safety for patients with HCC and Vp4, providing valuable real-world evidence to complement the trial data for Vp4 hCC. [ABSTRACT FROM AUTHOR]

Abstract In renal cell carcinoma (RCC) patients with inferior vena cava (IVC) tumor thrombus, neoadjuvant therapy could alleviate the burden of tumor thrombus, enhance the safety and feasibility of surgical resection, and improve patient prognosis. The combination of tislelizumab and axitinib has demonstrated efficacy in the treatment of advanced RCC. Our study aimed to evaluate the efficacy and safety in the neoadjuvant therapy setting of tislelizumab and axitinib in RCC patients with IVC tumor thrombus. In this retrospective study, seven patients of nonmetastatic RCC with IVC tumor thrombus who received 3 cycles of neoadjuvant therapy with tislelizumab plus axitinib at the First Affiliated Hospital of Xiamen University from May 2020 to December 2023 were included. The main outcomes included objective response rate (ORR), reduction of tumor thrombus size and level, surgical outcomes, and adverse events (AEs). The median age was 66 (range, 50–72) years, and five (71.4%) patients were male. Five (71.4%) patients were diagnosed with clear cell carcinoma, and two (28.6%) patients were papillary type I carcinoma. Four (57.1%) patients had level II tumor thrombus and three (42.9%) patients had level III. The ORR of patients was 57.1%. The mean decrease in thrombus diameter and length was 5.8 (1.8–17.2) mm and 18.5 (4.4–41.5) mm, respectively. All patients showed a decrease in IVC tumor thrombus. The mean time from the end of neoadjuvant therapy to radical nephrectomy and thrombectomy was 31.7(range, 22–45) days. No intraoperative complications or postoperative Clavien-Dindo grade>3 complications occurred. The most common AEs were all grade 1–2, and only one patient had grade 4 hepatic impairment. No AEs delayed the surgery schedule. This study of RCC patients receiving neoadjuvant combination with tislelizumab and axitinib effectively reduced primary tumor and IVC tumor thrombus with the absence of serious AEs, demonstrating a promising neoadjuvant therapy.

Pulmonary sarcomatoid carcinoma (PSC) is a scarce pathologic type of lung cancer of non-small cell lung cancer (NSCLC) that exhibits resistance to conventional chemotherapy and radiotherapy, resulting in a poor prognosis. Herein, a 67-year-old man was admitted to the hospital in January 2022 with a diagnosis of PSC for over 6 months and a newly discovered brain metastasis for 4 days. He had previously undergone two unsuccessful chemotherapy regimens: bevacizumab combined with pemetrexed and loplatin, and albumin-bound paclitaxel combined with loplatin. Radiotherapy was performed for the brain and skull metastases, followed by treatment with tislelizumab combined with anlotinib, a programmed cell death protein 1 (PD-1) inhibitor with anti angiogenic drug, respectfully. The patient initially received nine cycles of treatment with tislelizumab and anlotinib, resulting in a significant shrinkage of the lung tumor. Subsequently, anlotinib was discontinued due to bleeding in the brain metastasis, and the patient received two additional cycles of tislelizumab. Following improvement in the hemorrhage from brain metastasis, the patient received two cycles of treatment with tislelizumab and anlotinib. Treatment was subsequently interrupted for 1 month due to the coronavirus disease 2019 (COVID-19) pandemic, which then resumed with two additional cycles of tislelizumab and anlotinib. Finally, the patient refused to continue treatment due to the progression of the brain metastasis and economic conditions, despite the stable condition. At this point, the patient has achieved over a year of progression-free survival, with overall survival exceeding 39 months. This case illustrates the efficacy and safety of combining antitumor immunotherapy with anlotinib, a targeted anti-angiogenic therapy.

The use of immune checkpoint inhibitors (ICIs) often develops immune-related adverse events (irAEs). However, irAEs-induced multi-organ injuries remain a rare event. We herein report a case of multi-organ injuries induced by tislelizumab in a lung squamous cell carcinoma (LUSC) patient. A 68-year-old man had undergone neoadjuvant chemotherapy with paclitaxel, carboplatin, and tislelizumab. He presented with a 1-month history of nausea and poor appetite after the second dose of therapy. During investigations, rhabdomyolysis, liver, kidney, and thyroid damage were detected. After multi-disciplinary consultation, multi-organ injuries related to ICIs (striated muscle, liver, kidney, and thyroid) were considered to result from cumulated irAEs induced by tislelizumab. The patient was treated with levothyroxine, methylprednisolone, intravenous immunoglobulins, and continuous renal replacement therapy. After treatment, the patient recovered and was discharged from the hospital. The patient presented with multiple organ damage, not single immunity treatment adverse reactions, relatively rare. In clinical work, irAEs are likely not a single-system organ disorder and many kinds of attention need to be combined with the risk of multi-system damage.

Tislelizumab is a monoclonal antibody with high binding affinity for programmed death-1 (PD-1) receptors. In patients with extensive-stage small-cell lung cancer (ES-SCLC), the first-line use of tislelizumab combined with chemotherapy has shown significant efficacy. However, with the widespread use of PD-1 inhibitors, there are increasing reports of immune-related adverse events (irAEs) in clinical practice, with immune-related hepatitis (IRH) being particularly common. This article reports a case of an ES-SCLC patient (cT3N3M0 cStage IIIB) who developed corticosteroid-resistant hepatitis and recovered through dual immunosuppressant therapy. The patient was a 67-year-old male, diagnosed with ES-SCLC, who received a combination therapy of etoposide, cisplatin, and tislelizumab. Three weeks after the fourth treatment cycle, the patient experienced symptoms, such as decreased appetite, itching, yellow urine, and jaundice, and was diagnosed with IRH, manifested as “Grade 3 total bilirubin increase,” “Grade 3 alanine transaminase increase,” and “Grade 3 aspartate transaminase increase.” Despite intravenous injection of methylprednisolone (MP) 100 mg/day (2 mg/kg) and oral administration of mycophenolate mofetil (MMF) 1 g twice daily, liver function continued to be impaired. In this context, tacrolimus (TAC) (5 mg, twice daily) was added to the therapy, and the IRH level was reduced from Grade 3 to normal. Subsequently, TAC and MMF were gradually reduced and eventually discontinued. Unfortunately, after discontinuing immunosuppressants, IRH recurred. Although the patient still responded to TAC combined with MMF, liver function recovery took a longer time. Due to persistent liver dysfunction, the patient failed to receive second-line chemotherapy and ultimately passed away due to disease progression. Through this case, we hope to emphasize the importance of reasonably extending the use of immunosuppressants to avoid the recurrence of IRH and reduce the premature discontinuation of immunosuppressants. Besides, when tumor progression and IRH recurrence occur simultaneously, providing effective immunosuppressive therapy and reasonably arranging systemic anti-tumor therapy may bring clinical benefits to patients.

Drug-induced hyponatremia is an adverse reaction with accelerated electrolyte disturbance. This study reported a rare case of delayed hyponatremia in a 68year-old female with recurrent upper tract urothelial carcinoma after Gemcitabine plus Cisplatin (GC) and Tislelizumab treatment. She had left ureter surgery, recurrence a year later with mildly abnormal kidney function (glomerular filtration rate (GFR) was 54.9 ml/min). After the first cycle of GC plus Tislelizumab, severe hyponatremia leading to life-threatening conditions occurred eight days later. Hypothesizing Cisplatin as the cause, its usage was modified in the second cycle (40mg/day for three days). No severe hyponatremia followed. CT showed partial remission. From the third cycle, due to grade IV bone marrow suppression, she had Tislelizumab alone. Now, she is on 21-day Tislelizumab maintenance with a stable tumor status. Low-dose continuous Cisplatin may suit patients with borderline or mildly abnormal renal function (GFR: 40-60mL/min) better than single full-dose use. Tislelizumab alone for maintenance may be an option for those intolerant of chemotherapy. But Na+ decrease may be related to Tirelizumab or Gemcitabine, needing more clinical observation and experiments.

Immune checkpoint inhibitor (ICI) has demonstrated promising results in treating various cancers, but its associated cardiotoxicity, especially ICI-associated myocarditis, presents a serious concern. We reported a case of a 63-year-old male who complained of progressive dyspnea after tislelizumab, a novel humanized anti-PD-1 monoclonal antibody, for hepatocellular carcinoma. Upon diagnosing ICI-related myocarditis, corticosteroid therapy was initiated immediately. The elevated biomarkers quickly decreased, but the atrioventricular block progressed from first-degree to third-degree, necessitating pacemaker implantation. This is the first report of complete AVB consecutive to tislelizumab-induced myocarditis, highlighting the importance of early corticosteroid therapy and continuous electrocardiography monitoring., (© 2025 Wiley Periodicals LLC.)