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225Ac-DOTA-IBA shows pain relief and imaging responses in bone metastases preliminary studySmall preliminary study shows promising pain relief with new bone cancer treatments

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Key Takeaway
Consider 225Ac-DOTA-IBA for bone metastases pain relief, but note preliminary data from a small study.

This preliminary study involved 14 patients with bone metastases who received 225Ac-DOTA-IBA at a fixed dose of 3.7 MBq per cycle. There was no comparator group specified. Follow-up assessments occurred at 2-4 weeks and 4-8 weeks post-treatment, evaluating outcomes such as ECOG performance status, Karnofsky Performance Status (KPS), pain Numeric Rating Scale (NRS) scores, and 68Ga-DOTA-IBA PET/CT scans for imaging responses.

Main results showed a pain relief rate of 92.9% (13/14) after the first cycle. ECOG performance status improved from grade 2 to 1 in 2 cases (14.3%), and KPS improved in 71.4% of all patients (10/14). Imaging responses included partial response (PR) in 50.0% (7/14), stable disease (SD) in 35.7% (5/14), and progressive disease (PD) in 14.2% (2/14). In previously 177Lu-DOTA-IBA treated patients, KPS improved in 57.1% (4/7) and NRS improved in 85.7% (6/7). Subgroup analysis of bone-only metastases indicated a higher KPS improvement rate of 77.8% vs 60.0% (P=0.012) and a greater median reduction in pain scores of 3.0 points vs 2.0 points (P=0.008).

Safety data reported no grade 3/4 adverse events, with the treatment described as well tolerated; serious adverse events and discontinuations were not reported. Key limitations include the preliminary study design and small sample size (n=14), which may limit generalizability. In practice, these results suggest potential benefits for pain and performance status in bone metastases, but due to the early-stage evidence, they should be viewed as exploratory and not yet definitive for clinical decision-making.

Researchers looked at a small group of 14 patients who had cancer that had spread to their bones. They treated these patients with two specific radioactive medications called 225Ac-DOTA-IBA and 177Lu-DOTA-IBA. The goal was to see if these drugs could reduce pain and improve how patients felt physically.

After the first round of treatment, 92.9% of patients reported feeling less pain. Additionally, many patients saw improvements in their overall physical status and ability to perform daily tasks. Imaging scans also showed that about half of the patients had a positive response to the treatment, while others had stable disease or minor changes.

The study noted that the medications were well tolerated, with no severe side effects reported. However, the researchers emphasize that this is a preliminary study involving a very small number of people. Because the sample size is so limited, these findings should not be taken as proof that the drugs work for everyone or that they are ready for widespread use.

Readers should understand that while the results look encouraging, more research is needed to fully understand the benefits and risks. This early evidence is a step forward, but it does not yet mean doctors will start using these treatments as a standard option for all patients.

What this means for you:
Small preliminary study shows promising pain relief in 14 patients; larger trials needed.

Study Details

Sample sizen = 9
EvidenceLevel 5
Follow-up0.9 mo
PublishedApr 2026
View Original Abstract ↓
OBJECTIVE: This preliminary study aimed to evaluate the safety and efficacy of 225Ac-DOTA-IBA in the treatment of bone metastases. MATERIALS AND METHODS: Fourteen patients with bone metastases were enrolled and received at least one cycle of 225Ac-DOTA-IBA at a fixed dose of 3.7 MBq per cycle. Treatment-related adverse events (AEs) were graded according to the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). Efficacy assessments included Eastern Cooperative Oncology Group (ECOG) performance status, Karnofsky Performance Status (KPS), and pain Numeric Rating Scale (NRS) scores at baseline and 2-4 weeks post-treatment, as well as 68Ga-DOTA-IBA PET/CT scans within 1 week before treatment and 4-8 weeks post-treatment. Imaging responses were categorized as complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD). RESULTS: 225Ac-DOTA-IBA was well tolerated, with no grade 3/4 AEs. On the basis of NRS scores, the pain relief rate was 92.9% (13/14) after the first cycle and was maintained at this level after subsequent cycles. ECOG performance status remained stable in the majority of patients, with improvement (from grade 2 to 1) observed in 2 cases (14.3%). KPS improved in 71.4% (10/14) of all patients after treatment. 68Ga-DOTA-IBA PET/CT analysis showed PR in 50.0% (7/14), SD in 35.7% (5/14), and PD in 14.2% (2/14). Among 7 patients who had previously received 177Lu-DOTA-IBA, 57.1% (4/7) improved in KPS, and 85.7% (6/7) in NRS. Regarding imaging response in these 7 patients, 42.9% (3/7) achieved PR, 42.9% (3/7) had SD, and 14.3% (1/7) showed PD. Subgroup analysis revealed that patients with bone-only metastases (n=9) had a significantly higher rate of KPS improvement (77.8% vs. 60.0%, P=0.012) and achieved a greater median reduction in pain scores (3.0 vs. 2.0 points, P=0.008). CONCLUSIONS: This study indicated that 225Ac-DOTA-IBA was a promising and well-tolerated therapeutic for bone metastases, demonstrating acceptable toxicity and notable efficacy, including 177Lu-DOTA-IBA-refractory cases. Subgroup analyses indicated that patients with bone-only metastases derived particular clinical benefit.
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