Health-Related Quality of Life in KEYNOTE-010: a Phase II/III Study of Pembrolizumab Versus Docetaxel in Patients With Previously Treated Advanced,Programmed Death Ligand 1–Expressing NSCLC

Introduction

In the phase II/III KEYNOTE-010 study (ClinicalTrials.gov, NCT01905657), pembrolizumab significantly prolonged overall survival over docetaxel in patients with previously treated, programmed death ligand 1–expressing (tumor proportion score ≥ 1%), advanced NSCLC. Health-related quality of life (HRQoL) results are reported here.

Early experience with robotic aortic valve replacement.

We report our initial experience with aortic valve replacement using robotic assistance. All procedures were performed with peripheral cardiopulmonary bypass, transthoracic aortic cross-clamp, and antegrade cold crystalloid cardioplegia. One or two ports and a 5-cm intercostal incision in the right chest were used for access. All patients had aortic valve replacement performed robotically. Between February and September 2004, five patients underwent robotic aortic valve replacement. The mean age was 59 years (range 35-82 years). There were no incisional conversions, death, stokes, or reoperations for bleeding. Overall mean study times were as follows: procedure, 231.2 min (range 180-315 min); cardiopulmonary bypass, 121.5 min (range 83-173 min), and cross-clamp, 98.2 min (range 67-140 min). One patient developed postoperative pneumonia. Aortic valve replacement can be successfully performed with the da Vinci robotic system.     

Does the extent of lymph node dissection influence outcome in patients with stage I non-small-cell lung cancer?

OBJECTIVE: To assess the therapeutic effect of the extent of lymph node dissection performed in patients with a stage pI non-small-cell lung cancer (NSCLC). METHODS: We analysed data on 465 patients with stage I NSCLC who were treated with surgical resection and some form of lymph node sampling. The median number of lymph node sampled was 10 and the median number of ipsilateral mediastinal lymph node stations sampled was two. We chose to define a procedure that harvested 10 or more lymph nodes and sampled two or more ipsilateral mediastinal stations as a lymphadenectomy, by contrast with sampling when one or both criteria were not satisfied. The effect of the surgical techniques: lymph node sampling (LS; n=207) vs. lymphadenectomy (LA; n=258) on 30-day mortality and overall survival were investigated. RESULTS: A total of 6244 lymph nodes was examined, including 4306 mediastinal lymph nodes. The mean (+/-SD) numbers of removed lymph nodes were 7+/-6.1 per patient following LS vs.18.6+/-9.3 following LA (P=0.001). An average mean of 1+/-0.90 mediastinal lymph node station per patient was sampled following LS vs. 2.7+/-0.8 following LA (P<10(-6)). Overall 30-day mortality rates were 2.4 and 3.1%, respectively. LA was disclosed as a favourable prognosticator at multivariate analysis (Hazard Risk: 1.43; 95% Confidence Interval: 1.00-2.04; P=0.048), together with younger patient age, absence of blood vessels invasion, and smaller tumour size. CONCLUSIONS: Importance of lymph node dissection affects patients outcome, while it does not enhance the operative mortality. A minimum of 10 lymph nodes assessed, and two mediastinal stations sampled are suggested as possible pragmatic markers of the quality of lymphadenectomy.     

Effect of oral lactulose on clinical and immunohistochemical parameters in patients with inflammatory bowel disease: a pilot study

Background  

The prebiotic potential of lactulose is well established and preclinical studies demonstrated a protective effect of lactulose in murine models of colitis. The aim of the present study was to investigate the clinical and histological efficacy of lactulose in patients with inflammatory bowel disease (IBD), for which probiotic therapy yielded promising results.     

Major vascular injuries during gynecologic laparoscopy

Background:This study was undertaken to report our experience with major vascular injuries in gynecologic laparoscopy in order to specify the circumstances under which they occurred, the means of diagnosis, the risk factors, and the means for prevention.Study Design:Retrospective case review study.Results:Seventeen patients with 21 major vascular injuries were identified. The average age of the patients was 33.8 ± 11.6 years, and the mean body index mass was 21.6 ± 3.08 kg/m². Three of four of the accidents occurred during the set-up phase of laparoscopy (13 cases; 76.5%), and in 4 cases (23.5%) the accident occurred during the laparoscopic surgery procedure. Eleven (84.6%) of the complications occurring during the set-up phase were secondary to insertion of the umbilical trocar and 2 (15.4%) to insertion of the needle used to create the pneumoperitoneum (P-needle). Half (6 cases; 54.5%) of the major vascular injuries secondary to insertion of the umbilical trocar were observed when reusable trocars were used. In every case, the diagnosis was made during the operation. Two patients died, and two others presented a serious complication (phlebitis; acute ischemia requiring reoperation).Conclusions:Major vascular injuries are rare but serious complications of laparoscopic surgery. Prevention of these accidents relies on the surgeon’s experience and scrupulous respect of the safety rules. In the vast majority of cases, it is necessary to convert to laparotomy immediately, calling in a vascular surgeon.     

Chirurgie bei immunsupprimierten Patienten unter Notfall- und Elektivbedingungen

Zusammenfassung. Die Auswirkungen einer Immunsuppression auf perioperative pathophysiologische Vorg?nge stellen besondere Anforderungen sowohl in bezug auf die Indikationsstellung zu einem operativen Eingriff als auch an das perioperative Management. Eine immunsuppressive Therapie kann ein ver?ndertes oder v?llig fehlendes Abwehrverhalten bei entzündlichen Prozessen bewirken, so da? die hierfür typischen klinischen Anzeichen nur schwach oder gar nicht ausgepr?gt werden. Dies kann zu einer gef?hrlichen Latenz in der Diagnostik akut lebensbedrohlicher Erkrankungen bei immunsupprimierten Patienten führen. Darüber hinaus tragen die ver?nderte Reaktivit?t des Patienten auf Stre?, eine verz?gerte und verminderte Wundheilung sowie insbesondere die erh?hte Infektanf?lligkeit zu einem gesteigerten Operationsrisiko bei. Perioperativ sind daher eine konsequente klinische überwachung des Patienten und ein lückenloses Monitoring der Immunsuppression unverzichtbar. Für den klinischen Umgang mit immunsupprimierten Patienten ergeben sich hieraus 2 unterschiedliche Pr?missen hinsichtlich der Indikationsstellung bei Elektiv- und Notfalleingriffen. W?hrend unter Elektivbedingungen eine sorgf?ltige Operationsplanung unter besonderer Berücksichtigung der m?glichen Risiken für Patient und Transplantat unabdingbar ist, so lassen die oftmals gro?en diagnostischen Unsicherheiten bei entzündlichen Vorg?ngen sowie die erheblichen Risiken eines verz?gerten Therapiebeginns eine eher etwas gro?zügigere Indikationsstellung zur operativen Intervention in Zweifelsf?llen berechtigt erscheinen. Operativ technisch ist generell auf ein gewebeschonendes und atraumatisches Vorgehen zu achten, weiterhin sollte eine besondere Sorgfalt bei Anastomosenn?hten und Wundverschlu? bestehen. Darüber hinaus sind von Seiten des Chirurgen die Einflu?m?glichkeiten auf den postoperativen Verlauf begrenzt.      

Risk factors of influenza transmission in households.

BACKGROUND: Influenza transmission in households is a subject of renewed interest, as the vaccination of children is currently under debate and antiviral treatments have been approved for prophylactic use. AIMS: To quantify the risk factors of influenza transmission in households. DESIGN OF STUDY: A prospective study conducted during the 1999 to 2000 winter season in France. SETTING: Nine hundred and forty-six households where a member, the index patient, had visited their general practitioner (GP) because of an influenza-like illness were enrolled in the study. Five hundred and ten of the index patients tested positive for influenza A (subtype H3N2). A standardised daily questionnaire allowed for identification of secondary cases of influenza among their household contacts, who were followed-up for 15 days. Of the 395 (77%) households that completed the questionnaire, we selected 279 where no additional cases had occurred on the day of the index patient's visit to the GP. METHODS: Secondary cases of influenza were those household contacts who had developed clinical influenza within 5 days of the disease onset in the index patient. Hazard ratios for individual clinical and demographic characteristics of the contact and their index patient were derived from a Cox regression model. RESULTS: Overall in the 279 households, 131 (24.1%) secondary cases occurred among the 543 household contacts. There was an increased risk of influenza transmission in preschool contacts (hazard ratio [HR] = 1.85, 95% confidence interval [CI] = 1.09 to 3.26) as compared with school-age and adult contacts. There was also an increased risk in contacts exposed to preschool index patients (HR = 1.93, 95% CI = 1.09 to 3.42) and school-age index patients (HR = 1.68, 95% CI = 1.07 to 2.65), compared with those exposed to adult index cases. No other factor was associated with transmission of the disease. CONCLUSION: Our results support the major role of children in the dissemination of influenza in households. Vaccination of children or prophylaxis with neuraminidase inhibitors would prevent, respectively, 32-38% and 21-41% of secondary cases caused by exposure to a sick child in the household.