المؤلفون: Natally Horvat, Elizabeth Santana dos Santos, Daniela Reis Joaquim de Freitas, Frederico Costa, Regis Franca, Jack A. Tuszynski, Leonardo Testagrossa, Brenda Gumz, Fernanda Reis de Azevedo, Denis Leonardo Fontes Jardim, Antônio Francisco Iemma, Pablo Diego Lima, Tiago Biachi de Castria, Tulio Eduardo Flesch Pfiffer, Micelange Carvalho Sousa, Yone De Camargo Setogute, Jorge Sabbaga

المصدر: Journal of Clinical Oncology. 39:290-290

مصطلحات موضوعية: Oncology, Health related quality of life, Cancer Research, medicine.medical_specialty, business.industry, Standard treatment, Cancer, medicine.disease, Low energy, Quality of life, Internal medicine, Hepatocellular carcinoma, medicine, In patient, business

الوصف: 290 Background: Hepatocellular carcinoma (HCC) is a fatal cancer without curative option for most patients. Hence the importance to improve health related quality of life (HRQoL). Amplitude-modulated radiofrequency electromagnetic fields (EMF), as a novel and non-toxic therapy, has potential for improving HRQoL in advanced HCC patients. Methods: An open-label, single center, prospective clinical protocol was performed in advanced HCC patients as an initial and salvage treatment modality. Systemic exposure to EMF was used in combination with a systemic conventional treatment or as a single treatment. A spoon-shaped antenna placed in the oral cavity delivered EMF over 90 minutes with monthly repetitions until death or consent withdrawal. The effect on HRQoL was the primary objective of this study. Patients answered the EORTC-C30 v3.0 questionnaires prior to every EMF exposure. Clinically meaningful change (CMC) and time to deterioration (TTD) for Global Health (QoL), Role Functioning (RF) and Physical Functioning (PF) were used in the analysis. Results: From March 2018 to April 2020, 55 advanced HCC patients were submitted to 373 EMF exposures. 41/55 (75%) patients had repetitive exposures (mean # 4, ranging from 2-16). 87% were male, median age was 67, 84% were BLCL-C, 16% were Child-Pugh B, 29% had extra-hepatic metastasis, 55% had failed previous treatment and 71% had documented radiological progression. 31(56%) patients received EMF in combination with systemic therapy (28 TKI and 3 anti-PDL1). 24 patients received EMF as a single treatment modality. The mean baseline score was 68.1 for QoL and 77.1 for RF and PF. 61%, 76% and 49% of patients experienced positive change in QoL, RF and PS scores immediately prior to the second exposure, respectively. +CMC was reported in 20%, 17% and 32% of patients, respectively for QoL, RF and PS. The median QoL TTD was not reached. The median RF TTD was 7.2 month and the median PF TTD was 11.9 month. The median RF TTD for patients in combination treatment was 11.4 months and in a single treatment was 13.5 month. The median PF TTD for patients in combination treatment was 12.8 months and in single treatment was 14.5 month. Conclusions: Advanced HCC patients showed positive changes in QoL, RF and PF HRQoL scores after single exposure to EMF. The benefit from EMF in HRQoL was durable both in combination with TKI or as a single modality in advanced HCC patients. These results support future development as a novel palliative treatment modality in advanced HCC patients. Clinical trial information: NCT 01686412.

URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_________::c002e62c511a0c4b20945a742721fd8f
https://doi.org/10.1200/jco.2021.39.3_suppl.290

المؤلفون: Natally Horvat, Pablo Diego Lima, Tiago Biachi de Castria, Tatiana Zanesco, Regis Franca, Jack A. Tuszynski, Yone De Camargo Setogute, Jorge Sabbaga, Elizabeth Santana dos Santos, Daniela Reis Joaquim de Freitas, Denis Leonardo Fontes Jardim, Frederico Costa, Leonardo Testagrossa, Antônio Francisco Iemma, Fernanda Reis de Azevedo, Brenda Gumz, Micelange Carvalho Sousa, Luciana Carvalho

المصدر: Journal of Clinical Oncology. 39:332-332

مصطلحات موضوعية: Electromagnetic field, Cancer Research, Amplitude, Low energy, Oncology, business.industry, Standard treatment, Hepatocellular carcinoma, medicine, Cancer research, In patient, medicine.disease, business

الوصف: 332 Background: Exposure to amplitude-modulated radiofrequency electromagnetic fields (EMF) in immortalized hepatocellular carcinoma (HCC) cell cultures and xenograft models demonstrated anti-tumor effect. Patients with advanced HCC exposed to systemic EMF showed objective response with potential survival benefit. Methods: An open-label, single center, prospective clinical protocol was performed in advanced HCC patients as an initial, second or third treatment modality. Systemic exposure to EMF modulated at patient-specific frequencies was applied as an add-on strategy (combination) to systemic conventional treatment or as a single therapeutic modality. A spoon-shaped antenna placed in the oral cavity delivered EMF over 90 minutes with monthly repetitions until death or consent of withdrawal. The primary objective was overall survival (OS) in comparison with historical control group of 45 advanced patients HCC from the same institution. Retrospective radiological review was conducted by two independent radiologists for objective response (OR) using RECIST1.1 criterion. Results: From March 2018 to April 2020, 55 advanced HCC patients were submitted to 373 EMF exposures. 87% were male, median age of 67, 84% were BLCL-C, 16% were Child-Pugh B, 29% had extra-hepatic metastasis, 55% had failed previous treatment and 71% had documented radiological progression. 31(56%) patients received EMF in combination with systemic therapy (25 sorafenib, 3 lenvatinib, 3 nivolumab). 24 patients received EMF as single treatment modality. The median OS for the entire patient cohort was 11.5 months. The median OS for combination treatment was 12.0 month and the median OS for single modality was 11.3 months. The median OS for the historical control was 5.3 month. The median OS from the entire cohort and the historical control were significant different (p = 0.0026) but the median OS from combination and single modality were not (p = 0.3434). Radiological images were available from 38(69%) patients. There were 6/38 (16%) documented objective responses (1 CR and 5 PR) and 30/38 (79%) patients experienced disease control. 4/21 (19%) OR were in patients using TKIs + EMF and 2/17 (12%) OR were in patients using EMF alone. Conclusions: EMF showed objective anti-tumor effect in combination with TKI or as single modality in advanced HCC patients. EMF showed improvement in overall survival in comparison with the historical control group supporting future development as a novel systemic treatment modality in advanced HCC patients. Clinical trial information: NCT 01686412.

URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_________::a860db62f8222351a15bbf9a102bd671
https://doi.org/10.1200/jco.2021.39.3_suppl.332