Fundora Ramos Mercedes Iveet, Maden Lourdes Boulet, Casanova Fernando Oriol, Cruz Frank Hernández, Reyes Carina Salgado, Gato Adalberto Hernandez, Lyncon Israel Benítez, González Etna Vega, Morales Katia Palau, Lence Juan J, Sanz Eduardo
Department of Oncology, Hospital Universitario 'General Calixto Garcia', Havana CP10400, Cuba.
Department of Urologic, Hospital Universitario 'General Calixto Garcia', Havana CP10400, Cuba.
Mol Clin Oncol. 2021 Jan;14(1):5. doi: 10.3892/mco.2020.2167. Epub 2020 Nov 5.
The aim of the present study was to identify the efficacy and safety of Oncoxin-Viusid (OV) as a supportive treatment for patients with prostate cancer (PCA). A prospective, non-randomised, open-label phase II clinical trial, including 25 patients with hormone-refractory PCA (HRPC) was conducted at the Hospital Universitario General Calixto García (Havana, Cuba) between June 2017 and March 2018. Each of the patients received chemotherapy (CTX) and/or radiotherapy (RT) and OV treatment. Patients had a mean age of 73 years, clinical stage IV cancer and a high risk of relapse. Six cycles of CTX were completed by 80% of the patients, adverse reactions decreased and no weight loss was observed. Among the 25 patients, 5 were lost to follow-up and 4 died of disease progression. A total of 16 of these patients survived, of which 15 had an improved quality of life and 10 responded to treatment, with a significant reduction in pain and prostate symptoms and ≥50% reduction in baseline PSA. The progression-free survival (PFS) rate was 59% and the overall survival (OS) rate 64% at 1 year after treatment began. The OV nutritional supplement was effective, leading to a significant improvement in the patients' quality of life, good nutritional status and greater treatment tolerance. A clinical and humoral response was observed, with high survival rates and a delayed appearance of signs of disease progression. The present study was registered in ClinicalTrials.gov PRS with ID #NCT03543670.
本研究的目的是确定Oncoxin-Viusid(OV)作为前列腺癌(PCA)患者支持性治疗的疗效和安全性。2017年6月至2018年3月期间,在哈瓦那的加西亚将军大学医院(Hospital Universitario General Calixto García)开展了一项前瞻性、非随机、开放标签的II期临床试验,纳入了25例激素难治性PCA(HRPC)患者。每位患者均接受了化疗(CTX)和/或放疗(RT)以及OV治疗。患者的平均年龄为73岁,临床分期为IV期癌症,复发风险高。80%的患者完成了6个周期的CTX治疗,不良反应减少,未观察到体重减轻。25例患者中,5例失访,4例死于疾病进展。这些患者中共有16例存活,其中15例生活质量得到改善,10例对治疗有反应,疼痛和前列腺症状显著减轻,基线PSA降低≥50%。治疗开始后1年时,无进展生存期(PFS)率为59%,总生存期(OS)率为64%。OV营养补充剂有效,可显著改善患者的生活质量、营养状况良好并提高治疗耐受性。观察到临床和体液反应,生存率高,疾病进展迹象出现延迟。本研究已在ClinicalTrials.gov PRS上注册,注册号为#NCT03543670。