Lopez, G., Chaoul, A., Powers-James, C., Spelman, A., Wei, Q., Engle, R., . . . Cohen, L. (2018). A pragmatic evaluation of symptom distress after group meditation for cancer patients and caregivers: A preliminary report. Journal of Pain and Symptom Management, 55, 1321-1326.e1.

DOI Link: https://doi.org/10.1016/j.jpainsymman.2018.01.018

Study Purpose

To evaluate the effects of mediation group classes on patient and caregiver self-reported symptoms

Intervention Characteristics/Basic Study Process

This was an observational pilot that studied participants (patients and their caregivers) attending any of the three mediation group classes offered at a comprehensive cancer center. Classes were based on Tibetan mind-body mediation tradition, and spanned either 60 or 90 minutes in length, depending on type of class—power breath, sacred sounds, or movement and breath. Instructors of each mediation class consisted of mind-body therapists with at least five years of oncology experience. Participants completed a pre- and post-class Edmonton Symptom Assessment Scale (ESAS). Because participants could attend more than one meditation class, only data from the first visit of the 142 participants was examined. Data obtained from the ESAS was used to analyze symptoms individually and as subscales.

Sample Characteristics

N =142 (76 patients and 66 caregivers)
MEAN AGE: For patients: 57.5 years; for caregivers: 57.6 years
MALES: Patients: 19.7%; caregivers: 22.7%
FEMALES: Patients: 80.3%; caregivers: 77.3%
CURRENT TREATMENT: Participants spanned cancer continuum from prevention, active treatment, survivorship, or living with advanced cancer
KEY DISEASE CHARACTERISTICS: Patient diagnoses included: breast (38.2%), hematologic (10.5%), skin (10.5%), thoracic/head and neck (9.2%), gastrointestinal (6.6%), gynecological (6.6%), and other (18.4%). Cancer staging included: local (56.6%), advanced (15.8%), and unstaged (27.6%)

Setting

SITE: Single site
SETTING TYPE: Not specified
LOCATION: MD Anderson Cancer Center (Houston, Texas)

Phase of Care and Clinical Applications

PHASE OF CARE: Multiple phases of care

Study Design

Observational pilot that analyzed self-reported symptom information from patients and caregivers attending medication classes offered at a comprehensive cancer center between May and December 2015

Measurement Instruments/Methods

ESAS was completed by participants before and after classes. Symptoms of the ESAS were analyzed both globally (subscales) and individually. ESAS subscales were scored as follows:

Global Distress Score (GDS) as sum of pain, fatigue, nausea, depression, anxiety, drowsiness, appetite, sense of well-being and shortness of breath (0-90)
Physical Distress Score (PHS) as sum of pain, fatigue, nausea, drowsiness, appetite, and shortness of breath (0-60)
Psychological Distress Score (PSS) as sum of depression and anxiety (0-20)

Clinically significant reduction of an individual symptom was defined as > 1; for ESAS global distress score (GDS) > 3; for physical distress score (PHS) > 2; for psychological distress score (PSS) > 2. Higher scores represented worse outcomes for the stated symptom or subscale.

Results

For all participants there was a clinically and statistically significant decrease (improvement) in symptom of shortness of breath (mean = -1.2; p = 0.001), global distress (-5.17, p < 0.0001), fatigue (-1.34, p < 0.0001), anxiety (-1.26, p < 0.001). For patients, there was clinically significant improvement in dyspnea (mean = -1.12; p = 0.013). No clinically significant symptom change was observed when comparing class duration (60- versus 90-minute class). There was no clinically significant difference in participant symptom burden at baseline or in score reduction by group, or by attendance of one versus two or more classes.

Conclusions

Group mediation class, when used in conjunction to standard of therapy, shows a possible subjective improvement in shortness of breath, global distress, well-being, fatigue, and anxiety in the oncology population, but more research is warranted.

Limitations

Small sample (< 100)
Risk of bias (no control group)
Risk of bias (no blinding)
Risk of bias (no random assignment)
Risk of bias (no appropriate attentional control condition)
Findings not generalizable
Intervention expensive, impractical, or training needs
Other limitations/explanation: A limitation to the use of mediation classes for symptom reduction in the oncology population is the need/cost for training such techniques as described in the study. The instructors of the meditation classes described in this study were mind-body practitioners with at least five years of oncology experience, and the institution already had a long-established integrative medicine program that was offered to patients on a rolling basis as part of standard of care by clinicians. Generalizability of the population is limited because of the fact that participants were self-selected and not randomized to meditation class. Also limiting generalizability was the fact that participants were of variable staging, cancer diagnoses, care spectrum, and caregivers. There was also no account for participants who may have attended a meditation class prior to the study period or engage in self-practice. For self-reported symptoms, the longitudinal effects of attending regular meditation class has not been examined. Assessments were immediately pre- and post-intervention, so it is unknown if there are any long-term benefits of meditation in this population.

Nursing Implications

Further research on the long-term effects and continued use of group meditation on shortness of breath is warranted.

Nakano, J., Hashizume, K., Fukushima, T., Ueno, K., Matsuura, E., Ikio, Y., . . . Kusuba, Y. (2018). Effects of aerobic and resistance exercises on physical symptoms in cancer patients: A meta-analysis. Integrative Cancer Therapies, 17, 1048–1058.

DOI Link: https://doi.org/10.1177/1534735418807555

Purpose

STUDY PURPOSE: To conduct a meta-analysis to establish the effect of exercise interventions on multiple physical symptoms, including fatigue, nausea/vomiting, pain, dyspnea, insomnia, loss of appetite, constipation, and diarrhea in patients with cancer
TYPE OF STUDY: Systematic review

Search Strategy

DATABASES USED: Cochrane Library, the Center for Reviews and Dissemination, PubMed/MEDLINE, CINAHL, Scopus, PEDro, Health and Medical Collection, Psychology Database
YEARS INCLUDED: Articles published before April 2017
SEARCH TERMS: MeSH terms of cancer, tumor, randomized controlled trial, training, rehabilitation, and exercise, as well as outcome of physical symptoms
INCLUSION CRITERIA: Included RCTs that evaluated the effects of exercise intervention by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 or the C15-PAL
EXCLUSION CRITERIA: Excludes systematic reviews, editorials, cross-sectional studies, case reports, case series, and interventions that were not of high enough intensity (yoga, stretching, Pilates, and education). Also excluded shoulder exercise studies for breast patients and pelvic floor muscle training in gynecologic patients, as well was any trial that did not have a control group that received no major exercise intervention.

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 743 (only 45 reviewed full-text after exclusion for study design)
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Studies were evaluated for study design (RCT) and for data form, methodologic quality was evaluated with the PEDro scale

Sample Characteristics

FINAL NUMBER STUDIES INCLUDED: 10
TOTAL PATIENTS INCLUDED IN REVIEW: 893 (434 in intervention groups)
SAMPLE RANGE ACROSS STUDIES: Lists patients as having hematological malignancies (largest group), breast, prostate, and mixed cancer. Phases of care were heterogenous, although listed as “mainly postsurgery, posttransplantation (heme), and during chemotherapy
KEY SAMPLE CHARACTERISTICS: Heme malignancy was most prevalent, states that the largest number of patients with lung cancer was 46 “at most”--total breakdown of cancer types was not provided.

Phase of Care and Clinical Applications

PHASE OF CARE: Varied
APPLICATIONS: Palliative care

Results

Results showed exercise positively affected the symptoms of fatigue (p = 0.0004), pain (p = 0.02), insomnia (p < 0.0001), dyspnea (p = 0.001), and no significant effect on nausea/vomiting, loss of appetite, constipation, or diarrhea. For dyspnea specifically, only within the mixed exercise program subgroup (as opposed to resistance alone or aerobic exercise alone) was an improvement effect in favor of the intervention group found.

Conclusions

This study concluded that it had confirmed that exercise interventions improve fatigue, pain, and insomnia in cancer, and that it had a novel finding of a benefit of exercise on dyspnea, but showed no effect on nausea/vomiting, loss of appetite, or constipation/diarrhea. The analysis did show significant results in the areas listed previously, although it is difficult to determine generalizability given the unknown sample characteristics. The effect of exercise on dyspnea was only seen with the mixed exercise groups, and it is difficult to understand who was included in that subgroup of patients; unclear, in particular, with cancer type and phase of case. The mechanism of dyspnea in a heme malignancy patient is very different, for example, than for a solid tumor patient, and there was a highly limited number of patients with lung cancer in this study. Not knowing phase of care also limits the ability to understand who this could be applied to. More exploration of the effect of exercise on dyspnea should be undertaken to reach solid conclusions, but this analysis does suggest that the exploration is warranted.

Limitations

Limited number of studies included
Mostly low quality/high risk of bias studies
It can be argued, also, that the search process itself had limitations by using only studies that measured outcomes from the two tools they chose and would limit a number of high-quality studies using other tools.

Nursing Implications

With regard to dyspnea specifically, the nurse should be aware that there is a possibility that exercise may have an impact on dyspnea for some patients. It is unclear who these patients are, or what exercise regimens are most affected, so no clear recommendation can be provided to patients at this time based on this particular study.

Henshall CL., Allin L., & Aveyard H. (2018). A systematic review and narrative synthesis to explore the effectiveness of exercise-based interventions in improving fatigue, dyspnea, and depression in lung cancer survivors. Cancer Nursing, 42, 295-306.

DOI Link: https://doi.org/10.1097/NCC.0000000000000605

Purpose

STUDY PURPOSE: Examine evidence on the effects of exercise interventions on fatigue, dyspnea, and depression.
TYPE OF STUDY: Meta analysis and systematic review

Search Strategy

DATABASES USED: Using PRISMA guidelines, the databases CINAHL, MEDLINE, Embase, and Cochrane were accessed
YEARS INCLUDED: 2000 to 2017
INCLUSION CRITERIA: Lung cancer survivors, depression, fatigue, and dyspnea.
EXCLUSION CRITERIA: Patients undergoing therapy, duplicate studies, and participants aged 18 years or older, not primary research; fatigue, depression, and fatigue not outcome measures

Literature Evaluated

TOTAL REFERENCES: N = 852
EVALUATION METHOD AND COMMENTS ON LITERATURE: Three researchers reviewed looking for dyspnea, fatigue, and depression as primary measures, looking for pre- and post-testing.

Sample Characteristics

STUDIES INCLUDED: 10
TOTAL PATIENTS INCLUDED: 516
SAMPLE RANGE ACROSS STUDIES: 10 to 162.
KEY SAMPLE CHARACTERISTICS: 58% were post-treatment for lung cancer

Phase of Care and Clinical Applications

PHASE OF CARE: Late effects and survivorship
APPLICATIONS: Elder care, palliative care

Results

Dimeo et al. (2004): After three weeks of exercises and relaxation, no significant results were noted for dyspnea, but were significant for fatigue (p = 0.67 and 0.54)

Glattki et al. (2012): In a study with pulmonary rehab measured using modified research council (MRC), the dyspnea scale was significant (p = 0.007, 0.26, SD = 0.61) for improvement in dyspnea.

Peddle-McIntyre et al. (2012): The MRC dyspnea scale was measured after 10 weeks and was not significant (pre = 1.6, SD = 0.6; post = 1.4, SD = 0.8).

Riesenberg and Lubbe (2010): The study showed significant improvements in dyspnea after four weeks of QLQ testing (p < 0.001) and also for fatigue (mean difference = -13.7).

Spruit et al. (2006): Using the BORG scale, no significant difference was found (p = 0.2969)

Overall, six studies reported statistically significant reductions in fatigue, two reported significant improvement in dyspnea, and one had significant reduction in depression.

Conclusions

Although there were some studies that showed that exercise interventions could possibly be effective for relief of symptoms such as dyspnea, the results were mixed, and there are unclear variations between programs and high dropout rates, so no recommendations can be made based on this particular analysis.

Limitations

Limited number of studies included
Mostly low quality/high risk of bias studies

Nursing Implications

Nurses should be aware that there is the possibility that exercise may benefit some patients, and there is little risk of harm, but nurses should be aware that it is unclear what patients or what programs would be of benefit; therefore, no recommendations can be made at this time.

Henke, C.C., Cabri, J., Fricke, L., Pankow, W., Kandilakis, G., Feyer, P.C., & de Wit, M. (2014). Strength and endurance training in the treatment of lung cancer patients in stages IIIA/IIIB/IV. Supportive Care in Cancer, 22, 95–101.

DOI Link: https://doi.org/10.1007/s00520-013-1925-1

Study Purpose

To test the effects of a specially designed strength and endurance training on the independence and quality of life (QOL) in patients with stages III/IV lung cancer while undergoing chemotherapy

Intervention Characteristics/Basic Study Process

Endurance training and breathing techniques were performed five days per week, and strength training was performed every other day while patients received three cycles of inpatient chemotherapy (platinum based). Endurance training consisted of walking and stair exercises. Strength training consisted of four different endurance exercises (trunk stability, leg, arm, and abdominal musculature), as well as breathing techniques (active cycle of breathing) combined with conventional physiotherapy. Control arm received conventional physiotherapy. Evaluations were conducted at baseline and after three cycles of chemotherapy.

Sample Characteristics

N = 46; only 29 completed (of the 17 withdrawals, 6 withdrew due to death, 10 from noncompliance, and 1 from switching hospitals). 18 were in the intervention group, 11 in the control.
AGE: 18 years or older
MALES (%): Unknown
FEMALES (%): Unknown
CURRENT TREATMENT: Chemotherapy
KEY DISEASE CHARACTERISTICS: Patients with stage IIIA/IIIB or IV lung cancer undergoing platinum-based inpatient chemotherapy regimens
OTHER KEY SAMPLE CHARACTERISTICS: Includes patients with non-small cell lung cancer and small cell lung cancer

Setting

SITE: Single Site
SETTING TYPE: Hospital (inpatient)
LOCATION: Germany

Phase of Care and Clinical Applications

PHASE OF CARE: Active anti-tumor treatment

Study Design

Randomized controlled trial

Measurement Instruments/Methods

6 minute walk test, staircase walking (number of steps), Barthel Index (primary outcome measure), European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30, Modified Borg Scale

Results

After intervention, the intervention group had a significantly higher Barthel Index (p = 0.003), indicating higher independence with ADLs. In the single scores of the EORTC QLQ-C30, the intervention group reported higher physical functioning (p = 0.025), lower hemoptysis (p = 0.019), lower pain in the arms/shoulders (p = 0.048), peripheral neuropathy (p = 0.05) and cognitive functioning (p = 0.05). There were significant differences in ability on 6 minute walk test and stair walking as well as strength capacity (all p < 0.05). The level of dyspnea decreased significantly in the intervention group while performing submaximal walking activities.

Conclusions

This study shows both feasibility and effects of a strength and endurance program during chemotherapy for lung cancer. The effects were significantly positive for the intervention group in every area (strength, endurance, QOL, independence). There were many issues with the study, however, making it difficult to apply to other populations. One huge issue is that it is unclear how many of the patients were SCLC versus NSCLC. These populations would have a wide difference in the natural history of disease on platinum regimen for the first few cycles; therefore, not knowing the content of each group is problematic. There were also large differences at baseline, so the effects are harder to evaluate. There was a very small sample size and large dropout rate. The intervention was feasible, but only given inpatient, so it is unclear if it is feasible for an outpatient population and these regimens are currently most typically administered outpatient in the United States. Although promising, it would need to be repeated to be generalizable.

Limitations

Small sample (< 30)
Baseline sample/group differences of import
Risk of bias (sample characteristics)
Key sample group differences that could influence results
Findings not generalizable
Subject withdrawals 10% or greater
Other limitations/explanation: This study was conducted on an inpatient basis. At least in the United States, current chemotherapy for these diseases even at this stage would be outpatient, so feasibility not applicable. Also, there was a large difference between groups at baseline in physical capacity and strength. The dropout rate was high, but also different between groups. The study was conducted as inpatient for what is an outpatient regimen in the United States.

Nursing Implications

Nurses should take away from this study that there is the possibility that endurance, strength, and QOL are improved by a program of strength and endurance training during chemotherapy. The results are not generalizable and would need further studies to confirm. There was no harm, but it cannot be recommended based solely on this study at this time.

Maeda, T., & Hayakawa, T. (2017). Dyspnea-alleviating and survival-prolonging effects of corticosteroids in patients with terminal cancer. Progress in Palliative Care, 25, 117–120.

DOI Link: https://doi.org/10.1080/09699260.2017.1293207

Study Purpose

To evaluate the effectiveness of corticosteroid to improve dyspnea and prolong survival in patients with terminal cancer

Intervention Characteristics/Basic Study Process

Retrospective chart review of 52 patients with terminal cancer who received corticosteroid for dyspnea. Effectiveness of corticosteroid to reduce dyspnea was assessed using the Support Team Assessment Schedule (STAS-J) and patients were classified as responders (n = 30) and non-responders (n = 22) based on STAS-J scores. Survival was compared between the groups, with patient survival being the primary endpoint.

Sample Characteristics

N = 52
MEAN AGE: 70 years (total sample)
MALES: 57.7%
FEMALES: 42.3%
CURRENT TREATMENT: Not applicable
KEY DISEASE CHARACTERISTICS: Terminal phase of cancer
OTHER KEY SAMPLE CHARACTERISTICS: Dyspnea from pleural effusion, lymphangitis carcinomatosis, and lung metastasis

Setting

SITE: Not stated/unknown
SETTING TYPE: Not specified
LOCATION: Municipal hospital in Japan

Phase of Care and Clinical Applications

PHASE OF CARE: End-of-life care
APPLICATIONS: Palliative care

Study Design

Retrospective chart review of terminal patients who received either oral or IV corticosteroids. Patients were classified as responders or non-responders and survival was compared between the groups.

Measurement Instruments/Methods

Effectiveness of corticosteroids to alleviate dyspnea was assessed using the Support Team Assessment Schedule (STAS-J) dividing patients into responders and non-responders. The Mann-Whitney U test compared survival between responders and non-responders, the chi-square test analyzed patient background information, and the Common Terminology Criteria for Adverse Events (CTCAE), version 4, evaluated adverse effects.

Results

There was significant improvement in survival for patients who responded to corticosteroids with reduced dyspnea then those that did not using the Mann-Whitney U test (8.5 versus 5 days, p = 0.0019). Side effects observed with corticosteroids included insomnia (15.4%), delirium (11.5%), and hyperglycemia (3.8%).

Conclusions

The use of corticosteroid alone or in combination with opioid did reduce dyspnea in some patients at end of life and, therefore, resulted in prolonged survival. However, side effects of corticosteroids must be taken into consideration when assessing reduced dyspnea and evaluating the benefit of prolonged survival.

Limitations

Small sample (< 100)
Risk of bias (no control group)
Risk of bias (no blinding)
Risk of bias (no random assignment)
Other limitations/explanation: Retrospective study, lacks power to detect in depth statistical differences, no effective dose of corticosteroid established.

Nursing Implications

Dyspnea occurs at end of life and can be difficult to manage. Therapies to effectively reduce dyspnea at end of life are needed. Corticosteroid therapy may alleviate dyspnea in some patients at end of life. Nurses must continue to assess effectiveness of corticosteroids to reduce dyspnea along with side effects that may occur from therapy.

Starlight Therapy

Read more about Starlight Therapy

Starlight therapy consists of a moving low-light image of green stars against a dark blue background with moving clouds projected via a laser light lamp on the ceiling in the patient’s room.

Liu, F., Du, Y., Cai, B., Yan, M., Yang, W., & Wang, Q. (2017). A clinical study of polyethylene glycol recombinant human granulocyte colony-stimulating factor prevention neutropenia syndrome in patients with esophageal carcinoma and lung cancer after concurrent chemoradiotherapy. Journal of Cancer Research and Therapeutics, 13, 790–795.

DOI Link: https://doi.org/10.4103/jcrt.JCRT_320_17

Study Purpose

To compare the efficacy and safety of PEG-rhG-CSF (prevention cohort) and rhG-CSF (delayed therapy cohort) for febrile neutropenia and, therefore, hospitalization of concurrent chemoradiation treatment of esophageal carcinoma and patients with lung cancer

Intervention Characteristics/Basic Study Process

Prophylactic application: G-CSF administered 24 hours after chemotherapy completion, 100 μg/mg PEG-rhG-CSF subcutaneously injected, whereas 150 μg of rhG-CSF was subcutaneously injected; the injection was performed once daily until leukocytes >10×10⁹. Delayed application: G-CSF administered 5 days after the completion of chemotherapy.

Sample Characteristics

N = 163
AGE: 18-65 years
MALES (%): not stated
FEMALES (%): not stated
CURRENT TREATMENT: Combination radiation and chemotherapy
KEY DISEASE CHARACTERISTICS: Locally advanced esophageal carcinoma, non-surgical candidates, and patients with lung cancer endured induction plus concurrent chemoradiotherapy
OTHER KEY SAMPLE CHARACTERISTICS: KPS score of 90 points or greater; patients without serious complications; ANC ≥ 1.5; plt ct ≥ 100; Exclusions were patients with bone metastasis or bone marrow metastasis; ALT/AST ≥ 1.5 (ULN) and combined with ALK PO4 ≥ 2.5 (ULN) or bili > 2 (ULN) or creatinine > 1.5 (ULN); or patients with histories of chemoradiotherapy or radiotherapy systemically; unmanageable infection

Setting

SITE: Multi-site
SETTING TYPE: Multiple settings
LOCATION: China

Phase of Care and Clinical Applications

PHASE OF CARE: Active anti-tumor treatment
APPLICATIONS: Adult care

Study Design

Active treatment study for neutropenia-related hospitalizations for patients receiving concurrent chemoradiotherapy

Measurement Instruments/Methods

SPSS, version 22.0, software (α = 0.05)

Results

Comparison between the prevention group and the delayed group showed that the incidence of neutropenia-related hospitalizations were 4.44% and 14.62%, respectively (OR = 0.272, 95% CI [0.115, 0.642], p = 0.002). Comparison between the prevention group and the delayed group showed that the incidence of febrile neutropenia was 5.56% and 18.46%, respectively (OR = 0.26, 95% CI [0.12, 0.565], p = 0.001).

Conclusions

Prophylactic use of GCF decreased hospitalization rates and the use of IV antibiotics.

Limitations

Small sample (< 30)
Risk of bias (no control group)
Risk of bias (no blinding)
Risk of bias (no random assignment)

Nursing Implications

Nursing would teach effects of chemotherapy and depletion of white cells which could lead to hospitalizations and neutropenic fever. Administering this medication prophylactically would ensure less hospitalizations and less severe fevers as well as decrease use of antibiotics.

Blackwell, K., Gascon, P., Krendyukov, A., Gattu, S., Li, Y., & Harbeck, N. (2018). Safety and efficacy of alternating treatment with EP2006, a filgrastim biosimilar, and reference filgrastim: A phase III, randomised, double-blind clinical study in the prevention of severe neutropenia in patients with breast cancer receiving myelosuppressive chemotherapy. Annals of Oncology, 29, 244-249.

DOI Link: https://doi.org/10.1093/annonc/mdx638

Study Purpose

To confirm the safety and efficacy of the cost-effective filgrastim biosimilar EP2006 through a phase III, randomized, double blind study from the original PIONEER study, analyzing alternating treatments of EP2006 and reference filgrastim among patients receiving myelosuppressive chemotherapy. The alternating treatments were used to show there was no difference in efficacy, safety, or immunogenicity compared to patients who received EP2006 or filgrastim only.

Intervention Characteristics/Basic Study Process

Two patient groups from the original PIONEER study in which patients were randomized into one of four arms in a 1:1:1:1 ratio was analyzed in this study. Patients received an initial dose of either EP2006 or filgrastim and then alternated treatments over six cycles of chemotherapy TAC regimen (docetaxel 75 mg/m², doxorubicin 50 mg/m² and cyclophosphamide 500 mg/m²). The filgrastim was administered as 5 µg/kg body weight per day, subcutaneous injection from the second day of chemotherapy until reaching ANC ≥ 10 x 10⁹/l following nadir or for a maximum of 14 days.

Sample Characteristics

N = 109
AGE: Mean age = 48.6 years
FEMALES: 100%
CURRENT TREATMENT: Chemotherapy
KEY DISEASE CHARACTERISTICS: Women with confirmed breast cancer, Eastern Cooperative Oncology Group performance status ≤ 2, and adequate bone marrow function
OTHER KEY SAMPLE CHARACTERISTICS: Patients were excluded if they had a history of myelogenous leukemia, myelodysplastic syndrome or concomitant sickle cell disease, concurrent or prior radiotherapy within four weeks of randomization, use of prophylactic antibiotics, prior chemotherapy or anticancer treatment of breast cancer or previous G-CSF therapy.

Setting

SITE: Multi-site
SETTING TYPE: Not specified
LOCATION: 25 European centers

Phase of Care and Clinical Applications

PHASE OF CARE: Active anti-tumor treatment

Study Design

Randomized, double-blind, parallel-group, multicenter study of women (aged 18 years and older) with breast cancer receiving myelosuppressive chemotherapy

Measurement Instruments/Methods

Multiple variables from the original dataset were measured including: FN (oral temperature 38.3 C and ANC < 0.5x10⁹/l on the same day), incidence of infections, incidence of hospitalizations due to FN, time and depth of ANC nadir (the patient’s lowest ANC in the respective chemotherapy cycle), time to ANC recovery, and ANC proﬁle. Adverse events were also evaluated across all cycles of chemotherapy and included patients who received one or more dose of study medication and had one or more post-baseline safety assessment and the switched safety population of all patients who received one or more dose of study medication after cycle 1. Immunogenicity was evaluated.

Results

Comparing the switched groups (n = 109) to the filgrastim reference group (n = 52), there were three patients (3.4%) in the switched group who had febrile neutropenia across cycles 2-6 compared to no patients with FN in the reference group. Infections occurred in 9.3% of patients in the switched group and 9.9% in the reference group. There were no differences between groups for depth of ANC nadir, time of ANC nadir, and time course of ANC recovery. Treatment emergent adverse events were similar between groups with 42.1% in the switched group and 39.2% in the reference group. No neutralizing antibodies against recombinant human G-CSF were detected.

Conclusions

The biosimilar EP2006 is as safe and effective as filgrastim. There was no compromise in immunogenicity in EP2006, and EP2006 was shown to be equally clinically meaningful to filgrastim, but is more cost-effective.

Nursing Implications

Knowledge regarding risks for infections in women with breast cancer receiving TAC therapy and the utilization of EP2006 as an alternative to filgrastim for cost-effective improved outcomes.

Zhang, R., Chen, J., Huang, H., Ma, J., Meng, F., Tang, Y., . . . Han, M. (2017). Primary fungal prophylaxis in acute leukemia patients with different risk factors: retrospective analysis from the CAESAR study. International Journal of Hematology, 106, 221-228.

DOI Link: https://doi.org10.1007/s12185-017-2224-2

Study Purpose

To identify subgroups of patients undergoing treatment for leukemia who would receive the most benefit from primary antifungal prophylaxis (PAP).

Intervention Characteristics/Basic Study Process

Retrospective subgroup analysis of the observational China Assessment of Antifungal Therapy in Hematological Disease (CAESAR) study. Invasive Fungal Disease (IFD) was defined per the European Organization for Research and Treatment of Cancer/Invasive Fungal Infections Cooperative Group and the NIH/NIAID Mycoses Study Group criteria and classified as possible, probable, and proven. Treatments were categorized as antifungal prophylaxis, empirical treatment, preemptive therapy, and treatment of established IFD.

Sample Characteristics

N = 2015
AGE: Median age = 32; range = 1-82
MALES: 56%
FEMALES: 44%
CURRENT TREATMENT: Chemotherapy
KEY DISEASE CHARACTERISTICS: Patients (all ages) undergoing treatment with chemotherapy for acute leukemia.

Setting

SITE: Multi-site
SETTING TYPE: Multiple settings
LOCATION: Multiple hospitals in China; patients with IFD were followed through the next chemotherapy cycle or six weeks post discharge if it was the patient’s last cycle.

Phase of Care and Clinical Applications

PHASE OF CARE: Active anti-tumor treatment
APPLICATIONS: Pediatrics, elder care

Study Design

Retrospective subgroup analysis of a large observational study.

Measurement Instruments/Methods

Data analyzed from previously collected variables from patient medical records. Variables measured included demographic information, laboratory values (albumin [decreased y/n], chemotherapy, neutropenia status, renal dysfunction [y/n], indwelling central line [y/n], corticosteroid use [y/n], parenteral nutrition [y/n], primary antifungal prophylaxis (PAP) administered [y/n]). Type of antifungal medications were also analyzed.

Results

Among the 2015 patients in this sub-study of patients with acute leukemia, 2,274 courses of chemotherapy were administered: 1,410 courses of chemotherapy for acute myeloid leukemia and 864 courses for acute lymphocytic leukemia. Patients treated for AML incurred more IFDs than patients with ALL (11.8% versus 7.1%, p < 0.001). IFD was also higher among patients who received induction chemotherapy (21.6%) compared to consolidation chemotherapy (3.7%) (p < 0.0001). IFD risk factors included decreased albumin, indwelling central line, parenteral nutrition, and being male. Receiving PAP was protective against IFD; significant for patients on induction chemotherapy (p < 0.0001).

Conclusions

PAP is effective against IFD in patients undergoing induction chemotherapy for acute leukemia. PAP may reduce the risk of IFD in patients receiving consolidation chemotherapy, having a decreased serum albumin, indwelling central line, receiving parenteral nutrition, or having severe neutropenia.

Limitations

Risk of bias (no control group)

Nursing Implications

Understanding the risks for invasive fungal disease and recommending primary antifungal prophylaxis for patients receiving chemotherapy (particularly induction chemotherapy) for the treatment of acute leukemia.

Pana, Z.D., Kourti, M., Vikelouda, K., Vlahou, A., Katzilakis, N., Papageorgiou, M., . . . Roilides, E. (2018). Voriconazole antifungal prophylaxis in children with malignancies: A nationwide study. Journal of Pediatric Hematology/Oncology, 40, 22-26.

DOI Link: https://doi.org/10.1097/MPH.0000000000000926

Study Purpose

To determine the safety of voriconazole (VRC) as antifungal prophylaxis (AFP) in pediatric hematology/oncology patients.

Intervention Characteristics/Basic Study Process

Patients received IV VRC 5-7 mg/kg every 12 hours as AFP, not as empiric treatment. Dosing and duration of VRC therapy was at the discretion of the treating physician. Median VRC dose = 7 mg/kg. Median duration of VRC = 17 days (range = 1-31 days). Median number of AFP courses = 1.7 (range = 1-6) per patient.

Sample Characteristics

N = 249
AGE: Median = 6; range not specified. Inclusion criteria states ages 0-17.
MALES: 55%
FEMALES: 45%
CURRENT TREATMENT: Chemotherapy
KEY DISEASE CHARACTERISTICS: Pediatric cancer patients (any malignancy), although the majority had acute lymphoblastic leukemia, non-Hodgkin lymphoma, or acute myeloid leukemia.
OTHER KEY SAMPLE CHARACTERISTICS: Researchers assessed risk factors for IFIs in the two weeks prior to initiation of VRC treatment. These risk factors included corticosteroid use, severity of neutropenia, grading of mucositis, type of surgery, ICU transfer, chemotherapy, and previous antibiotic therapy.

Setting

SITE: Multi-site
SETTING TYPE: Inpatient
LOCATION: Greece

Phase of Care and Clinical Applications

PHASE OF CARE: Active anti-tumor treatment
APPLICATIONS: Pediatrics

Study Design

Retrospective chart review

Measurement Instruments/Methods

Researchers assessed the rate of breakthrough IFIs during AFP and tabulated the incidence, time of onset, and severity of all AEs related to VRC.

Results

Only one breakthrough IFI was found in the 429 courses of VRC given to 249 unique patients. Median duration of AFP with VRC was 17 days (range = 1-31 days). Median number of courses of VRC was 1.7 (range = 1-6) per patient. Females required more courses of VRC (median = 2, range = 1-4) than males (median = 1, range = 1-6) (p > 0.05). The underlying malignancy had a significant effect on the number of courses of VRC, with patients with leukemia receiving a median of 2 courses (range = 1-6). Patients without leukemia required a median of one course (range = 1-4) (odds ratio = 0.47; 95% CI [0.047, 0.5]; p = 0.019).

Seventy AEs of any grade were reported (a rate of 16.3%). There was no significant correlation between age, sex, and type of AEs. Of the 70 AEs, 38.5% were grade I, 48.4% were grade II, and 12.8% were grade III. Severity of AEs was not impacted by sex (p = 0.745), age (p = 0.78), and type of AE (p = 0.365). None of the AEs was severe enough to warrant discontinuation of VRC.

Conclusions

VRC provides effective prophylaxis in pediatric hematology/oncology patients at risk for IFIs. AEs were tolerable and manageable. However, the pediatric population may not be able to report subjective AEs, which could result in underdiagnosis of AEs. The risk of long-term AEs remains unknown.

Limitations

Risk of bias (no control group)

Nursing Implications

Although AFP with VRC is effective, safe, and fairly well-tolerated, nurses should monitor their patients for early signs of AEs.

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