Incidence of febrile neutropenia among early-stage breast cancer patients receiving anthracycline-based chemotherapy

Objectives

The aim of this study was to investigate the incidence of febrile neutropenia (FN) with adjuvant AC (doxorubicin and cyclophosphamide) chemotherapy among Asian early-stage breast cancer (ESBC) patients, to evaluate the impact of FN on chemotherapy delivery, and to identify specific risk factors that would predispose ESBC patients to FN.

Methods

This was a single-center, observational, retrospective cohort study conducted in Singapore. All ESBC patients who have received the AC regimen as adjuvant chemotherapy between January 2007 and July 2010 were included into the study. Patients did not receive granulocyte colony-stimulating factors (G-CSF) as primary prophylaxis.

Results

One hundred and eighty-nine patients and 729?cycles of chemotherapy were analyzed in this study, of which, majority were Chinese (84%). Median age of the patients was 54?years old (IQR 49–58). In total, 26 patients (13.8%) manifested at least one episode of FN, of which 17 patients developed FN during the first cycle of treatment. Patients who manifested FN received similar dose intensities of chemotherapy, compared to those patients who did not manifest FN (100% versus 98%, p?=?0.95). After adjusting for age, race, and presence of comorbidities, low body mass index (BMI) (<23?kg/m²) was found to be associated with a higher risk of FN (OR 4.4, 95% CI?=?1.65–12.01, p?=?0.003).

Conclusions

Asian patients are at moderate risk for FN when they receive the AC regimen for treatment of ESBC. Further studies should evaluate the role of G-CSF to reduce the occurrence of FN in Asian patients with low BMI.     

A phase III open-label study to assess safety and efficacy of palonosetron for preventing chemotherapy-induced nausea and vomiting (CINV) in repeated cycles of emetogenic chemotherapy

Purpose

Prevention of chemotherapy-induced nausea and vomiting (CINV) is of great importance for the completion of multiple cycles of cancer chemotherapy. Palonosetron is a second-generation 5-HT₃ receptor antagonist with proven efficacy for both acute and delayed CINV. This study was designed to assess the safety and efficacy of 0.75?mg palonosetron in repeated cycles of highly emetogenic chemotherapy or anthracycline–cyclophosphamide combination (AC/EC).

Methods

We gave 0.75?mg palonosetron to 538 patients 30?min prior to ≥50?mg/m² cisplatin or AC/EC on day?1. Prophylactic dexamethasone was administered on days?1–3. The primary endpoint was the incidence rate of adverse events (AEs). The secondary endpoint was complete response rate (CR, defined as no emesis and no rescue medication) throughout the study period.

Results

Treatment-related AEs were seen in 44% (237 of 538 patients). Serious AEs were seen in 4% (23 of 538 patients), all considered unrelated or unlikely to be related to palonosetron. Only one patient discontinued the study due to a treatment-related AE. No trend toward worsening of AEs was observed in subsequent cycles of chemotherapy. Complete response rates were maintained throughout repeated cycles.

Conclusion

The extraordinary safety profile and maintenance of efficacy of 0.75?mg palonosetron combined with dexamethasone were demonstrated throughout repeated chemotherapy cycles.     

Immunonutrition before and during radiochemotherapy: improvement of inflammatory parameters in head and neck cancer patients

Purpose

Inflammatory, angiogenic and oxidative stress markers have been explored in head and neck squamous cell carcinoma (HNSCC) patients before and during radiochemotherapy. Furthermore, the effects of an oral supplementation containing amino acids, ω-3 fatty acids, ribonucleic acids, vitamins, and antioxidants on biological markers and acute toxicities were investigated.

Methods

Thirty-one patients with non-metastatic stage III or IV HNSCC treated with concomitant radiochemotherapy were recruited. A nutritional support (Oral Impact?) was given during 5?days before each cycle of chemotherapy. Biological samples were collected at baseline, after 5?days of oral supplementation and before the last cycle of chemotherapy. Acute phase proteins levels, proteomic cytokines determination and urinary isoprostanes levels were used as inflammatory and oxidative stress biomarkers. Toxicities were followed up during radiochemotherapy.

Results

At baseline, median levels of inflammatory (CRP 9.8?mg/l [0.8–130.1], IL-6 4.2?pg/ml [0.7–126.5]), pro-angiogenic (VEGF 229.5?pg/ml [13.1–595.9]) and pro-oxidative stress (urinary isoprostanes 118 pmol/mmol creatinine [51–299]) markers were increased. Decrease in CRP (p?=?0.002) and α-1 acid glycoprotein (p?=?0.020) levels were observed after 5?days of oral supplementation. During radiochemotherapy, no significant variation of inflammatory markers was reported, and a low incidence of severe acute mucositis was noted.

Conclusions

Stage III or IV HNSCC patients are characterised by a pro-inflammatory, pro-angiogenic and pro-oxidative status. Nutritional support could improve this inflammatory state and could prevent severe acute mucositis.     

Systematic review of cytokines and growth factors for the management of oral mucositis in cancer patients

Purpose

The aim of this project was to review the literature and define clinical practice guidelines for the use of cytokines and growth factor agents for the prevention or treatment of oral mucositis induced by cancer chemotherapy or radiotherapy.

Methods

A systematic review was conducted by the Mucositis Study Group of the Multinational Association of Supportive Care in Cancer/International Society for Oral Oncology (MASCC/ISOO). The body of evidence for each intervention, in each cancer treatment setting, was assigned an evidence level. Based on the evidence level, one of the following three guideline determinations was possible: Recommendation, Suggestion, No guideline possible.

Results

Sixty-four clinical studies across 11 interventions were evaluated. A recommendation was made for the use of recombinant human KGF-1 (palifermin) at a dose of 60???g/kg per day for 3?days prior to conditioning treatment and for 3?days post-transplant for prevention of oral mucositis in patients receiving high-dose chemotherapy and total body irradiation followed by autologous stem cell transplantation for hematological malignancies. A suggestion was made against using granulocyte macrophage colony-stimulating factor mouthwash for the prevention of oral mucositis in the setting of high-dose chemotherapy followed by autologous or allogeneic stem cell transplantation. No guideline was possible for any other cytokine or growth factor agents due to inconclusive evidence.

Conclusions

Of the cytokine and growth factor agents studied for oral mucositis, the evidence only supports use of palifermin in the specific population listed above. Additional well-designed research is needed on other cytokine and growth factor interventions and in other cancer treatment settings.     

Use of pegfilgrastim primary prophylaxis and risk of infection,by chemotherapy cycle and regimen,among patients with breast cancer or non-Hodgkin’s lymphoma

Purpose

This study aims to examine granulocyte colony-stimulating factor (G-CSF) prophylaxis by cancer type, chemotherapy regimen, and cycle in a real-world setting to assess if practice conforms to clinical guidelines, which recommend G-CSF prophylaxis every cycle when a patient’s risk of febrile neutropenia (FN) is 20 % or greater, and to describe the incidence of FN among patients who discontinue pegfilgrastim (peg) prophylaxis.

Methods

The cohort was selected from administrative claims data and includes adults diagnosed with non-Hodgkin’s lymphoma (NHL) or breast cancer (BC) who began chemotherapy 2005–2010.

Results

About 83.2 % of the 4,470 patients with BC treated with dose-dense doxorubicin, cyclophosphamide (ddAC), 83.6 % of 2,197 patients with BC treated with docetaxel, doxorubicin, cyclophosphamide (TAC), and about 55.6 % of the 2,722 patients with NHL treated with cyclophosphamide, doxorubicin, vincristine, with or without prednisone for 3-week cycles (CHOP-R Q3W) received peg prophylaxis in cycle 1. Among patients on these regimens who received peg prophylaxis in cycle 1 and were still on the regimen in cycle 4, about 90 % received peg prophylaxis in that cycle. Among patients with BC or NHL who discontinued G-CSF, the incidence proportion of infection or FN varied by regimen and cycle, with a range from 0 to 14 %.

Conclusions

Despite clinical guidelines recommending G-CSF prophylaxis with chemotherapy regimens with a high risk of FN, many NHL and BC patients do not receive FN prophylaxis in cycle 1. However, among patients who receive G-CSF in cycle 1 and remain on the regimen, the majority appear to continue prophylaxis as indicated.     

Bindungsstil und Zytokinspiegel bei Fibromyalgiesyndrom

Background and objectives

The association between attachment style and subjective pain is controversially discussed and the influence of attachment styles on cytokine levels in chronic pain has received little attention in research. In this prospective longitudinal clinical study, we evaluated the relationship between cytokines, attachment style and subjective pain intensity as well as pain-related functioning in patients with fibromyalgia (FM) who underwent a 4-week multidisciplinary pain therapy.

Materials and methods

The attachment style was determined in 43 patients with FM using the relationship questionnaire (RQ-2) and subjective pain with the German version of the West Haven-Yale multidimensional pain inventory. Serum levels of the proinflammatory cytokines tumor necrosis factor alpha (TNF-α) and interleukin 8 (IL-8) and the anti-inflammatory cytokines IL-4 and IL-10 were assessed before and after treatment and additionally once only in 18 healthy controls (Bio-Plex system).

Results

Patients with FM syndrome were significantly more often insecurely attached than healthy controls (p?=?0.001). Serum levels of TNF-α (p?=?0.001) and IL-10 (p?=?0.039) were significantly higher in FM patients compared to controls. Attachment was unrelated to IL-4, IL-8, and IL-10 levels. Insecurely attached FM patients had significantly higher levels of TNF-α (p?=?0.002). than securely attached patients. Insecurely and securely attached patients did not differ in subjective levels of pain severity, activity or functional interference. Cytokine levels were not correlated with subjective levels of pain severity or functional interference. Multidisciplinary pain therapy significantly reduced cytokine levels, pain severity, anxiety and depression independent of attachment style.     

Monocyte deactivation in neutropenic acute respiratory distress syndrome patients treated with granulocyte colony-stimulating factor

Introduction

In severely neutropenic septic acute respiratory distress syndrome (ARDS) patients, macrophages and monocytes are the last potentially remaining innate immune cells. We have previously shown, however, a deactivation of the alveolar macrophage in neutropenic septic ARDS patients. In the present study, we tried to characterize in vitro monocyte baseline cytokine production and responsiveness to lipopolysaccharide exposure.

Methods

Twenty-two consecutive patients with cancer were prospectively enrolled into a prospective observational study in an intensive care unit. All patients developed septic ARDS and were divided into two groups: neutropenic patients (n = 12) and non-neutropenic patients (n = 10). All of the neutropenic patients received granulocyte colony-stimulating factor whereas no patient in the non-neutropenic group received granulocyte colony-stimulating factor. We compared monocytes from neutropenic patients with septic ARDS with monocytes from non-neutropenic patients and healthy control individuals (n = 10). Peripheral blood monocytes were cultured, and cytokine levels (TNFα, IL-1β, IL-6, IL-10, and IL-1 receptor antagonist) were assayed with and without lipopolysaccharide stimulation.

Results

TNFα, IL-6, IL-10 and IL-1 receptor antagonist levels in unstimulated monocytes were lower in neutropenic patients compared with non-neutropenic patients. Values obtained in the healthy individuals were low as expected, comparable with neutropenic patients. In lipopolysaccharide-stimulated monocytes, both inflammatory and anti-inflammatory cytokine production were significantly lower in neutropenic patients compared with non-neutropenic patients and control individuals.

Conclusion

Consistent with previous results concerning alveolar macrophage deactivation, we observed a systemic deactivation of monocytes in septic neutropenic ARDS. This deactivation participates in the overall immunodeficiency and could be linked to sepsis, chemotherapy and/or the use of granulocyte colony-stimulating factor.     

An evaluation on the neuropsychological tests used in the assessment of postchemotherapy cognitive changes in breast cancer survivors

Objectives

The choice of appropriate neuropsychological tests is important in evaluating the onset, severity, duration, and site of cognitive changes in postchemotherapy breast cancer survivors. This literature review is designed to evaluate and provide a summary of suitable neuropsychological tests to determine cognitive changes in breast cancer survivors.

Method

A literature search restricted to publications in English before June 2011 was performed using the following combination of keywords: “neuropsychological assessments,” “breast cancer,” “chemotherapy,” and “cognitive impairment.” Only observational studies that performed cognitive assessments on breast cancer survivors were included. The neuropsychological assessments were grouped as “objective” (traditional batteries and screening tests), “subjective,” or “computerized.”

Results

Of the 43 studies extracted, memory (88?%) and attention/concentration (88?%) are the two most commonly assessed domains. A majority (63?%) employed the use of Wechsler Adult Intelligent Scale (an objective test), while only 49?% incorporated subjective assessments to assess perceived cognitive impairment. Computerized tests received low popularity (28?%) despite their numerous advantages, which include overcoming the language- and cultural-dependent limitations of traditional objective tests.

Conclusions

In the selection of a suitable neuropsychological tool to determine the onset, severity, site, and duration of cognitive changes in breast cancer survivors, incorporation of both subjective and objective tests is essential to facilitate a comprehensive assessment. With more validation work performed in future studies, it may be feasible to employ computerized neuropsychological assessments in both clinical and research settings.     

Palonosetron plus single-dose dexamethasone for the prevention of nausea and vomiting in women receiving anthracycline/cyclophosphamide-containing chemotherapy: meta-analysis of individual patient data examining the effect of age on outcome in two phase III trials

Purpose

Data from two randomized trials, evaluating a single-day regimen of palonosetron plus dexamethasone against emesis due to moderately emetogenic chemotherapy, were assessed for the impact of age on outcome in a pooled sample of women receiving anthracycline and/or cyclophosphamide (AC)-containing chemotherapy.

Methods

Chemo-naïve breast cancer patients randomized to receive palonosetron (0.25 mg) plus dexamethasone (8 mg IV) on day 1 of chemotherapy (n?=?200), or the same regimen followed by oral dexamethasone (8 mg) on days 2 and 3 (n?=?205), were included in the analysis. The primary endpoint was complete response (CR: no vomiting and no rescue anti-emetics) in the 5-day study period. The effect of the 1-day regimen and age (<50 and ≥50 years) was investigated by a meta-analysis of individual patient data.

Results

Younger patients comprised 43 % and 49 % of the 1-day and 3-day regimen groups, respectively; 94 % of the pooled sample received the AC combination. There were no between-treatment differences in CR rate according to age during all observation periods. In the 1-day regimen group, 55.2 % of younger patients achieved overall CR compared with 54 % of older patients. In the 3-day regimen group, 51.5 % of younger patients achieved overall CR compared with 58.7 % of older patients. In the adjusted analysis, younger age was not associated with overall CR to treatment (risk difference, ?3.1 %; 95 % CI, ?13.0 to 6.7 %; P?=?0.533).

Conclusions

These results provide evidence that, irrespective of age, the dexamethasone-sparing regimen is not associated with a significant loss in overall anti-emetic protection in women undergoing AC-containing chemotherapy.     

Electroencephalogram power changes as a correlate of chemotherapy-associated fatigue and cognitive dysfunction

Purpose

Persistent fatigue and cognitive dysfunction are poorly understood potential long-term effects of adjuvant chemotherapy. In this pilot study, we assessed the value of electroencephalogram (EEG) power measurements as a means to evaluate physical and mental fatigue associated with chemotherapy.

Patients and methods

Women planning to undergo adjuvant chemotherapy for breast cancer and healthy controls underwent neurophysiologic assessments at baseline, during the time of chemotherapy treatment, and at 1 year. Repeated measures analysis of variance was used to analyze the data.

Results

Compared with controls, patients reported more subjective fatigue at baseline that increased during chemotherapy and did not entirely resolve by 1 year. Performance on endurance testing was similar in patients versus controls at all time points; however, values of EEG power increased after a physical task in patients during chemotherapy but not controls. Compared with controls, subjective mental fatigue was similar for patients at baseline and 1 year but worsened during chemotherapy. Patients performed similarly to controls on formal cognitive testing at all time points, but EEG activity after the cognitive task was increased in patients only during chemotherapy.

Conclusion

EEG power measurement has the potential to provide a sensitive neurophysiologic correlate of cancer treatment-related fatigue and cognitive dysfunction.     

French version of the Functional Assessment of Cancer Therapy–Cognitive Function (FACT-Cog) version 3

Purpose

Impairment of cognitive function, a common complaint in patients receiving chemotherapy, is usually measured through neuropsychological tests. Patient self-evaluation of cognitive difficulties is an important complement to those tests. The Functional Assessment of Cancer Therapy–Cognitive Function (FACT-Cog) is a self-report questionnaire with potential to be used in standard clinical practice as a tool for evaluating patient's cognitive function before, during, and after chemotherapy. The purpose of our study was to conduct linguistic validation of the French version of the FACT-Cog.

Methods

Both qualitative and quantitative methods were used in this study. After undergoing a rigorous translation methodology, the French FACT-Cog version was pretested in France with 35 cancer patients undergoing chemotherapy treatment. Interviews were conducted with all patients to ascertain their understanding of each item. The validation of the final version was conducted among 63 cancer patients, and sociodemographic information was collected as well as brief measure of cognitive function and depression score.

Results

Patient comments obtained through the cognitive debriefing interviews indicated that patients understand the French FACT-Cog items as they are intended and that the measure is culturally appropriate. Internal consistency reliability of the subscales, evaluated using Cronbach's coefficient alpha, was high for all four subscales: Perceived Cognitive Impairments?=?0.93, Impact On QOL?=?0.85, Comments From Others?=?0.70, and Perceived Cognitive Abilities?=?0.89. All item-total correlations for each subscale were greater than 0.20, and most were greater than 0.50.

Conclusions

Results from this study effectively demonstrate that the French FACT-Cog is a reliable instrument for the self-reporting of cognitive abilities in patients undergoing chemotherapy.     

Lack of a chemobrain effect for adjuvant FOLFOX chemotherapy in colon cancer patients. A pilot study

Purpose

Chemotherapy improves the survival rate of stage III colon cancer patients. The combination of oxaliplatin, 5-fluorouracil, and leucovorin (the FOLFOX4 regimen) has emerged as the standard of care. This prospective study evaluates potential alterations in cognitive function in FOLFOX4-treated patients.

Methods

We evaluated 57 consecutive colorectal cancer patients who received adjuvant chemotherapy with FOLFOX4. Patients underwent a complete battery of neuropsychological tests at three different times: before (T0), at the end (T1), and 6 months after treatment (T2).

Results

We have analyzed cognitive impairment (Mini Mental State Examination, MMSE), visuo-spatial memory (Clock Drawing Test, CDT, Rey Complex Figure, copy and recall), information processing speed (Trial Making Test-A, TMT-A, and Trial Making Test-B, TMT-B), verbal memory (Rey Auditory Verbal Learning Test, call and recall), emotional distress (Psychological Distress Inventory, PDI), anxiety (State and Trait Anxiety Inventory, STAI-Y1 and Y2), and depression (Beck Depression Inventory, BDI). Then we have calculated, for each test and for each interval of time, mean?±?standard deviation for the mean. In a subsequent phase, we tested the significance of different results through the ANOVA analysis for repeated measures. In this case, we could not find any statistically significant modification in cognitive function, but we could notice an improvement in emotional performance, anxiety and depression a short time after chemotherapy administration.

Conclusions

We found no effect on cognitive function related to chemotherapy, the only little modification is about some emotional performance during chemotherapy. These findings may be explained by the central role of the psychological adaptation process, which occurs during the period from diagnosis to completion of treatment and is characterized by anxiety and adjustment depression. Our results seem to rule out any significant cognitive impairment due to adjuvant FOLFOX4 chemotherapy in colon cancer patients.     

Validation and feasibility of a caloric expenditure measuring device in women with early-stage breast cancer

Purpose

The purpose of this study is to validate the Bodybugg (BB), a caloric expenditure measuring device, in breast cancer patients undergoing adjuvant and neoadjuvant chemotherapy for early-stage breast cancer.

Methods

Twenty-five women with stages I–III breast cancer who were to receive adjuvant dose-dense doxorubicin/cyclophosphamide were recruited. Participants were asked to wear the BB and record activity logs for seven pretreatment days (prior to commencing chemotherapy) and seven posttreatment days (upon completing cycle 4 of chemotherapy). The BB’s caloric expenditure measurements were used to calculate metabolic equivalent (MET) values of patients’ recorded activities. BB-calculated METs were compared with matching METs from the 2011 Compendium of Physical Activities Tracking Guide to assess accuracy of the device.

Results

The overall patient sample wore the device for an average of 5.32 (SD 1.75) pre- and 4.88 (SD 2.01) posttreatment days. The mean pairwise difference between BB and Compendium METs was 0.043 (SD 0.77) for 308 pretreatment activities recorded by 12 patients and 0.065 (SD 0.61) for 108 posttreatment activities recorded by 6 patients, indicating close to zero bias between the BB’s and Compendium’s measurements. Hierarchical linear modeling showed that Compendium METs strongly predict for BB METs (P?<?0.00001).

Conclusions

The BB is feasible to use in study designs involving defined time periods of measurement and provides accurate and objective measurements of caloric expenditure in breast cancer patients.     

The use of Ginkgo biloba for the prevention of chemotherapy-related cognitive dysfunction in women receiving adjuvant treatment for breast cancer, N00C9

Purpose

Patients undergoing treatment for cancer often report problems with their cognitive function, which is an essential component of health-related quality of life. Pursuant to this, a two-arm randomized, placebo-controlled, double-blind, phase III clinical trial was conducted to evaluate Ginkgo biloba (EGB 761) for the prevention of chemotherapy-related cognitive dysfunction in patients with breast cancer.

Methods

Previously chemotherapy naïve women about to receive adjuvant chemotherapy for breast cancer were randomized to receive 60 mg of EGB 761 or a matching placebo twice daily. The study agent was to begin before their second?cycle of chemotherapy and to be taken throughout chemotherapy and 1 month beyond completion. The primary measure for cognitive function was the High Sensitivity Cognitive Screen (HSCS), with a secondary measure being the Trail Making Tests (TMT) A and B. Subjective assessment of cognitive function was evaluated by the cognitive subscale of the Perceived Health Scale (PHS) and the Profile of Mood States (POMS). Data were collected at baseline and at intervals throughout and after chemotherapy, up to 24 months after completion of adjuvant treatment. The primary statistical analysis included normalized area under the curve (AUC) comparisons of the HSCS, between the arms. Secondary analyses included evaluation of the other measures of cognition as well as correlational analyses between self-report and cognitive testing.

Results

One hundred and sixty-six women provided evaluable data. There were no significant differences in AUC up to 12 months on the HSCS between arms at the end of chemotherapy or at any other time point after adjuvant treatment. There were also no significant differences in TMT A or B at any data point. Perceived cognitive functions, as measured by the PHS and confusion/bewilderment subscale of the POMS, were not different between arms at the end of chemotherapy. There was also little correlation between self-reported cognition and cognitive testing. No differences were observed in toxicities per Common Terminology Criteria for Adverse Events (CTCAE) assessment between Ginkgo biloba and placebo throughout the study; however, after chemotherapy, the placebo group reported worse nausea (p?=?.05).

Conclusion

This study did not provide any support for the notion that Ginkgo biloba, at a dose of 60 mg twice a day, can help prevent cognitive changes from chemotherapy. These analyses do provide data to further support the low associations between patients' self-report of cognition and cognitive performance, based on more formal testing.     

Palonosetron in combination with 1-day versus 3-day dexamethasone for prevention of nausea and vomiting following moderately emetogenic chemotherapy: a randomized, multicenter, phase III trial

Purpose

A phase III trial assessed the efficacy of palonosetron plus dexamethasone given once in preventing acute and delayed chemotherapy-induced nausea and vomiting (CINV) following a broad range of moderately emetogenic chemotherapy (MEC) regimens.

Methods

This multicentre, randomized, open-label, non-inferiority trial evaluated two different treatment groups. One group received palonosetron (0.25?mg intravenously) and dexamethasone (8?mg intravenously) before chemotherapy, while the other was administered the same regimen on day?1 followed by dexamethasone 8?mg orally on days?2 and 3. The primary endpoint was complete response (CR; defined as no emetic episodes and no rescue medication) during the overall phase (days?1?C5 after chemotherapy initiation). The non-inferiority margin was predefined as a 15% difference between groups in the primary endpoint.

Results

Of 332 chemotherapy-na?ve patients included in the intention-to-treat analysis, 65.1% were female, and 35.2% received anthracycline plus cyclophosphamide (AC)-based regimens. Overall CR rates were 67.5% for those administered dexamethasone only on day?1 (n?=?166), and 71.1% for those also administered dexamethasone on days?2 and 3 (n?=?166; difference ?3.6% (95% confidence interval, ?13.5 to 6.3)). CR rates were not significantly different between groups during the acute (0?C24?h post-chemotherapy; 88.6% versus 84.3%; P?=?0.262) and delayed phases (days?2?C5; 68.7% versus 77.7%; P?=?0.116).

Conclusions

Palonosetron plus single-dose dexamethasone administered before common MEC regimens provide protection against acute and delayed CINV which is non-inferior to that of palonosetron plus dexamethasone for 3?days. However, the major benefit of the single-day regimen occurs in patients receiving non-AC MEC regimens.     

Associations of interleukin-6 with vegetative but not affective depressive symptoms in terminally ill cancer patients

Purpose

Previous studies have reported associations of depressive symptoms with pro-inflammatory cytokines, especially with interleukin-6 (IL-6) in noncancer subjects and cancer patients. Meanwhile, symptoms such as tiredness and appetite loss may be vegetative symptoms of depression when associated with other diagnostic criteria of depression. Such vegetative-type symptoms worsen during the last 6 months of life in cancer patients and may not be associated with affective depressive symptoms such as sadness and nervousness. This study explored associations between depressive symptoms and plasma IL-6 in terminally ill cancer patients whose survival period was confirmed to be less than 6 months by follow-up, with attention to differences in vegetative and affective depressive symptoms.

Methods

Data from 112 consecutively recruited terminally ill cancer patients who registered at a palliative care unit without any active anticancer treatment were used. Plasma IL-6 levels were measured using an electrochemiluminescence assay. Depressive symptoms included in the DSM-IV and Cavanaugh criteria were assessed by structured interviews and were categorized into affective symptoms and vegetative symptoms. Affective symptoms were also measured with the depression subscale of the Hospital Anxiety and Depression Scale, which does not include vegetative symptoms.

Results

Vegetative symptoms, such as appetite loss, insomnia, and fatigue, were significantly associated with IL-6 levels. However, neither of the affective symptoms nor their severity was associated with IL-6 levels.

Conclusions

IL-6 was associated with vegetative depressive symptoms in terminally ill cancer patients but not with affective depressive symptoms, suggesting possible differences in the pathophysiological mechanisms between these sets of symptoms.     

Patterns of physical activity participation across the cancer trajectory in colorectal cancer survivors

Purpose

The purpose of the present study was to explore the participation in physical activity (PA) by colorectal cancer survivors across cancer trajectories and based on selected demographic and medical variables.

Methods

A total of 431 participants were surveyed individually at the Shinchon Severance Hospital, Seoul, Korea, to determine their PA levels before diagnosis, during treatment and after completion of cancer treatment.

Results

Percentage of survivors meeting American College of Sports Medicine guideline significantly reduced from 27 % before diagnosis to 10 % during treatment due to reduced strenuous intensity PA (28.8?±?106.2 vs 11.8?±?95.9 min, p?=?0.042), while total PA and mild intensity PA did not change. Total (187.2?±?257.7 vs. 282.6?±?282.0 min, p?<?0.001) and mild (99.1?±?191.5 vs. 175.1?±?231.2 min, p?<?0.001) intensity PA significantly increased after the completion of treatments compared with their PA level before diagnosis. Further analyses showed that age (more vs. equal or less than 60 years) and chemotherapy (chemotherapy vs. no chemotherapy) significantly influenced the level of physical activity (p?=?0.004). Survivors who were older or received chemotherapy increased their total PA and mild intensity PA after the completion of treatment more than those who did not receive chemotherapy.

Conclusions

The level and the pattern of physical activity by colorectal cancer survivors differed across cancer trajectories, which were significantly influenced by age and adjuvant chemotherapy.     

Testing the ‘teachable moment’ premise: does physical activity increase in the early survivorship phase?

Purpose

Little is known about objectively measured physical activity during the early survivorship period. This study measured physical activity, fatigue, and quality of life (QOL) in breast cancer patients over the first year after completion of chemotherapy and compared results to a matched non-cancer group.

Methods

Data was obtained from 24 breast cancer subjects (mean ± SD) 50.9?±?12.8 years at time points of 6 weeks, 6 months and 1 year after completion of adjuvant chemotherapy and from 20 matched women. The following variables were assessed, physical activity (RT3 accelerometer and International Physical Activity Questionnaire), quality-of-life (EORTC QLQ C-30) and fatigue (Brief Fatigue Inventory).

Results

At 6 weeks after completion of chemotherapy, high levels of sedentary behaviour were found (6.8?±?1.9 h sedentary per day), which did not improve, and was no different to the comparison group (6.5?±?1.4 h). Less light activity was performed in the cancer cohort compared to the comparison group (p?=?0.003). Body mass index (BMI) increased significantly in the cancer cohort (p?=?0.015) and 1 year after chemotherapy finished only 13 % (n?=?3) had a BMI <25, while the comparable value was 45 % (n?=?9) in the non-cancer group. The QOL domain of cognitive function improved over the first 6 months (p?=?0.034) but physical functioning declined (p?=?0.008) over this time period. Fatigue did not change, and at the 1-year time point, 38 % of the cancer patients (n?=?11) reported high levels of fatigue.

Conclusion

This study highlighted the unchanging sedentary behaviour and weight gain of breast cancer survivors during the first year after completion of chemotherapy, which may inform rehabilitation models in this population.     

Are serum cytokines early predictors for the outcome of burn patients with inhalation injuries who do not survive?

Introduction

Severely burned patients suffering from inhalation injury have a significantly increased risk for mortality compared with burned patients without inhalation injury. Severe burn is associated with a distinct serum cytokine profile and alterations in cytokines that contribute to morbidity and mortality. The aim of the present study was therefore to determine whether severely burned pediatric patients with concomitant inhalation injury who had a fatal outcome exhibited a different serum cytokine profile compared with burn patients with inhalation injury who survived. Early identification followed by appropriate management of these high-risk patients may lead to improved clinical outcome.

Methods

Thirteen severely burned children with inhalation injury who did not survive and 15 severely burned pediatric patients with inhalation injury who survived were enrolled in the study. Blood was collected within 24 hours of admission and 5 to 7 days later. Cytokine levels were profiled using multiplex antibody coated beads. Inhalation injury was diagnosed by bronchoscopy during the initial surgery. The number of days on the ventilator, peak inspiratory pressure rates, arterial oxygen tension (PaO₂)/fraction of inspired oxygen (FiO₂) ratio and incidence of acute respiratory distress syndrome were recorded for those patients.

Results

Significantly altered levels of IL-4, IL-6, IL-7, IL-10, and IL-13 were detected within the first 7 days after admission in serum from burn pediatric patients with concomitant inhalation injury who did not survive when compared with similar patients who did (P < 0.05). Alterations in these cytokines were associated with increased incidence of acute respiratory distress syndrome, number of days under ventilation, increased peak inspiratory pressure, and lower PaO₂/FiO₂ ratio in this patient population. Multiple logistic regression analysis revealed that patients with increased IL-6 and IL-10 as well as decreased IL-7 serum levels had a significantly greater risk for mortality (P < 0.05).

Conclusion

Early alterations in serum levels of IL-6, IL-7 and IL-10 may constitute useful predictive markers for identifying patients those who have sustained a burn with concomitant inhalation injury and who have high mortality.     

Ginger (Zingiber officinale) reduces acute chemotherapy-induced nausea: a URCC CCOP study of 576 patients

Purpose

Despite the widespread use of antiemetics, nausea continues to be reported by over 70% of patients receiving chemotherapy.

Methods

In this double blind, multicenter trial, we randomly assigned 744 cancer patients to four arms: 1) placebo, 2) 0.5?g ginger, 3) 1.0?g ginger, or 4) 1.5?g ginger. Nausea occurrence and severity were assessed at a baseline cycle and the two following cycles during which patients were taking their assigned study medication. All patients received a 5-HT₃ receptor antagonist antiemetic on Day 1 of all cycles. Patients took three capsules of ginger (250?mg) or placebo twice daily for 6?days starting 3?days before the first day of chemotherapy. Patients reported the severity of nausea on a 7-point rating scale (“1”?=?“Not at all Nauseated” and “7”?=?“Extremely Nauseated”) for Days 1–4 of each cycle. The primary outcomes were to determine the dose and efficacy of ginger at reducing the severity of chemotherapy-induced nausea on Day 1 of chemotherapy.

Results

A total of 576 patients were included in final analysis (91% female, mean age = 53). Mixed model analyses demonstrated that all doses of ginger significantly reduced acute nausea severity compared to placebo on Day 1 of chemotherapy (p?=?0.003). The largest reduction in nausea intensity occurred with 0.5?g and 1.0?g of ginger (p?=?0.017 and p?=?0.036, respectively). Anticipatory nausea was a key factor in acute chemotherapy-induced nausea (p?<?0.0001).

Conclusions

Ginger supplementation at a daily dose of 0.5?g–1.0?g significantly aids in reduction of the severity of acute chemotherapy-induced nausea in adult cancer patients.