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PDF file - 284KB, CONSORT study diagram.

PDF file - 61KB

PDF file - 2804KB, Association of antibody response with patient's survival.

Purpose: Racotumomab-alum is an anti-idiotype vaccine targeting the NeuGcGM3 tumor-associated ganglioside. This clinical trial was conducted to provide a preliminary estimate of efficacy and safety of racotumomab as switch maintenance for patients with advanced non–small cell lung cancer (NSCLC).Experimental design: Patients with stage IIIb/IV NSCLC who have at least stable disease after first-line chemotherapy were randomized 1:1 to racotumomab-alum (5 immunizations every 2 weeks and re-immunizations every 4 weeks) or placebo. Treatment was administered beyond progressive disease, until severe performance status worsening or toxicity. At progression, only five patients per group received further anticancer therapy. The primary endpoint was overall survival (OS).Results: One-hundred and seventy-six patients were randomized to racotumomab-alum (n = 87) and placebo (n = 89). Median OS was 8.23 and 6.80 months, respectively [HR, 0.63; 95% confidence interval (CI), 0.46–0.87; P = 0.004]. Median progression-free survival (PFS) in vaccinated patients was 5.33 versus 3.90 months for placebo (HR, 0.73; 95% CI 0.53–0.99; P = 0.039). The most common adverse events in the racotumomab-alum arm were burning and pain at the injection site, bone pain, and asthenia. A high antibody response of IgM and IgG isotype against the NeuGcGM3 ganglioside was obtained. Hyperimmune sera were able to specifically recognize and kill the NeuGcGM3-expressing L1210 cell line. Patients who developed anti-NeuGcGM3 antibodies capable to bind and kill ≥30% L1210 cells showed longer median survival times.Conclusions: Switch maintenance with racotumomab-alum is an effective and a well-tolerated treatment option for patients with advanced NSCLC. Clin Cancer Res; 20(14); 3660–71. ©2014 AACR.

PDF file - 47KB, Adverse event severity.

PDF file - 132KB, Number of doses received, maximal titer and isotype analysis against Racotumomab-mAb and NeuGcGM3, percentages of binding and cytotoxicity against L1210 cells, and survival times in vaccinated NSCLC patients.

PDF file - 66KB, Summary of adverse events.

PDF file - 137KB, Association of functional capacity of elicited anti-NeuGcGM3 antibodies with patient's survival.

PDF file - 144KB, Overall survival HRs (racotumomab over placebo) in subgroups according to baseline characteristics.

Purpose Informal caregivers play an important supportive care role for patients with cancer. This may be especially true for pancreatic cancer which is often diagnosed late, has a poor prognosis and is associated with a significant symptom burden. We systematically reviewed the evidence on caregiver burden, unmet needs and quality-of-life of informal caregivers to patients with pancreatic cancer. Method PubMed, Medline, CINAHL and Embase databases were systematically searched on 31 August 2021. Qualitative and quantitative data on informal caregivers’ experiences were extracted and coded into themes of burden, unmet needs or quality-of-life with narrative synthesis of the data undertaken. Results Nine studies (five qualitative, four quantitative), including 6023 informal caregivers, were included in the review. We categorised data into three key themes: caregiver burden, unmet needs and quality-of-life. Data on caregiver burden was organised into a single subtheme relating to symptom management as a source of burden. Data on unmet needs was organised into three subthemes need for: better clinical communication; support and briefings for caregivers; and help with navigating the health care system. Data on quality-of-life indicate large proportions of informal caregivers experience clinical levels of anxiety (33%) or depression (12%-32%). All five qualitative studies were graded as good quality; three quantitative studies were poor quality, and one was fair quality. Conclusion High-quality pancreatic cancer care should consider the impacts of informal caregiving. Prospective longitudinal studies examining multiple dimensions of caregiver burden, needs, and quality-of-life would be valuable at informing supportive care cancer delivery to pancreatic cancer informal caregivers.

Background Preoperative Obstructive Sleep Apnoea (OSA) screening, followed by sleep studies as indicated, is commonly performed for patients undergoing bariatric surgery in our hospital but not for patients with similar weight undergoing other surgeries such as laparoscopic cholecystectomy. The purpose of this audit was to understand if laparoscopic cholecystectomy can be performed safely in patients with a Body Mass Index (BMI) ≥35 kg/m2 without such screening. Methods Patients with a BMI ≥ 35 kg/m2 undergoing elective laparoscopic cholecystectomy between 2nd May 2014 and 4th April 2022 were included. Patients with known OSA were excluded and no patients were referred for sleep studies. Data on patient demographics, co-morbidities, and any intraoperative or postoperative surgical complications were extracted and analysed. Univariate associations between different preoperative and operative variables and 30-day morbidity were studied using the Fisher's exact test. Results A total of 434 patients were included in the audit (64 male, 370 female). The mean age was 49 +/- 15 years. The mean weight and BMI were 110 +/- 20 kg (range 70–79kg) and 37 +/- 6 kg/m2 respectively. The mean operating time was 70 +/- 31 minutes (median=62). Approximately, 92% (398/434) had a day case procedure. The readmission rate at 30-day was 1% (5/434). There were no intraoperative complications. 17 patients had post-operative complications including deep vein thrombosis (n=2), leak in transverse colon secondary to cholecysto-colic fistula (n=1), wound infection (n=9), bile leak and post-op ERCP (n=3), common bile duct stone requiring ERCP (n=1) and pneumonia (n=1). No patients required ITU or HDU admission for further organ support. The 30-day mortality rate was 0% (0/434) while the 30-day morbidity rate was 3.9% (17/434). ASA grade, previous abdominal surgery, hypertension, diabetes, dyslipidemia, smoking history, chronic obstructive pulmonary disease, ischemic heart disease, fatty liver disease, preoperative liver reducing diet, number of ports, and conversion to laparotomy were not associated with increased 30-day morbidity rate (p Conclusions This audit demonstrated that laparoscopic cholecystectomy can be performed safely without the need for preoperative sleep studies in patients with BMI ≥35 kg/m2.

Acute pancreatitis (AP) is an inflammatory disease, and NLRP3 inflammasome activation is involved in the pathogenesis of AP. Previous research showed that inhibition of NLRP3 inflammasome may exert protective effects on animal models of AP and reduces disease severity. The aim of this systematic review and meta-analysis is to evaluate the effects of drug treatment of NLRP3 inflammasome on the outcomes of experimental AP. PubMed, Embase, Medline, and Web of Science databases were searched for relevant articles without language restrictions. The main outcomes for this study included local pancreatic injury, the incidence of systemic inflammatory responses, and the incidence of organ failure. Twenty-eight animal studies including 556 animals with AP were included in the meta-analysis. Compared with controls, inhibition of NLRP3 inflammasome significantly reduced the pancreatic histopathological scores, serum amylase, and lipase levels. In addition, inhibition of NLRP3 inflammasome reduced the levels of circulating inflammatory cytokines, as well as mitigating severity of AP-associated acute lung injury and acute intestinal injury. To conclude, inhibition of NLRP3 inflammasome has protective effects on AP by mitigating organ injury and systemic inflammation in animal studies, indicating that NLRP3 inflammasome holds promise as a target for specific AP therapy.