Meeting Abstract | 2007 ASCO Annual Meeting

15155

Background: Phase I data show that low levels of electromagnetic fields modulated at specific frequencies administered intrabucally with the THERABIONIC device are a safe and potentially effective treatment for advanced cancer. The device emits a 27.12 MHz radiofrequency signal, amplitude-modulated at tumor-specific frequencies ranging from 0.2 to 23,000 Hz. The device is connected to a spoon- like coupler placed in the patient’s mouth during treatment. Patients with advanced HCC and limited therapeutic options were offered treatment with HCC-specific frequencies. Methods: From October 2005 to October 2006, 38 patients with advanced HCC were recruited in a phase II study. The patients received three daily 40 min treatments until disease progression or death. The median age was 64.0 ± 14.2 years. 32 patients were male and 29 patients had documented progression of disease (POD) by IV contrast imaging prior to study entry. 8 patients had not received prior therapy because of metastases (3), poor medical condition (3), declined chemotherapy (2). Results: As of January 2007, 12 patients are still on therapy, 20 patients died of tumor progression, 2 patients are lost to follow-up and 3 patients withdrew consent. 27 patients are eligible for response. The overall objective response rate as defined by partial response (PR) or stable disease (SD) in patients with prior documented POD was 31.6%: 3 PR and 9 SD. The median survival was 20.7 weeks with a median duration of therapy of 17.5 weeks. 13 patients have received therapy for more than six months. The median duration of response is 12.9 weeks. 12 patients reported pain at study entry: 8 of them (66%) experienced decreased pain during treatment. There were no NCI grade 2/3/4 toxicities. One patient had grade 1 mucositis and grade 1 fatigue. Conclusion: In patients with advanced HCC, THERABIONIC is a safe and effective novel therapeutic option, which has significant anti-tumor effect and provides pain relief in the majority of patients.

Table

Patient''s Characteristics (n=38)

Patient''s Characteristics (n=38)

Cirrhosis 36
Portal Vein Thrombosis 9
Elevated AFP 25
Extra-hepatic metastasis 12
Previus intra-hepatic/systemic therapy 30
Previous hepatic resection/RFA/Ethanol 8
CLIP score * 0/1: 12 >=2:22
Okuda score * I:14 II/III: 20
Child-Pugh * A:15 B:19
MELD * median: 10

Data presented as number of patients;

*analysis from 34 patients

No significant financial relationships to disclose.

American Society of Clinical Oncology

COMPANION ARTICLES

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ARTICLE CITATION

DOI: 10.1200/jco.2007.25.18_suppl.15155 Journal of Clinical Oncology 25, no. 18_suppl (June 20, 2007) 15155-15155.

Published online June 20, 2007.

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