Availability of virtual-assisted lung mapping affects procedure selection for early-stage lung cancer: a web-based cross-sectional study.

OBJECTIVES: The availability of new techniques may affect surgeons' procedure selection and thereby affect clinical outcomes. This study aimed to evaluate the effect of the availability of virtual-assisted lung mapping (VAL-MAP) on the selection of lung resection methods. METHODS: Members of the Japanese Association for Chest Surgeons were invited to participate in a web-based survey. Participants were divided into those who had never used VAL-MAP (group 0), those who had used only VAL-MAP 1.0 (multiple dye marks on the pleural surface; group 1) and those who had used VAL-MAP 2.0 (multiple dye marks and intrabronchial microcoils for three-dimensional mapping; group 2). Participants were shown chest computed tomography images of 6 ground-glass opacity nodules and asked to choose surgical procedures to resect the nodules with sufficient resection margins greater than the lesion diameter or 2 cm. RESULTS: There were 197 surgeons in group 0, 49 in group 1 and 26 in group 2. All groups showed a similar trend of avoiding wedge resection for deeply located nodules. However, group 1 showed a trend of disagreeing with the selection of wedge resection compared with group 0 as measured by a Likert scale (1-5) by -0.21 points (95% confidence interval, -0.41 to -0.008 points, P = 0.042). This tendency disappeared in group 2. CONCLUSIONS: The availability of VAL-MAP 1.0 led to the selection of segmentectomy, while the availability of VAL-MAP 2.0 led to aggressive deep wedge resection.

Effect of intraoperative needle biopsy on the survival of nonsmall cell lung cancer patients: a propensity score matching analysis.

PURPOSE: It is unknown whether intraoperative needle biopsy (INB) predisposes to the postoperative recurrence of lung cancer and compromises the prognosis of these patients. We conducted this study to identify the effect of INB before lobectomy on the postoperative recurrence rate and prognosis of patients with nonsmall cell lung cancer (NSCLC). METHODS: The subjects of this retrospective study were 953 patients with pathological stage I-III NSCLC who underwent lobectomy between 2001 and 2016. The patients were divided into two groups: the INB group (n = 94) and the non-INB group (n = 859). After propensity score matching (PSM), we compared the postoperative cumulative recurrence rate, recurrence-free survival (RFS), disease-specific survival (DSS), and overall survival (OS) between the two groups. RESULTS: After PSM, 94 patient pairs were matched. The cumulative recurrence rate was significantly higher in the INB group than in the non-INB group (P = 0.01). The 5-year RFS rate was significantly lower in the INB group than in non-INB group (48% vs 68%), as were the 5-year DSS (76% vs 92%) and 5-year OS rates (67% vs 84%) (all P < 0.05). CONCLUSIONS: The findings of this analysis suggest that INB before lobectomy may increase the cumulative recurrence rate and worsen the prognosis of patients with resectable NSCLC. Thus, we believe that INB should be avoided unless a lung lesion cannot be diagnosed by another type of biopsy.

Virtual-assisted lung mapping in sublobar resection of small pulmonary nodules, long-term results.

OBJECTIVES: The short-term efficacy of virtual-assisted lung mapping (VAL-MAP), a preoperative bronchoscopic multi-spot lung-marking technique, has been confirmed in 2 prospective multicentre studies. The objectives of this study were to analyse the local recurrence and survival of patients enrolled in these studies, long-term. METHODS: Of the 663 patients enrolled in the 2 studies, 559 patients' follow-up data were collected. After excluding those who did not undergo VAL-MAP, whose resection was not for curative intent, who underwent concurrent resection without VAL-MAP, or who eventually underwent lobectomy instead of sublobar resection (i.e. wedge resection or segmentectomy), 422 patients were further analysed. RESULTS: Among 264 patients with primary lung cancer, the 5-year local recurrence-free rate was 98.4%, and the 5-year overall survival (OS) rate was 94.5%. Limited to stage IA2 or less (≤2 cm in diameter; n = 238, 90.1%), the 5-year local recurrence-free and OS rates were 98.7% and 94.8%, respectively. Among 102 patients with metastatic lung tumours, the 5-year local recurrence-free rate was 93.8% and the 5-year OS rate was 81.8%. Limited to the most common (colorectal) cancer (n = 53), the 5-year local recurrence-free and OS rates were 94.9% and 82.3%, respectively. CONCLUSIONS: VAL-MAP, which is beneficial in localizing small barely palpable pulmonary lesions and determining the appropriate resection lines, was associated with reasonable long-term outcomes. SUBJ COLLECTION: 152, 1542.

Risk Factors for Invisible Intraoperative Markings After Virtual-Assisted Lung Mapping.

BACKGROUND: Virtual-assisted lung mapping (VAL-MAP) is a preoperative bronchoscopic multispot dye-marking technique that can be combined with bronchoscopic placement of a microcoil (VAL-MAP 2.0). VAL-MAP can identify unpalpable pulmonary lesions; however, the markings are occasionally deemed invisible intraoperatively. We investigated preoperative risk factors for invisible markings after VAL-MAP. METHODS: We prospectively performed preoperative VAL-MAP in patients at the University of Tokyo between January 2014 and June 2020. Data of 219 patients (257 lesions) and 857 markings were retrospectively reviewed. Dye markings were categorized as grade 0 (invisible) or 1-5 (visible). The risk factors for grade 0 markings were assessed using multiple logistic regression analysis. Subsegments of the bronchus showing grade 0 markings were also evaluated for 133 lesions and 504 markings without missing data for the target segment. RESULTS: Sixty-one of the 257 lesions (24%) displayed ≥1 grade 0 markings. Seventy-six (8.9%) of the 857 markings were grade 0 intraoperatively. VAL-MAP 1.0 was performed for 202 (79%) and 25 lesions (10%) without and with electromagnetic navigation bronchoscopy, and VAL-MAP 2.0 with a microcoil was performed for 30 lesions (11%). Upper lobe markings were associated with a significantly increased risk of invisible markings. There was no significant difference in the frequency of grade 0 markings among the VAL-MAP methods. Among all bronchi subsegments, left B1+2c exhibited the highest rate of grade 0 markings. CONCLUSIONS: Markings placed using VAL-MAP are more likely to be invisible for upper lobe pulmonary lesions. Injecting markings for lesions in the left S1+2c thus require caution.

Left apicoposterior segmentectomy for lung cancer with displaced segmental bronchus: a case report.

BACKGROUND: Pulmonary segmentectomy can be challenging when thoracic surgeons encounter anatomical anomalies. A displaced left apicoposterior bronchus is a rare bronchial anomaly that makes lung anatomical resection challenging. We herein present a case of successful left apicoposterior segmentectomy for lung cancer in a patient with an anomalous segmental bronchus. CASE PRESENTATION: A 70-year-old man was clinically diagnosed with early-stage lung cancer for which segmentectomy was indicated. A preoperative image revealed a displaced left apicoposterior bronchus that branched behind the left main pulmonary artery. With the aid of three-dimensional reconstruction imaging and systemic indocyanine green injection, we successfully performed left apicoposterior segmentectomy under complete video-assisted thoracic surgery. The pathological diagnosis was adenocarcinoma. The patient was alive without recurrence 8 months after segmentectomy. CONCLUSION: Preoperative three-dimensional imaging and systemic indocyanine green injection enabled us to successfully conduct challenging segmentectomy in a patient with an anomalous bronchus.

A meta-analysis of preoperative bronchoscopic marking for pulmonary nodules.

OBJECTIVES: Recent studies have suggested the usefulness of preoperative bronchoscopic marking techniques for the localization of pulmonary nodules in thoracic surgery. This systematic review and meta-analysis aimed to evaluate the efficacy and safety of preoperative bronchoscopic marking. METHODS: The PubMed and Cochrane Library databases were searched for clinical studies evaluating preoperative bronchoscopic marking for pulmonary resection. Non-comparative and random effects model-based meta-analyses were conducted to calculate the pooled success and complication rates of bronchoscopic marking. RESULTS: Twenty-five eligible studies were included. Among these, 15 studies conducted dye marking under electromagnetic navigation bronchoscopy, 4 used virtual-assisted lung mapping and 7 used other marking methods. The overall pooled successful marking rate, successful resection rate and complete resection rate were 0.97 [95% confidence interval (CI) 0.95-0.99], 0.98 (95% CI 0.96-1.00) and 1.00 (95% CI 1.00-1.00), respectively. The overall pooled rates of pleural injury and pulmonary haemorrhage were 0.02 (95% CI 0.01-0.05) and 0.00 (95% CI 0.00-0.00), respectively. CONCLUSIONS: This meta-analysis demonstrated that bronchoscopic marking is very safe and effective. Bronchoscopic marking should be considered, especially if there are concerns about the safety of other localization methods.

Progressively increasing density of the solid center of a ground-glass nodule in a solitary pulmonary capillary hemangioma: A case report.

Solitary pulmonary capillary hemangiomas (SPCHs) are recently recognized, rare benign lesions that form solitary nodules owing to capillary proliferation. These lesions are usually detected incidentally as small ground-glass nodules (GGNs) on computed tomography (CT), and progressively enlarge over time. The radiological distinction from peripheral lung cancers is particularly challenging. However, to date, there have been no reports on progressive changes in the central density of SPCH on CT. An asymptomatic 49-year-old man was referred to our hospital for an abnormal shadow that was detected on chest CT during medical check-up. He was subsequently followed-up with chest CT. The nodule increased in size, and the central area became progressively denser. He underwent surgery 5 years and 10 months after the first visit owing to suspicion of lung cancer. Despite the collapse of the surgical specimen by artifacts, histopathological examination revealed a diagnosis of SPCH; collagenous fibers were found in the walls of the intralesional capillaries. The patient is presently alive without any recurrence, 6 months after the operation. In this case, the SPCH demonstrated a GGN with progressively increasing density of the central solid area on the CT. This remarkable feature made the preoperative distinction from lung cancer particularly difficult.

Arteritis and Plexiform Lesion in Intralobar Pulmonary Sequestration: The First Case With Such Two Distinct Complex Lesions Associated With Local Pulmonary Hypertension.

In intralobar pulmonary sequestrations, vascular changes similar to those in pulmonary hypertension (PH) are generally observed, such as intimal proliferation and plexiform lesions. However, to our knowledge, a sequestrated lung manifesting vascular changes with both arteritis and a plexiform lesion has never been reported. A 25-year-old man was diagnosed with intralobar pulmonary sequestration. Pathologically, both arteritis and a plexiform lesion were observed in the sequestrated lung. Systemic vasculitis syndrome was clinically excluded, and the pathological findings appeared to be associated with local PH. Arteritis is an extremely rare finding; only one case of arteritis associated with local PH has been reported in intralobar sequestration. In this case, the artery near the plexiform lesion had milder inflammation and fibrosis, suggesting that the arteritis formed prior to the plexiform lesion. This is the first case of arteritis and a plexiform lesion co-occurring in intralobar pulmonary sequestration associated with local PH. This case may shed light on the formation of plexiform lesions and their association with arteritis.

Effect of patient position during virtual-assisted lung mapping.

BACKGROUND: Virtual-assisted lung mapping (VAL-MAP) is a preoperative multi-spot bronchoscopic dye-marking technique. Marking failure reportedly occurs in approximately 10% of marks. The aim of the present study was to investigate whether the patient position during dye injection in VAL-MAP affected the quality of markings. METHODS: This study was a retrospective review of patients with barely palpable pulmonary nodules who underwent VAL-MAP at a single institution between December 2016 and September 2017. Easily visible markings without bulla formation were defined as "appropriate", while other markings were defined as "inappropriate". Patients were divided in accordance with the position during dye injection into the supine position group (n=6) and the lateral position group (n=8). The two groups were compared regarding the appropriate markings rate. The Fisher exact test and logistic regression model were used for statistical analyses. RESULTS: Fourteen patients with 17 nodules underwent VAL-MAP with a total of 48 markings (3.4±0.9 markings per patient). Of these, 21 markings were performed in supine position, whereas 27 were performed in lateral position. There were no significant differences between the two groups in lesion size, depth, and characteristics. Almost all of the performed procedures were thoracoscopic wedge resections (94%), while one procedure was thoracoscopic left upper division segmentectomy. The appropriate markings rate was significantly greater in the lateral position group than in the supine position group (88% vs. 57%, P=0.02). Among the markings located in dorsal and ventral lung segments, the appropriate markings rate in the lateral position group tended to be greater than that in the supine position group (89% vs. 59%, P=0.06). Multivariate logistic regression analysis revealed that the lateral position was independently associated with appropriate markings (P=0.014). CONCLUSIONS: The lateral position may enable the creation of better quality markings in VAL-MAP.

Influence of Smoking and Histologic Subtype on Developing Extrathymic Malignancy in Thymoma Patients.

BACKGROUND: Patients with thymomas are at high risk of developing extrathymic malignancies. We investigated the impact of extrathymic malignancies on the prognosis of patients with thymoma who underwent surgery and the risk factors for postoperative extrathymic malignancies. METHODS: A multicenter retrospective review of 252 patients who underwent surgical resection of thymomas from January 1977 to March 2016 was conducted. The exclusion criteria were recurrent thymoma, rare types of thymoma, and missing data. The overall number and incidence of extrathymic malignancies were calculated. Potential predictors of extrathymic malignancies were also evaluated. RESULTS: Two hundred twenty-eight patients were analyzed. Fifty-five extrathymic malignancies were observed (23 postoperative, 8 synchronous, and 24 preoperative). Among the overall cohort, the incidence of extrathymic malignancies significantly increased the patients' risk of death (hazard ratio [HR], 4.02; 95% confidence interval [CI], 1.72 to 9.40; p < 0.01). Among patients aged less than 70 years, the incidence of extrathymic malignancies was an independent risk factor for death. The incidence of postoperative extrathymic malignancies was significantly higher in patients with indolent forms of thymoma (type A/AB/B1) than aggressive forms (type B2/B3) (p = 0.02). In the multivariate analysis, indolent forms of thymoma (type A/AB/B1) (HR, 4.03; 95% CI, 1.12 to 14.6, p = 0.03) and a history of ever having smoked (HR, 5.29; 95% CI, 1.30 to 21.6; p = 0.02) were significant risk factors for the cumulative incidence of postoperative extrathymic malignancies. CONCLUSIONS: Extrathymic malignancies increased the risk of death in patients with thymomas. Indolent forms of thymoma and a history of ever having smoked were risk factors for postoperative extrathymic malignancies.

Differential diagnosis of solitary gastric Peutz-Jeghers-type polyp with stomach cancer: a case report.

INTRODUCTION: Solitary Peutz-Jeghers-type polyps of the stomach are extremely rare. They are defined as unique polyps that are not associated with Peutz-Jeghers syndrome (PJS). PRESENTATION OF CASE: A 37-year-old woman presented at our hospital with anemia and epigastric discomfort. Esophagogastroduodenoscopy to determine the cause of anemia revealed a 5 × 6-cm pedunculated polypoid tumor at the greater curvature of the upper gastric body. Pathological examination of a biopsy specimen confirmed a Group 1 hyperplastic polyp. Computed tomography revealed neither lymph node swelling nor distant metastasis. A malignant component of the polypoid tumor was difficult to deny because of its size. The patient underwent local resection of the stomach. Her postoperative course was uneventful. A pathological examination of the surgical specimen revealed a Peutz-Jeghers-type, hamartomatous polyp containing an enlarged crypt with hyperplastic foveolar epithelium and smooth muscle proliferating into the lamina propria. No atypical cells were found in the overlying epithelium. Based on these findings, we performed colonoscopy and capsule endoscopy of the intestine. No polyps were found in the intestine or colon. She had no family history of any type of tumor and no mucocutaneous pigmentation. DISCUSSION: There were only 10 reports of solitary gastric Peutz-Jeghers polyps published to date. Although most of them did not have atypical cells, one case has proliferative component. A few reports have described relationship with malignant tumor. CONCLUSION: Solitary gastric PJ-type polyps are rare. Careful follow-up should be recommended and further studies are needed to evaluate cancer risk of solitary gastric PJ-type polyps.

Gastric carcinogenesis by N-Methyl-N-nitrosourea is enhanced in db/db diabetic mice.

In 2005, a Japanese epidemiological study showed that increase in plasma glucose levels is a risk factor for gastric cancer. However, no animal model has hitherto shown any association between diabetes mellitus and neoplasia in the stomach. Diabetic (db/db) mice have obese and diabetic phenotypes, including hyperglycemia, because of disruption of the leptin receptor. In the present study, effects of hyperglycemia and/or hyperinsulinemia on the development of proliferative lesions were therefore examined in db/db mice given N-methyl-N-nitrosourea (MNU). A total of 120 mice were assigned to four groups: Group A, 40 db/db mice with MNU; Group B, 40 + /db mice with MNU; Group C, 30 misty (wild-type) mice with MNU; Group D, 10 db/db mice without MNU. MNU was given at 60 ppm in drinking water for 20 weeks. Subgroups of animals were sacrificed at weeks 21 and 30 and blood samples were collected to measure glucose, insulin, leptin, and adiponectin concentrations. The removed stomachs were fixed in formalin, and embedded in paraffin for histological examination and immunohistochemistry. At week 30 in Groups A, B, C and D, hyperplasia was observed in 100, 79, 57, and 0%, and dysplasia in 91, 43, 71, and 0%, respectively. Adenocarcinomas and pepsinogen-altered pyloric glands (PAPG), putative preneoplastic lesions, were observed only in Group A, at an incidence of 45%. The serum levels of insulin and leptin were also elevated in Group A. Gastric carcinogenesis by MNU was enhanced in db/db mice, possibly in association with hyperinsulinemia and hyperleptinemia.

Emergence of spasmolytic polypeptide-expressing metaplasia in Mongolian gerbils infected with Helicobacter pylori.

Spasmolytic polypeptide (TFF2)-expressing metaplasia (SPEM) is observed in mucosa adjacent to human gastric cancer and in fundic glands showing oxyntic atrophy in Helicobacter felis-infected mice. Mongolian gerbils infected with Helicobacter pylori (Hp) develop goblet cell intestinal metaplasia and adenocarcinoma, but the presence of SPEM has not been studied in gerbils. We therefore have sought to examine the development of metaplastic mucosal changes in Hp-infected Mongolian gerbils. Mongolian gerbils were assigned to either uninfected controls or infected with Hp at 17 weeks of age. The animals were killed at 17, 20, 26, 31, 41 and 56 weeks of age. Stomach sections were stained using antibodies for TFF2, intrinsic factor, H/K-ATPase, BrdU and MUC2. Dual immunofluorescence staining for TFF2 with intrinsic factor and for TFF2 with MUC2 was performed. In uninfected animals, no SPEM or intestinal metaplasia was observed. Infected gerbils developed SPEM initially in the intermediate zone along the lesser curvature and subsequently spread out towards the greater curvature. In the earlier stages of infection, SPEM glands demonstrated TFF2 and intrinsic factor double staining cells. However, after 35 weeks of infection, the number of double staining SPEM cells decreased. While early in infection SPEM organized in straight glands, in the later stages of infections, SPEM glands became distorted or dilated along with the development of gastritis cystica profunda that was TFF2 positive. Goblet cell intestinal metaplasia developed only late in the infection. Dual staining for TFF2 and MUC2 showed glands containing both SPEM- and MUC2-positive goblet cell intestinal metaplasia. SPEM develops early in Hp infection in Mongolian gerbils, and alterations in gland morphology arise from SPEM glands during the course of gastric infection with goblet cell intestinal metaplasia developing subsequent to SPEM.

[Gastric cancer and eradication of H. pylori].

Diagnosis and treatment of gastric cancer has now been established, and prevention is thought to be of importance to overcome this disease. Many experimental and clinical researches have clarified the pivotal role of H. pylori infection in gastric carcinogenesis. Therefore, prevention of gastric carcinogenesis by H. pylori eradication seems to be promising, and the possibility has been suggested by experimental and clinical studies. The issues to be solved are to select the candidates for eradication and to assess the timing of eradication. Development of new diagnostic methods and biomarkers for H. pylori eradication is required.

Nutritional comparisons between a pylorus-preserving gastrectomy with and without suprapyloric lymph node clearance: a preliminary report.

BACKGROUND/AIMS: A pylorus-preserving gastrectomy (PPG) is a procedure for gastric cancer (GC) patients which attempts to control gastric emptying and to minimize postoperative nutritional disadvantages. The persistence of conflicting stances concerning qualifying candidates for PPG--a narrower or wider segment of patients--is attributable to a lack of decisive evidence concerning the precise nutritional impact of suprapyloric lymph node clearance. METHODOLOGY: Forty-eight patients underwent a PPG with (30 patients; dissection group) or without (18 patients; preservation group) suprapyloric lymph node clearance between 2002 and 2004. Patients with mucosal GC located in the middle third of the stomach were assigned to the preservation group and the other early GC patients formed the dissection group. Those who were followed up more than one year postoperatively were selected from the preservation (8 patients) and the dissection (16 patients) groups, and changes in body weight, hemoglobin, total protein, and albumin were compared between the two groups. Baseline clinicopathological characteristics, surgically related events, and supportive medications were also compared between the two groups. RESULTS: Dissection group patients received significantly longer surgery (p < 0.01) and a wider scope of lymphadenectomy (p < 0.0001) than preservation group patients. Other factors including the length of postoperative hospital stay and morbidity rate did not differ between the two groups. Percent changes in body weight, hemoglobin, total protein, and albumin, as well as postoperative profiles of each parameter were similar between the two groups. CONCLUSIONS: These results suggest that suprapyloric lymph node clearance resulted in more traumatic surgery while it did not exacerbate postoperative nutritional status as compared with suprapyloric lymph node preservation. PPG is justifiable for submucosal GC or an even wider segment of patients by suprapyloric lymph node clearance without nullifying the anticipated nutritional benefit.

Helicobacter pylori-negative / API2-MALT1 translocation-negative low-grade MALT lymphoma.

A 71-year-old man with a Helicobacter pylori infection-negative and API2-MALT1 translocation-negative extranodal marginal-zone B-cell lymphoma of mucosa-associated lymphoid tissue (MALT) type of the stomach has been followed conservatively for over 5 years. The lesion has shown no major morphological changes or malignant progression into a diffuse large-cell type during the time course. The absence of genetic translocation of API2-MALT1 was confirmed with fluorescence in situ hybridization (FISH). The prognosis of H. pylori-negative and API2-MALT1 translocation-negative low-grade MALT lymphoma is unknown, and a standard treatment for such lymphoma has yet to be defined. The case of MALT lymphoma negative for both of the above factors that we report has shown no obvious rapid progression or malignant change over the long-term course. Although curative operation and/or chemoradiotherapy should still be discussed as the treatment of choice, the treatment of this type of lymphoma must be carefully determined on a case-by-case basis, according to its biological status and prognosis.

Laparoscopy-assisted pylorus-preserving gastrectomy with quality controlled lymph node dissection in gastric cancer operation.

BACKGROUND: Pylorus-preserving gastrectomy (PPG) with extensive lymph node dissection is useful for treatment of early gastric cancer with preservation of function. This technique could be improved by using laparoscopy-assisted gastrectomy. STUDY DESIGN: Between September 2000 and September 2004, 109 patients with T1 gastric cancer underwent surgical treatment; 72 underwent laparoscopy-assisted PPG (LAPPG) and 37 underwent conventional PPG (CPPG). Total numbers of dissected lymph nodes, retrieval at each lymph node station, intraoperative blood loss, and operation times were used as measures of the quality of lymph node dissection to compare the procedures. Continuous data are summarized as mean +/- SE. RESULTS: Operation times with the LAPPG procedure (279 +/- 6 minutes) were significantly, but only 20 minutes, longer than with CPPG (259 +/- 8 minutes) (p = 0.047), although estimated blood loss for LAPPG patients (153 +/- 13 mL) was not significantly different for those undergoing CPPG (184 +/- 13 mL, p = 0.13). Mean total number of dissected lymph nodes was 32.3 +/- 1.6 in the LAPPG group and 28.5 +/- 2.2 in the CPPG group (p = 0.16). There was no significant difference in the number of lymph nodes retrieved for any of the nodal stations between the LAPPG and CPPG procedures. CONCLUSIONS: Clinical outcomes of surgical treatment were comparable for gastric cancer patients who underwent LAPPG and those treated with CPPG in terms of station-dependent lymph node dissection and estimated blood loss.

Performance of outpatient regimen of S-1 in combination with fractional cisplatin for advanced or recurrent gastric cancers: a phase I study.

BACKGROUND: We designed an outpatient regimen consisting of fractional cisplatin in combination with S-1, a novel oral fluoropyrimidine derivative for the treatment of recurrent or advanced gastric cancer and conducted a phase I study to determine the dose limiting toxicities (DLTs) and recommended dose (RD). METHODS: Escalating dosages of cisplatin (15, 20, and 25 mg/m(2), as levels 1, 2, and 3, respectively) were administered over 2 h on days 1, 8, and 15, with a fixed dose of S-1 for 3 consecutive weeks (days 1-21), repeated every 5 weeks. National Cancer Institute common toxicity criteria(NCI-CTC) grade 2 toxicities required treatment delay. Primary first cycle DLTs were defined as NCI-CTC grade 3 or 4 toxicities (except for hemoglobin levels, nausea, and vomiting). RESULTS: Nine patients were initially enrolled, and DLTs did not appear; however, one level-3 patient experienced grade 3 anemia. An additional three patients were enrolled in level 3 to confirm the toxicity profiles, and none experienced DLTs. Toxicity evaluations throughout a total of 62 cycles revealed that grade 1 or 2 hematological toxicities were common, although mostly transient, with recovery without specific treatment. One patient each in levels 1 and 3 required hospitalization due to grade 3 toxicities in the later cycles. Mean dose intensities for S-1 and cisplatin were both more than 91%. There were no treatment-related deaths. The preliminary response rate was 44%. CONCLUSIONS: It was concluded that the RD of cisplatin in this regimen was 25 mg/m(2) (level 3). S-1 in combination with fractional cisplatin is a promising regimen that allows repeated drug administration, in an outpatient setting, for advanced or recurrent gastric cancers. A phase II study of the RD is now under way.

Efficacy of triple therapy plus cetraxate for the Helicobacter pylori eradication in partial gastrectomy patients.

In the present study, we aimed to establish an additional standardized protocol with a higher H. pylori eradication rate in the remnant stomach. Fifty-five H. pylori-positive patients were randomly allocated to one of three regimens: LAC--lansoprazole, amoxicillin, and clarithromycin b.i.d. for 7 days (n = 17); LAC+CET--LAC b.i.d. plus cetraxate q.i.d. for 7 days (n = 20); and LEFT--LAC for 7 days in a horizontal body position on the left side for 30 min (n = 18). Patient compliance and side effects were checked via interviews. H. pylori eradication was successful in 75, 72, and 41% in LAC+CET, LEFT, and LAC, respectively. The eradication rate was significantly higher in LAC+CET than in LAC (P = 0.024) but not in LEFT (P = 0.058). Adverse events that occurred in each group were almost all mild ones. Cetraxate plus LAC for 1 week is a safe and effective regime for the eradication of H. pylori in patients after partial gastrectomy.