Y90 Radioembolization of Colorectal Hepatic Metastases using Glass Microspheres: Safety and Survival Outcomes from a 531-Patient Multicenter Study (original) (raw)

Survival Outcomes of a Salvage Patient Population after Radioembolization of Hepatic Metastases with Yttrium-90 Microspheres

Journal of Vascular and Interventional Radiology, 2010

To determine in a retrospective study the potential benefit on survival outcomes of radioembolization using yttrium-90 ( 90 Y) resin microspheres in a cohort of patients presenting with chemotherapy-refractory liver metastases, primarily from colorectal cancer (CRC). MATERIALS AND METHODS: Over 3 years, 249 patients were referred to the authors' center to determine suitability for radioembolization as treatment for hepatic metastases. All patients were defined as salvage, having failed first-line and second-line chemotherapies. These patients were divided into group 1 (CRC) and group 2 (all other cancers, eg, breast, neuroendocrine) and assessed for overall survival (OS) as a whole and according to group. RESULTS: Using 90 Y resin microspheres, 208 patients were treated, undergoing 223 radioembolization treatments. The median OS was 8.3 months for the whole cohort, 7.9 months for group 1, and 8.7 months for group 2. At the 3-month follow-up, there was an overall adverse event rate of 9%. At the end of the data collection period, 62 patients were still alive.

Radioembolization of colorectal hepatic metastases using yttrium-90 microspheres

Cancer, 2009

The objective of the current study was to determine the safety and efficacy of Yttrium-90 (Y90) microsphere treatment in patients with liver-dominant colorectal metastases. METHODS: Seventytwo patients with unresectable hepatic colorectal metastases were treated at a targeted absorbed dose of 120 Gray (Gy). Safety and toxicity were assessed using version 3 of the National Cancer Institute Common Terminology Criteria. Response was assessed by anatomic imaging and positron emission tomography (PET). Survival from the diagnosis of hepatic metastases and first treatment were estimated using the Kaplan-Meier method. Substratification analyses were performed. RESULTS: The median dose delivered was 118 Gy. Treatment-related toxicities included fatigue (61%), nausea (21%), and abdominal pain (25%).

Radioembolization with (90)Y glass microspheres for the treatment of unresectable metastatic liver disease from chemotherapy-refractory gastrointestinal cancers: final report of a prospective pilot study

Journal of gastrointestinal oncology, 2016

This prospective pilot single-institution study was undertaken to document the feasibility, safety, and efficacy of radioembolization of liver-dominant metastatic gastrointestinal cancer using (90)Y glass microspheres. Between June 2010 and October 2013, 42 adult patients (26 men, 16 women; median age 60 years) with metastatic chemotherapy-refractory unresectable colorectal (n=21), neuroendocrine (n=11), intrahepatic bile duct (n=7), pancreas (n=2), and esophageal (n=1) carcinomas underwent 60 lobar or segmental administrations of (90)Y glass microspheres. Data regarding clinical and laboratory adverse events (AE) were collected prospectively for up to 5.5 years after radioembolization. Radiographic responses were evaluated using Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. Time to maximum response, response duration, progression-free survival (PFS) (hepatic and extrahepatic), and overall survival (OS) were measured. Median target dose and activity were 109.4 ...

Yttrium-90 microsphere radioembolization for treatment of lung cancer hepatic metastases

2012

Radioembolization with yttrium-90 microspheres ( 90 Y-RE), either glass-or resin-based, is increasingly applied in patients with unresectable liver malignancies. Clinical results are promising but overall response and survival are not yet known. Therefore a meta-analysis on tumor response and survival in patients who underwent 90 Y-RE was conducted. Based on an extensive literature search, six groups were formed. Determinants were cancer type, microsphere type, chemotherapy protocol used, and stage (deployment in firstline or as salvage therapy). For colorectal liver metastases (mCRC), in a salvage setting, response was 79% for 90 Y-RE combined with 5-fluorouracil/ leucovorin (5-FU/LV), and 79% when combined with 5-FU/LV/oxaliplatin or 5-FU/LV/irinotecan, and in a first-line setting 91% and 91%, respectively. For hepatocellular carcinoma (HCC), response was 89% for resin microspheres and 78% for glass microspheres. No statistical method is available to assess median survival based on data presented in the literature. In mCRC, 90 Y-RE delivers high response rates, especially if used neoadjuvant to chemotherapy. In HCC, 90 Y-RE with resin microspheres is significantly more effective than 90 Y-RE with glass microspheres. The impact on survival will become known only when the results of phase III studies are published.

Yttrium-90 microsphere radioembolization for the treatment of liver malignancies: a structured meta-analysis

European Radiology, 2008

Radioembolization with yttrium-90 microspheres (90 Y-RE), either glass-or resin-based, is increasingly applied in patients with unresectable liver malignancies. Clinical results are promising but overall response and survival are not yet known. Therefore a meta-analysis on tumor response and survival in patients who underwent 90 Y-RE was conducted. Based on an extensive literature search, six groups were formed. Determinants were cancer type, microsphere type, chemotherapy protocol used, and stage (deployment in firstline or as salvage therapy). For colorectal liver metastases (mCRC), in a salvage setting, response was 79% for 90 Y-RE combined with 5-fluorouracil/ leucovorin (5-FU/LV), and 79% when combined with 5-FU/LV/oxaliplatin or 5-FU/LV/irinotecan, and in a first-line setting 91% and 91%, respectively. For hepatocellular carcinoma (HCC), response was 89% for resin microspheres and 78% for glass microspheres. No statistical method is available to assess median survival based on data presented in the literature. In mCRC, 90 Y-RE delivers high response rates, especially if used neoadjuvant to chemotherapy. In HCC, 90 Y-RE with resin microspheres is significantly more effective than 90 Y-RE with glass microspheres. The impact on survival will become known only when the results of phase III studies are published.

Multi-centre phase II clinical trial of yttrium-90 resin microspheres alone in unresectable, chemotherapy refractory colorectal liver metastases

British journal of cancer, 2010

This multi-centre phase II clinical trial is the first prospective evaluation of radioembolisation of patients with colorectal liver metastases (mCRC) who failed previous oxaliplatin- and irinotecan-based systemic chemotherapy regimens. Eligible patients had adequate hepatic, haemopoietic and renal function, and an absence of major hepatic vascular anomalies and hepato-pulmonary shunting. Gastroduodenal and right gastric arteries were embolised before hepatic arterial administration of yttrium-90 resin microspheres (median activity, 1.7 GBq; range, 0.9-2.2). Of 50 eligible patients, 38 (76%) had received > or =4 lines of chemotherapy. Most presented with synchronous disease (72%), >4 hepatic metastases (58%), 25-50% replacement of total liver volume (60%) and bilateral spread (70%). Early and intermediate (>48 h) WHO G1-2 adverse events (mostly fever and pain) were observed in 16 and 22% of patients respectively. Two died due to renal failure at 40 days or liver failure at ...

TheraSphere Yttrium-90 Glass Microspheres Combined With Chemotherapy Versus Chemotherapy Alone in Second-Line Treatment of Patients With Metastatic Colorectal Carcinoma of the Liver: Protocol for the EPOCH Phase 3 Randomized Clinical Trial (Preprint)

2018

BACKGROUND Colorectal cancer is one of the most common cancers and causes of cancer-related death. Up to approximately 70% of patients with metastatic colorectal cancer (mCRC) have metastases to the liver at initial diagnosis. Second-line systemic treatment in mCRC can prolong survival after development of disease progression during or after first-line treatment and in those who are intolerant to first-line treatment. OBJECTIVE The objective of this study is to evaluate the efficacy and safety of transarterial radioembolization (TARE) with TheraSphere yttrium-90 (90Y) glass microspheres combined with second-line therapy in patients with mCRC of the liver who had disease progression during or after first-line chemotherapy. METHODS EPOCH is an open-label, prospective, multicenter, randomized, phase 3 trial being conducted at up to 100 sites in the United States, Canada, Europe, and Asia. Eligible patients have mCRC of the liver and disease progression after first-line chemotherapy wit...

Hepatic imaging response to radioembolization with yttrium-90-labeled resin microspheres for tumor progression during systemic chemotherapy in patients with colorectal liver metastases

Journal of gastrointestinal oncology, 2015

To assess response and the impact of imaging artifacts following radioembolization with yttrium-90-labeled resin microspheres ((90)Y-RE) based on the findings from a central independent review of patients with liver-dominant metastatic colorectal cancer (mCRC). Patients with mCRC who received (90)Y-RE (SIR-Spheres(®); Sirtex Medical, Sydney, Australia) at nine US institutions between July 2002 and December 2011 were included in the analysis. Tumor response was assessed at baseline and 3 months using either the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 or 1.1. For each lesion, known artifacts affecting the interpretation of response (peri-tumoral edema and necrosis) were documented. Survivals (Kaplan-Meier analyses) were compared in responders [partial response (PR)] and non-responders [stable (SD) or progressive disease (PD)]. Overall, 195 patients (mean age 62 years) received (90)Y-RE after a median of 2 (range, 1-6) lines of prior chemotherapy. Using RECIST...

Patterns of Failure in Colorectal Patients With Liver Metastases After Yttrium-90 Radioembolization

American Journal of Clinical Oncology, 2014

Objectives: To assess patterns of failure and factors affecting recurrence patterns in colorectal cancer patients treated with 90 Y-labeled resin microspheres for metastatic liver disease. Methods: We retrospectively reviewed 30 colorectal patients treated with Yttrium-90 radioembolization and assessed follow-up computed tomography scans and positron emission tomography scans to determine disease outcomes. All patients were included in survival analysis. Twenty-six patients with hepatic metastases were assessed for patterns of failure after radioembolization treatment and grouped into 3 patterns: (1) hepatic; (2) extrahepatic; and (3) intrahepatic and extrahepatic. Results: The median overall survival and progression-free survival for all colorectal patients treated with radioembolization was 9.4 and 3.2 months, respectively. Overall survival and progression-free survival were not significantly different between patterns of failure (P = 0.43 and 0.26, respectively). Logistic regression analysis demonstrated a trend toward the predictive value of tumor volume in determining patterns of failure. Smaller tumor volumes had a higher predictive probability for extrahepatic failure than larger tumor volumes (P = 0.057). Tumor volumes <300 mL were predictive for extrahepatic failure patterns compared with hepatic recurrence (P = 0.046). Conclusions: Radioembolization with 90 Y-labeled resin microspheres continues to be an effective salvage treatment for colorectal liver metastases. Analysis of patterns of radiologic failure demonstrated that patients treated by radioembolization develop a greater proportion of extrahepatic failure. Tumor volumes >300 mL were predictive for hepatic recurrence, suggesting that increased dosing or retreatment of these lesions may lead to improved hepatic control of disease and better patient outcomes.