Long-Term Outcomes After Fenestration Closure in High-Risk Fontan Candidates.

The study aimed to assess the long-term outcomes after fenestration closure in patients at risk for Fontan failure. Of 119 patients who underwent Fontan operation between 1995 and 2004, fenestration was not created in 89 patients (NF group) and created in 30 patients with hypoplastic left heart syndrome, heterotaxy syndrome, high pulmonary arterial pressure, high systemic ventricular end-diastolic pressure, low ventricular ejection fraction, or atrioventricular valve regurgitation. All fenestrations were closed spontaneously or by catheter/surgical interventions, excepting two patients, and therefore, they were excluded. In fenestration group, patients with pre-Fontan mean pulmonary arterial pressure ≥ 15 mmHg or systemic atrioventricular valve regurgitation ≥ moderate were classified as high-risk Fontan candidates (F-HR group, n = 16), and the remaining patients were as standard-risk (F-SR group, n = 12). Protein-losing enteropathy-free survival rates did not differ among the three groups (p = 0.72). Serial follow-up catheter examinations after Fontan operation were completed in 69 patients in NF group and 11 patients in both F-SR and F-HR groups. Cardiac index and pulmonary vascular resistance significantly and similarly decreased over time in all groups, though the F-HR group showed lowest arterial oxygen saturation, lowest cardiac index, and highest pulmonary vascular resistance. The F-HR group also showed much veno-venous collaterals (p = 0.049), low peak oxygen consumption (p = 0.019), and low anaerobic threshold (p = 0.023) as compared to those in the F-SR group. In F-HR group, cyanosis remained after fenestration closure due to transformation from fenestration to veno-venous collaterals, which resulted in elevation of pulmonary vascular resistance, low cardiac index, and deterioration of exercise tolerance.

Systemic Atrioventricular Valve Replacement in Patients With Functional Single Ventricle.

To review the outcome after atrioventricular valve replacement in single ventricle patients. The medical records of 37 consecutive patients who underwent initial valve replacement between 2001 and 2016 were reviewed. Actuarial survival rates were 73%, 65%, and 59% at 1, 5, and 10 years, respectively. Multivariate analysis indicated body surface area <0.28 m2 (P = 0.007; hazard ratio, 31.1), preoperative inotropic support (P < 0.001; hazard ratio, 24.5), primary valve replacement (P = 0.044; hazard ratio, 6.1), oversized prosthesis (P = 0.001; hazard ratio, 14.5), and intra- or postoperative extracorporeal membrane oxygenation support (P < 0.001; hazard ratio, 53.2) were the risk factors for mortality. Cumulative incidences of redo replacement were 11%, 17%, and 17% at 1, 5, and 10 years, respectively. There was no risk factor for redo replacement. Among 11 patients undergoing valve replacement before or at the time of bidirectional cavopulmonary shunt, all 4 patients who reached Fontan completion survived. Among 13 patients undergoing valve replacement after bidirectional cavopulmonary shunt, only 3 patients reached Fontan completion. Among 11 patients undergoing valve replacement after Fontan completion, there were 3 operative mortalities and 2 late mortalities. For 7 of 8 hospital survivors, cardiac index improved from 2.2 L/min/m2 (interquartile range, 2.0-2.4) to 3.4 (2.8-3.7) (P = 0.002). Atrioventricular valve replacement was a reasonable choice of treatment for single ventricle patients. For small patients with impaired ventricular function who had no choice other than valve replacement, commercially available valves were oversized and outcomes remained poor.

Surgical Outcomes of Biventricular Repair for Hypoplastic Left Ventricle With Congenital Mitral Valve Stenosis.

OBJECTIVE: Surgical outcomes of biventricular repair for hearts with hypoplastic left ventricle with congenital mitral valve stenosis are described. Serial changes of left ventricular geometry and clinical features after biventricular repair were reviewed. METHODS: Eight patients with hypoplastic left ventricle and congenital mitral valve stenosis who underwent first surgical intervention for biventricular circulation in neonatal or infantile period between 2001 and 2014 comprise the study population. Serial change in left ventricular end-diastolic diameter, left ventricular mass index, and relative wall thickness after biventricular repair were evaluated by two-dimensional echocardiography. RESULTS: The median Z-scores of left ventricular end-diastolic diameter and mitral valve diameter before the first surgical intervention were -3.0 (range, -4.8 to -2.0) and -1.0 (-2.9 to 2.1), respectively. Mitral valves were surgically treated in five patients; they were replaced in two and repaired in three patients. Left ventricular end-diastolic diameter Z-score at five years after biventricular repair was 0.1 (-3.0 to 1.0), which was significantly larger than before first surgical intervention ( P = .005). Left ventricular mass index, on the other hand, did not change, but relative wall thickness significantly decreased ( P = .009). Postoperative catheter study showed pulmonary hypertension with high left ventricular end-diastolic pressure in more than half of survivors. CONCLUSIONS: Left ventricle increased in size after the biventricular repair with appropriate mitral valve procedures before progression of pulmonary hypertension. Left ventricular mass, however, did not accompany the increase. Some patients may have suffered from mild, but certain restrictive left ventricular physiology and subsequent pulmonary hypertension as the result of abnormal remodeling process of the myocardium.

Application of decellularized allograft for primary repair of congenital heart disease in Japan.

A 6-month-old infant with a double outlet right ventricle, doubly committed ventricular septal defect, and right ventricle outflow tract (RVOT) stenosis underwent intracardiac repair with RVOT reconstruction using a fresh decellularized allograft derived from a 1-year-old heart transplant recipient in Japan. Early postoperative evaluation via echocardiography and cardiac magnetic resonance imaging revealed that the pulmonary allograft and cardiac function were stable. This is the first case report on using a decellularized heart valve, which was resected from a heart transplant recipient, for primary repair of congenital heart disease in Japan.

Left Ventricular Function After Repair of Totally Anomalous Pulmonary Venous Connection.

BACKGROUND: Poor left ventricular (LV) growth and diastolic dysfunction long after simple total anomalous pulmonary venous connection (TAPVC) repair has been well documented and is believed to originate from insufficient preoperative volume preload. The objective of the study was to confirm these findings. METHODS: Of 61 patients undergoing simple TAPVC repair between 1996 and 2016, 42 patients undergoing postoperative catheter examinations were enrolled. The mean age at the time of repair was 39 ± 117 days. Postoperative catheter examinations were conducted at a mean duration of 1.1 years after the repair. LV end-diastolic volume (LVEDV) was calculated by biplane cineangiography with the use of Simpson's method as a Graham modification. RESULTS: LV ejection fraction, LV end-diastolic pressure (LVEDP), and cardiac index were 72% ± 5%, 10.3 ± 2.7 mm Hg, and 4.0 ± 0.7 L •·min-1 • m-2, respectively. LVEDV was 102% ± 16% of the predictive normal value, and it strongly correlated with the predictive normal value of LV end-diastolic diameter (LVEDd) calculated by two-dimensional echocardiography (R2 = 0.29, p = 0.005). LVEDd maintained a normal range thereafter during the entire follow-up period. LVEDP correlated linearly with age at the time of TAPVC repair (R2 = 0.18, p = 0.007) but not with LVEDV (p = 0.67). CONCLUSIONS: LV size maintained a normal range after the repair of simple TAPVC. High LVEDP was frequently observed a year after repair; it did not correlate with LV size but had a strong negative correlation with age at the time of repair.

Utility of a super-flexible three-dimensional printed heart model in congenital heart surgery.

OBJECTIVES: The objective of this study was to assess the utility of 3D printed heart models of congenital heart disease for preoperative surgical simulation. METHODS: Twenty patient-specific 3D models were created between March 2015 and August 2017. All operations were performed by a young consultant surgeon who had no prior experience with complex biventricular repair. All 15 patients with balanced ventricles had outflow tract malformations (double-outlet right ventricle in 7 patients, congenitally corrected transposition of great arteries in 5, transposition of great arteries in 1, interrupted aortic arch Type B in 1, tetralogy of Fallot with pulmonary atresia and major aortopulmonary collateral arteries in 1). One patient had hypoplastic left heart complex, and the remaining 4 patients had a functional single ventricle. The median age at operation was 1.4 (range 0.1-5.9) years. Based on a multislice computed tomography data set, the 3D models were made of polyurethane resins using stereolithography as the printing technology and vacuum casting as the manufacturing method. RESULTS: All but 4 patients with a functional single ventricle underwent complete biventricular repair. The median cardiopulmonary bypass time and aortic cross-clamp time were 345 (110-570) min and 114 (35-293) min, respectively. During the median follow-up period of 1.3 (0.1-2.5) years, no mortality was observed. None of the patients experienced surgical heart block or systemic ventricular outflow tract obstruction. CONCLUSIONS: Three-dimensional printed heart models showed potential utility, especially in understanding the relationship between intraventricular communications and great vessels, as well as in simulation for creating intracardiac pathways.

Application of a Fresh Decellularized Pulmonary Allograft for Pulmonary Valve Replacement in Japan.

BACKGROUND: Tissue engineering has advanced the technique of decellularization of the heart valve. The valve is reseeded with the patient's own cells after implantation with suppression of immunologic reactions. The same advantage has been reported for fresh decellularized heart valves, and more than 10 years of excellent outcomes have been achieved. We began performing such heart valve implantations in 2013 as part of a clinical study at Osaka University. We report our evaluation of the safety and efficacy of heart valve implantation.Methods and Results:Human pulmonary valves from the German Society for Tissue Transplantation (n=2) or from Japanese heart transplant recipient heart (n=4) were used to make decellularized heart valves; the decellularization process was the same as that used in Europe. Valves were implanted in 5 adults with pulmonary valve insufficiency after tetralogy of Fallot repair and in 1 infant with a double-outlet right ventricle with pulmonary stenosis. Postoperative echocardiography and cardiac magnetic resonance imaging revealed that the valve and ventricular function were significantly improved and maintained postoperatively. CONCLUSIONS: Decellularized heart valves could be the new material used as artificial heart valves. Pulmonary allografts derived from the hearts of heart transplant recipients are considered to be useful material for decellularized heart valves. The application of this valve to Japanese clinical circumstances and using the hearts of heart transplant recipients is considered to be very significant.

Venovenous malformation developed prior to a Kawashima operation in a patient with an interrupted inferior vena cava.

An 11-month-old girl with an unbalanced atrioventricular septal defect, coarctation of the aorta and an interrupted inferior vena cava with hemiazygos continuation post-surgical status of coarctation repair and pulmonary artery banding underwent a Kawashima operation. Severe hypoxia occurred immediately after she was weaned from cardiopulmonary bypass, which was successfully resolved by the ligation of the hemiazygos vein. Postoperative enhanced computed tomography detected significant venovenous malformation from the hemiazygos vein to the left renal vein.

Clinical Predictors of Right Ventricular Myocardial Fibrosis in Patients With Repaired Tetralogy of Fallot.

BACKGROUND: This study aimed to identify the clinical predictors of the degree of right ventricular (RV) myocardial fibrosis in patients with repaired tetralogy of Fallot (TOF) with special focus on the RV pressure load.Methods and Results:From April 2004 to March 2017, 30 patients with repaired TOF underwent pulmonary valve replacement and concomitant RV myocardial biopsy. The stroke volume ratio (RV stroke volume/left ventricular stroke volume), RV end-diastolic volume index, and right-to-left ventricular systolic pressure ratio were evaluated with respect to their prognostic value for the degree of RV myocardial fibrosis. Significant positive linear correlations were detected between the stroke volume ratio and the degree of RV myocardial fibrosis (P=0.003, r=0.52). Patients with a right-to-left ventricular systolic pressure ratio >0.45 showed a significantly greater degree of RV myocardial fibrosis under an equivalent stroke volume ratio. CONCLUSIONS: Under conditions of RV volume overload, a right-to-left ventricular systolic pressure ratio >0.45 was a predisposing factor for progression of RV myocardial fibrosis in patients with repaired TOF.

Application of hybrid Stage I palliation for patients with two ventricular cavities and hypoplastic left heart structures.

OBJECTIVES: To assess the feasibility of hybrid Stage I palliation consisting of bilateral pulmonary artery bandings and ductal stenting for patients with 2 ventricular cavities and hypoplastic left heart structures. METHODS: Eleven consecutive patients who underwent hybrid Stage I palliation between 2010 and 2017 were enrolled. The diagnoses were interrupted aortic arch/coarctation of the aorta, ventricular septal defect and significant left ventricular (LV) outflow tract obstruction in 5 patients, critical aortic stenosis and reduced LV contraction in 3 patients and hypoplastic left heart complex in 3 patients. RESULTS: The median age at definitive surgery was 12 months (range 6-22 months). During the mean follow-up period of 24 months (range 9-83 months) following the definitive surgery, there was 1 death. Two patients with interrupted aortic arch/coarctation of the aorta did not undergo the Yasui operation but underwent arch repair and ventricular septal defect closure after the growth of the aortic valve and LV outflow tract. For 2 of the 3 patients with critical aortic stenosis, biventricular repair was performed. Of the 3 patients with hypoplastic left heart complex, 2 patients showed growth of the mitral valve and left ventricle following LV rehabilitation by balloon pulmonary artery dilatation or surgical debanding of the banded pulmonary arteries and subsequently underwent biventricular repair, which resulted in 1 death. CONCLUSIONS: Hybrid Stage I palliation would be a safe and beneficial treatment for patients with 2 ventricles, as a bridge to decide whether and how to achieve a biventricular repair and whether it should be preceded by a preliminary LV rehabilitation.

Clinical standard for valve area after common atrioventricular valve plasty for a single ventricle.

OBJECTIVES: To determine a clinical standard for post-repair common atrioventricular valve orifice area based on mid- to long-term valve function in patients with a functional single ventricle. METHODS: The medical records of 19 single-ventricle patients who underwent common atrioventricular valve plasty from July 1988 to January 2013 were retrospectively reviewed. Bivalvation valvuloplasty was performed in 7 patients with relatively hypoplastic leaflets. The relationship between the orifice area of the repaired common atrioventricular valve measured intraoperatively and valve function and ventricular volume in the early postoperative period (median, 9.5 months) and at mid- to long-term follow-up (median, 4 years) were analysed. RESULTS: Post-repair valve area was significantly positively correlated with valve regurgitation severity in the early postoperative period (P = 0.001, r = 0.69) and at mid- to long-term follow-up (P = 0.02, r = 0.57). Patients who did not undergo bivalvation had favourable valve function at mid- to long-term follow-up and in the early postoperative period when the post-repair valve area was 96-136% of the normal mitral valve area. Bivalvation patients had significantly more valve regurgitation in the early postoperative period than patients without bivalvation, despite equivalent repaired valve area (P = 0.02). CONCLUSIONS: The post-repair orifice area of the common atrioventricular valve is significantly related to postoperative valve function. The clinical standard of post-repair valve orifice area might be 96-136% of the normal mitral valve area in patients undergoing repair without bivalvation. Patients undergoing bivalvation require greater reduction to obtain favourable mid- to long-term valve function.

Stroke Volume Ratio Predicts Redilatation of the Right Ventricle After Pulmonary Valve Replacement.

BACKGROUND: This study aimed to identify the prognostic value of the preoperative stroke volume ratio (right ventricular stroke volume/left ventricular stroke volume) for redilatation of the right ventricle after pulmonary valve replacement in patients with repaired tetralogy of Fallot. METHODS: From April 2004 to November 2013, 20 patients with repaired tetralogy of Fallot underwent pulmonary valve replacement for pulmonary valve regurgitation and right ventricular dilatation. Serial changes in ventricular volume were examined by cardiac magnetic resonance or computed tomography imaging. The redilatation ratio was calculated for right ventricular end-diastolic and end-systolic volume indices by dividing the increment in right ventricular volume from the first (median, 1.1 years) to the second (median, 3.2 years) evaluations after pulmonary valve replacement by the first evaluation. The relationships between the stroke volume ratio and redilatation ratio were assessed. The degree of right ventricular myocardial fibrosis was examined in 13 patients and compared with the stroke volume ratio. RESULTS: Right ventricular volume (redilatation) significantly increased from a median of 1.1 to 3.2 years after pulmonary valve replacement. Significant positive correlations were detected between the stroke volume ratio and redilatation ratio of the right ventricular end-diastolic (r = 0.50. p = 0.02) and end-systolic volume indices (r = 0.49, p = 0.03). The stroke volume ratio also showed a significant positive correlation with the degree of right ventricular myocardial fibrosis (r = 0.73, p = 0.005). CONCLUSIONS: The preoperative stroke volume ratio can predict redilatation of the right ventricle after pulmonary valve replacement and the degree of right ventricular myocardial fibrosis.

Sirtuin1 Regulates the Stem Cell Therapeutic Effects on Regenerative Capability for Treating Severe Heart Failure in a Juvenile Animal Model.

BACKGROUND: This study hypothesized that autologous cell transplantation therapy could have greater therapeutic efficacy in juvenile patients than in adult patients, related to differences in sirtuin1 (SIRT1) expression in transplanted cells. METHODS: A model of heart failure was established in mini-pigs by using coronary artery occlusion. Stem cell cultures were established from juvenile and adult mini-pigs. The cells were prepared as cell sheets and transplanted into corresponding adult or juvenile mini-pigs, and the therapeutic effects were examined in vivo and in vitro. Next, SIRT1 knockdown cells were established using small interfering RNAs for SIRT1, and the therapeutic effects of the cells were examined in vitro and in vivo in Lewis rat models of heart failure. RESULTS: Cardiac function showed significantly more improvement in juvenile than in adult pigs. Histologic analysis revealed significant reduction of myocardial fibrosis and hypertrophic response in juvenile pigs. In vitro analysis demonstrated that doubling time was significantly shorter, the ratio of Ki67-positive cells was significantly greater, and the expression of SIRT1, hypoxia-induced factor-1α, hepatocyte growth factor, and stromal cell-derived factor-1 was significantly upregulated in juvenile cells. SIRT1 knockdown cells showed decreased proliferation and cytokine release potential compared with wild-type cells. Transplantation of SIRT1 knockdown stem cell sheets showed lesser improvement of cardiac function after severe heart failure in Lewis rats than in controls. CONCLUSIONS: Sirtuin1 expression in transplanted cells enhances the skeletal stem cell sheet therapeutic effects for treating severe heart failure in a juvenile animal model.

Pulmonary Valve Replacement With Fresh Decellularized Pulmonary Allograft for Pulmonary Regurgitation After Tetralogy of Fallot Repair　- First Case Report in Japan.

BACKGROUND: Pulmonary valve replacement (PVR) is a common reoperation, typically required approximately 10 years following right ventricular outflow tract reconstruction and especially true in cases of tetralogy of Fallot. However, an improved prosthetic valve is required. METHODS AND RESULTS: A fresh decellularized pulmonary allograft was used for PVR to correct pulmonary valve regurgitation in a 35-year-old man 33 years following tetralogy of Fallot repair. The postoperative course and short-term valve function were excellent. This is the first case of a decellularized pulmonary allograft in Japan. CONCLUSIONS: Fresh decellularized pulmonary allografts have the potential to become a new source of material for PVR in patients who have undergone right ventricular outflow tract reconstruction.

Pulmonary artery rupture after bilateral pulmonary artery banding in a neonate with Loeys-Dietz syndrome and an interrupted aortic arch complex: report of a case.

Loeys-Dietz syndrome (LDS) is a recognized connective tissue disorder characterized by progressive aortic aneurysm and dissection. Patients are at high risk of aortic dissection or rupture at an early age, but to our knowledge, surgery on the great arteries has never been attempted in the neonatal period. We report a case of LDS with dilated pulmonary arteries and an interrupted aortic arch complex in a neonate. We performed bilateral pulmonary artery banding, but 12 days after the procedure, the infant died of rupture of the distal portion of the banding sites following massive dilatation.

Contractility-afterload mismatch in patients with protein-losing enteropathy after the Fontan operation.

This study aimed to clarify the relationship between onset of protein-losing enteropathy (PLE) and Fontan circulation, with special reference to the development of contractility-afterload mismatch. The PLE group comprised 9 patients who experienced PLE after undergoing the Fontan operation, and the control group consisted of 32 patients had did not experienced PLE more than 10 years after the Fontan operation. The study compared the pre- and postoperative values of arterial elastance (Ea), end-systolic elastance (Ees), and contractility-afterload mismatch (Ea/Ees). Furthermore, the variations in the values were examined during the preoperative, postoperative, and midterm postoperative periods in seven PLE patients who underwent cardiac catheterization at the onset of PLE and during the pre- and postintervention periods in three PLE patients who underwent surgical intervention to improve the Fontan circulation after the onset of PLE. Comparison of the values obtained before and after Fontan operations showed that the Ea values increased significantly in the PLE group. However, the pre- and postoperative Ees values did not differ in the two groups. During the postoperative period, Ea/Ees increased significantly, and the Ea and Ea/Ees values increased continuously until the onset of PLE in the PLE group. In the patients who underwent surgical intervention to improve the Fontan circulation after the onset of PLE, the Ea/Ees decreased significantly, and the serum albumin levels improved after the intervention. Contractility-afterload mismatch, mainly caused by the increase in the afterload of the systemic ventricle, may have an important role in the development of PLE after the Fontan operation.

Use of the Damus-Kaye-Stansel procedure prevents increased ventricular strain in Fontan candidates.

OBJECTIVES: In Fontan candidates, we have recently been aggressively performing the Damus-Kaye-Stansel procedure (DKS) to prevent increased afterload on the systemic ventricle. The present study investigated the efficacy of the DKS procedure in terms of the ventricular function following a Fontan operation. METHODS: Patients undergoing a Fontan operation were divided into three groups: DKS performed at the time of the bidirectional Glenn or Fontan operation (DKS group, n = 25); DKS not performed at any stage due to mild pulmonary stenosis (PS) (PS group, n = 23) and DKS not performed due to pulmonary atresia (PA) or severe PS (PA group, n = 24). Ventricular function, afterload on the systemic ventricle and atrioventricular valve regurgitation were compared between groups. RESULTS: Cardiac catheterization before a Glenn or Fontan operation and at 1-year following the Fontan revealed significantly decreased ventricular end-diastolic pressure in the DKS group. The ventricular ejection fraction was significantly deteriorated in the PS group. Effective arterial elastance, as an index of total ventricular afterload, was increased after a Fontan in all groups, with a substantial increase in the PS group. As an index of ventricular mechanical efficiency, ventriculoarterial coupling was significantly increased only in the PS group. Cardiac ultrasonography revealed atrioventricular valve regurgitation above grade 3 persisting in many patients from the PS group. Semilunar valve function after DKS operation did not progress to moderate or worse in any patients. CONCLUSIONS: The proactive performance of the DKS procedure prevents increased ventricular afterload, avoiding deterioration of cardiac function and contributing to improved long-term results following a Fontan operation.

First pediatric heart transplantation from a pediatric donor heart in Japan.

BACKGROUND: Since the revision of the Japanese Organ Transplantation Act, children younger than 15 years old can donate their organs after brain death. METHODS AND RESULTS: A teenage boy with endstage restrictive cardiomyopathy underwent the first heart transplantation with a pediatric donor heart in Japan on April 12, 2011. He had a good postoperative clinical course and no histological rejection episodes. His waiting period was relatively short (237 days) compared with adult patients, because of the pediatric patient-first policy for a pediatric donor heart. CONCLUSIONS: To increase pediatric heart transplantation in Japan, further enlightenment of the general population about pediatric organ donation is desirable.

Staged Starnes Operation Preserving Patent Ductus Arteriosus for Neonates with Ebstein's Anomaly and Pulmonary Atresia.

We herein reported 2 successful neonates with Ebstein's anomaly and small pulmonary arteries undergoing Starnes operation preserving the patent ductus arteriosus. Subsequent Blalock-Taussig shunt was carried out 1 or 2 months after the first surgery. One case had already undergone a successful Fontan operation, and the other had a successful bidirectional Glenn shunt so far. This staged Starnes strategy might be a safe and simple choice for neonates with Ebstein's anomaly and small pulmonary arteries.

[Efficacy of uracil/tegafur (UFT) plus oral Leucovorin (LV) therapy for colorectal cancer in elderly patients].

BACKGROUND & AIMS: The uracil/tegafur (UFT) plus oral Leucovorin (LV) regimen is one of the standard chemotherapy modalities for colorectal cancer, and has been reported to have fewer side effects. In this study, we investigated the efficacy and toxicity of UFT/LV regimen in elderly patients. PATIENTS AND METHODS: The subjects were twelve patients older than 70 years (median age, 76 years), who received a UFT/LV regimen for colorectal cancer between January 2004 and June 2005. Chemotherapy was attempted for metastatic colorectal cancer in seven patients and for postoperative adjuvant chemotherapy in five patients. The response rate and toxicity were compared with those of patients younger than 70 years old. RESULTS: Four courses of chemotherapy, in median, were delivered. The regimen consisting of UFT 300 mg/m(2) was completed in all patients. One patient achieved a complete response and another patient a partial response, thus resulting in an overall response rate of 28.6%. Three patients experienced Grade 1 diarrhea, and seven patients had Grade 1 or 2 anemia. Grade 3 or 4 toxicity was not recognized in all patients. CONCLUSIONS: Treatment with UFT/LV regimen is effective and well tolerated in elderly as well as younger patients.