Administration of docetaxel plus ramucirumab with primary prophylactic pegylated-granulocyte colony-stimulating factor for pretreated non-small cell lung cancer: a phase II study.

PURPOSE: Although docetaxel plus ramucirumab has shown superior treatment efficacy over docetaxel monotherapy for patients with non-small cell lung cancer (NSCLC), the high rate of febrile neutropenia (FN) presents a clinical problem. This study aimed to validate the primary prophylactic use of pegfilgrastim with docetaxel and ramucirumab treatment in Japanese patients with NSCLC. METHODS: Patients with NSCLC with progression after at least one round of chemotherapy were enrolled and administered docetaxel (60 mg/m2) plus ramucirumab (10 mg/kg) intravenously on day 1, followed by pegylated-granulocyte colony-stimulating factor (3.6 mg) on day 2 of a 21-day treatment cycle. The primary study endpoint was the percentage of patients who developed FN. Secondary endpoints included overall survival, progression-free survival, overall response rate, and safety. RESULTS: Overall, 20 patients (15 men and 5 women) were enrolled, of whom one developed FN, resulting in an overall FN rate of 5%. The response and disease control rates were 40% and 85%, respectively. The median progression-free survival was 6.6 (95% confidence interval [CI], 0.5-NR) months. The median overall survival was 18.4 (95% CI, 2.2-11.0) months. Six patients aged over 75 years were included in this study, and although most adverse events were durable, ramucirumab-associated adverse events occurred more frequently in these patients. CONCLUSIONS: We observed a 5% FN rate using primary prophylactic pegylated-granulocyte colony-stimulating factor with docetaxel plus ramucirumab in Japanese patients with NSCLC. While most adverse events were durable, elderly patients should be closely monitored.

FF-10832 enables long survival via effective gemcitabine accumulation in a lethal murine peritoneal dissemination model.

Chemotherapy has been the treatment of choice for unresectable peritoneal dissemination; however, it is difficult to eradicate such tumors because of poor drug delivery. To solve this issue, we developed FF-10832 as liposome-encapsulated gemcitabine to maintain a high concentration of gemcitabine in peritoneal tumors from the circulation and ascites. A syngeneic mouse model of peritoneal dissemination using murine Colon26 cell line was selected to compare the drug efficacy and pharmacokinetics of FF-10832 with those of gemcitabine. Despite the single intravenous administration, FF-10832 treatment enabled long-term survival of the lethal model mice as compared with those treated with gemcitabine. Pharmacokinetic analysis clarified that FF-10832 could achieve a more effective gemcitabine delivery to peritoneal tumors owing to better stability in the circulation and ascites. The novel liposome-encapsulated gemcitabine FF-10832 may be a curative therapeutic tool for cancer patients with unresectable peritoneal dissemination via the effective delivery of gemcitabine to target tumors.

Laparoscopic-assisted partial ileectomy for crohn's disease associated with chronic anemia due to frequent hemorrhage.

Crohn's disease can involve any part of the gastrointestinal tract. Although good conservative treatment is given as soon as possible, most patients with this disease will eventually require surgery. We encountered a case of Crohn's disease associated with anemia which we treated with laparoscopic-assisted ileectomy. The postoperative course was satisfactory. The most important characteristic of Crohn's disease, fat wrapping and extending over the serosal surface toward the antimesenteric border, was observed in the ileum, distinguishing the disease and pinpointing the lesion accurately. This surgical method has an advantage over open surgery in that the recovery time is shorter and incisions are smaller, allowing easier surgery in the future, shortening the patient's hospital stay, and improving the patient's quality of life.

Blood group substances as potential therapeutic agents for the prevention and treatment of infection with noroviruses proving novel binding patterns in human tissues.

Blood group-related glycans determining ABO and Lewis blood groups are known to function as attachment factors for most of the norovirus (NoV) strains. To identify binding specificity of each NoV, recombinant norovirus-like particles (VLPs) and human saliva samples with different ABO, Lewis phenotypes and secretor status have been commonly applied. When binding specificities of VLPs prepared from 16 different genotypes of NoVs in GI and GII genogroups were characterized in samples of human gastric mucosa compared to human saliva based on blood group phenotypes, considerable differences were observed for several strains. Novel binding specificities determined by an ELISA using preparations from human gastric mucosa were also ascertained by immunohistochemical analyses using human jejunal mucosa, widely believed to be susceptible to NoV infection. Further, A, B and O(H) blood group substances prepared from porcine and squid tissues were found to be effective for preventing ABO blood group-specific binding of VLPs to both saliva and mucosa samples. Therefore, these blood group substances might have potential for the prevention and treatment of NoV infection.

Mosapride citrate improves postoperative ileus of patients with colectomy.

BACKGROUND AND AIMS: Postoperative ileus is a transient bowel dysmotility that occurs following many types of operations and is a common complication of gastrointestinal surgery. Mosapride citrate is an agonist of the 5-hydroxytryptamine 4 receptor and accelerates upper gut motility. No study has evaluated its effect on gastrointestinal motility after surgery. The aim of this study was to investigate whether mosapride citrate reduces the duration of postoperative ileus. METHODS: Thirty patients with colon cancer who underwent colectomy were divided into two groups: the mosapride group and the control group. The mosapride group received mosapride 15 mg by mouth with a minimal amount of water three times a day, starting on postoperative day 1. The control group received only a minimal amount of water on the same schedule. Patients were allowed to resume oral feeding on postoperative day 4. Postoperative time to first flatus and defecation were evaluated, and the amount of food intake was observed. Gastrointestinal motility was recorded on postoperative day 8. RESULTS: The appearance ratio of interdigestive migrating contractions and the motility index at the antrum and duodenum were significantly higher in the mosapride group than in the control group. The time to first flatus and defecation were significantly shorter in the mosapride group than in the control group. The amount of food intake on postoperative days 6 and 7 was significantly larger in the mosapride group than in the control group. CONCLUSION: Mosapride citrate reduces the duration of postoperative ileus and may improve outcomes after gastrointestinal surgery.