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Antineoplastons as adjuvant therapy improve survival rate after hepatectomy

In a phase 2 clinical trial, antineoplastons, such as A10 injection and AS2-1, were a useful form of adjunctive therapy after hepatic arterial infusion, and improved cancer-specific survival in patients with liver metastases from colorectal cancer, according to study data.

Sixty-five patients with metastatic colon adenocarcinoma of the liver who had undergone hepatectomy or thermal ablation for liver metastases, were randomly assigned to receive systemic antineoplastons (A10-I infusion, then AS2-1) with hepatic arterial infusion (n = 32, HAI) or HAI alone (n = 33). The primary endpoint was cancer-specific survival (CSS), according to the research.

Upon completion of therapy, overall survival in the antineoplastons group did not improve a great deal (P = .105) and relapse-free survival also did not improve (P = .343). However, CSS rate was longer in the antineoplastons/HAI group with a median survival time of 67 months vs. the HAI alone group with a median of 39 months.  The 5-year CSS rate was 60% in the antineoplastons/HAI group vs. 32% in the HAI alone group. Patients in the antineoplastons/HAI group experienced cancer recurrence more often in a single organ as opposed to multiple organs compared with the HAI alone group. More patients in the antineoplastons/HAI group compared with the HAI alone group experienced full stomach (8 vs. 2; P = .044) and phlebitis (6 vs. 0; P < .024), the only significantly different adverse events between the two groups. Serious toxicity was not observed in the antineoplastons/HAI group.  

“The administration of antineoplaston AS2-1 may be clinically effective as a postoperative adjuvant therapy in liver metastasis from colorectal cancer,” the researchers concluded. “The results of this study have warranted the initiation of a new randomized, controlled clinical trial of adjuvant therapy using antineoplaston A10 and AS2-1 combined with HAI after hepatectomy in patients with colorectal metastasis to the liver.” – by Melinda Stevens

Disclosure: The researchers report no relevant financial disclosures.