Olaine R. Gray Lovio, Alfredo Abreu Daniel, Liset A. García Yánez, Marta Osorio Rodríguez, Carlos Vásquez González, Juan J. Lence Anta and Eduardo Sanz
Objective: Surgery is the treatment of choice of melanoma, but in advanced stages, it is often necessary to combine this with other therapeutic options. Oncoxin-Viusid has demonstrated antitumor and immunomodulating effects in various type of cancers, in addition to boosting the antiproliferative effect of standard chemotherapy agents in experimental studies. Our study was aimed to identify the efficacy and safety of the Oncoxin-Viusid as an adjuvant treatment for patients with stage IIB-III cutaneous melanomas.
Methods: From September 2014 to June 2017, a proof of concept, open label nonrandomized and uncontrolled study was conducted at the Manuel Fajardo University Hospital (Havana, Cuba), including 20 patients with histologically confirmed diagnosis of stage IIB-III of primary cutaneous melanoma. All patients received surgical treatment with or without chemotherapy in combination with Oncoxin-Viusid 25 ml twice a day for 1 year. Progression-free survival rate with its 95% confidence interval was estimated after one year of inclusion and quality of life was measured at inclusion and after a year using QLQ-C-30 EORTC questionnaire.
Results: Most of the patients were women with a median age of 59 years, cutaneous phototypes II-III, occupations without photo exposure, without personal history of skin cancer or family of cutaneous melanoma. 40% of patients presented with superficial spreading melanoma, epithelioid presentation being histologically predominant. Adverse reactions were, for the most part, mild and short-lived. Only 2 patients progressed and one of them died. Two patients were early withdrawal to follow-up. The progression-free survival rate was 90% (95% CI: 0.65-0.97).
Conclusion: Nutritional supplement Oncoxin-Viusid showed safety; meanwhile patients kept a stable quality of life at the end of study and a high progression-free survival rate.
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