STUDY PURPOSE: To determine the risk of hepatitis B virus (HBV) reactivation with or without antiviral prophylaxis, and the effectiveness of prophylaxis

TYPE OF STUDY: Meta-analysis and systematic review

• FINAL NUMBER STUDIES INCLUDED = 26
• TOTAL PATIENTS INCLUDED IN REVIEW: 2,079
• SAMPLE RANGE ACROSS STUDIES: 6–258 patients
• KEY SAMPLE CHARACTERISTICS: Included patients with chronic HBV and resolved HBV

PHASE OF CARE: Active antitumor treatment

Risk for HBV reactivation without prophylaxis ranged from 4%–68% (median = 25%) and with prophylaxis ranged from 0.9%–31.4% (median = 4.1%). Among 13 studies comparing reactivation risk between patients who did and did not receive HBV prophylaxis, the pooled odds ratio [OR] was 0.12 (95% confidence interval [CI] [0.06, 0.22]).

HBV prophylaxis can help reduce the odds of HBV reactivation in patients with solid tumors undergoing chemotherapy.

• High heterogeneity among studies prevented an analysis of risk of reactivation in individuals without prophylaxis.
• Only one RCT
• Small effect size, although statistically significant

HBV prophylaxis may reduce the chance of patients with a history of HBV experiencing reactivation when undergoing chemotherapy for solid tumors. The authors of this article noted that guidelines regarding HBV screening vary. While the American Society of Clinical Oncology (ASCO) recommends screening for individuals at high risk, the Centers for Disease Control and Prevention (CDC) and others recommend screening all patients receiving immunosuppressive therapy. The findings here provide some support for broad HBV screening and the appropriate use of HBV prophylaxis; however, this analysis had multiple limitations. Further study is warranted to determine the screening, prophylaxis, and cost-effectiveness benefits of these actions.

To examine the effectiveness of intravenous (IV) versus subcutaneous (SC) granulocyte colony-stimulating factor (G-CSF) as related to time to neutropenia resolution and secondarily to assess comparative rates of infection, adverse effects, and patient satisfaction

Randomized, controlled, open-label trial with a 1:1 randomization to SC versus IV filgrastim. Patients were given either IV or SC filgrastim on a prescribed day (day 7 of chemotherapy for patients with acute myeloid leukemia [AML], day 2 after completion of chemotherapy for lymphoma and myeloma, and the day after infusion for patients undergoing hematopoietic stem cell transplantation [HSCT]). On the subsequent chemotherapy course (at least 30 days later), patients were crossed over to the alternative study arm.

• N = 120 
• MEAN AGE = 49.2 years
• MALES: 43.9% (first-course IV); 59% (first-course SC), FEMALES: 56.1% (first-course IV); 41% (first-course SC)
• KEY DISEASE CHARACTERISTICS: All hematologic malignancies. AML: IV (26.3%) and SC (37.7%). Acute lymphoblastic leukemia (ALL): IV (8.8%) and SC (13.1%). Non-Hodgkin's lymphoma (NHL): IV (36.8%) and SC (19.7%). Myeloma: IV (19.3%) and SC (19.7%). Other: IV (8.8%) and SC (9.8%).
• OTHER KEY SAMPLE CHARACTERISTICS: Almost 30% of patients in each cohort had a fever episode before randomization. 20%–25% had infection documented before randomization. The total median neutrophil count in the IV group was 0.1; the median neutrophil count in the SC group was 0; the median total leukocyte count in the IV group was 0.29; and the median leukocyte count in the SC group was 0.41.

• SITE: Single-site    
• SETTING TYPE: Inpatient    
• LOCATION: Hematology/oncology and bone marrow transplantation wards at the Davidoff Cancer Center, Beilinson Hospital, Petah Tikva, Israel

• PHASE OF CARE: Active antitumor treatment

Randomized, controlled, open-label trial

• Primary outcomes: Time from start of filgrastim to stable neutrophil recovery (> 500 cells/µL for three consecutive days) and a composite clinical outcome of 30-day mortality or infection (clinically or morphologically documented infections, bacteremia or probable/proven invasive fungal infections)
• Secondary outcomes: Time to stable neutrophil recovery (> 100 cells/µL), any invasive fungal infections (IFIs) including possible IFIs, fever days, thrombocytopenia duration, duration of hospital stay for patients discharged within 30 days, and adverse events
• Patients’ pain and satisfaction were also assessed by interview.

Time to neutrophil resolution was longer with an IV bolus G-CSF compared to SC G-CSF with an overall mean difference of 2.5 days. There were no differences in clinical outcomes, including infection rates or adverse events observed.

The trial was not powered to examine possible serious complications of SC G-CSF administration and was stopped prematurely due to the observed results.

Findings support the continued use of SC G-CSF for limiting the duration of neutropenia. Education about the use of G-CSF in the prevention of neutropenia and managing related side effects is important.

To compare the time of first bowel movement (BM) following pelvic reconstructive surgery in patients randomized to placebo or senna with docusate.

Patients were enrolled prior to surgery. After surgery, patients were randomized to either senna with docusate or placebo. Dosing was as follows.

• Take two tablets on the first night postoperation.
• If no BM, take two tablets the following morning.
• If no BM, take three tablets in the evening.
• If no BM the following morning, take three additional tablets twice daily until BM, or take magnesium citrate.

• The study reported on a sample of 93 women.
• Mean patient age was 59.5 years (SD = 12.6) in the senna with docusate group and 56.2 years (SD = 10) in the placebo group.
• The sample comprised patients with nonmalignant gynecologic and genitourinary cancer undergoing pelvic reconstructive surgery. Vaginal parity was 2 in the senna with docusate group (range 0–4) and 3 in the placebo group (range 0–7).

• Single site
• Inpatient
• Hartford Hospital in Connecticut

Patients were undergoing the active treatment phase of care.

This was a randomized, double-blinded, placebo-controlled trial.

• Seven-day bowel diary (baseline)
• Bristol Stool Scale
• Degree of strain and pain (11-point visual analog scale from 0 to 10)
• Medications taken
• Daily diary

• A significant difference existed in time of first BM in the senna with docusate group compared with the placebo group (3 days, SD = 1.5 versus 4 days, SD = 1.5; p < 0.002).
• More patients in the placebo group needed to use magnesium citrate to initiate a BM than in the senna with docusate group (43.6% versus 7%, p < 0.001).

The use of a stool softener with a laxative such as senna with docusate decreases the time to first BM following pelvic reconstructive surgery compared with placebo and lessens the need for use of magnesium citrate.

• The sample size was small (fewer than 100 patients).
• The study lacked an intention-to-treat analysis.

Nurses should be proactive in the management of patients' bowels following reconstructive surgery. Management with medications such as senna with docusate may be an option for patients following this form of surgery.

The purpose of the study was to evaluate the effects of gabapentin with nonsteroidal anti-inflammatory drugs (NSAIDs) and morphine versus gabapentin alone.

Participants were randomized into three groups. Group 1, consisting of 25 participants, received gabapentin alone, titrated weekly from 300 mg per day to 3,600 mg per day in divided doses. Group 2, consisting of 25 participants, received gabapentin 1,200 mg per day and diclofen 100 mg per day, also titrated over the first week. Group 3, consisting of 25 participants, received gabapentin 900 mg per day, diclofen 100 mg per day, and morphine 60 mg per day all in divided doses. Patients were treated for six weeks and assessed on a weekly basis.

• Seventy-five participants, all women aged 23–74 years (with a median age of 44 years), took part in the study.
• Participants were patients with breast cancer who were previously treated with any combination of chemotherapy, radiation therapy, and surgery, with neuropathic pain occurring post-treatment.
• Additional eligibility requirements included participants having a pain intensity rating of 5 or higher on a visual analog scale, having pain duration of at least three months, being older than age 18, being cognitively intact, having normal renal function, and having no gastrointestinal issues.

This single-site study was conducted in an outpatient setting in Serbia.

Phase of care

• Transition
• Long-term follow-up

Applications

• Late effects
• Survivorship

This study was quasiexperimental.

• Measurement tools included a visual analog scale, a modified Brief Pain Inventory, and the Pain Intensity Difference scale.
• Side effects from the medications used were assessed using a four-point Likert-type scale (0–3), with 0 indicating no side effects and 3 indicating severe side effects.

Participants in all three groups saw diminished pain and diminished influence of pain on their daily activities. No significant difference was noted between groups (p = 0.05).

Although all groups achieved significant pain control, the authors concluded that the multimodal therapy used in group 3 provided the best pain relief with the fewest side effects. However, inconsistency existed regarding doses between groups and, although differences in pain levels in each group diminished over time, between-group differences were not significant. No firm conclusions can be made.

• Limitations include a lack of control group, the potential for bias with no blinding method enacted, and that no valid measure of neuropathy was used.
• Actual dosages used varied from group to group, so clear conclusions are difficult.

The results support a multimodal approach to pain management in patients with breast cancer with neuropathic pain, but are not specific to peripheral neuropathy. The findings do not suggest any difference between the treatments tested in terms of efficacy; however, multiple limitations did exist in the study.

To evaluate the effects of multimodal therapy on intensity and relief of treatment-related neuropathic pain in patients with breast cancer

This study consisted of 75 patients with breast cancer who were experiencing neuropathic pain randomly divided into three groups. Group 1 received gabapentin only, starting at 300 mg, titrated up to 3,600 mg/day until an adequate response was obtained. Group 2 received a constant dose of 1,200 mg gabapentin and 100 mg diclofen gradually titrated up. Group 3 received multimodal therapy including 900 mg gabapentin, 100 mg diclofen, and 60 mg M-Eslon. Additional medicine was allowed PRN.

• The study reported on 75 patients with breast cancer experiencing neuropathic pain.
• Median patient age was 44 years.
• Patient gender was not specified directly, but was assumed to be 100% female due to breast cancer population.
• Patients underwent different treatments and therapies for breast cancer.
• At study entry, all patients had pain intensity of at least 5 on a visual analog scale (VAS), and pain duration of at least three months.

• Single site
• Serbia

• Patients were undergoing the transition phase of care after initial treatment.
• The study has clinical applicability for late effects and survivorship.

A randomized, three-group, parallel study design was used.

Modified Brief Pain Inventory questionnaire (VAS/Likert scale)

Group 3 (which received the combination of three medications) achieved the highest level of pain relief; however, there was no significant difference between groups. There was a statistically significant drop in pain intensity for all groups. The largest decrease was achieved at time of the first visit. Side effects increased in intensity over time, and group 2 experienced the most intense side effects.

Multimodal therapy seems to have some benefit on neuropathic pain in patients with breast cancer.

• The study did not include an appropriate control group.
• The study had a small sample, with less than 100 patients.
• The study lacked blinding, and confounding variables were present. Patients were to receive morphine as needed for breakthrough pain; however, breakthrough episodes and opioids used were not evaluated.

Patients with breast cancer would appear to benefit from multimodal therapy including different drugs and dosages to treat their neuropathic pain. Nurses should watch for an increase in side effects at subsequent follow-up visits.

To determine if quetiapine, an atypical antipsychotic, would improve insomnia in patients with breast cancer being treated with tamoxifen (tamoxifen-related insomnia).

Quetiapine was initiated at 25 mg/day, given one hour before bedtime. Dosages were titrated up to 100 mg/day based on patient tolerance and response to medication. Patients were assessed using tools for depression and insomnia at baseline and weeks 1 and 6 weeks into therapy.

• The sample was comprised of six women.
• Age ranged from 38 to 52 years.
• Patients were women with localized breast cancer (stage II–III-A) receiving tamoxifen (20 mg) 3 to 12 months after definitive primary therapy, including adjuvant chemotherapy and radiotherapy.
• Four of six patients were married.
• Patients had taken no psychotropic medications in the preceding month.

• Single site  
• Italy

Patients were undergoing the transition phase of care after initial treatment.

This was a single-group, repeated measure, case study.

• Structured Clinical Interview for DSM-IV (SCID-I)
• Beck Depression Inventory (BDI)
• Hamilton Rating for Depression (HAM-D)
• Insomnia Severity Index (ISI), Italian version

Five of six patients had rapid (at one week) improvement in insomnia based on ISI scores. This effect maintained improvement at six weeks.

Quetiapine may be a useful agent in treating tamoxifen-related or tamoxifen-induced insomnia in women with breast cancer.

• This was a case study or case report only.
• The study had a small sample size.
• No statistical analysis was performed.
• The study lacked biobehavioral assessments and objective sleep measures.
• Dosages of quetiapine were variable.

Quetiapine, an atypical antipsychotic, may be a potential option for treating tamoxifen-related insomnia without depression. A larger study is required.

To retrospectively examine how axillary reverse lymphatic mapping (ARM) affects patients perceived incidence of lymphedema compared to patients who did not receive ARM

A retrospective review of 46 patients with breast cancer who had greater than 10 lymph nodes removed were recruited and surveyed to determine which patients identified as having lymphedema and whether they required treatment or therapy for it. Patients were also asked if they underwent the ARM procedure.

• N = 46   
• MEAN AGE = 57 years  
• FEMALES: 100%
• CURRENT TREATMENT: Not applicable
• KEY DISEASE CHARACTERISTICS: Patients with breast cancer with axillary node dissection

• SITE: Retrospective (not applicable)
• SETTING TYPE: Retrospective (not applicable)
• LOCATION: Portland, Oregon

• PHASE OF CARE: Late effects and survivorship 
• APPLICATIONS: Palliative care 

• Retrospective review

A survey was created and sent to all women who qualified for the study from the Community Hospital Tumor Registry in Portland, Oregon.

Twenty-two patients reported undergoing the ARM procedure compared to 24 patients who did not undergo the ARM procedure. Of the 22 who did, 39% reported having lymphedema compared with 50% of the non-ARM patients. Eighteen percent of the ARM group reported requiring a compression sleeve for treatment of lymphedema compared to 45.8% of women in the non-ARM group.

The incidence of patient perceptions of lymphedema and the use of compression sleeves were lower in the ARM group than in the non-ARM group.

• Small sample (< 100)
• Baseline sample/group differences of import
• Risk of bias (no control group)
• Risk of bias (no random assignment) 
• Risk of bias (no appropriate attentional control condition)  
• Risk of bias (sample characteristics)
• Unintended interventions or applicable interventions not described that would influence results 
• Selective outcomes reporting
• Measurement/methods not well described
• Measurement validity/reliability questionable 
• Findings not generalizable
• Fifty-seven percent of patients contacted for the retrospective study did not complete the survey.

The effect of using the ARM procedure to decrease lymphedema cannot be ascertained from this study.

The Family Caregiver Cancer Education Program consisted of three group sessions in two-hour blocks as a psychoeducational program for caregivers led by nurse–social worker teams. A panel of 20 multidisciplinary experts in oncology designed the program content.

Topic areas in the program included

• Talking to a loved one’s physician and managing in the healthcare system
• Handling role and family relationship changes
• Care of medical equipment
• Managing symptoms
• Talking to children
• Managing other jobs and responsibilities
• Handling insurance and financial issues
• Dealing with emotional reactions
• Finding and asking for help
• Self-care maintenance.

• The sample (N = 187) included English- or Spanish-speaking caregivers who attended the program and completed baseline and four-month follow-up measures.
• Caregivers provided care to patients with a variety of cancer diagnoses during or after transition points of illness.

Caregivers of patients with cancer from 18 healthcare agencies in a large northeastern city (results from one site of a larger multisite study)

A nonrandomized, well-designed trial design was used, with pretest, post-test, baseline, and four-month postintervention scores completed.

• Caregiver Reaction Assessment
• Caregiver Demands Scale

• Only the impact of caregiving on household finances (dimension of burden) showed significant improvement from baseline to four months postintervention.
• Significant improvement was found in knowledge and assessment of the caregiver role at four months postintervention.
• A significant gender difference existed: More men withdrew and did not complete the second interview. However, no statistical differences in measured burden were found by gender.

• Selection and self-selection bias is a potential limitation in the study.
• Generalizing is difficult because the burden of caregivers who were unable to attend the program may differ from those who did.

Manual search and MEDLINE, CINAHL, and PsycInfo database searches using the search terms caregiver, caregiving, family, cancer, outcomes, interventions, quality of life, coping, and psychological distress were used.

Twenty-nine articles that described interventions aimed at assisting caregivers of patients with cancer were reviewed. Quality of life, knowledge about pain, caregiver burden, depression, psychological adjustment or functioning, and anxiety were not clearly defined in many of the studies.

Psychosocial status and aspects of caregiver quality of life improved, although improvement in burden not was not described. The effectiveness of interventions to reduce caregiver burden or strain was not established.

• The review was not limited to studies that associated interventions with outcomes and did not critique individual studies.
• Interventions often were not clearly described, and well-delineated outcome variables were lacking.
• Small sample sizes and attrition were problems.
• Randomized trials were lacking.
• Most studies revealed selection bias, often to well-adjusted caregivers.

To review published literature concerning the use of compression treatments in the management of venous and lymphatic diseases and establish where reliable evidence exists to justify the use of medical compression and where further research is required to address areas of uncertainty

The authors searched medical literature databases and reviewed their own collections of papers, monographs, and books for papers providing information about the effects of compression and randomized clinical trials of compression devices. Studies were included in the review if they used compression stockings, bandages, and intermittent pneumatic compression devices. Exclusion criteria were not specified.

The International Compression Club (ICC) reviewed and to commented critically on published literature on compression therapy concentrating on two issues: (a) experimental findings concerning clinically relevant effects of compression therapy and (b) randomized clinical trials (RCTs) addressing the use of compression for particular clinical indications. The findings were presented by several members of the group and discussed at a meeting of the ICC, held in May 2007 in Vienna, Austria. The assessment of the strength of the recommendations from randomized trials was based on the scoring criteria from the international Grading of Recommendations Assessment, Development, and Evaluation (GRADE) group. Thereafter, the data were summarized in tables that were circulated among the members of the ICC by email. The corrected version of these tables was agreed upon by a majority of the active participants at a follow-up ICC meeting, held in November 2007 in Paris.

The number of studies included in the report, total sample size, sample range across studies, and sample characteristics were not mentioned.

A wide range of compression levels was reported to be effective. Low levels of compression 10–30 mm Hg applied by stockings are effective in the management of telangiectases after sclerotherapy, varicose veins in pregnancy, the prevention of edema, and deep vein thrombosis (DVT). High levels of compression produced by bandaging and strong compression stockings (30–40 mmHg) are effective at healing leg ulcers and preventing progression of post-thrombotic syndrome as well as in the management of lymphedema. In some areas no reliable evidence was available to permit recommendations of level of compression or duration of treatment. These included management of varicose veins to prevent progression following surgical treatment or sclerotherapy for varicose veins and the level of compression required to treat acute DVT.

The review shows that while good evidence for the use of compression is available in some clinical indications, there is much still to be discovered. Little is known about dosimetry in compression or for how long and at what level compression should be applied. The differing effects of elastic and short-stretch compression are also little understood.