STUDY PURPOSE: To explore whether family-involved interventions for reducing burden and improving caregiver skills improve five outcomes for adult patients diagnosed with cancer or memory-related disorders (more specifically, to explore the benefits of psychosocial interventions delivered by family or a caregiver as compared to usual care or wait-listed care for those patients), and to identify the benefits of a caregiver or family psychosocial intervention as compared to a different family-related intervention or patient-directed intervention for those patients

• FINAL NUMBER STUDIES INCLUDED = 27 
• SAMPLE RANGE ACROSS STUDIES: 12–476 (median of 120 dyads/sample)
• TOTAL PATIENTS INCLUDED IN REVIEW = 3,345 patients in analysis for 26 trials
• KEY SAMPLE CHARACTERISTICS: Patients: the average age was 60 years (range: 46–71 years); 80% were married; 51% were male, and the majority had prostate cancer; 49% were female, with most having breast cancer; 79% were white. Family members: the average age was 56 years (range: 49–62 years); 61% were female; no other family caregiver data reported

PHASE OF CARE: Multiple phases of care

APPLICATIONS: Palliative care 

The systematic review, focused on five interventions for cancer, indicated some support for family-involved interventions over usual care for decreasing patient anxiety and depression. Weak evidence was found for better patient outcomes with family-involved interventions as compared to patient-focused or health education/psychoeducational interventions. Family-involved interventions, directed toward specific subgroups of patients and those involving teaching of skills to meet patient needs, may be more effective for alleviating cancer symptoms and depression and anxiety than usual care. Little evidence was found that symptom management (e.g., pain, fatigue, nausea), quality of life, or relationships adjustment between the patient and family caregiver improved following interventions examined for the systematic review. Only 2 of the 27 trials received a “good” quality evaluation, mandating caution in applying findings to practice.

The systematic review found heterogeneous studies and evidence that family-involved interventions improved patient depression but had little effect on their anxiety and physical health.

• Study findings resulted from 25 of 27 trials (RCTs) deemed as “poor” or “fair” in quality without observational evidence to support other findings.
• Some studies focused on interventions specific to improving caregiver and family health, which was not the review focus.
• Study samples were limited to those with cancer or memory-related illness.
• Non-inclusion of large-scale interventions similar to those used by the Department of Veterans Affairs
• Lack of data to assess the intervention effect on healthcare utilization
• Limited study generalizability

Current evidence indicates that targeted interventions for specific conditions, behaviors, and symptoms of the cancer experience may improve patient outcomes and minimize caregiver burden. Previous evidence has shown that psychosocial/psychoeducational interventions with caregivers reduce caregiver strain and burden. Findings from this systematic review provide some evidence that such interventions aimed at the family, rather than the individual caregiver or caregiver/patient dyad, may not substantially improve caregiver outcomes, while skill training for family members may be helpful. Additional work in this area is needed to determine the best foci and method of delivery of these types of interventions.

To evaluate the effect of fiber on bowel function by comparing increased fiber intake with instructions versus regular diet.

Women were randomized into two groups: high fiber (treatment) or regular diet (control). Both groups were evaluated at one, four, and seven months after surgery.

The treatment group received dietary counseling with instructions to increase their dietary intake to 30 to 40 g per day. Patients received all-bran cereal (unmarked) containing 15 g of fiber per bowl. Patients also were encouraged to increase their intake of insoluble fibers (eg, whole-grain, whole-wheat, and pumpernickel breads; all-bran cereal; butter; lima, pinto, and white beans; split and black-eyed peas; blackberries; boysenberries; raspberries; dried figs and prunes; artichokes; asparagus; Brussels sprouts; corn; parsnips; spinach; winter squash; turnip greens).

The study reported on a sample of 35 women with cervical cancer who had a type II or III radical hysterectomy.

University of Texas MD Anderson Cencer Center

This was a randomized controlled trial (RCT).

• Use of medications to achieve regularity was measured in terms of straining and pain with elimination.
• Patients completed subjective questionnaires, exercise log (seven days), food diary (three days), and bowel function assessment (seven days) at intervals. 

• Mean daily dietary fiber intake was 22.4 g in the treatment group and 12.4 g in the control group.
• Insoluble fiber intake for the treatment and control groups was 16.2 g and 8.1 g, respectively.
• Caloric intake was discussed.
• Patients in the control group had a significant increase in the amount of medications used to achieve regularity; no other significant changes existed pre-/postoperation in either group.

Patients with higher fiber intake had significantly less cramping abdominal pain and reports of straining, bowel-movement retention, more bowel movements with gas, and made in less than three minutes.

• The sample size was small (fewer than 100). Although this was an RCT, the sample size of 35 could be considered a major flaw and, therefore, decreased the impact level of evidence.
• The sample comprised women only.
• Findings were postsurgical only; presurgical fiber intake for the control group (10 g) was significantly higher than in the treatment group (7 g, p = 0.005).

To test the safety, tolerance, and efficacy of an appetite stimulant and an anabolic beta 2 agonist in patients with cancer cachexia

Patients were asked to take formoterol 40 mcg and megestrol 320 mg each morning and 40 mcg formoterol and 160 mg megestrol each evening for eight weeks. Self-reported intake and tablet counts were used to determine patient adherence. Patients were admitted to a clinical research facility on day 1 and discharged after the first dose of study drugs. Patients were contacted by phone after 24 hours for assessment. Additional assessments were done at weeks 2, 4, 6, 8, and 12.

• N = 9 (completed four weeks); 7 (completed eight weeks)  
• MEDIAN AGE = 67 years
• MALES: Not provided, FEMALES: Not provided
• KEY DISEASE CHARACTERISTICS: All had advanced disease; specific types were not described.
• OTHER KEY SAMPLE CHARACTERISTICS: Mean weight loss was 11% body weight over the prior five to seven months. 

• SITE: Single-site    
• SETTING TYPE: Outpatient    
• LOCATION: Scotland

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

Single arm observational

• National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI's CTCAE) version 3.0
• Body weight
• Maximum isometric knee extensor, lower limb extension, and maximum handgrip strength via dynamometry
• Muscle size measurement via MRI
• Physical activity measured via accelerometry as average daily step count
• European Organization for Research and Treatment of Cancer (EORTC) Quality of Life C30 questionnaire

Patients showed an increase in muscle strength and muscle size. Mean body weight increased by 2.6%. Physical activity increased in three of six patients who responded to treatment. Appetite improved (p = .005). Adverse events were tremor (n = 7), peripheral edema (n = 3), tachycardia (n = 2), and dyspepsia (n = 2).

The combination of megestrol and formoterol may have benefit for patients with cachexia. The sample size of this study was too small to draw conclusions.

• Small sample (< 30)
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment) 
• Subject withdrawals ≥ 10% 
• Other limitations/explanation: Four patients discontinued possibly due to study drug; 40% overall attrition

The combination of medications tested here may be associated with improved muscle function and appetite in patients with advanced cancer; however, due to the limitations of this study, efficacy and tolerance is not clear. Further well-designed research with these medications is needed to determine efficacy, safety, and tolerance.

To determine the feasibility and usefulness of providing brief behavioral interventions to manage dyspnea in patients with advanced lung cancer

Participants received two 30-minute intervention sessions by the same nurse practioner, the second session provided within four weeks of the first. Two nurse practioners were trained in psychoeducation, behavioral techniques, and relaxation. The first session consisted of the nurse practioner explaining cognitive behavioral therapy and the effects of breathlessness, triggers, physiological factors, and behavioral responses on patients. Patients were taught pursed lip breathing, how to use a battery-operated fan, postural techniques, relaxation exercises, diaphragmatic breathing, and meditation. Participants were provided MP3 players with a recording of the guided breathing exercises to practice at home. The second intervention session consisted of reviewing and reinforcing the above instruction, answering questions, and identifying problems or obstacles.

• N = 32   
• AGE = 63.34 years
• MALES: 43.7%, FEMALES: 56.3%
• CURRENT TREATMENT: Other
• KEY DISEASE CHARACTERISTICS: Advanced lung cancer
• OTHER KEY SAMPLE CHARACTERISTICS: Eastern Cooperative Oncology Group (ECOG) performance status of 0–2, ongoing outpatient oncology treatment, English language literacy, and Modified Medical Research Council Dyspnea Scale (MMRCDS) score of less than or equal to 2 

• SITE: Single site   
• SETTING TYPE: Outpatient    
• LOCATION: Scheduled visits in an outpatient infusion suit and a follow-up appointment or telephone call

• PHASE OF CARE: Multiple phases of care
• APPLICATIONS: Palliative care 

• Pre/post design

Participants completed three measurements: the MMRCDS, the Functional Assessment of Cancer Therapy–Lung Trial Outcome Index (FACT-L TOI), and the Hospital Anxiety and Depression Scale (HADS) at baseline and again postassessment (six weeks after enrollment). Also used was the enrollment rate/study completion rate to examine feasibility.

Fifty-seven patients were referred to the study with 32 patients enrolled. Four patients could not complete it and one withdrew, leaving 27 participants completing all study procedures (84%). First intervention sessions were provided in the infusion suite, and half of the second sessions were provided in the infusion suite and half over the phone. Participants reported reduction in dyspnea (MMRCDS) over time and improvement in quality of life (QOL) (FACT–L TOI) and depression (HADS), but no significant differences in anxiety. Results were unchanged for all outcomes when adjusting for primary and secondary analyses for the line of chemotherapy.

This study demonstrates the feasibility and possible benefit of providing brief behavioral interventions to patients with advanced lung cancer to decrease breathlessness, improve QOL, and decrease depression. The study showed that a potential barrier may be the availability of resources and time for staff in cancer centers to provide education and training to patients. With a small sample size and pre/post design, larger randomized controlled studies are needed to determine intervention effectiveness.

• Small sample (< 100)
• Risk of bias (no control group)
• Risk of bias (sample characteristics)
• Unintended interventions or applicable interventions not described that would influence results
• Findings not generalizable
• Patients may have simultaneously responded to chemotherapy resulting in decreased breathlessness.
• Recruitment limited to clinician referral
• Homogenous sample limited the generalizability of results.
• The racial makeup was 93% Caucasian, and 63% were college graduates.
• Participants consisted of only patients with lung cancer.

Dyspnea, which impairs QOL, is a common symptom in patients with advanced lung cancer. Oncology nurses are in unique position to assess dyspnea and how it relates to patient distress and overall QOL. Nurses trained in strategies and interventions to decrease dyspnea are also in a unique position to provide this education to their patients.

To examine the use of cognitive-behavioral therapy (CBT) as an intervention to reduce anxiety in patients diagnosed with terminal cancer

CBT was adapted by the development of training modules targeting skills for relaxation, coping, and activity pacing. Eligibility included patients who were 18 years or older with an incurable solid tumor, four weeks post-diagnosis, and found to have anxiety as evidenced by a Hamilton Anxiety Rating Scale (HAM-A) score of 14 or higher. They were screened via telephone and met with a licensed clinical psychologist or postdoctoral psychology fellow for a baseline assessment and self-report questionnaires. If criteria was met, they were randomized to either individualized CBT or a wait-list control group. The intervention group met with a therapist for six to seven (optional) weekly sessions of CBT tailored to patient concerns. A post-treatment or eight-week assessment with a blinded independent evaluator was used, and the nonintervention patients were then able to cross over to receive CBT if desired.

• The study reported on a sample of 40 patients.
• Mean patient age was 55.90 years, with a range of 31–81 years.
• The sample was 70% female and 30% male.
• Patients were diagnosed with lung (30%), pancreatic (17%), colorectal (15%), other (38%) cancers.
• Patients had solid tumors only and were mostly white (95%).
• Demographic characteristics did not differ between the two groups.

• Single site
• Outpatient setting
• Massachusetts General Hospital Cancer Center

• Patients were undergoing active antitumor treatment.
• The study has clinical applicability for elder care and palliative care.

A pilot feasibility and randomized controlled trial design was used.

• For the clinician-administered assessment, the primary outcome measure was total score on the HAM-A
• Montgomery-Asberg Depression Rating Scale (MADRS)
• Hospital Anxiety and Depression Scale (HADS)
• Impact of Event Scale (IES)
• Functional Assessment of Cancer Therapy–General (FACT-G)

Forty patients with terminal cancers were randomized to receive CBT (n = 20) or to a wait-list control group (n = 20), with 70% completing the post-treatment assessments. In the treatment group, 80% completed at least five of the six required sessions. Analysis revealed that those receiving CBT had greater improvements in HAM-A scores compared to the control group, with an adjusted mean difference of -5.41 (95% confidence interval: -10.78 to -0.04) and a large effect size for intervention (Cohen’s d = 0.80).

It was found that the majority of patients in the intervention sample were able to complete the requirements of the trial, and beneficial effects were observed in reducing anxiety and improving quality of life over time, but no significant differences in depression between the two groups.

• The study had a small sample size, with less than 100 participants.
• Study findings are not generalizable.
• The intervention was expensive, impractical, or had training needs.
• The use of routine screening procedures would be beneficial.
• The sample lacked racial and ethnic diversity, limiting generalizability to minority patients.

Patients who are newly diagnosed with incurable cancer can be at high risk for anxiety. The early identification of these patients and assisting them in accessing care using CBT can lead to significant improvements in anxiety and quality of care.

PURPOSE: To provide evidence-based and consensus recommendations for the management of cancer-related pain to guide practice by assessing existing guidelines to develop standards of care

TYPES OF PATIENTS ADDRESSED: All patients with cancer including pediatric cases, the elderly, the cognitively impaired, and culturally diverse patients. Both non-cancer and cancer-related pain guidelines were considered.

APPLICATIONS: Elder care, end of life care, pediatrics

The reference provides AGREE scores for 11 aspects of pain management across eight published guidelines as well as detailed recommendations for each of these aspects of pain management.

• Patient self-report is the most reliable indicator of pain.
• Valid assessment tools need to be used and need to be age and population appropriate.

• Establish a written plan for pain management. Patients, family members, and caregivers should receive a written pain management plan. 
• The plan should be updated upon reassessment. Adherence to the plan and other factors should be reassessed at regular intervals and with each new report of pain.

• A key principle is to titrate analgesic dosage to achieve desired pain relief and minimize unwanted side effects.  
• Specific guidelines for opioid use, management of breakthrough pain, principles for dose titration, and use of long acting opioids when dosages are stable are provided. It is recommended that the same opioid for breakthrough pain is used for round-the-clock dosing, and opioid rotation should be considered.

• Side effects should be anticipated, and prophylactic treatment should be instituted.

• These agents are important adjuncts for pain control. Anticonvulsants and antidepressants provide analgesia for specific types of pain. These should be used with extra caution in the elderly.

To assess existing guidelines, related and unrelated to cancer, as a means of developing evidence-based, consensual recommendations regarding the management of cancer-related pain in adults and children with cancer

• Investigators retrieved 25 guidelines for review. Two or three panel members, working independently, scored each set of guidelines by using the Appraisal of Guidelines for Research and Evaluation (AGREE) Instrument to assess quality. Panel members evaluated the domains included in each set of guidelines, including target audience of healthcare providers, environment for which the guideline was written, and the population for whom it was written. Based on quality and domains, eight guidelines were selected as sources from which to extract information to use to develop recommendations.
• The database searched was MEDLINE, using the OVID system, 2000–May 2006. In addition, investigators searched the Internet to retrieve unpublished guidelines from Canadian and non-Canadian health organizations. The National Guidelines Clearinghouse, Guideline International Network, and the McMillan Group were included.
• Search keywords were pain, pain management, neoplasm, pediatric, aged, guideline, and practice guideline.

The reference provides AGREE scores for 11 aspects of pain management across the eight published guidelines as well as detailed recommendations for each of the aspects of pain management.

The authors reviewed these guidelines:

• Scottish Intercollegiate Guidelines Network (SIGN): Control of Pain in Patients With Cancer
• The American Geriatrics Society (AGS): The Management of Persistent Pain in Older Persons
• Registered Nurse Association of Ontario (RNAO): Assessment and Management of Pain
• National Breast Cancer Center and National Cancer Control Initiative (NBCC-NCCI), Australia: Clinical Practice Guidelines for the Psychosocial Care of Adults With Cancer
• Canadian Association of Nursing Oncology (CANO): Cancer Pain Management Manual
• American Pain Society (APS): Guideline for the Management of Cancer Pain in Adults and Children
• Canadian Pain Society (CPS): Accreditation Pain Standard: Making It Happen
• Cancer Care Nova Scotia (CCNS): Best Practice Guidelines for the Management of Cancer-Related Pain in Adults

The analysis led to the statements and recommendations that follow.

• Assessment of pain:
  • Patient self-reporting is the most reliable indicator of pain.
  • Assessment should include physical, functional, spiritual, and social domains of pain.
  • Assessment tools must be valid and appropriate to the age of the patient and the patient's population.
• Plan of care:
  • Establish a written plan of pain management. The plan should be interdisciplinary and consistent with individual and family goals. The guidelines list factors to be considered in the plan.
  • Patients, family members, and caregivers should receive a copy of the written pain management plan. The plan should include causes of pain; types and reasons for analgesic medications; instructions regarding dosage and titration; the side effects of analgesics; the name of the person to call if pain is not relieved or side effects occur; instructions about when and how to use nonpharmacologic approaches; instructions about filling and renewing prescriptions; and realistic goals, timelines, and expectations about pain control.
  • The plan should be updated upon reassessment.
  • Adherence to the plan and other factors should be reassessed at regular intervals and with each new report of pain.
• Pharmacologic Interventions
  • A key principle is to titrate analgesic dosage to achieve desired pain relief and minimize unwanted side effects. Selecting analgesics should involve consideration of pain intensity, patient age, comorbidities, concurrent drugs, prior treatment outcomes, patient preferences and convenience, and cost. The guidelines outline specific considerations relating to each of these areas.
  • Use the simplest analgesic dosage schedules and least-invasive modalities; however, using other than the oral route may be appropriate to provide immediate relief. The route should be tailored to the pain situation and the care setting.
  • The intramuscular route is not recommended.
  • The guidelines provide specific recommendations about opiod use, management of breakthrough pain, principles regarding dose titration, and use of long-acting opiods when dosages are stable. The guidelines recommend
    • Using the same opiod  for round-the-clock dosing and breakthrough pain.
    • Considering opiod rotation.
• Safety and efficacy:
  • To prevent barriers to pain relief, providers should know the difference between addiction, tolerance and dependency. The guidelines define each condition.
  • Respiratory impairment should not be a reason to avoid opiod use, but patients with respiratory impairment who are using opiods should be closely monitored.
  • Establish a protocol for the use of naloxone to manage opiod-induced respiratory depression.
• Side effects: Clinicians should anticipate side effects and institute prophylactic treatment to avoid them.
• Coanalgesic agents: These agents are important adjuncts for pain control. Anticonvulsants and antidepressants provide analgesia for specific types of pain. These should be used with extra caution when prescribed for the elderly.
• Nonpharmacologic interventions: Combine nonpharmacologic interventions with pharmacologic methods according to individual preferences and goals, including such things as psychosocial and spiritual support services.
• Specialty care: Provide access to specialists in cases involving complex pain problems, such as palliative radiation, pulse chemotherapy, spinal infusion, etc.
• Documentation: Documentation should comprise all components of the assessment, including the plan of care, information about interventions and patient responses, and a summary of all education provided to the patient and family. Documentation should be updated as often as pain is assessed or changes occur.
• Education: Education should be provided to patients, family members, and informal care providers, to clarify myths and misconceptions about tolerance and addiction and to promote involvement in effective pain management.
• Outcome measures: Use outcome measures as part of a formal process to evaluate and improve the quality of pain management across all disease stages and across all settings.

Authors did not identify any conflicts of interest.

This reference, a set of standards of practice, provides extensive and detailed guidance regarding all aspects of pain management. The standards can be a very useful reference through the entire process of pain management for patients with cancer.

Refer to the original document: This summary does not contain the full detail that the guidelines provide. The guidelines discuss opioid dosage determination in detail and recommend nonpharmacologic methods; however, the guidelines do not make specific recommendations about modality.

4,900 references were identified that were published between January 1, 1990 and December 31, 2013. 203 articles were included in the final review although only 174 were referenced. Grades used and reported here were A: recommended, high certainty of benefit, B: recommended, high certainty of moderate to substantial benefit, D: recommends against use, moderate to high certainty of no net benefit, and H: recommends against use, moderate to high certainty that harms outweigh benefits.

Interventions for specific symptoms that had strong recommendations for or against use were:

• Anxiety: Music therapy during RT and chemotherapy sessions, meditation, and yoga for patients undergoing therapy (B-level recommendation)
• Depression: Mindfulness-based stress reduction for patients undergoing radiotherapy, relaxation, and yoga (level A recommendation); massage and music therapy (level B)
• Fatigue: Energy conservation (level B)
• CINV: Acupressure and electroacupuncture in addition to antiemetics (B level)
• Neuropathy: Acetyl L carnitine was not recommended because of harm (H level).
• Radiodermatitis: Aloe vera and hyaluronic acid cream were not recommended as standard therapy because of lack of effect (D level).

It appears that only specific types of interventions were included, and there are numerous types of integrative or complementary interventions that were not considered in this review. The findings considered were limited to women with breast cancer. Quality rating of evidence was not discussed individually.

These guidelines provided an evidence-based evaluation of various integrative therapies in women with breast cancer. This set of interventions is not all-inclusive; however, it does provide some guidance to clinicians and others regarding evidence strength in these areas as assessed by this specific study group.

To investigate electroacupuncture to prevent or reduce chemotherapy-induced peripheral neuropathy (PN) associated with taxanes

Women with breast cancer scheduled to receive 12 weeks of adjuvant or neoadjuvant paclitaxel were recruited. Patients were randomized to receive either 12 weekly electroacupuncture or sham electroacupuncture treatment. These were done within two days of the weekly chemotherapy administration. A standard acupuncture protocol was used. The sham procedure did not include any true acupuncture points, and no electric current was transmitted. Study assessments were conducted at weeks 6, 12, and 16.

• N = 48   
• MEAN AGE = 50.1 years
• AGE RANGE = 27–79
• FEMALES: 100%
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: All had breast cancer and were receiving chemotherapy with taxane; most had paclitaxel only.

• SITE: Single site   
• SETTING TYPE: Outpatient    
• LOCATION: New York

PHASE OF CARE: Active antitumor treatment

Single-blind, sham-controlled, randomized, controlled trial

• Brief Pain Inventory (BPI)
• Functional Assessment of Cancer Therapy (FACT) neurotoxicity (NTX) and taxane (TAX) questionnaires
• Grooved pegboard test
• Biothesiometer testing

In the sham group, 45% completed all sessions, and 59% completed the electroacupuncture sessions. The number of sessions attended ranged from 1–12. There were no differences in pain scores at weeks 6 and 12. At week 16, the worst pain in the sham group returned to baseline but increased in the acupuncture group (p = 0.03). There were no differences between groups in biothesiometer or pegboard test results. At week 16, those receiving actual acupuncture reported higher pain on the FACT questionnaires.

Women who received electroacupuncture reported greater increases in pain over time compared to controls. There were no other differences in neuropathy findings between groups.

• Small sample (< 100)
• Subject withdrawals ≥ 10%
• High variability in adherence to sham and actual treatment sessions

The findings of this study did not support the use of electroacupuncture to prevent or mitigate symptoms of PN in women receiving paclitaxel chemotherapy.

The purpose of the study was to evaluate the efficacy of a single fixed 6 mg dose of pegfilgrastim compared with daily filgrastim.

Patients were randomly assigned to receive either a single fixed dose injection of 6 mg pegfilgrastim on day 2 of their treatment cycle or daily injections of filgrastim 5 mcg/kg per day, begun about 24 hours after chemotherapy until documented absolute neutrophil count (ANC) of 10 x 10⁹/L or greater. Chemotherapy dose reductions were permitted if patients had grade 3-4 non-hemopoetic toxicities.

• 152 total participants were evaluated.
• Mean age of the participants was 52.4 years, with a range of 30–75 years.
• All of the participants were women.
• The disease type was not stated. All were receiving doxorubicin and docetaxel chemotherapy every three weeks.
• Patients were excluded if they received systemic anti-infective treatment within 72 hours of chemotherapy.

• Multi-site
• Outpatient 
• 37 centers in Europe, Australia, and the United States

Active antitumor treatment

Double-blind randomized phase III

• Weekly blood samples for ANC determination
• Grade 4 neutropenia defined as ANC less than 0.5 x 10⁹/L
• Neutrophil recovery defined as ANC of 2.0 x 10⁹/L or greater

In cycle 1, mean duration of neutropenia was 1.8 days with pegfilgrastim and 1.6 days in the filgrastim group—no significant difference.  There were no differences between groups for duration of grade 4 neutropenia during other treatment cycles. The safety profile of pegfilgrastim was similar to that for filgrastim.

A single fixed dose of pegfilgrastim per chemotherapy cycle is as safe and effective as daily filgrastim injections.

No significant study limitations were identified.

This study demonstrated that a single fixed dose of pegfilgrastim was as safe and effective as daily filgrastim in these patients. The ability to provide the same effectiveness with fewer injections can be beneficial to patients.