Safety and Tolerability of Docetaxel,Cyclophosphamide, and Trastuzumab Compared to Standard Trastuzumab-Based Chemotherapy Regimens for Early-Stage Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer

Purpose

We evaluated the tolerability and cardiac safety of docetaxel, cyclophosphamide, and trastuzumab (TCyH) for the treatment of early-stage human epidermal growth factor receptor 2 (HER2)-positive breast cancer and compared to the standard trastuzumab-based chemotherapy regimens doxorubicin with cyclophosphamide followed by paclitaxel and trastuzumab (AC-TH) and docetaxel, carboplatin, and trastuzumab (TCaH).

Methods

We retrospectively reviewed early-stage, resectable, HER2-positive breast cancer patients treated with trastuzumab-based chemotherapy at a single comprehensive cancer center between 2004 and 2011. Patient characteristics, comorbidities, relative dose intensity (RDI) of each regimen, tolerability, and cardiac toxicity were evaluated.

Results

One hundred seventy-seven patients were included in the study (AC-TH, n=114; TCaH, n=39; TCyH, n=24). TCyH was solely administered in the adjuvant setting, whereas two-thirds of the AC-TH and TCaH groups were administered postoperatively. Patients treated with TCyH tended to have a more significant underlying cardiac history, higher Charlson comorbidity index, and were of an earlier stage. All patients treated with TCyH received granulocyte colony stimulating factor primary prophylaxis. No febrile neutropenia or grade ≥3 hematologic toxicity was observed in the TCyH group as compared to the AC-TH and TCaH groups. There were no significant differences in the rates of early termination, hospitalization, dose reduction, or RDI between the regimens. The symptomatic congestive heart failure rate between AC-TH, TCaH, and TCyH groups was not significantly different (4.4% vs. 2.6% vs. 8.3%, respectively, p=0.57). There was also no significant difference in the rate of early trastuzumab termination between patients treated with each regimen.

Conclusion

TCyH is well tolerated and should be investigated as an alternative adjuvant chemotherapy option for patients who are not candidates for standard trastuzumab-containing regimens. Larger clinical trials are necessary to support the wider use of TCyH as an adjuvant regimen.     

Gradual sucrose gastric loading test: A method for the prediction of nonsuccess gastric enteral feeding in critically ill surgical patients

Background and Aims:

Intolerance of gastric enteral feeding (GEN) commonly occurs in surgical Intensive Care Unit (SICU). A liquid containing sugar could prolong gastric emptying time. This study was to propose a method for prediction of nonsuccess GEN using gastric volume after loading (GVAL) following gradual sucrose gastric loading.

Materials and Methods:

Mechanical ventilator supported and hemodynamically stable patients in SICU were enrolled. About 180-240 min before the GEN starting, a sucrose solution (12.5%; 450 mosmole/kg, 800 mL) was administered via gastric feeding tube over 30 min with 45° head upright position. GVAL was measured at 30, 60, 90, and 120 min after loading. GEN success status using clinical criteria was assessed at 72 h after the starting GEN protocol. The receiving operating characteristic (ROC) and c statistic were used for discrimination at each time point of GVAL.

Results:

A total of 32 patients were enrolled and completed the protocol. 14 patients (43.7%) were nonsuccessful GEN. The nonsuccess group was found to have significantly more GVAL than the other group at all-time points during the test (P < 0.05). The most discriminating point of GVAL for the prediction of nonsuccess was 150 mL at 120 min after loading with a sensitivity of 92.3%, specificity of 88.9%, positive predictive value of 85.7%, negative predictive value of 94.1%, and ROC area 0.97 (95% confidence interval 0.91–1.00).

Conclusion:

A high GVAL following sucrose gastric loading test might be a method to predict nonsuccess GEN in critically ill surgical patients.     

Height prediction from anthropometric length parameters in Thai people

Height is an important clinical parameter. However, there were no specific measurements available for particular clinical situations. Although many anthropometric measurements were suggested, no formula was recommended in Thailand. The objective of this study was to develop a formula for height prediction with acceptable validity. Two thousand volunteers were included and were divided consecutively according to both age and gender. Model and validation groups were further separated independently. Linear regression was analyzed to create a predictive formula. Ten parameters were included and analyzed. Of these, demispan, sitting height and knee height were selected with a correlation coefficient of more than 0.5 and significant F test in all age groups and genders. All single parameters and the highest predictive value of double (sitting and knee height) and triple regression models (demispan, sitting and knee height) were proposed and these were modified into a simple formula. After validation of both formulas the correlation, quantitative error and relative error were comparable. The simple formula had more than 90% precision with an error of up to 10 cm in the validation group (89.7 to 99.0% in range). Of these, knee height had the least predictive error in all subgroups. The double and triple models had decreased error only in the younger group. In summary, anthropometric parameters with demispan, sitting height, knee height and combination could be applied to height prediction in the adult Thai with acceptable error. These formulas should be applied only in people who could not be directly measured.     

Prediction of massive transfusion in trauma patients in the surgical intensive care units (THAI-SICU study)

Purpose: After damage control surgery, trauma patients are transferred to intensive care units to restore the physiology. During this period, massive transfusion might be required for ongoing bleeding and coagulopathy. This research aimed to identify predictors of massive blood transfusion in the surgical intensive care units (SICUs). Methods: This is an analysis of the THAI-SICU study which was a prospective cohort that was done in the 9-university-based SICUs in Thailand. The study included only patients admitted due to trauma mechanisms. Massive transfusion was defined as received 10 units of packed red blood cells on the first day of admission. Patient characteristics and physiologic data were analyzed to identify the potential factors. A multivariable regression was then performed to identify the significant model. Results: Three hundred and seventy patients were enrolled. Sixteen patients (5%) received massive transfusion in the SICUs. The factors that significantly predicted massive transfusion were an initial sequential organ failure assessment (SOFA) ≥9 (risk difference (RD) 0.13, 95% confidence interval (CI): 0.03-0.22, p = 0.01); intra-operative blood loss ≥4900 mL (RD 0.33, 95% CI: 0.04-0.62, p = 0.02) and intra-operative blood transfusion ≥10 units (RD 0.45, 95% CI: 0.06 to 0.84, p = 0.02). The probability to have massive transfusion was 0.976 in patients who had these 3 factors. Conclusion: Massive blood transfusion in the SICUs occurred in 5%. An initial SOFA ≥9, intra-operative blood loss ≥4900 mL, and intra-operative blood transfusion 10 units were the significant factors to predict massive transfusion in the SICUs.     

Professional burnout among physicians and nurses in Asian intensive care units: a multinational survey

Purpose

Professional burnout is a multidimensional syndrome comprising emotional exhaustion, depersonalization, and diminished sense of personal accomplishment, and is associated with poor staff health and decreased quality of medical care. We investigated burnout prevalence and its associated risk factors among Asian intensive care unit (ICU) physicians and nurses.

Methods

We conducted a cross-sectional survey of 159 ICUs in 16 Asian countries and regions. The main outcome measure was burnout as assessed by the Maslach Burnout Inventory-Human Services Survey. Multivariate random effects logistic regression analyses of predictors for physician and nurse burnout were performed.

Results

A total of 992 ICU physicians (response rate 76.5%) and 3100 ICU nurses (response rate 63.3%) were studied. Both physicians and nurses had high levels of burnout (50.3% versus 52.0%, P?=?0.362). Among countries or regions, burnout rates ranged from 34.6 to 61.5%. Among physicians, religiosity (i.e. having a religious background or belief), years of working in the current department, shift work (versus no shift work) and number of stay-home night calls had a protective effect (negative association) against burnout, while work days per month had a harmful effect (positive association). Among nurses, religiosity and better work-life balance had a protective effect against burnout, while having a bachelor’s degree (compared to having a non-degree qualification) had a harmful effect.

Conclusions

A large proportion of Asian ICU physicians and nurses experience professional burnout. Our study results suggest that individual-level interventions could include religious/spiritual practice, and organizational-level interventions could include employing shift-based coverage, stay-home night calls, and regulating the number of work days per month.

     

Mixed fibers diet in surgical ICU septic patients

Diarrhea commonly occurs in surgical critically ill patients, especially septic patients and fiber formulas have been reported to improve diarrhea. Most reports have used soluble or insoluble fiber exclusively, while the effects of a mixed fiber diet remain unclear. This study compares diarrhea scores between mixed-fiber and non-fiber diets in surgical septic patients receiving broad spectrum antibiotics. We conducted a prospective randomized control double blind study in a general surgical ICU. Patients who received broad spectrum antibiotics and no contraindication to enteral feeding were randomly allocated to a fiber or non-fiber diet for up to 14 days. Nutritional delivery and diarrhea scores were recorded daily. Intention to treat analysis was performed. Thirty-four patients were enrolled in the study, 17 in the fiber group and 17 in non-fiber group. These two patients groups were similar in demographics, disease severity, nutritional status, cause of sepsis and total feeding per day. The proportion of patients with diarrhea score ≥12 was higher in the non-fiber group than in the fiber group, but the difference was not statistically significant [8/17 (47.06%) vs. 4/17(23.53%); p=0.15]. However, the fiber group had a lower mean diarrhea score (fiber vs. non-fiber = 3.6 ± 2.3 vs. 6.3 ± 3.6; p=0.005), as well as a lower global diarrhea score from the generalized estimation equation model for repeated measurement [Coefficient -3.03 (95%CI= -5.03 to -0.92); p=0.005]. In summary, a mixed fiber diet formula can reduce the diarrhea score in surgical critically ill septic patients who received broad spectrum antibiotics.