Risk factors for infection of totally implantable central venous access ports among patients requiring port removal.

BACKGROUND: Totally implantable central venous access ports, are required for various purposes, ranging from chemotherapy to nutrition. Port infection is a common complication. In many patients with port infection, the ports are removed because antibiotics are ineffective. We evaluated the risk factors associated with port removal due to port infection. METHODS: By retrospective chart review, we collected data of 223 patients who underwent port removal for any reason. Port infection was defined as infection symptoms, such as fever; elevated white blood cell counts or C-reactive protein levels; or redness at the port site, in the absence of other infections, which improved with port removal. The characteristics of patients with or without port infection were compared using univariate (chi-squared test, t-test) and multivariate logistic regression analyses. RESULTS: We compared 172 patients without port infection to 51 patients with port infection. Univariate analysis identified sex (p = 0.01), body mass index (BMI) ⩽20 kg/m2 (p = 0.00004), diabetes mellitus (p = 0.04), and purpose of use (p = 0.0000003) as significant variables. However, male sex (p = 0.03, 95% confidence interval [CI]: 0.01-0.23), BMI ⩽20 kg m2 (p = 0.002, 95% CI: 0.06-0.29), and purpose of use (total parenteral nutrition (TPN); p = 0.000005, 95% CI: 0.31-0.76) remained significant using multivariate analysis. Moreover, the patients with short bowel syndrome and difficulty in oral intake tended to be infected easily. Additionally, Staphylococcus species were the most common microbes involved in port infection. CONCLUSIONS: Male sex, BMI ⩽20 kg/m2, and purpose of use as a TPN were risk factors for port infection. Ports should not be used for long duration of TPN or used only in exceptional cases.

Feasibility and efficacy of newly developed eco-friendly, automatic washer for endoscope using electrolyzed alkaline and acidic water.

INTRODUCTION: As well as preventing nosocomial and healthcare-associated infections, a reliable and eco-friendly washer for medical equipment would also be safe for the global environment. The aim of this study was to evaluate the efficacy of a newly developed automatic washing system (Nano-washer) that uses electrolyzed water and ultrasonication without detergent for washing endoscopes. METHODS: Patients who underwent laparoscopic lobectomy or laparoscopic colectomy at Nagasaki University between 2018 and 2022 were included. A total of 60 cases of endoscope use were collected and classified according to endoscope washing method into the Nano-washer group (using no detergent) (n = 40) and the manual washing group (n = 20). Protein and bacterial residues were measured before and after washing, using absorbance spectrometry and 16S rRNA polymerase chain reaction. The effectiveness of protein and bacterial removal and endoscope surface damage after washing were compared under specular vision between the groups. RESULTS: Nano-washer did not use detergent unlike manual washing. There was no difference in demographic or clinical characteristics between the groups except for the presence of comorbidities in the lobectomy group (Nano-washer, 85%; manual washing, 40%, P = .031). Compared with the manual washing group, residual protein levels in the Nano-washer group were significantly reduced after washing (lobectomy, 0.956 mg/mL vs 0.016 mg/mL, P < .001; colectomy, 0.144 mg/mL vs 0.002 mg/mL, P = .008). Nano-washer group showed a significant reduction in bacteria between before and after lobectomy (9437 copies/cm2 vs 4612 copies/cm2 , P = .024). CONCLUSION: Nano-washer is a promising, effective, and eco-friendly automatic washing device that is safer and more efficient than manual washing.

Impacts of trans-anal tube placement in patients with sigmoid colon cancer: Risk verification analysis using inverse probability weighting analysis.

Purpose: Anastomotic leakage (AL) is a serious postoperative complication that affects short- and long-term outcomes. The use of a trans-anal drainage tube (TDT) is reported to prevent AL in rectal cancer patients, but its value in sigmoid colon cancer patients is unknown. Methods: Admitted to the study were 379 patients who underwent surgery for sigmoid colon cancer between 2016 and 2020. Patients were divided into two groups according to the placement (n = 197) or nonplacement of a TDT (n = 182). To determine the factors affecting the association between TDT placement and AL, we estimated average treatment effects by stratifying each factor using the inverse probability of treatment weighting method. The association between prognosis and AL was evaluated in each identified factor. Results: Factors associated with postsurgical insertion of a TDT were advanced age, male sex, high body mass index (BMI), poor performance status, and presence of comorbidities. TDT placement was associated with a significantly lower AL in male patients (odds ratio [OR], 0.22; 95% confidence interval [CI], 0.07-0.73; P = .013) and for BMI ≥ 25 kg/m2 (OR, 0.13; 95% CI, 0.02-0.65; P = .013). In addition, there was a significant association of AL with poor prognosis in patients with BMI ≥ 25 kg/m2 (P = .043), age > 75 y (P = .021), and pathological node-positive disease (P = .015). Conclusion: Sigmoid colon cancer patients with BMI ≥ 25 kg/m2 are the most appropriate candidates for postoperative TDT insertion, in terms of reduced incidence of AL and improved prognosis.

Safety and Effectiveness Analyses of Dolutegravir/Lamivudine in Patients with HIV: 2-Year Report of Post-Marketing Surveillance in Japan.

INTRODUCTION: Since 2019, for the first time, a two-drug regimen with dolutegravir/lamivudine (DTG/3TC) has been recommended for HIV treatment as initial and subsequent therapy in the international guidelines. However, safety and efficacy data of DTG/3TC in Japanese people living with HIV (PLHIV) in clinical trials are limited and have not been evaluated in clinical practice. In this report, we evaluated safety and effectiveness of DTG/3TC in Japanese PLHIV through post-marketing surveillance. METHODS: Post-marketing surveillance was conducted to evaluate the real-world safety and effectiveness of DTG/3TC in Japanese PLHIV. One hundred ninety-seven patients who received oral DTG 50 mg/3TC 300 mg as a single-tablet fixed-dose combination regimen (STR) were registered in clinical practice. The safety was evaluated by incidence of adverse drug reactions (ADRs). The effectiveness was evaluated by plasma HIV RNA and peripheral CD4+ cell counts. RESULTS: This is a 2-year (from 2020 to 2022) report of approximately 6 years of survey, and 187 patients were registered from 21 Japanese sites. The number of antiretroviral therapy (ART)-experienced patients was 178, and > 60% of their previous antiretrovirals (ARVs) were DTG/abacavir (ABC)/3TC. There were only nine ART-naïve patients. Four of 178 ART-experienced patients (2.25%) reported ADRs, and 1 serious ADR of syphilis was reported. There was no clear causal relationship between DTG/3TC and the ADRs. Plasma HIV RNA and peripheral CD4+ cell counts maintained the pre-DTG/3TC level in ART-experienced patients. CONCLUSION: No new clinical concerns of safety and effectiveness were identified in Japanese ART-experienced PLHIV treated with DTG/3TC. We could not discuss the safety and effectiveness in ART-naïve patients because of the small sample size.

Trend of oral antimicrobial use after removal of broad-spectrum antimicrobials from the formulary at a pediatric primary emergency medical center.

INTRODUCTION: While the effects of the Japanese action plan formulated in 2016 have gradually appeared, the appropriate use of antimicrobials in outpatient settings is still important. We conducted a previous study to recommend appropriate antimicrobial use via monthly newsletters at a pediatric primary emergency medical center (PEC). As a result, the rate of inappropriate prescription of oral third-generation cephalosporins (3GCs) decreased by 67.2%. This decrease prompted our institution to change the antimicrobials adopted from 3GCs to first-generation cephalosporins. There have been no reports on the prescribing trend of narrow-spectrum antimicrobials after the discontinuation of 3GCs in pediatric PECs. METHODS: We conducted a single-center, observational study at one pediatric PEC between April 2020 and March 2022. We recorded the total number of patients and oral antimicrobial prescriptions, diagnoses, and descriptions of the electronic health records and evaluated the prescription trends and appropriateness of antimicrobial use after removal of cefditoren-pivoxil and fosfomycin from the formulary. RESULTS: The total number of patients was 22,744 during the study period, and antimicrobials were prescribed to 496 (2.2%) patients. The proportion of amoxicillin prescriptions among total antimicrobials was high (53.4%). For each prescription, 85 of 259 prescriptions (32.8%) for amoxicillin, 161 of 185 prescriptions (87.0%) for cephalexin, and 17 of 43 prescriptions (39.5%) for clarithromycin were judged to be appropriate. CONCLUSION: We suggest that after the removal of broad-spectrum antimicrobials and achieving a reduction in the prescription rate of oral antimicrobials, it is necessary to evaluate whether narrow-spectrum antimicrobials are used properly in pediatric PECs.

Effect of oxaliplatin in elderly colon cancer patients with pathological T4 and/or N2 disease: a multicenter, propensity score-matched analysis.

PURPOSE: Although adjuvant chemotherapy (AC) using fluoro-pyrimidine and oxaliplatin (FU + oxaliplatin) is recommended after curative resection for locally advanced colon cancer patients, several randomized controlled trials have shown no additional effect of oxaliplatin in patients aged ≥ 70 years. Here, we examined the effectiveness of FU + oxaliplatin on the long-term outcome of old patients with a high risk of recurrence. METHODS: This multicenter, retrospective study included 346 colon cancer patients diagnosed with pathological T4 and/or N2 disease from 2016 to 2020. They were divided into an old group (≥ 70 years, n = 197) and a young group (< 70 years, n = 167). Propensity score matching was used to minimize selection bias, and 126 patients per group were matched. RESULTS: Before matching, the rates of poor performance status (p < 0.001) and the presence of comorbidities (76.1% vs. 47.9%, p < 0.001) were higher in the old group. Although all baseline factors were similar between groups, after matching, the AC rate was lower in the old group (45.2% vs. 65.1%, p = 0.002). In the old group, relapse-free (82.2% vs. 55.6% and 69.6%, p < 0.05) and overall survival (83.1% vs. 80.0% and 44.4%, p < 0.05) rates were significantly higher in the AC patients with FU + oxaliplatin than in the AC patients with only FU and the non-AC patients. CONCLUSION: The selected old colon cancer patients with a high risk of recurrence gained an additional benefit with respect to prognosis from FU + oxaliplatin as AC.

Usefulness of structured-cadaveric training for trans-anal pelvic exenteration.

PURPOSE: Structured training using cadaveric simulation is useful for trans-anal surgery; however, no studies have examined the effectiveness of cadaveric training for advanced trans-anal surgery including pelvic exenteration (PE). METHODS: Twelve colorectal surgeons attended a total of 10 cadaveric simulation training courses between 2016 and 2021 and completed a questionnaire at the end of the program. We divided 14 consecutive patients who underwent trans-anal PE between 2015 and 2021 into two groups: pre-training group and post-training group, and compared the clinico-pathological features between the groups. RESULTS: The median length of clinical experience of the surgeons was 12 years. There was high score agreement among the surgeons that the course was useful for recognition of anatomical and layer structure, training for trans-anal total mesorectal excision and trans-anal PE, and reducing complications specific to the trans-anal approach. Compared with the pre-training group, patients in the post-training group had a higher rate of two-team surgery (77.8% vs 0%, P = .021), and shorter time to specimen removal (273 vs 423 min, P = .045). CONCLUSIONS: Structured-cadaveric training has potential use as a technical step-up in advanced trans-anal surgery that might contribute to better short-term outcomes in the clinical setting.

Pathological complete response to pembrolizumab in patients with metastatic ascending colon cancer with microsatellite instability.

Pembrolizumab is a novel immune-checkpoint inhibitor used for treatment of microsatellite instability-high (MSI-H) colorectal cancer. Several studies have reported clinical complete response (CR) after treatment with pembrolizumab, but none has confirmed pathological CR. Here we provide the first description of pathological CR with R0 resection after immune-checkpoint therapy. A 45-year-old man presented at our hospital with abdominal distention and highly elevated tumor markers. Contrast-enhanced abdominal CT showed a 110 × 75 mm bulky mass with markedly swollen lymph nodes and an isolated peritoneal metastasis in the pelvic space. Biopsy revealed poorly differentiated adenocarcinoma. We diagnosed ascending colon cancer cT4aN2bM1c Stage IVc. A biopsy specimen obtained during systemic chemotherapy (FOLFOXIRI) was confirmed pathologically as MSI-H, after which the treatment was changed to pembrolizumab. The tumor markers rapidly decreased to within normal ranges after three courses of treatment. After twenty courses, CT revealed shrinkage of the main tumor, lymph node metastases, and the peritoneal metastasis, and we performed extended right hemi-colectomy with dissection of the peritoneal metastasis. No residual tumor cells were found histologically. The patient achieved pathological CR and the postoperative course was uneventful. An accurate diagnosis and appropriate follow up are crucial for obtaining sufficient therapeutic effect of pembrolizumab.

Combined transabdominal and transperineal endoscopic pelvic exenteration for colorectal cancer: feasibility and safety of a two-team approach.

PURPOSE: Pelvic exenteration (PE) is a highly invasive procedure with high morbidity and mortality rates. Promising options to reduce this invasiveness have included laparoscopic and transperineal approaches. The aim of this study was to identify the safety of combined transabdominal and transperineal endoscopic PE for colorectal malignancies. METHODS: Fourteen patients who underwent combined transabdominal and transperineal PE (T group: 2-team approach, n = 7; O group: 1-team approach, n = 7) for colorectal malignancies between April 2016 and March 2020 in our institutions were included in this study. Clinicopathological features and perioperative outcomes were compared between groups. RESULTS: All patients successfully underwent R0 resection. Operation time tended to be shorter in the T group (463 minutes) than in the O group (636 minutes, P = 0.080). Time to specimen removal was significantly shorter (258 minutes vs. 423 minutes, P = 0.006), blood loss was lower (343 mL vs. 867 mL, P = 0.042), and volume of blood transfusion was less (0 mL vs. 560 mL, P = 0.063) in the T group, respectively. Postoperative complications were similar between groups. CONCLUSION: Combined transabdominal and transperineal PE under a synchronous 2-team approach was feasible and safe, with the potential to reduce operation time, blood loss, and surgeon stress.

Safety and Effectiveness Analysis of Dolutegravir in Patients with HIV-1: Interim Report of Post-Marketing Surveillance in Japan.

INTRODUCTION: Dolutegravir (DTG), a novel HIV-integrase strand transfer inhibitor (INSTI), is usually used with multiple antiretrovirals (ARVs) for treatment of HIV. DTG is now approved as Tivicay tablets in over 120 countries and Triumeq combination tablets (DTG/abacavir [ABC]/lamivudine [3TC]) in over 90 countries. In Japan, these formulations have been marketed since 2014 and 2015. The post-marketing prospective surveillance has been conducted as part of the HIV-Related Drug (HRD) cooperative survey aimed to collect actual drug use information in all of these DTG-treated patients in accordance with conditions for initial approvals. METHODS: The survey has been conducted to evaluate long-term safety and effectiveness of DTG since 2014, for approximately 6 years. The safety was evaluated by incidence of adverse drug reactions (ADRs) and change in body weight. The effectiveness was evaluated by plasma HIV RNA copies/mL and peripheral CD4+ cell counts. RESULTS: Of 2292 patients in 30 Japanese sites, 565 (24.65%) reported ADRs. The most common ADR was blood creatinine increased (4.28%). Incidence of ADRs was statistically significantly higher in patients with severe symptoms (Centers for Disease Control and Prevention [CDC] categories B and C) than those with category A, and in patients with comorbidities than those without comorbidities. Whereas incidence of ADRs was statistically significantly lower in antiretroviral therapy (ART)-experienced patients than that in ART-naïve patients. Incidence of ADRs related to suicide or self-injurious behavior was statistically significantly higher in patients with comorbidities of psychiatric disorders than those without comorbidities. The body weight tended to increase over time and those changes and percentage changes from baseline were greater in ART-naïve patients compared with ART-experienced patients. HIV RNA copies/mL and CD4+ cell counts showed favorable shifts from baseline in both ART-naïve and ART-experienced patients. CONCLUSION: The results of the survey identified no new safety and effectiveness risks in Japanese patients with HIV/AIDS treated with DTG.

Complete closure of a colo-duodenal fistula in a patient with advanced ascending colon cancer after pembrolizumab combined with radiation therapy: a case report.

BACKGROUND: A colo-duodenal fistula is a very rare complication of colon cancer that presents with not only severe clinical symptoms, but a poor prognosis due to locally advanced cancer. A novel immune checkpoint inhibitor for colon cancer patients provides a high objective response rate. Recently, radiation therapy combined with immune checkpoint inhibitor therapy has been reported to have a synergistic antitumor effect. A case of complete closure of a colo-duodenal fistula in a patient with locally advanced colon cancer after combined pembrolizumab and radiation therapy is reported. CASE PRESENTATION: A 66-year-old man presented with abdominal distention. Abdominal contrast-enhanced computed tomography (CT) showed a 80-mm bulky mass in the right upper quadrant. The tumor created a fistula to the second portion of the duodenum. Upper gastrointestinal endoscopy showed a colo-duodenal fistula. Gastro-jejunal bypass and ileostomy were performed to prevent bowel obstruction, followed by systemic chemotherapy. MSI-high was diagnosed on examination of the biopsy specimen. Treatment was then changed to immunotherapy using pembrolizumab; after six courses, the tumor markers were decreased to within normal ranges, but the main tumor increased. Radiation therapy was then given for local control of the main tumor, after which CT showed that all of the tumor, including the main tumor, lymph node metastases, and the colo-duodenal fistula, had gradually shrunk. Follow-up upper gastrointestinal endoscopy showed that the colo-duodenal fistula had closed completely. PET-CT showed no abnormal uptake in all tumors, and clinical complete response was diagnosed. Now, 21 months after diagnosis, the tumor is well controlled without evidence of regrowth. CONCLUSIONS: Pembrolizumab combined with radiation therapy has a potentially dramatic therapeutic effect for advanced colon cancer.

Colorectal cancer in Crohn's disease: a series of 6 cases.

BACKGROUND: Colorectal cancer (CRC) is the most malignant complication in patients with Crohn's disease (CD). We report 6 cases of CD-related CRC treated surgically at our hospital. CASE PRESENTATION: From 2010 to 2016, six CD patients were diagnosed with CRC. All patients were diagnosed with CD at < 25 years old, and the interval from onset of CD to diagnosis of CRC was > 10 years (range, 15-42 years) in all patients. The histological type of cancer was mucinous carcinoma in two cases, well-differentiated tubular adenocarcinoma in two cases, and moderately differentiated tubular adenocarcinoma in two cases. CRC was detected by screening colonoscopy in three cases (50%), and from clinical symptoms in the remaining three cases (50%). Two cases underwent colonoscopy within 2 months after symptom onset, detecting CRC in the relatively early stage. However, one case was diagnosed with advanced-stage CRC by endoscopy 1 year after symptom onset, and experienced poor prognosis. CONCLUSIONS: Regular surveillance colonoscopy is needed to detect early-stage CRC in CD patients. Clear surveillance methods need to be established based on evidence.

Epidermoid cyst of the cecum resected by single-incision laparoscopic colectomy: a case report.

BACKGROUND: Epidermoid cyst arising from the cecum is extremely rare. Single-incision laparoscopic surgery is the latest innovation in minimally invasive surgery, and shortens incisions, improves cosmesis, and reduces postoperative pain. We report here the first description of a patient with epidermoid cyst of the cecum treated by ileocecal resection by single-incision laparoscopic surgery. CASE PRESENTATION: A 20-year-old woman presented to our hospital with abdominal pain in the right lower quadrant. Abdominal contrast-enhanced computed tomography showed a 56 × 35-mm cystic mass in the ileocecal area. Magnetic resonance imaging revealed a 56 × 43-mm, T1-hypointense, T2-hyperintense mass attached to the cecum. Gastrointestinal tumor or duplication cyst was suspected, and ileocecal resection was performed using single-incision laparoscopic surgery. Intraoperative examination showed the tumor as a round, whitish mass arising from the cecum. Operation time was 162 min, and intraoperative blood loss was 10 ml. Macroscopic examination showed a 56 × 45-mm elastic-hard, whitish, round mass arising from the cecal wall. Microscopic examination revealed the cyst wall lined by keratinized stratified squamous epithelium. No malignant findings were identified. The final diagnosis was epidermoid cyst of the cecum. The postoperative course was uneventful and she was discharged on postoperative day 5. CONCLUSIONS: A rare case of cecal epidermoid cyst is reported. Single-incision laparoscopic colectomy using an organ retractor represents a promising option for treating cecal epidermoid cyst.

Effects of a nudge-based antimicrobial stewardship program in a pediatric primary emergency medical center.

Outpatient medical facilities tend to have high antimicrobial prescription rates and are therefore major targets for antimicrobial stewardship programs (ASPs). Pediatric primary emergency medical centers in Japan have difficulties in implementing conventional ASPs due to the low continuity of stewardship. Accordingly, there is a need to develop effective ASP models for these facilities. We conducted a single-center, quasi-experimental study to evaluate the effects of a nudge-based ASP in reducing unnecessary third-generation cephalosporin (3GC) prescriptions in a pediatric primary emergency care center (PEC). The implemented ASP utilizes monthly newsletters that report current antimicrobial use patterns and prescribing targets. We compared the monthly 3GC prescription numbers and proportions of unnecessary prescriptions before and after the ASP was implemented. The trends in 3GC prescriptions were examined using an interrupted time-series analysis. The numbers of patients before and after ASP implementation were 129,156 and 28,834, respectively. The number of unnecessary 3GC prescriptions decreased by 67.2% in the year after ASP implementation. The interrupted time-series analysis showed that the ASP was significantly associated with a reduction in 3GC prescriptions (regression coefficient - 0.58, P < 0.001).Conclusion: The nudge-based ASP was effective in reducing 3GC use in a Japanese PEC. This simple and inexpensive approach may have applications in other outpatient facilities. What is Known: • Outpatient medical facilities tend to have high antimicrobial prescription rates. Despite the development of several strategies for outpatient antimicrobial stewardship programs, these approaches have not sufficiently reduced antimicrobial use. What is New • Our nudge-based antimicrobial stewardship program using newsletters was shown to be a simple, inexpensive, and feasible method for reducing unnecessary antimicrobial use in a pediatric primary emergency care center. This may represent an effective antimicrobial stewardship strategy in Japanese outpatient facilities.

A case report of adult rectal duplication cyst resected by synchronous trans-abdominal and trans-anal total mesorectal excision.

INTRODUCTION: Rectal duplication cyst is extremely rare. Most of the cases diagnosed before two years old. Adult onset rectal duplication cyst usually contains malignant formation. Then complete tumor resection is needed for the disease to prevent malignant change. PRESENTATION OF CASE: A 52-year-old man was referred to our hospital due to bloody stool. Colonoscopy showed 20-mm of sub-mucosal tumor at low rectum. Biopsy revealed no specific findings. Abdominal computed tomography showed that a 20-mm low density mass at posterior of lower rectum. As the existence of malignant lesion was unassailable, we planned two team, trans abdominal and trans-anal, laparoscopic low anterior resection. Perioperative course was good. Macroscopically, rectum had a submucosal cystic mass fulfilled mucinous content. Histologically, cyst wall was covered with heterotopic ciliated epithelium and composed of smooth muscle. DISCUSSION: Trans-anal total mesorectal excision (ta-TME) was introduced as beneficial approach for rectal malignancies. CONCLUSION: Complete resection was possible by TME was necessary for patients with adult rectal duplication cyst, and synchronous trans-abdominal and trans-anal approach is a promising option.

Single-incision laparoscopic total colectomy using an organ retractor: A case report.

INTRODUCTION: Single-incision laparoscopic surgery (SILS) has benefits, including less postoperative pain, a shorter incision, and improved cosmesis. However, SILS is technically difficult because of the limited movement. An organ retractor is an instrument that has the potential to overcome these limitations. PRESENTATION OF CASE: An 85-year-old woman with hematochezia was referred to our hospital. Emergency endoscopy showed diverticulosis of the entire colon and active bleeding from the ascending colon. Despite endoscopic clipping, the bleeding continued. SILS total colectomy using an organ retractor was performed due to uncontrollable diverticular bleeding. A 3-cm incision was placed in the umbilicus, and three conventional ports were inserted into the single umbilical incision. An organ retractor was used for hepatocolic ligament transection, transection of the ileocolic vessels, and transection of the mesentery of the sigmoid colon. For each transection, the tension was adjusted to provide a good operative view. The patient's postoperative course was uneventful. CONCLUSION: An organ retractor was effective for SILS total colectomy to maintain an adequate operative view, which enabled safe dissection.

Safety analysis of Lexiva tablets 700 (fosamprenavir calcium hydrate) in post-marketing surveillance in Japan.

Objective: Fosamprenavir, a protease inhibitor (PI) to treat human immunodeficiency virus (HIV)-infected patients, has been approved in more than 40 countries and mainly used with nucleoside reverse transcriptase inhibitors. In Japan, Lexiva tablet (fosamprenavir calcium hydrate) has been marketed since January 2005 and used in clinical practice. The safety and effectiveness of fosamprenavir in HIV-infected Japanese patients were evaluated in an observational surveillance study (OTH112334).Methods: A post-marketing surveillance study (PMS) of fosamprenavir usage in HIV-infected Japanese subjects evaluating drug safety was conducted under Good Post-marketing Study Practice from January 2005 to December 2014.Results: Of 364 patients receiving fosamprenavir, 51% received emtricitabine/tenofovir disoproxil fumarate. Adverse events whose causal relationship could not be completely ruled out (adverse drug reactions; ADRs) were reported in 43.7%; the most common were diarrhoea (10.4%), hyperlipidaemia (8.5%) and hypertriglyceridaemia (6.9%). Serious ADRs were reported in 26 patients (32 events), including 1 death attributed to hepatic failure. Most ADRs occurred within 180 days after fosamprenavir was started. ADRs were more frequent in patients with the Centers for Disease Control and Prevention category B (AIDS or lipid disorders) or in those taking fosamprenavir combined with abacavir and lamivudine. Although spontaneous bleeding has been reported in hemophiliac patients taking other PIs, in this survey, only one muscle haemorrhage case was reported in 24 hemophiliac patients.Conclusions: The results of this PMS analysis in Japan support its known safety profile and identified no new safety risks for people living with HIV/AIDS in Japan currently on, or beginning treatment with, fosamprenavir.

Prognostic value of the preoperative prognostic nutritional index in oldest-old patients with colorectal cancer.

BACKGROUND: The prognostic nutritional index (PNI), which is calculated using serum albumin and the peripheral lymphocyte count, is a simple and useful score for predicting the prognosis in patients with various cancers. The correlation between the preoperative PNI and long-term outcomes is unclear in oldest-old patients with colorectal cancer. METHODS: A total of 84 consecutive patients ≥ 85 years old who underwent resection for primary colon adenocarcinoma at our institution between April 2008 and March 2017 were retrospectively reviewed. The cut-off value of the PNI for predicting the relapse-free survival (RFS) was 42.4 on a receiver operating characteristic curve analysis. The clinical characteristics and markers of systemic inflammation were then compared between patients with a low PNI (PNI < 42.4, n = 33) and a high PNI (PNI ≥ 42.4, n = 51). RESULTS: A low PNI was associated with systemic inflammation marker levels, including a low neutrophil-to-lymphocyte ratio (p = 0.048), a low platelet-to-lymphocyte ratio (p = 0.006), and a high lymphocyte-to-monocyte ratio (p < 0.001). The median follow-up period of this cohort was 34 months (1-151 months). The 5-year RFS, overall survival (OS), and cancer-specific survival were significantly worse in the low-PNI group than in the high-PNI group (p = 0.032, p = 0.004, p = 0.049, respectively). In the multivariate analysis, a low PNI was an independent predictor for both the RFS (HR 3.188, p = 0.041) and OS (HR 3.953, p = 0.027). CONCLUSIONS: A low-preoperative PNI was significantly associated with a poor prognosis in oldest-old colorectal cancer patients. Perioperative nutritional support may be important for prolonging the survival.