To the Editor Qin and colleagues conducted an important trial to compare tislelizumab with sorafenib. The study was designed within a noninferiority setting for overall survival (OS) by claiming tislelizumab would be noninferior to sorafenib if the upper bound of the 95.003% CI for the hazard ratio (HR) was less than 1.08. The observed HR was 0.85 with a 95.003% CI of 0.71 to 1.02. The objective response rates were 14.3% and 5.4% for tislelizumab and sorafenib, respectively. The corresponding median durations of response were 36.1 and 11.0 months, respectively. There are several issues that may deserve our attention for conducting future clinical studies in a similar setting.
Risultati per: Terapia sistemica del carcinoma epatocellulare
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Quantification of Treatment Effect of Tislelizumab vs Sorafenib for Hepatocellular Carcinoma—Reply
In Reply I thank and have provided responses to Sun et al for their comments on our article that compared tislelizumab vs sorafenib in first-line treatment of unresectable hepatocellular carcinoma. The noninferiority margin of 1.08 is clearly clinically justifiable. It is based on the data from the 2 sorafenib trials in first-line hepatocellular carcinoma (HCC), namely the SHARP trial. Using the 95% CI lower limit method on log hazard ratio (HR) as described in Rothmann et al, the noninferiority margin corresponding to 60% retention of the sorafenib effect vs placebo was calculated as 1.08. Given the consistent survival improvement of sorafenib vs placebo demonstrated in the SHARP and Asia-Pacific trials, and the fact that, at the time the BGB-A317-301 study was designed, no other monotherapy treatment was able to show superiority compared with sorafenib since its approval in 2007, a margin of 1.08 derived from 2 well-conducted phase 3 pivotal trials was statistically persuasive. Notably, the same margin was used in other noninferiority monotherapy HCC trials, namely the REFLECT (lenvatinib) and HIMALAYA (durvalumab) trials.
Association of GLP-1 receptor agonists and hepatocellular carcinoma incidence and hepatic decompensation in patients with type 2 diabetes
Hepatocellular carcinoma (HCC) is a leading cause of cancer death. HCC is preventable with about 70 percent of HCC attributable to modifiable risk factors. Glucagon-like peptide-1 receptor agonists (GLP-1RAs), FDA-approved medications for treating type 2 diabetes mellitus (T2DM), have pleiotropic effects on counteracting risk factors for HCC. Here we evaluate the association of GLP-1RAs with incident HCC risk in a real-world population.
Tumore delle vie biliari, terapia aumenta la sopravvivenza a 3 anni nella forma avanzata
Immunoterapia più chemioterapia raddoppia il tasso a lungo termine
Tumore delle vie biliari, terapia aumenta la sopravvivenza a 3 anni
Immunoterapia più chemioterapia raddoppia il tasso a lungo termine
Terapia genica ora rimborsabile anche per bambini con SMA tipo 2
Permetterà di fermare progressione con singola somministrazione
Nuova terapia per il Parkinson, farmaco a infusione sottocutanea
All’Arnas Brotzu di Cagliari primo trattamento di un paziente
Overall Survival with Adjuvant Pembrolizumab in Renal-Cell Carcinoma
New England Journal of Medicine, Volume 390, Issue 15, Page 1359-1371, April 2024.
Identificazione della popolazione eleggibile alla terapia con Acido Bempedoico in medicina generale
CXCR4 Antagonist in HPV5-Associated Perianal Squamous-Cell Carcinoma
New England Journal of Medicine, Volume 390, Issue 14, Page 1339-1341, April 2024.
Ok Fda alla prima terapia digitale per la depressione, è un'app
Download solo con prescrizione, non è alternativa ai farmaci
Diagnostic values of contrast-enhanced MRI and contrast-enhanced CT for evaluating the response of hepatocellular carcinoma after transarterial chemoembolisation: a meta-analysis
Objectives
To assess and compare the diagnostic value of contrast-enhanced MRI (CEMRI) and contrast-enhanced CT (CECT) for evaluating the response of hepatocellular carcinoma (HCC) after transarterial chemoembolisation (TACE).
Design
Systematic review and meta-analysis.
Data sources
PubMed, Embase, the Cochrane Library, CNKI and Wanfang databases were systematically searched from inception to 1 August 2023.
Eligibility criteria
Studies with any outcome that demonstrates the diagnostic performance of CEMRI and CECT for HCC after TACE were included.
Data extraction and synthesis
Two authors independently extracted the data and assessed the quality of included studies. Study quality was assessed using Quality Assessment of Diagnostic Accuracy Studies-2. The diagnostic performance of CEMRI and CECT for the response of HCC was investigated by collecting true and false positives, true and false negatives, or transformed-derived data from each study to calculate specificity and sensitivity. Other outcomes are the positive likelihood ratio/negative likelihood ratio (NLR), the area under the receiver operating characteristic curve (AUC) for diagnostic tests and the diagnostic OR (DOR). Findings were summarised and synthesised qualitatively according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.
Results
This study included 5843 HCC patients diagnosed with CEMRI or CECT and treated with TACE from 36 studies. The mean proportion of men in the total sample was 76.3%. The pool sensitivity, specificity and AUC of CEMRI in diagnosing HCC after TACE were 0.92 (95% CI: 0.86 to 0.96), 0.94 (95% CI: 0.86 to 0.98) and 0.98 (95% CI: 0.96 to 0.99). The pool sensitivity, specificity and AUC of CECT in diagnosing HCC after TACE were 0.74 (95% CI: 0.68 to 0.80), 0.98 (95% CI: 0.93 to 1.00) and 0.90 (95% CI: 0.88 to 0.93).
Conclusions
In conclusion, this study found that both CEMRI and CECT had relatively high predictive power for assessing the response of HCC after TACE. Furthermore, the diagnostic value of CEMRI may be superior to CECT in terms of sensitivity, AUC, DOR and NLR.
Induction Chemotherapy Followed by Radiotherapy vs Chemoradiotherapy in Nasopharyngeal Carcinoma
This randomized clinical trial examines if radiotherapy is noninferior to chemoradiotherapy after induction chemotherapy for locoregionally advanced nasopharyngeal carcinoma.
Clinical variables associated with immune checkpoint inhibitor outcomes in patients with metastatic urothelial carcinoma: a multicentre retrospective cohort study
Objectives
Immune checkpoint inhibitors (ICIs) are indicated for metastatic urothelial cancer (mUC), but predictive and prognostic factors are lacking. We investigated clinical variables associated with ICI outcomes.
Methods
We performed a multicentre retrospective cohort study of 135 patients who received ICI for mUC, 2016–2021, at three Canadian centres. Clinical characteristics, body mass index (BMI), metastatic sites, neutrophil-to-lymphocyte ratio (NLR), response and survival were abstracted from chart review.
Results
We identified 135 patients and 62% had received ICI as a second-line or later treatment for mUC. A BMI ≥25 was significantly correlated to a higher overall response rate (ORR) (45.4% vs 16.3%, p value=0.020). Patients with BMI ≥30 experienced longer median overall survival (OS) of 24.8 vs 14.4 for 25≤BMI
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