PURPOSE: To provide evidence-based guidance on the use of platelet transfusion in patients with cancer.

TYPES OF PATIENTS ADDRESSED: Adults and children (> 4 months of age)

RESOURCE TYPE: Evidence-based guideline

PROCESS OF DEVELOPMENT: Expert panel conducted an SR from 2014-2016. The current guideline builds on previous ASCO guidelines first published in 2001. For new questions not addressed by previous guidelines, the search went back to 2000.

DATABASES USED: PubMed and Cochrane     
    

INCLUSION CRITERIA: Adults and children (> 4 months) with cancer, prophylactic or therapeutic platelet transfusion; outcomes were bleeding, alloimmunization, and platelet refractoriness. Publication types were CPG, SR, MA, RCT, and observational studies.
  

 EXCLUSION CRITERIA: Meeting abstracts not published in peer-reviewed journals, editorials, etc. Non-English publications

PHASE OF CARE: Multiple phases of care

APPLICATIONS: Pediatrics, elder care, palliative care

24 total publications were new to this guideline: 3 CPG, 8 SRs, and 13 observational studies.

The most significant change involved platelet transfusion in HSCT. Adult patients who undergo autologous stem cell transplantation at experienced centers may receive a transfusion at the first sign of bleeding. Prophylactic platelet transfusion at defined thresholds is still recommended for pediatric patients undergoing autologous SCT and for adults and pediatric patients undergoing allogeneic SCT.

Relatively few studies are available on prophylactic platelet transfusions in solid tumors, and information is lacking about the safety of invasive procedures in patients with thrombocytopenia.

This is an updated guideline for adult and pediatric patients who require platelet transfusions.

STUDY PURPOSE: The primary aim was to evaluate the safety of lysine analogs administered to patients with cancer, with respect to the development of thromboembolic events. The secondary outcome was the efficacy of lysine analogs administered to patients with cancer, with respect to transfusion risk and blood loss.

TYPE OF STUDY: Meta-analysis and systematic review

DATABASES USED: MEDLINE, Embase, Cochrane Library

YEARS INCLUDED: Inception to June 2016

INCLUSION CRITERIA: Randomized controlled trials comparing administration of a lysine analog to either placebo or active control, or standard of care in surgical and nonsurgical patients with cancer. 

EXCLUSION CRITERIA: No specific exclusion criteria

TOTAL REFERENCES RETRIEVED: N = 5,627 records were retrieved.

EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Studies were selected for review based on PRISMA guidelines. A standardized data review extraction form was piloted by the two reviewers; the Cochrane Risk of Bias Tool was utilized to assess the risk of bias.

• FINAL NUMBER STUDIES INCLUDED: N = 11 
• TOTAL PATIENTS INCLUDED IN REVIEW: 1,177
• SAMPLE RANGE ACROSS STUDIES: 12-219
• KEY SAMPLE CHARACTERISTICS: surgical and nonsurgical patients with cancer were included; TXA was administered in nine trials, EACA in one, and both lysine analogs in one study.

PHASE OF CARE: Multiple phases of care     

APPLICATIONS: Elder care, palliative care

There was a significant reduction in blood loss noted in 9 of 11 studies in which a lysine analog was administered. Data from two studies were not included in the meta-analysis because of statistical heterogeneity between trials. In the seven studies reporting transfusion data, there was a significant decrease in the risk of receiving a blood transfusion in patients who had received a lysine analog.

The administration of a lysine analog was correlated with a significant reduction in blood loss and the risk of receiving a blood transfusion in patients with cancer.

• Limited number of studies included
• Mostly low-quality and/or high risk of bias studies   
• High heterogeneity   
• Low sample sizes
• Efficacy of lysine analogs administered to patients with cancer, with respect to transfusion risk and blood loss, was a secondary outcome. It is not clear from this review what search items were used: were only studies evaluated which included information regarding efficacy and VTE? If so, that would omit studies which only evaluated efficacy.

The administration of lysine analogs in patients with cancer has been shown to be efficacious in the reduction of blood loss and in reducing the risk of receiving a blood transfusion. Nurses, however, need to be aware of the potential inherent risks of VTE-associated administration of these agents. This has not been adequately studied, to date.

To test FOCUS, which is an evidence-based psychoeducational intervention, in terms of its feasibility, cost, and program satisfaction and assess its impact on patients' and caregivers' emotional distress and QOL as primary outcomes and benefits of illness, self-efficacy, and dyadic communication as secondary outcomes in two community service centers.

FOCUS is a psychoeducational intervention that is delivered to dyads of patients and their caregivers and addresses the following components: family involvement, optimistic attitude, coping effectiveness, uncertainty reduction, and symptom management. The components cover 104 activities relevant to the components in five sessions. The FOCUS program was administered by a trained social worker in one site and a family therapist in the second site. FOCUS was administered in a group format (3 to 4 dyads) and involved five weekly face-to-face sessions; each was two hours. 11 five-session programs were given over 12 months. The program implementation was guided by the Translating Research into Practice model; a one-day training program was held for the site directors and facilitators and they were given training manuals that were developed based on their role. Pre-packaged material to implement the five-week sessions were provided, weekly calls between program facilitators took place, and monthly meetings occurred between investigators.

• N = 36 dyads, 36 caregivers
• AGE: 55.9 years (SD = 15.1)
• MALES: 44.4%  
• FEMALES: 55.6%
• KEY DISEASE CHARACTERISTICS: Any cancer type, including advanced cancer, currently on treatment, or completed treatment in the past 18 months
• OTHER KEY SAMPLE CHARACTERISTICS: English-speaking only; married/partnered, largely Caucasian, with college degrees, and employed with moderate incomes, mostly caring for patients with stage II or IV cancer in current treatment

• SITE: Multi-site   
• SETTING TYPE: Other; local cancer support community. The CSC is a large network of community agencies in the United States that provide professional psychosocial care in a group format at no cost to patients with cancer and their caregivers.
• LOCATION: Cincinnati, Ohio and Santa Monica, California

PHASE OF CARE: Multiple phases of care

Pre-/postintervention design. Outcomes were assessed prior to the first intervention session and after the last session at week 5 postintervention. Translating research into practice model was used to implement the intervention in the two sites.

Primary outcomes:

• Cancer Support Distress Scale (CSSD) to assess emotional distress
• Functional Assessment of Cancer Treatment-General (FACT-G) to assess QOL

Secondary outcomes:

• Benefits of illness Scale to assess caregivers’ perceived benefits
• Lewis’ Cancer Self-efficacy Scale (CASE) to assess confidence to manage cancer
• Lewis’ Mutuality and Interpersonal Sensitivity Scale (MIS) to assess communication about cancer between patient and caregiver

Feasibility, satisfaction with program, and cost were also assessed. Feasibility was assessed by enrollment, retention, and intervention fidelity rates. Satisfaction was assessed by the FOCUS satisfaction instrument. Cost was assessed by multiplying hourly time estimates and median hourly wages for healthcare social workers in California and Ohio based on the U.S. Bureau of Labor statistics.

• Primary outcomes: FOCUS had significant positive effects on dyad (both caregiver and patient) QOL (p = 0.014), emotional well-being (p = 0.12), functional well-being (p = 0.049), and emotional distress (p = 0.002), but not on physical and social well-being. 
• Secondary outcomes: FOCUS has significant effect on benefits of illness (p = 0.13) and self-efficacy (p = 0.001), but not on dyadic communication. 
• Feasibility: FOCUS intervention program was feasible (enrollment rate 71.4% and retention rate 90%, intervention fidelity 85%).
• Satisfaction: High satisfaction among caregivers about helpfulness of intervention, length of sessions, and number of sessions. 
• Cost: Average cost estimates for oversight and delivery of one five-session FOCUS program with four dyads was $669.45 ($722.17 in California and $577.42 in Ohio).

In CSC, FOCUS intervention five-session, social-worker driven program is effective in improving caregivers’ (and patients’) outcomes. FOCUS appears to be feasible and acceptable with reasonable costs.

• Small sample (< 100)
• Risk of bias (no control group). 
• Risk of bias (sample characteristics)
• Intervention expensive, impractical, or training needs
• Other limitations/explanation: Administered by trained social worker/family therapist, not a nurse; nurses could be trained. Results reported as “a dyad,” not CG-specific. Authors justified no control group because three prior RCTs demonstrated efficacy of FOCUS and all showed significant positive impact.

FOCUS is an effective psychoeducational intervention that can be administered by someone trained on the intervention and can be administered successfully in CSC.