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An Exploratory Study of Sequential Transarterial Chemoembolization With Lipiodol and Neoadjuvant Chemotherapy in the Treatment of Initial Unresectable Colorectal Cancer (CRC)

ABSTRACT: This is a prospective, open-labelled study to evaluate the efficacy and safety of sequetial transarterial chemoembolization with lipiodol and neoadjuvant chemotherapy in the treatment of initial unresectable colorectal cancer. The progression-free-survival (PFS) will be evaluated as the primary endpoints.

DISEASE(S): Colorectal Cancer,Colorectal Neoplasms

PROVIDER: 2719684 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:BACKGROUND:Optimal administration of transarterial chemoembolization (TACE), the standard approach for intermediate-stage hepatocellular carcinoma (HCC), requires clinical and technical expertise. We sought to evaluate whether TACE retains its effectiveness when administered across a broad range of health care settings. Furthermore, as the use of yttrium(90) (Y(90)) radioembolization has been increasing, we explored the comparative effectiveness of Y(90) as an alternative to TACE. METHODS:Patients with HCC diagnosed from 2004 through 2009 treated initially with TACE or Y(90) were identified from the SEER-Medicare linkage. Key covariates included prediagnosis ?-fetoprotein (AFP) screening, complications of cirrhosis, and tumor extent. Effect of treatment, patient, and health care system factors on overall survival (OS) was evaluated using multivariable Cox proportional hazards. Stratified OS estimates are provided. Propensity score (PS) weighting was used to compare effectiveness of Y(90) with TACE. RESULTS:Of 1528 patients who underwent intra-arterial embolization, 577 received concurrent chemotherapy (eg, TACE). Median OS was 21 months (95% CI, 18-23) following TACE and 9 months (95% CI, 1-41) following Y(90). Refined survival estimates stratified by stage, AFP screening, and liver comorbidity are presented. The 90-day mortality rate after TACE was 21% to 25% in patients with extrahepatic spread or vascular invasion. In the PS-weighted analysis, Y(90) was associated with inferior survival, with an adjusted hazard ratio of 1.39 (95% CI, 1.02-1.90). CONCLUSIONS:The effectiveness of TACE is generalizable to Medicare patients receiving care in a variety of treatment settings. However, early posttreatment mortality is high in patients with advanced disease. We found no evidence of improved outcomes with Y(90) compared with TACE. Survival estimates from this large cohort can be used to provide prognostic information to patients considering palliative TACE.

Project description:Colorectal cancer is the third most frequently diagnosed cancer and the third leading cause of cancer related deaths in Taiwan. Of the 10,248 new colorectal patients diagnosed each year approximately 60% will develop liver metastasis during the course of their disease. In approximately 30% of these patients who develop liver metastasis the metastatic disease will remain confined to the liver. For the 70-75% of colorectal patients with colorectal liver metastasis not suitable for hepatic resection or similarly ablative therapy with curative intent, systemic chemotherapy is the standard initial management. However, after a patient has failed first- line and in some cases second-line chemotherapy, response rates fall to as low as 12% (Chen HX 2006). Transarterial chemoembolization (TACE) with microsphere is an alternative treatment because normal liver tissue receives most of its blood supply from the portal vein, while colorectal liver metastases derive most of their flow from the hepatic artery. Several clinical trials have explored the feasibility and the efficacy of TACE with microsphere as a treatment for patients with colorectal liver metastasis. HepaSphere represents a novel drug delivery system for chemoembolization, which can add two benefits to embolization therapy. First, by ionically binding the doxorubicin throughout the microspheres, more drug can be delivered into the tumor, with less escape into peripheral circulation. Second, conformability to the architecture of the vessel lumen, providing more contact surface area with the embolic material and the vessel intima, leading to a more complete occlusion. However, there are limited experiences in using HepaSphere TACE for colorectal liver metastasis in Taiwan. In this pilot study, we will evaluate the initiate safety and efficacy of Hepasphere microspheres loaded with a chemotherapeutic agent doxorubicin for the treatment of patients who have failed first-line and second-line systemic chemotherapy.

Project description:AimsThe purpose of the present study was to compare the efficacies of transarterial chemoembolization (TACE) combined with sorafenib versus TACE monotherapy for treating patients with advanced hepatocellular carcinoma (HCC).MethodsWe enrolled 321 patients and selected 280 with advanced HCC (Barcelona Clinic Liver Cancer stage C) who underwent TACE therapy between February 2009 and February 2013. TACE alone (monotherapy group) was administered to 198 patients (70.7%), and the remaining 82 (29.3%) underwent repeat combined TACE and sorafenib therapy (combined group). To minimize selection bias, these latter 82 patients were matched using propensity-score matching at a 1∶2 ratio with 164 patients who received TACE monotherapy. The primary endpoints were overall survival (OS) and related subgroup analysis. The secondary endpoints were time to progression (TTP) and treatment-related adverse events.ResultsOf the respective patients in the combined and monotherapy groups, 64.6% and 49.2% had vascular invasion, 87.8% and 91.1% had extrahepatic metastasis, and 54.3% and 47.1% had both. In the propensity-score-matched cohort, the OS survival of the combined group was significantly higher compared with the monotherapy group (7.0 months vs. 4.9 months, respectively, P = 0.003). The TTP was significantly longer in the combined group (2.6 months vs. 1.9 months, respectively, P = 0.001). Subgroup analysis showed that the outcomes of patients with advanced HCC without main portal vein invasion who were treated with combined therapy were significantly better compared with those who received monotherapy (P<0.05). Univariate and subsequent multivariate analyses revealed that the addition of sorafenib was an independent predictor of favorable OS and TTP (adjusted hazard ratios, 0.63 and 0.62, respectively; P<0.05 for both).ConclusionSorafenib plus TACE was more effective than TACE monotherapy for treating patients with advanced HCC without main portal vein invasion. Future trials with larger samples are required to validate these preliminary findings.

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An Exploratory Study of Sequential Transarterial Chemoembolization With Lipiodol and Neoadjuvant Chemotherapy in the Treatment of Initial Unresectable Colorectal Cancer (CRC)

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