RESUMEN
This prospective nonrandomized, multicenter clinical trial was performed to investigate the efficacy and safety of 131I-labeled metuximab in adjuvant treatment of unresectable hepatocellular carcinoma. Methods: Patients were assigned to treatment with transcatheter arterial chemoembolization (TACE) combined with 131I-metuximab or TACE alone. The primary outcome was overall tumor recurrence. The secondary outcomes were safety and overall survival. Results: The median time to tumor recurrence was 6 mo in the TACE + 131I-metuximab group (n = 160) and 3 mo in the TACE group (n = 160) (hazard ratio, 0.55; 95% CI, 0.43-0.70; P < 0.001). The median overall survival was 28 mo in the TACE + 131I-metuximab group and 19 mo in the TACE group (hazard ratio, 0.62; 95% CI, 0.47-0.82; P = 0.001). Conclusion: TACE + 131I-metuximab showed a greater antirecurrence benefit, significantly improved the 5-y survival of patients with advanced hepatocellular carcinoma, and was well tolerated by patients.
Asunto(s)
Carcinoma Hepatocelular , Quimioembolización Terapéutica , Neoplasias Hepáticas , Anticuerpos Monoclonales , Carcinoma Hepatocelular/patología , Quimioembolización Terapéutica/efectos adversos , Terapia Combinada , Arteria Hepática/patología , Humanos , Radioisótopos de Yodo , Neoplasias Hepáticas/patología , Recurrencia Local de Neoplasia , Estudios Prospectivos , Resultado del TratamientoRESUMEN
The objective of this study is to evaluate the efficacy and safety of combining low-dose, short-interval target vessel regional chemotherapy delivered through the hepatic artery (TVRC) with transarterial embolization (TAE) in advanced gastric cancer (AGC) patients with liver metastases after failure of first-line or second-line chemotherapy. All AGC patients with hepatic metastases had an indwelling arterial catheter placed in the hepatic artery and hepatic metastases were embolized with ultrafluid lipiodol, followed by two to three TVRC treatments in one cycle. After 3 weeks, the efficacy of TVRC treatment was evaluated using computed tomography (CT) or MRI scans before starting the next cycle. Follow-up assessments were performed every 2 months. The patients received a median of 7 (2-33) TVRC treatments together with TAE. All 22 AGC patients received a total of 191 TVRC treatments, which included 80.1% FOLFOX, 11.0% FOLFIRI, and 8.9% DC treatments. The median time-to-progression was 5.97 months; the median survival time was 11.6 months; and the 1-year and 2-year survival rates were 45.5 and 9.1%, respectively. The median overall survival from the diagnosis of liver metastasis (mOS) was 19.3 months. The most common side effects were grade I-II of abdominal pain, nausea, and vomiting. Combining TAE and TVRC administration through the hepatic artery for AGC patients with liver metastases resulted in decreased overall dose of chemotherapy, alleviation of side effects, and increased QOL of patient. This approach can be used as salvage therapy for AGC patients with predominant liver metastases after failure of intravenous chemotherapy.