Clinical efficacy and safety of second line and salvage aflibercept for advanced colorectal cancer in Akita prefecture

BACKGROUND Angiogenesis inhibitors(AIs)combination with cytotoxic chemotherapy is a promising treatment for patients with colorectal cancer(CRC).Aflibercept(AFL)is an option for second-line treatment of CRC,according to the‘VELOUR’trial.Currently,we can choose from three AIs,including bevacizumab,ramucirumab,and AFL.Different AIs can be used in subsequent treatment because of their distinctive mechanisms of action.We addressed the uncertainty regarding AFL efficacy and safety in heavily-treated patients by comparing outcomes of survival treatment with second-line treatment.AIM To determine and compare the efficacy and safety profiles of AFL in the secondline and salvage therapy settings.METHODS Clinical data of 41 patients with advanced CRC who received intravenous AFL combined with the folinic acid-fluorouracil-irinotecan(FOLFIRI)regimen were collected retrospectively from six institutions in Japan,for the period from May 2017 to March 2019.Patient characteristics collected included age,sex,tumor location,RAS and RAF status,metastatic sites,number of previous treatment cycles,therapeutic response,adverse events,duration of previous AI treatment,and survival time.The end points were time to AFL treatment failure(aTTF)and median survival time post-AFL(aMST).Statistical analyses were performed to compare the efficacy and safety in the second-line setting with those of the salvage therapy setting,which was defined as the days since the end of secondline therapy.RESULTS All 41 patients who received AFL+FOLFIRI for advanced CRC had metastatic or unresectable cancer.Twenty-two patients received AFL in the second-line setting and nineteen in the salvage therapy setting.The patient characteristics were similar in the two groups,except for two factors.The median duration of the previous AI administration was shorter in the second-line patients compared with that in the salvage therapy patients(144 d vs 323 d,P=0.006).In the second-line and salvage therapy groups,the objective response rates were 11%and 0%,respectively(P=0.50),and the disease control rates were 53%and 50%,respectively(P=1.00).In the second-line and salvage therapy groups,the aTTF(123 d vs 71 d,respectively),aMST(673 d vs 396 d,respectively),and incidence of adverse events of grade 3[8(36%)vs 9(47%)]were not significantly different between the two groups.CONCLUSION AFL can be used to treat advanced CRC patients,with a similar safety and efficacy in the salvage therapy setting as in the second-line setting.

Investigation of the Burnout Stages Experienced by Nurses Working in Hospitals and Related Factors

Background: The purpose of this study was to elucidate the stages of nurse burnout in hospitals (their states of emotional exhaustion and depersonalization) as well as factors related to the nurses personal characteristics and coping behaviors in order to obtain suggestions for stress and health management strategies that nurses themselves can employ. Methods: We conducted a cross-sectional study using anonymous self-administered questionnaires. The subjects were nurses employed at public hospitals with 500 beds in 3 cities in Hokkaido, Japan. The questionnaire items for burnout were those included on the Japanese Maslach Burnout Inventory (MBI), which are designed to ascertain the subjects’ emotional exhaustion, depersonalization, and sense of personal accomplishment. In addition, we used 11 items related to physical and mental stress responses on the Stress Coping Inventory and the Brief Job Stress Questionnaire to determine factors such as the nurses’ basic attributes, whether or not they worked night shifts, and their overtime hours, etc. Results: We received responses from 1461 hospital nurses. Those whose scores for both emotional exhaustion and depersonalization were the mean or above were 40.2% of those in their twenties, 35.8% of those in their thirties, and 26.8% of those in their forties or older. The results of logistic regression analysis indicated that among those in the group that scored high for both emotional exhaustion and depersonalization, the influential factors were stress score (odds ratio 1.889), twenties age group (odds ratio 1.982), thirties age group (odds ratio 1.720), coping behavior: avoidance-focused behaviors (odds ratio 1.140), and engaged in childcare (odds ratio 0.487). Similarly, when looked at by age group, being in the twenties age group and having a spouse were influential factors (odds ratio 3.114 - 4.171). Conclusion: The results of this study elucidated the fact that for hospital nurses, the burnout stage, age, state of physical and mental stress response, and coping behavior can be effectively used as predictive indices.

The State of Fatigue and Sleep among Clinical Nurses in Japan

The objective of this study was to investigate the state of fatigue and sleep among clinical nurses in Japan. This descriptive cross-sectional study was conducted from December 2015 to January 2016. The participants were nurses who worked in public hospitals with 500 beds in the major cities and regional cities of Hokkaido. Fatigue was quantitatively assessed using the Cumulative Fatigue Symptoms Index (CFSI). Among nurses in their twenties, the rate of complaints about anxiety and decrease in vitality were high, which was replaced with complaints about irritability among nurses in their thirties. The most popular complaint among nurses in their forties was general fatigue. There was no difference in complaint ratios concerning the workplace location among nurses in their twenties and thirties, nurses in their forties working in suburban areas complained about fatigue more than their urban area. Nurses with sleep problems related to anxiety have a significantly higher complaint rate for all the eight items of CFSI compared with the nurses who do not have such problems (p < 0.001). This is an intermediate report and is part of a study that aims to develop a health management program for hospital nurses regarding fatigue and sleep.

Relationship between Sleep and Subjective Fatigue in Rotating Shift Nurses: Validation Using a Wearable Device

The objective of this study was to determine if sleep indicators are associated with subjective fatigue in nurses working in a rotating, two-shift system with a 16-hour night shift, using the wearable device Fitbit One. Subjective fatigue was evaluated using the Subjective Fatigue Symptom Questionnaire (SFSQ), a rating scale developed by the Working Group for Occupational Fatigue of the Japan Society for Occupational Health. Subjects were asked to continuously wear a Fitbit One to obtain the following data: time in bed (TIB), deep sleep time, length and frequency of nighttime awakening, sleep efficiency, waking time, and bed time. Nurses had a mean age and standard deviation of 33.2 ± 7.5 years and had worked as nurses for 9.8 ± 6.2 years on average. Eight nurses were in their 20s (42.1%), 5 in their 30s (26.3%), and 6 in their 40s (31.6%). All participants were female. Participants’ SFSQ scores calculated from the 9 evenings in the study period were averaged to establish a threshold for categorizing high-fatigue (HF) and low-fatigue (LF) groups. No significant differences were found between HF and LF nurses in terms of TIB, deep sleep time, nighttime awakening time or frequency, or sleep efficiency on any type of day (as classified by shift, day off, etc.). Nurses in both groups woke up significantly later on days off and on pre-night-shift days than on day-shift days. These results demonstrate the variation in sleep patterns of nurses on a rotating, two-shift system between day-shift and night-shift days.