Randomized Phase II Study of 5-Fluorouracil Hepatic Arterial Infusion with or without Antineoplastons as an Adjuvant Therapy after Hepatectomy for Liver Metastases from Colorectal Cancer
| Autor: | Keiko Matono, Shinji Uchida, Hideaki Tsuda, Yoshito Akagi, Masataka Ushijima, Kazuo Shirouzu, Yutaka Ogata |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2015 |
| Předmět: |
medicine.medical_specialty
Pathology Antimetabolites Antineoplastic animal structures Colorectal cancer Science medicine.medical_treatment Glutamine Benzeneacetamides Gastroenterology chemistry.chemical_compound Hepatic arterial infusion Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Adjuvant therapy Hepatectomy Humans Infusions Intra-Arterial Piperidones Aged Phenylacetates Multidisciplinary business.industry Liver Neoplasms Middle Aged medicine.disease Survival Analysis Drug Combinations Phenylacetylglutamine Phenylacetate Treatment Outcome chemistry Fluorouracil Chemotherapy Adjuvant Antineoplaston A10 Medicine business Colorectal Neoplasms medicine.drug Research Article |
| Zdroj: | PLoS ONE PLoS ONE, Vol 10, Iss 3, p e0120064 (2015) |
| ISSN: | 1932-6203 |
| Popis: | BackgroundAntineoplastons are naturally occurring peptides and amino acid derivatives found in human blood and urine. Antineoplaston A10 and AS2-1 reportedly control neoplastic growth and do not significantly inhibit normal cell growth. Antineoplastons contain 3-phenylacetylamino-2, 6-piperidinedione (A10), phenylacetylglutamine plus phenylacetylisoglutamine (A10-I), and phenylacetylglutamine plus phenylacetate (AS2-1). This open label, non- blinded randomized phase II study compared the efficacy of hepatic arterial infusion (HAI) with 5-fluorouracil,with or without antineoplastons as a postoperative therapy for colorectal metastasis to the liver.MethodsSixty-five patients with histologically confirmed metastatic colon adenocarcinoma in liver, who had undergone hepatectomy, and/or thermal ablation for liver metastases were enrolled between 1998- 2004 in Kurume University Hospital. Patients were randomly assigned to receive systemic antineoplastons (A10-I infusion followed by per-oral AS2-1) plus HAI (AN arm) or HAI alone (control arm) based on the number of metastases and presence/ absence of extra-hepatic metastasis at the time of surgery. Primary endpoint was cancer-specific survival (CSS); secondary endpoints were relapse-free survival (RFS), status and extent of recurrence, salvage surgery (rate) and toxicity.FindingsOverall survival was not statistically improved (p=0.105) in the AN arm (n=32). RFS was not significant (p=0.343). Nevertheless, the CSS rate was significantly higher in the AN arm versus the control arm (n=33) with a median survival time 67 months (95%CI 43-not calculated) versus 39 months (95%CI 28-47) (p=0.037) and 5 year CSS rate 60% versus 32% respectively. Cancer recurred more often in a single organ than in multiple organs in the AN arm versus the control arm. The limited extent of recurrent tumours in the AN arm meant more patients remained eligible for salvage surgery. Major adverse effects of antineoplastons were fullness of the stomach and phlebitis. No serious toxicity, including bone marrow suppression, liver or renal dysfunction, were found in the AN arm.InterpretationAntineoplastons (A10 Injection and AS2-1) might be useful as adjunctive therapy in addition to HAI after hepatectomy in colorectal metastases to the liver.Trial registration informationClinicalTrials.gov UMIN000012099. |
| Databáze: | OpenAIRE |
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