A phase 1 trial of xentuzumab, an IGF-neutralizing antibody, in Japanese patients with advanced solid tumors.

Xentuzumab is an insulin-like growth factor (IGF) ligand-neutralizing antibody. This phase 1 trial assessed xentuzumab in Japanese patients with solid tumors. Patients aged ≥20 y old with solid tumors that were refractory or not amenable to standard therapy were enrolled. Patients received xentuzumab intravenously at a starting dose of 750 mg/wk. Dose escalation used a 3 + 3 design with dose de-escalation. The primary endpoint was to determine the maximum tolerated dose (MTD) of xentuzumab. Safety, pharmacokinetics, pharmacodynamics, and anti-tumor activity were also assessed. Fifteen patients received xentuzumab in the dose escalation part (750 mg/wk [n = 6]; 1000 mg/wk [n = 3]; 1400 mg/wk [n = 6]). There were no dose-limiting toxicities at any dose; the MTD of xentuzumab was not reached. Xentuzumab 1000 mg/wk was recommended as the relevant biological dose. Six further patients received xentuzumab 1000 mg/wk in an expansion cohort. Of 21 patients, 13 (61.9%) experienced a drug-related adverse event, most commonly fatigue (23.8%), neutropenia (19.0%), diarrhea, nausea, white blood cell count decrease, and muscle spasms (14.3% each). No relevant deviations from dose linearity of xentuzumab exposure were observed during dose escalation. Total IGF-1 and IGF-2 levels increased and bioactive IGF levels decreased from baseline to 24 h after the first infusion in cycle 1. Partial response was observed in 2 (9.5%) patients with desmoid-type fibromatosis. Disease control was achieved in 6 (28.6%) patients (median duration 42.4 mo). Xentuzumab monotherapy was well tolerated in Japanese patients and showed evidence of anti-tumor activity. This study was registered with www.clinicaltrials.gov (NCT02145741).

A randomized, controlled trial of the efficacy of percutaneous transesophageal gastro-tubing (PTEG) as palliative care for patients with malignant bowel obstruction: the JIVROSG0805 trial.

BACKGROUND: A randomized, controlled trial to evaluate the superiority of percutaneous transesophageal gastro-tubing over nasogastric tubing as palliative care for bowel obstruction in patients with terminal malignancy was conducted. SUBJECTS AND METHODS: The subjects were patients with malignant bowel obstruction with no prospect of improvement, for whom surgery was not indicated and with a Palliative Prognostic Index of < 6. They were randomly allocated in a 1:1 ratio to receive either percutaneous transesophageal gastro-tubing (PTEG group) or nasogastric tubing (NGT group). Their symptom scores (the worst 0 to no symptoms 10) were measured for a 2-week period after enrollment, and the areas under the curves for the two groups were compared. The EQ-5D and SF-8 were also used to assess overall quality of life. RESULTS: Forty patients were enrolled between October 2009 and January 2015, with 21 allocated to the PTEG group and 19 to the NGT group. The mean areas under the curves (95% confidence intervals) for the PTEG group and the NGT groups were 149.6 (120.3-178.8) and 44.9 (16.4-73.5), respectively, significantly higher for the NGT group (p < 0.0001). The secondary endpoints of quality of life as assessed by the EQ-5D and SF-8 scores were also significantly higher for patients in the PTEG group (p = 0.0036, p = 0.0020). There was no difference in survival between the groups. No serious adverse events were observed. CONCLUSIONS: In terms of quality of life, percutaneous transesophageal gastro-tubing was superior to nasogastric tubing as palliative care for patients with bowel obstruction due to terminal malignancy.

Evaluation of stent placement for vena cava syndrome: phase II trial and phase III randomized controlled trial.

PURPOSE: Vena cava syndrome (VCS) from stenosis of the superior vena cava or inferior vena cava caused by compression from a malignant tumor is one of the typical clinical conditions in patients with advanced stage malignant disease. VCS is difficult to manage and painful, reducing patients' quality of life. Although several reports have investigated stent placement for VCS, this treatment has never been established as the standard because of the lack of evidence of the safety and efficacy. We conducted a phase II trial and a phase III randomized controlled trial to clarify the role of stent placement in managing patients with VCS. METHODS: In the phase II trial, 28 eligible patients were treated with stent placement. The efficacy of stent placement for VCS was evaluated based on the reduction of patients' symptom scores during 14 days following treatment. Technical success, technical feasibility, overall survival, recurrence of symptoms, and adverse events were evaluated. In the phase III trial, 32 patients were enrolled and randomly assigned to the test (n = 16) and control groups (n = 16). The area under the symptom score curve was compared between the groups. The EQ-5D, SF-8, and adverse events were evaluated until discontinuation of the protocol treatment or 28 days after enrollment. RESULTS: In the phase II trial, the median patients' symptom scores significantly decreased from 10.50 before the procedure to 3.00 after the procedure. Technical success and technical feasibility rates were 96.4% and 100%, respectively. The incidence of treatment-related grade 3 or higher adverse events was 14.3%. In the phase III trial, significant superiority of stent placement was observed in the test, compared to that in the control, group. There was no significant difference in most other evaluations between the groups. CONCLUSIONS: Stent placement significantly improved the symptoms of VCS; thus, it might be accepted as the standard treatment to manage the symptoms of VCS. TRIAL REGISTRATION: JIVROSG-0402, JIVROSG-0807.

Value of Percutaneous Radiologic Gastrostomy for Patients with Advanced Esophageal Cancer.

BACKGROUND: Nutritional management is important throughout the treatment period for esophageal cancer patients. This study aimed to evaluate the feasibility of percutaneous radiologic gastrostomy (PRG) and to investigate whether PRG can be applied for patients with advanced esophageal cancer. METHODS: In this study, 89 patients (74 men and 15 women) with advanced esophageal cancer underwent PRG using computed tomography and fluoroscopic guidance. These patients were unsuitable candidates for endoscopic intervention because of esophageal stricture. Primary placement of a mushroom-retained gastrostomy catheter was intended. The end points were technical success and complications after PRG as well as clinical outcomes and survival of the patients. These end points also were compared between the pre-chemoradiotherapy (pre-CRT) and post-CRT groups using the Chi square test, Fisher's exact test, and the Wilcoxon rank sum test. The survival rate was calculated using the Kaplan-Meier method and compared using the log-rank test. RESULTS: All the patients had a successful PRG. The mushroom-tip gastrostomy catheter was primarily inserted in 77 patients (86.5 %) and finally achieved for all the patients. Complications occurred for 14 patients (15.7 %) including Dindo-Clavien classification grade 3 (1 catheter dislodgement), grade 2 (2 gastric hemorrhages), and grade 1 (7 skin infections and 4 oozing hemorrhages) complications. During the follow-up period (median, 6 months), 60 patients (67.4 %) died, giving a 12-month survival rate of 37.7 %. Gastrostomy removal was more common in the pre-CRT group (P = 0.011). The pre-CRT group had higher survival rates than the post-CRT group (P = 0.021). CONCLUSIONS: Because PRG provided high technical success with limited complications, it can be used for patients with advanced esophageal cancer whose treatment plan involves multimodal therapy.

Phase I trial of volasertib, a Polo-like kinase inhibitor, in Japanese patients with advanced solid tumors.

PURPOSE: This trial evaluated the maximum tolerated dose (MTD), safety, pharmacokinetics, and clinical effects of volasertib, a selective Polo-like kinase inhibitor that induces mitotic arrest and apoptosis, in Japanese patients with advanced solid tumors (NCT01348347; 1230.15). METHODS: In this phase I, open-label, dose-escalation trial, sequential patient cohorts (3 + 3 dose-escalation design) received volasertib (200-350 mg) as a single dose by intravenous infusion over 2 h on day 1 every 21 days until disease progression or unacceptable toxicity. The primary endpoint was the MTD of volasertib in Japanese patients with an advanced solid tumor; secondary endpoints included safety, pharmacokinetics, and clinical benefit. RESULTS: Fifteen patients with an advanced solid tumor were treated. Dose-limiting toxicities of grade 4 neutropenia for ≥7 days and grade 4 thrombocytopenia were both experienced by 2/6 patients in the 350 mg cohort. The MTD of volasertib in Japanese patients was 300 mg. The most common (≥3 patients) drug-related non-hematologic adverse events included fatigue, decreased appetite, and nausea. Exposure to volasertib and its metabolite increased with increasing doses. A partial response in a patient with gastric cancer and stable disease in eleven patients were observed. CONCLUSIONS: Volasertib had a manageable safety profile up to the MTD determined as 300 mg. Exposure to volasertib and its metabolite increased with increasing doses. The safety profile of volasertib in Japanese patients is comparable with those previously obtained in Caucasian patients. These data support enrollment of Japanese patients in global clinical trials without dose modification.

Infusion of 50% glucose solution to occlude an intrahepatic portosystemic venous shunt before percutaneous transhepatic portal embolization: report of a case.

A 68-year-old man with cholangiocarcinoma underwent percutaneous transhepatic portal embolization to expand the indication for hepatic resection. Selective right posterior portography revealed an intrahepatic portosystemic venous shunt (IPSVS) connecting the segment VII branch to the right hepatic venous branch. An infusion of 50 % glucose solution was given to occlude the shunt. This is novel management for IPSVSs when they are numerous, small, or torturous, and makes the subsequent procedures simpler, shorter, and less expensive.

Phase II study of percutaneous transesophageal gastrotubing for patients with malignant gastrointestinal obstruction; JIVROSG-0205.

PURPOSE: This multicenter, prospective study was conducted to evaluate the efficacy of percutaneous transesophageal gastrotubing (PTEG) as an esophagostomy procedure for bowel decompression in patients with malignant bowel obstruction. MATERIALS AND METHODS: The study subjects were patients with malignant bowel obstruction treated with a nasogastric tube (NGT). After receiving PTEG, efficacy evaluations were conducted, with NGT designated as the control state. The procedure was considered effective only when discomfort in the nasopharynx was improved for at least 2 weeks. Safety was evaluated by using National Cancer Institute Common Toxicity Criteria, version 2.0. PTEG was performed by using a PTEG kit. RESULTS: From February 2003 to December 2005, 33 patients were enrolled. The technical success rate was 100%, and the procedure was considered effective in 30 of 33 cases. The three cases in which the procedure was ineffective could not be evaluated as a result of deterioration of general status or early death. The one recorded complication was a tracheoesophageal fistula that caused grade 2 aspiration pneumonia. CONCLUSIONS: PTEG is an effective technique to relieve discomfort in the nasopharynx caused by NGT in patients with terminal malignant tumors. PTEG should be considered an efficacious method for bowel decompression in patients who are ineligible for surgical procedures, percutaneous gastrostomy, or percutaneous enterostomy.

Prospective study of transcatheter arterial chemoembolization for unresectable hepatocellular carcinoma: an Asian cooperative study between Japan and Korea.

PURPOSE: To evaluate the safety and efficacy of transcatheter arterial chemoembolization used for the treatment of unresectable hepatocellular carcinoma (HCC) with an Asian cooperative prospective study between Japan and Korea. MATERIALS AND METHODS: Patients with unresectable HCC unsuitable for curative treatment or with no prior therapy for HCC were enrolled. The patients underwent transcatheter arterial chemoembolization with emulsion of Lipiodol and anthracycline agent, followed by embolization with gelatin sponge particles, which was repeated on an as-needed basis. The primary endpoint was 2-year survival rate, and the secondary endpoints were adverse events and response rate. RESULTS: The 2-year survival rate of 99 patients was 75.0% (95% confidence interval, 65.2%-82.8%). The median time-to-progression was 7.8 months, and the median overall survival period was 3.1 years. Of 99 patients, 42 (42%) achieved a complete response, and 31 (31%) had a partial response. The response rate was 73% using modified Response Evaluation Criteria in Solid Tumors. The grade 3-4 toxicities included increased alanine aminotransferase level in 36%, increased aspartate aminotransferase level in 35%, thrombocytopenia in 12%, and abdominal pain in 4% of patients. All other toxicities were generally transient. CONCLUSIONS: Asian transcatheter arterial chemoembolization demonstrated sufficient safety and reasonable efficacy as a standard treatment for unresectable HCC. These results could be useful as reference data for future trials of transcatheter arterial chemoembolization.

Safety and efficacy of primary metallic biliary stent placement with tract embolization in patients with massive ascites: a retrospective analysis of 16 patients.

PURPOSE: To evaluate the safety and efficacy of primary metallic biliary stent placement with tract embolization in patients with massive ascites. MATERIALS AND METHODS: Sixteen patients with malignant biliary obstruction and massive ascites (age range, 44-79 y; median age, 59 y) were treated with primary percutaneous stent placement with tract embolization. These patients were unsuitable candidates for endoscopic intervention. Etiologies of biliary obstruction were gastric cancer with hilar nodal metastases (n = 9), pancreatic carcinoma (n = 5), cholangiocarcinoma (n = 1), and gallbladder carcinoma (n = 1). Eight patients had nonhilar lesions and the remaining eight had hilar lesions. Percutaneous accesses to the biliary system and stent placements were performed in a one-step procedure, and catheters were removed with tract embolization with metallic coils. RESULTS: Stent placement and tract embolization were successful in all patients, without external drainage catheters left in place. Significant reduction of serum bilirubin level was observed in 14 patients (87.5%). No bile peritonitis or intraperitoneal hemorrhage occurred. Major complications included postprocedural cholangitis (12.5%), bloody bowel discharge (6.2%), and right pleural effusion (25.0%). One patient who died 19 days after intervention was deemed to represent a procedure-related mortality. During the survival period (range, 19-175 d; median, 66 d), stent occlusion was noted in two patients at 6 and 159 days after the procedure. Primary stent patency was achieved in 14 patients (87.5%). CONCLUSIONS: Primary biliary stent placement with tract embolization is technically safe and offers an effective palliative treatment option for patients with malignant biliary obstruction and massive ascites when endoscopic intervention is not possible.

Phase I/II multicenter study of transarterial chemoembolization with a cisplatin fine powder and porous gelatin particles for unresectable hepatocellular carcinoma: Japan Interventional Radiology in Oncology Study Group Study 0401.

PURPOSE: A multicenter phase I/II study of transarterial chemoembolization with a fine cisplatin powder and gelatin particles (GPs) for multifocal hepatocellular carcinoma (HCC) was conducted. Primary endpoints were dose-limiting toxicity (DLT) and recommended dose (RD). Secondary endpoints were the incidence and severity of adverse events and tumor response. MATERIALS AND METHODS: Nonselective transarterial chemoembolization was performed until all tumor enhancement disappeared. Lipiodol was not used. In the phase I study, the cisplatin dose was escalated from 35 mg/m(2) to 65 mg/m(2) in 15-mg/m(2) increments to determine DLT and RD. In the phase II study, 40 patients were treated with the RD. Toxicity was assessed by Common Toxicity Criteria for Adverse Effects (version 3.0), and tumor response was evaluated by Response Evaluation Criteria in Solid Tumors (RECIST; version 1.0) and European Association for the Study of the Liver (EASL) criteria. RESULTS: A total of 46 patients were enrolled. As no DLT occurred at any dose level in the phase I study, RD was determined as 65 mg/m(2). In the phase II study, the treatment was discontinued in one patient as a result of vasovagal response. Toxicities of grade 3 or higher included nausea (2.2%), pancreatitis (2.2%), cholecystitis (2.2%), thrombocytopenia (8.7%), hyperbilirubinemia (2.2%), and increased aspartate aminotransferase (28.3%) and alanine aminotransferase (21.7%) levels. Tumor response rates under RD were 25.6% and 64.1% by RECIST and EASL criteria, respectively. CONCLUSIONS: Nonselective transarterial chemoembolization with fine cisplatin powder and GPs was well tolerated and effective in patients with multifocal HCC at the RD of 65 mg/m(2).

Phase I/II study of radiologic hepatic arterial infusion of fluorouracil plus systemic irinotecan for unresectable hepatic metastases from colorectal cancer: Japan Clinical Oncology Group Trial 0208-DI.

PURPOSE: Treatment of patients who have metastatic colorectal cancer (CRC) by using a combination of hepatic arterial infusion chemotherapy (HAIC) and systemic chemotherapy has resulted in promising clinical outcomes. Additionally, image-guided HAIC is reported to be less invasive and distribute drugs more accurately than surgical HAIC. The purpose of this study was to assess the combination of image-guided delivery of fluorouracil through HAIC and systemic irinotecan in a multicenter phase I/II study. MATERIALS AND METHODS: Twenty-five patients with unresectable liver metastases from CRC were fitted with hepatic arterial catheter and port systems by using image-guided methods. Intraarterial fluorouracil (1,000 mg/m(2)) was administered on days 1, 8, and 15 of each treatment cycle. The dose of systemic irinotecan on days 1 and 15 was escalated from 75 mg/m(2). RESULTS: No dose-limiting toxicity was encountered during phase I, and the recommended dose of irinotecan was set at 150 mg/m(2). Grade 3 or higher adverse events included hyperglycemia (15%), elevated γ-glutamyl transpeptidase levels (15%), and neutropenia (9%). The response rate and median survival time were 72% and 49.8 months (95% CI, 27.5-78.1 mo), respectively. CONCLUSIONS: The combination of image-guided delivery of fluorouracil through HAIC and systemic irinotecan yielded favorable safety, response rate, and survival results. This combination should be evaluated in a large study.

Assessment of the interface between retroperitoneal fat infiltration of pancreatic ductal carcinoma and the major artery by multidetector-row computed tomography: surgical outcomes and correlation with histopathological extension.

BACKGROUND: Precise assessment of retroperitoneal invasion is clinically important to allow the achievement of negative margin resections. METHODS: The clinical records of 132 patients who underwent macroscopic curative pancreaticoduodenectomy for invasive ductal carcinoma of the pancreas between 2004 and 2008 were retrospectively examined. The clinicopathological factors, including retroperitoneal fat infiltration classified into four groups by multidetector-row computed tomography (MDCT), were analyzed. The relationship between the grade of retroperitoneal fat infiltration and surgical outcomes, as well as various histopathological factors, was also investigated. RESULTS: The 5 year survival rate was 55.6 % for grade 0 infiltration (n = 8), 38.7 % for grade 1 (n = 54), 16.4 % for grade 2 (n = 49), and 0 % for grade 3 (n = 21). There were significant differences in survival in each group. Extrapancreatic nerve invasion and the surgical margin status were significantly associated with retroperitoneal fat infiltration demonstrated on MDCT. According to the grading classification among the 43 patients with pathological portal vein invasion, the 5 year survival rate was 45.9 % for patients with grade 1, which was significantly better survival that those with grade 2 (P = 0.007). CONCLUSION: The grading criteria for retroperitoneal fat infiltration may be useful as a predictor of survival after pancreaticoduodenectomy for pancreatic head carcinoma. Pancreaticoduodenectomy with portal vein resection could provide favorable survival in patients with grade 1 retroperitoneal fat infiltration, even if histopathological portal vein invasion is present.

[Shared web-based data center for multi-institutional clinical trials: evaluation of UMIN-INDICE (university hospital medical information network-internet data and information center for medical research)in clinical trials of JIVROSG (Japan interventional radiology in oncology study group)].

A patient registration system is mandatory for establishing the scientific credibility of the multi-center clinical trials. The Japan Interventional Radiology in Oncology Study Group (JIVROSG) was organized in 2002 to establish evidence supporting the procedures used in interventional radiology. The Internet Data and Information Center for Medical Research (INDICE), provided by the University Hospital Medical Information Network(UMIN), has been utilized for patient registration in the clinical trials of JIVROSG. In this study, the safety and efficacy of UMIN-INDICE were evaluated. From 2002 to 2010, 18 clinical trials, including one international trial, were conducted. A total of 736 patients were enrolled from 51 institutions. No significant trouble was encountered during this period. A questionnaire survey demonstrated that 90% of participating researchers could use this system without difficulties. UMIN-INDICE may contribute to promoting clinical trials as an infrastructure of multicenter studies.

CT-Guided Femoral Approach for Psoas Muscle Abscess Drainage.

PURPOSE: To evaluate the feasibility and safety of the computed tomography (CT)-guided femoral approach for draining a psoas muscle abscess (PMA). MATERIALS AND METHODS: Between January 2014 and November 2018, the CT-guided femoral approach was employed for 9 abscesses in 8 patients who could not tolerate the prone position because of advanced age or other underlying conditions. A 17-gauge blunt metal needle was used to puncture the iliacus muscle below the groin under CT fluoroscopic guidance. A drainage catheter was then placed within the abscess cavity in the psoas major muscle. Technical success, clinical success, complications, the drainage therapy duration, susceptibility to antibiotics, survival, and recurrence were evaluated. RESULTS: The technical success rate was 100% among all nine lesions. The clinical success rate was 89% among all eight patients. One patient died of concomitant meningitis 15 days after the procedure. No patients developed therapy-related complications. The median duration of the drainage therapy was 15 days (range 6-71 days). Appropriate antibiotics based on the culture susceptibility were achieved in all patients. Four patients survived, and the remaining four died at 15 to 758 days (median, 36 days) after the procedure; no therapy-related deaths occurred. No recurrence was seen. CONCLUSION: The CT-guided femoral approach seems feasible, effective, and safe for draining psoas muscle abscesses in ill patients who cannot tolerate the prone position.

Anchoring system-assisted coil tract embolization: a new technique for management of arterial bleeding associated with percutaneous nephrostomy.

Anchoring system-assisted coil tract embolization (AACTE), a new nonvascular treatment technique for massive bleeding associated with percutaneous nephrostomy (PCN), consists of packing the tract with embolization coils, with a balloon catheter used as an anchoring system. After arterial bleeding associated with PCN was successfully treated with AACTE in three patients, no severe complications were noted, and renal function was not affected. AACTE is a potentially useful and safe method for management of vascular complications associated with nephrostomy.

Phase I/II study of transjugular transhepatic peritoneovenous venous shunt, a new procedure to manage refractory ascites in cancer patients: Japan Interventional Radiology in Oncology Study Group 0201.

OBJECTIVE: This multicenter phase I/II study evaluated the safety and the efficacy of transjugular transhepatic peritoneovenous shunt (PVS), a new palliative treatment for malignant refractory ascites. SUBJECTS AND METHODS: Patients with refractory malignant ascites and patent hepatic veins and vena cava were included in this study. Eligible patients underwent the placement of transjugular transhepatic PVS catheter via the jugular vein into the abdominal cavity through the hepatic vein. In phase I, a step-by-step analysis of the safety was performed. The safety and the efficacy were determined through phases I and II. RESULTS: Thirty-three patients were entered in this study, nine in phase I and 24 in phase II. Transjugular transhepatic PVS was technically successful in all patients. No severe adverse events were observed during the placement procedure. After the placement, 22 adverse events (grade 2 or higher) occurred. Frequent adverse events were hypoalbuminemia (24%) and decrease in hemoglobin (18%), which resolved within 1 week without additional treatment. The clinical efficacy rate at 1 week after the procedure was 67%. Occlusion of the catheter due to fibrin sheath was observed in seven patients, and the revision of the system was performed. CONCLUSION: Transjugular transhepatic PVS is a safe and feasible procedure for managing refractory ascites in patients with cancer. Sufficient efficacy was observed in our initial experience, but a larger clinical trial is warranted.

Feasibility of externalized peritoneovenous shunt (EPVS) for malignant ascites.

PURPOSE: To evaluate a new modified peritoneovenous shunt therapy, the externalized peritoneovenous shunt (EPVS) system placement, used to treat patients with malignant ascites. METHODS: We retrospectively reviewed 10 patients, who were not suited for conventional peritoneovenous shunts (PVS), with malignant ascites, which was refractory to medical therapies. Patient characteristics, technical success, efficacy, duration of EPVS placement, adverse events, and outcome were evaluated. Clinical efficacy of the EPVS was evaluated by the change in subjective symptoms. RESULTS: The primary reasons for applying EPVS were severe anasarca in 4 patients, potential PVS dysfunction in 3 patients, poor performance status in 2 patients, and a history of PVS occlusion in 1 patient. EPVS was successfully placed in all patients, and it provided clinical efficacy in 8 patients (80%). Early death occurred within 7 days after EPVS placement in 2 patients because of renal failure. The median duration of EPVS placement was 10.4 days (range, 2-28 days). In 6 patients (60%), the EPVS was exchanged to conventional PVS sequentially, since the initial EPVS placement resulted in an improvement of the subjective symptoms of the patients, without serious complications. CONCLUSION: EPVS placement may be an option for patients with malignant ascites who may not be appropriate for conventional PVS placement.

Phase I/II multiinstitutional study of uterine artery embolization with gelatin sponge for symptomatic uterine leiomyomata: Japan Interventional Radiology in Oncology Study Group study.

PURPOSE: This multicenter prospective study was conducted to evaluate the safety and the efficacy of uterine artery embolization (UAE) with gelatin sponge for symptomatic leiomyomas. MATERIALS AND METHODS: Patients with symptomatic uterine leiomyomas were enrolled and treated with UAE. In phase I, nine patients were evaluated for safety. In phase II, 24 patients were accrued, and an intent-to-treat analysis was performed on all 33 patients. The primary endpoint was safety. Secondary endpoints included technical success, hospital stay, change in symptoms, leiomyoma volume on magnetic resonance (MR) imaging, and incidence of treatment failure. RESULTS: UAE procedures were performed for all 33 patients. Two patients were lost to follow-up at 3 and 12 months. The median follow-up period was 33.4 months. Minor adverse events (AEs) occurred in 10 patients (33%); major AEs of permanent amenorrhea and leiomyoma expulsion occurred in two (6%). The most common AE was transient amenorrhea. Technical success was achieved in all patients. The median hospital stay was 5 days. At 12 months after UAE, menorrhagia had improved in 90% of patients, pelvic pain in 78%, and bulk-related symptoms in 97%. The mean reduction in leiomyoma volume on MR imaging at 12 months was 61%. Treatment failure occurred in one patient, who underwent hysterectomy for recurrent menorrhagia at 21 months. CONCLUSIONS: UAE with gelatin sponge is safe, with efficacy comparable to other embolic agents based on published data. Gelatin sponge should be an option for UAE, but a prospective comparison versus other standard UAE embolic agents may be warranted.