Local Control and Extended Survival in Locally Advanced Hepatocellular Carcinoma

To the Editor We read with interest the recent article by Dawson and colleagues. This multicenter, phase 3 study (RTOG 1112) offers robust evidence on stereotactic body radiotherapy (SBRT) followed by sorafenib in the treatment of locally advanced hepatocellular carcinoma (HCC). Although the primary outcome, overall survival (OS), did not demonstrate a statistically significant difference between the SBRT with sorafenib and sorafenib alone groups, a multivariable analysis adjusted for stratification factors revealed a 28% lower mortality risk for the SBRT plus sorafenib group. The study holds positive implications because its enrollment criteria matched radiologists’ clinical practices for treating patients with HCC. Several issues should be considered in designing and conducting future clinical studies in similar contexts.

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Giugno 2025

Local Control and Extended Survival in Locally Advanced Hepatocellular Carcinoma—Reply

In Reply Sherry et al and Song et al provide insightful remarks on the NRG/RTOG 1112 clinical trial that strengthen the conclusion regarding stereotactic body radiotherapy (SBRT) being associated with clinically important improvements in overall survival (OS) in patients with hepatocellular carcinoma (HCC). Using an adjusted model specific to phase 3 randomized clinical trials, Sherry et al estimate that the probability that SBRT and sorafenib improves OS was 97%, despite the univariate OS primary analysis with a hazard ratio (HR) of 0.77 (90% CI, 0.59 to 1.01) and 1-sided P value of .06, not meeting the statistically significant threshold. They point out that information provided by a P value of .06 vs .05 is nearly identical because P value is a continuous statistic, not binary. In fact, for the present study, the P value for the univariate OS end point was .055, but was reported as .06, consistent with the journal’s reporting guidelines. In addition to reporting effect sizes and clinical importance of the effect sizes, a consortium of statisticians recommended to “report P values to a single significant figure unless the P value is close to .05, in which case, report to 2 significant figures.” The Lancet requires that all P values should be reported to 2 significant figures, unless P 

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Giugno 2025

Interventional arterial chemotherapy versus sorafenib for advanced hepatocellular carcinoma in China: a health economic evaluation of open-label, randomised, phase 3 study

Objectives
This post hoc study aimed to evaluate the cost-effectiveness of hepatic artery infusion chemotherapy (HAIC) with fluorouracil, leucovorin and oxaliplatin (HAIC-FO) compared with sorafenib in patients with advanced hepatocellular carcinoma (HCC). The analysis was conducted from the perspective of Chinese payers.

Design
A cost-effectiveness analysis was performed using a Markov model derived from data obtained in the FOHAIC-1 trial (phase 3 randomised controlled trial; conducted 2017–2020).

Setting
The study was conducted in tertiary care centres in China.

Participants
The study included advanced HCC patients enrolled in the FOHAIC-1 trial. Inclusion criteria followed the trial protocols, with patients stratified by disease severity (including the presence of Vp4 portal vein tumour thrombus (PVTT) and high tumour burden).

Interventions
HAIC-FO (fluorouracil, leucovorin and oxaliplatin) was compared with sorafenib for cost and health outcomes.

Primary outcome measure
The primary outcome was the incremental cost-effectiveness ratio (ICER), calculated as the additional cost per quality-adjusted life year (QALY) gained.

Results
Sorafenib yielded 0.66 QALYs at a cost of $15 011.73, whereas HAIC-FO yielded 1.00 QALY at a cost of $18 470.98. The ICER of HAIC-FO compared with sorafenib was $10 235.56 per QALY, which was below the willingness-to-pay (WTP) threshold of $30 492.00 per QALY. Sensitivity analyses confirmed that HAIC-FO remained cost-effective across variable assumptions, with probabilistic sensitivity analysis showing a 99.9% probability of cost-effectiveness at the WTP threshold. Subgroup analyses demonstrated more favourable ICERs for patients with Vp4 PVTT ($7003.33 per QALY) and those with high tumour burden ($7382.86 per QALY).

Conclusions
HAIC-FO is a more cost-effective treatment for advanced HCC than sorafenib from the Chinese payer’s perspective, particularly in patients with Vp4 PVTT and/or high tumour burden. Further research is needed to explore long-term economic implications and real-world effectiveness data.

Trial registration number
NCT03164382.

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Maggio 2025

Diagnostic value of BNLF2b antibody, dual-antibody testing and Epstein-Barr virus DNA in nasopharyngeal carcinoma: a prospective cohort study in Hunan Province, China

Objectives
This study evaluates the diagnostic value of the BNLF2b antibody, dual antibody testing and Epstein-Barr virus DNA (EBV-DNA) individually and in combination for nasopharyngeal carcinoma (NPC) detection.

Design
A prospective cohort study.

Setting
The study was conducted at Hunan Cancer Hospital, in a region in China with a high incidence of NPC, between January 2024 and June 2024.

Participants
A total of 350 patients with suspected NPC were enrolled based on clinical suspicion (eg, metastatic cervical lymph nodes or nasopharyngeal abnormalities with non-specific symptoms). The inclusion criteria included age ≥18 years, residency in Hunan Province, and provision of informed consent. The exclusion criteria included prior history of NPC or other head and neck malignancies, severe immunological/systemic diseases and inability to complete diagnostic evaluations.

Primary and secondary outcome measures
Demographic, clinical and biomarker data were collected, including BNLF2b antibody, EBV-DNA and dual antibody testing. Diagnostic performance metrics were calculated against histopathological confirmation as the gold standard. Follow-up assessments were conducted for non-NPC cases.

Results
Among 350 suspected NPC participants, 74 were diagnosed with NPC through biopsy. BNLF2b antibody exhibited the highest sensitivity (83.78%) and specificity (95.65%) among single biomarkers in NPC diagnosis, outperforming dual-antibody testing and EBV-DNA. Combining BNLF2b with dual-antibody testing improved specificity to 99.64%, although with reduced sensitivity (67.57%). NPC-diagnosed participants and those testing positive for BNLF2b or dual antibody biomarkers had a significantly higher prevalence of family history of NPC (p

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Maggio 2025