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BACE plus tislelizumab shows activity in advanced NSCLC patients ineligible for standard careCombination treatment shows promise for advanced lung cancer patients ineligible for standard care

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Key Takeaway
Consider single-arm Phase II data on BACE plus tislelizumab in advanced NSCLC as exploratory, pending randomized trials.

This prospective, single-arm Phase II trial enrolled 30 patients with Stage IIIA-IIIC non-small cell lung cancer (NSCLC) who had refused or were ineligible for standard treatments. All participants received bronchial arterial chemoembolization (BACE) followed by 200-mg tislelizumab every 3 weeks. There was no comparator group.

At a median follow-up of 23 months, the median progression-free survival (PFS) was 10.5 months (95% CI, 7.8-13.2), and median overall survival (OS) was 15.0 months (95% CI, 8.2-21.8). The objective response rate (ORR) was 60.0% (18 of 30 patients), and the disease control rate (DCR) was 80.0% (24 of 30 patients). Quality of life measures for global, physical, and emotional functioning improved significantly after 1 treatment cycle compared to baseline.

Safety was acceptable. Common Grade 1-2 treatment-related adverse events (TRAEs) included nausea, chest pain, and anemia. No Grade ≥3 TRAEs were observed. Treatment continued until disease progression, intolerable toxicities, or investigator-determined discontinuation.

Key limitations include the single-arm, exploratory design and small sample size of 30 patients, which preclude establishing efficacy versus standard care. The study supports further investigation in randomized trials. Clinical relevance is restrained as this evidence cannot establish whether the regimen is superior or inferior to existing treatments for this population.

Researchers conducted a small Phase II study to test a combination treatment for advanced non-small cell lung cancer. The study included 30 patients with Stage IIIA-IIIC disease who had refused or were ineligible for standard treatments like chemotherapy or radiation. They received bronchial arterial chemoembolization (a procedure that delivers chemotherapy directly to lung tumors) followed by tislelizumab, an immunotherapy drug given every three weeks.

The study found that patients had a median progression-free survival of 10.5 months (meaning half of patients lived without their cancer worsening for at least that long) and a median overall survival of 15.0 months. About 60% of patients had their tumors shrink significantly, and 80% had their disease controlled. Quality of life measures improved after treatment. Safety was acceptable, with no severe treatment-related side effects reported.

It's important to understand this was an early, exploratory study without a comparison group. Because there was no group receiving standard treatment or placebo, we cannot say if this combination works better than existing options. The small size (30 patients) and single-arm design mean results should be interpreted cautiously.

This research provides preliminary evidence that this combination approach might help patients who cannot receive standard treatments, but it does not change current medical practice. The findings support conducting larger, randomized trials to compare this approach against standard care.

What this means for you:
Early study shows promise for lung cancer patients ineligible for standard treatments, but more research is needed.

Study Details

Study typePhase2
EvidenceLevel 3
Follow-up0.7 mo
PublishedApr 2026
View Original Abstract ↓
PURPOSE: To assess the effectiveness and safety of bronchial arterial chemoembolization (BACE) combined with tislelizumab for advanced non-small cell lung cancer (NSCLC). MATERIALS AND METHODS: In a prospective single-arm, Phase II study, patients with Stage IIIA-IIIC NSCLC who refused or were ineligible for standard treatments were enrolled. Patients received BACE followed by 200-mg tislelizumab every 3 weeks until disease progression, intolerable toxicities, or discontinuation determined by the investigators. The primary endpoint was progression-free survival (PFS); secondary endpoints were overall survival (OS), objective response rate (ORR), disease control rate (DCR), safety, and quality of life (QoL). RESULTS: Thirty patients (median age, 67 years, 24 men) were enrolled between December 2021 and August 2022. The median follow-up was 23 months (95% CI, 21.5-24.5). At data cutoff (March 1, 2024), median PFS was 10.5 months (95% CI, 7.8-13.2), and median OS was 15.0 months (95% CI, 8.2-21.8). ORR was 60.0% (18 of 30 patients), and DCR was 80.0% (24 of 30 patients). PD-L1 expression, tumor feeding arteries, and previous treatment history were prognostic factors for PFS and OS. Throughout the treatment and follow-up period, no Grade ≥3 treatment-related adverse events (TRAEs) were observed, as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Common Grade 1-2 TRAEs were nausea, chest pain, and anemia. QoL (global, physical, and emotional functioning) improved significantly after 1 treatment cycle versus baseline. CONCLUSIONS: The prospective study suggests that BACE plus tislelizumab offer promising effectiveness and acceptable safety in advanced NSCLC, supporting further randomized trials.
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