Safety and Efficacy of amplitude-modulated radiofrequency electromagnetic fields in advanced hepatocellular carcinoma

Abstract

IMPORTANCE: Hepatocellular carcinoma (HCC) is the third leading cause of cancer death worldwide. Despite the recent approval of several new agents, long-term disease control remains elusive for most patients. Administration of 27.12 MHz radiofrequency (RF) electromagnetic fields (EMF) by means of a spoon-shaped antenna (TheraBionic P1 device) placed on the anterior part of the tongue results in systemic delivery of low and safe levels of RF EMF from head to toe. OBJECTIVE: To report treatment outcomes and adverse events associated with treatment with the TheraBionic P1 device in comparison to suitable historical placebo and actively treated controls. DESIGN: Pooled case series with comparison to historical controls. PARTICIPANTS: Patients with advanced HCC receiving this treatment, 18 real-world patients and 41 patients from a previously reported phase II study. Historical controls from previously conducted clinical trials. INTERVENTIONS: Three hours daily treatment with the TheraBionic P1 device compared with standard of care as received by historical controls in the previously conducted trials. MAIN OUTCOMES AND MEASURES: Overall survival (OS), time to progression, response rate, and adverse events in the combined pooled patients and in appropriate subgroups comparable to the historical control groups. RESULTS: In the pooled treatment group, median OS of patients with Child-Pugh A disease ( = 32) was 10.36 (95% CI 5.42-14.07) months, 4.44 (95% CI 1.64-7.13) months for patients with Child-Pugh B disease ( = 25), and 1.99 (95% CI 0.76-3.22) months for patients with Child-Pugh C disease ( = 2). Median OS for Child-Pugh A patients was 2.62 (33.9%) months longer than the 7.74 months OS of comparable historical controls ( = 0.036). The 4.73 (95% CI 1.18-8.28) months median OS for Child-Pugh B patients receiving TheraBionic P1 device as first line therapy is slightly higher than the 4.6 months median OS of historical controls receiving Sorafenib as first line therapy. Only grade 1 mucositis and fatigue were reported by patients using the device, even among Child-Pugh B and C patients. No patients discontinued treatment because of adverse events. CONCLUSIONS AND RELEVANCE: Treatment of advanced HCC with the TheraBionic P1 device is well tolerated, even in patients with severely impaired liver function, and results in improved overall survival compared to historical controls without any significant adverse events, even after many years of continuous treatment. This treatment modality appears to be well suited for patients who have failed or are intolerant to currently approved therapies.

AI evidence extraction

Main findings

In pooled patients treated with the TheraBionic P1 device, median OS was 10.36 months (Child-Pugh A, n=32), 4.44 months (Child-Pugh B, n=25), and 1.99 months (Child-Pugh C, n=2). Median OS for Child-Pugh A patients was 2.62 months longer than comparable historical controls (p=0.036); Child-Pugh B first-line therapy OS was slightly higher than historical controls receiving sorafenib. Reported adverse events were limited to grade 1 mucositis and fatigue, and no patients discontinued due to adverse events.

Outcomes measured

• overall survival (OS)
• time to progression
• response rate
• adverse events

Limitations

• Pooled case series design
• Comparison to historical controls (non-randomized)
• Use of previously reported phase II study plus real-world patients (potential heterogeneity)
• Very small Child-Pugh C subgroup (n=2)

{
    "study_type": "other",
    "exposure": {
        "band": "RF",
        "source": "medical device (TheraBionic P1 spoon-shaped antenna placed on tongue)",
        "frequency_mhz": 27.120000000000000994759830064140260219573974609375,
        "sar_wkg": null,
        "duration": "3 hours daily"
    },
    "population": "Patients with advanced hepatocellular carcinoma (HCC)",
    "sample_size": 59,
    "outcomes": [
        "overall survival (OS)",
        "time to progression",
        "response rate",
        "adverse events"
    ],
    "main_findings": "In pooled patients treated with the TheraBionic P1 device, median OS was 10.36 months (Child-Pugh A, n=32), 4.44 months (Child-Pugh B, n=25), and 1.99 months (Child-Pugh C, n=2). Median OS for Child-Pugh A patients was 2.62 months longer than comparable historical controls (p=0.036); Child-Pugh B first-line therapy OS was slightly higher than historical controls receiving sorafenib. Reported adverse events were limited to grade 1 mucositis and fatigue, and no patients discontinued due to adverse events.",
    "effect_direction": "benefit",
    "limitations": [
        "Pooled case series design",
        "Comparison to historical controls (non-randomized)",
        "Use of previously reported phase II study plus real-world patients (potential heterogeneity)",
        "Very small Child-Pugh C subgroup (n=2)"
    ],
    "evidence_strength": "low",
    "confidence": 0.7800000000000000266453525910037569701671600341796875,
    "peer_reviewed_likely": "yes",
    "keywords": [
        "hepatocellular carcinoma",
        "TheraBionic P1",
        "amplitude-modulated radiofrequency",
        "27.12 MHz",
        "radiofrequency electromagnetic fields",
        "overall survival",
        "historical controls",
        "adverse events"
    ],
    "suggested_hubs": []
}

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