Kahl, C., Sayer, H. G., Hinke, A., Freund, M., & Casper, J. (2012). Early versus late administration of pegfilgrastim after high-dose chemotherapy and autologous hematopoietic stem cell transplantation. Journal of Cancer Research and Clinical Oncology, 138, 513–517.
To evaluate the optimal application time for pegfilgrastim in autologous hematopoietic stem cell transplant (AHSCT) recipients.
Within two institutions, patients were assigned to either receive pefilgrastim 6 mg subcutaneously on day 1 (Peg1) or pegfilgrastim 6 mg subcutaneously on day 4 (Peg4). Primary study endpoint was time between transplant and neutrophil recovery to greater than 500/µl. A difference of less than 1 day was not considered clinically significant.
Patients were undergoing the active antitumor treatment phase of care.
This was an open-label, phase II study.
Both groups had a median of 10 days to neutrophil engraftment >500 µl and granulocyte engraftment greater than 1,000 µl, with no difference between groups. There were no differences between groups in time to platelet engraftment, incidence of febrile neutropenia, incidence or duration of IV antibiotics, or transfusion requirements.
Early administration of pegfilgrastim demonstrated no benefit versus administration on day 4 after AHSCT. No clear recommendation can be made with respect to an optimal time for pegfilgrastim use.
The study findings suggest that early and late administration of pegfilgrastim are equally effective in terms of time to neutrophil, granulocyte, and platelet recovery after AHSCT, need for IV antibiotics, transfusion, and incidence of febrile neutropenia.
Kahler, K.C., Hassel, J.C., Heinzerling, L., Loquai, C., Mossner, R., Ugurel, S., . . . \"Cutaneous Side Effects\" Committee of the Work Group Dermatological Oncology (ADO). (2016). Management of side effects of immune checkpoint blockade by anti-CTLA-4 and anti-PD-1 antibodies in metastatic melanoma. Journal of the German Society of Dermatology, 14, 662–681.
RESOURCE TYPE: Expert opinion
PROCESS OF DEVELOPMENT: Clinical review
This article provides an overview of the mechanisms of action of immune checkpoint blockade and clinical effects in metastatic melanoma. The focus is the adverse effect profile and therapeutic management. The side effect profile includes a review of a meta-analysis of 1,265 patients from 22 clinical trials who received ipilimumab. Eighty-two to ninety-five percent of patients experienced treatment-related side effects. Incidence tables are provided as well as a checklist for important questions during patient visits, blood test recommendations, and organ-specific side effects. Diarrhea and colitis are described with a table of trade, treatment, and follow-up. Other organ-specific side effects are also reviewed. Recommendations for management algorithms are discussed.
Comprehensive clinical studies have shown a major benefit of anti-CTLA-4 antibody ipilimumab and two anti-PD-1 antibodies nivolumab and pembrolizumab in various tumors, including melanoma. These agents enhance an autoimmune phenomenon that affects various organs. Persistent diarrhea and colitis are evidenced early in treatment and can be serious adverse effects. The clinical significance is the debilitating effect they have on patients, with electrolyte disturbances and protracted weight loss. Intestinal perforation is a serious risk. Grade 1–2 diarrhea is treated with loperamide and electrolyte replacement. An endoscopy should be considered with persistent low-grade diarrhea because it diagnoses the true extent of the colitis. For grade 3–4 diarrhea/colitis, immunotherapy should be discontinued and high-dose corticosteroids initiated. Symptoms improve markedly with this regimen. Treatment with infliximab (5 mg/kg) is used in rare cases in which steroids do not induce a response. Colitis is associated with ocular inflammation, and observing for this side effect is imperative. Comprehensive study data identify that the timely and consistent use of corticosteroids allows for control and regression of symptoms in the majority of cases.
This is an overview of a complex multidisciplinary side-effect management concern with new checkpoint inhibitors. Further study would be necessary for a nurse to acquire in-depth knowledge for patient care.
Immuno-oncology is becoming a mainstay of pharmacological cancer treatment. Knowledge of side effects of these checkpoint inhibitors, especially diarrhea and colitis, is essential to their prevention, treatment, and management. Early recognition and intervention can reduce sequelae for patients.
Kahler, K.C., & Hauschild, A. (2011). Treatment and side effect management of CTLA-4 antibody therapy in metastatic melanoma. Journal of the German Society of Dermatology, 9, 277–286.
RESOURCE TYPE: Expert opinion
PHASE OF CARE: Active antitumor treatment
N/A
Expert opinion level information
Currently, limited research evidence regarding interventions for the prevention and management of various side effects associated with immunotherapies exists. Corticosteroids are suggested to treat most side effects.
Kachare, S.D., Sanders, C., Myatt, K., Fitzgerald, T.L., & Zervos, E.E. (2014). Toward eliminating catheter-associated urinary tract infections in an academic health center. The Journal of Surgical Research, 192, 280–285.
To determine if implementing two interventions would cause a reduction in catheter-associated urinary tract infections (CAUTIs) in an inpatient surgical oncology unit (The first intervention was designed to decrease the use of Foley catheters, and the second intervention was designed to initiate early removal while preventing reinsertion of the Foley catheter.)
The first intervention was the development of a hospital-wide guideline outlining the indications for Foley catheter use. There were six defined reasons for the use of a Foley catheter in a patient. If the patient did not meet one of these criteria, then Foley catheter use was not recommended. The second intervention included two measures. The first was aimed at the early removal of the catheter by designing a daily electronic query sent to the attending physician regarding continuing use of the Foley catheter, and the second was direct personal contact with the primary medical team to determine the medical necessity of continued Foley catheter use. They also focused on the prevention of catheter reinsertion by following a developed algorithm for the healthcare team.
This study design was a pre/post design with preintervention data obtained in a retrospective manner followed by the authors obtaining postintervention data.
There was a significant reduction in the use of Foley catheters after the interventions were put in place (P < 0.0001). There also was a significant reduction in CAUTI rates for patients who did require a Foley catheter after interventions were put into place, from 4.6 to 0 (P = 0.03). For patients who required a Foley catheter and had a diagnosed CAUTI during the postintervention time period, none of the Foley catheters were reinserted. The preintervention group had four patients with positive CAUTIs who had a Foley reinserted.
Even though the study was limited to one inpatient surgical oncology unit, the findings support other similar studies of best practice indicating use of Foley catheter insertion criteria as well as algorithm guidelines for care after catheter removal. Because infections can be detrimental in the oncology population, healthcare teams working with these patients should explore the literature surrounding the prevention of CAUTIs and ways of implementing best practices.
Oncology nurses need to be diligent with hand hygiene, not only among themselves but with other members of the healthcare team. They also need to adhere to Foley catheter bundles, including the daily verification of continuing need for the catheter, the use of catheter securement devices, keeping tubing below the level of the bladder, keeping the bag off of the floor, and providing perineal care at least twice per day. If the institution does not have a catheter bundle, nurses need to lead the initiative to implement one. This study demonstrated successful institutional approaches for protocol implementation and ongoing auditing and interventions with care providers.
Julião, M., Oliveira, F., Nunes, B., Vaz Carneiro, A., & Barbosa, A. (2014). Efficacy of dignity therapy on depression and anxiety in Portuguese terminally ill patients: A phase II randomized controlled trial. Journal of Palliative Medicine, 17, 688–695.
To determine the influence of dignity therapy on depression and anxiety in palliative care unit inpatients diagnosed with a terminal illness and experiencing high levels of distress
Dignity therapy (DT) is brief psychotherapy aimed at decreasing the loss of dignity for patients with a life-limiting illness. This nonblinded, phase II, randomized, controlled trial involved a control group receiving standard palliative care (SPC) and an intervention group receiving SPC plus DT. Participants received a baseline assessment of anxiety and depression, an explanation of DT, and a copy of the DT questions at T1 of the study. They were then randomized into two groups. Within two to three days, the intervention group received audio recorded 30–60-minute DT sessions that were transcribed verbatim within the next two to three days and transformed into a written narrative. The DT therapist read the narrative to the patient and received corrections, returning the final narrative to the patient. Follow-up measurements of depression and anxiety in both groups were conducted on days 4 (T2), 15 (T3), and 30 (T4).
This nonblinded, phase II, randomized, controlled trial involved a control group receiving SPC and an intervention group receiving SPC plus DT.
Terminally ill patients experience high levels of depression and anxiety. DT was suggested as a feasible offering to people with increased or severe psychological distress. Participants who received DT experienced depression and anxiety score reductions, suggesting psychological benefits at least to the 30-day measurement period.
DT can be offered to patients with terminal conditions near the end of life (six-month prognosis). DT implementation requires careful training in the practice. Additional randomized, controlled trials testing DT against other psychological interventions in other populations of severely ill or terminally ill patients are needed.
Jo, S.J., Shin, H., Jo, S., Kwon, O., & Myung, S.K. (2015). Prophylactic and therapeutic efficacy of pyridoxine supplements in the management of hand-foot syndrome during chemotherapy: A meta-analysis. Clinical and Experimental Dermatology, 40, 260–270.
PHASE OF CARE: Active treatment
Eight studies (two retrospective, two prospective comparative trials, four RCTs) for preventive efficacy and three studies (one RCT and two non-RCTs) for treatment efficacy. Random-effects meta-analysis did not reveal any significant associations between ppx pyridoxine supplementation and HFS development (RR = 0.95%, 95% CI [0.87, 1.05]) or any significant preventive efficacy against HFS in subgroup meta-analyses of study design, chemotherapeutic agents, pyridoxine dose, HFS severity, publication year, or observation period. However, pyridoxine did show significant efficacy in treating HFS (RR = 1.75, 95% CI [1.09, 2.8]) but did not show efficacy in the only RCT (RR = 1.12, 95% CI [0.58, 2.14]).
No evidence to support the use of pyridoxine supplements to prevent HFS during chemotherapy exists.
Further nursing research on the alternative uses of topical and oral therapies for HFS is warranted given that no evidence of clinical benefit was revealed.
Van Meter, M.E., McKee, K.Y., & Kohlwes, R.J. (2011). Efficacy and safety of tunneled pleural catheters in adults with malignant pleural effusions: A systematic review. Journal of General Internal Medicine, 26(1), 70-76.
The objective of this systematic review was to review published data on the efficacy and safety of tunneled indwelling pleural catheters (TIPCs).
Databases searched were MEDLINE, EMBASE, and ISI Web of Science through 2009. A manual search was conducted of reference lists for relevant additional studies.
Search keywords were malignant pleural effusion (MPE), tunneled indwelling pleural catheter (TIPC), and palliative care.
Studies were included if they reported on
Studies with and without control were included.
Studies were excluded if they reported on non-malignant effusions, empyema, chylothoras, long-bore chest tubes, or non-tunneled catheters. Studies in which all patients underwent thorascopy, video-assisted thorascopic surgery (VATS), or pleurodesis were excluded. Studies were excluded if they weren't published in English. Studies without primary data also were excluded.
This systematic review pertains to the dyspnea Putting Evidence Into Practice topic in that one outcome of the review evaluated “symptomatic improvement” with emphasis, although not exclusive focus, on dyspnea.
Symptom relief was variably defined in the studies. Three studies reported symptom improvement without further delineation. One study rated dyspnea improvement on a three-point scale. The remaining studies reported symptomatic relief as “relief of dyspnea” or “improvement in respiratory performance,” “increased exercise tolerance,” “ improvement of pain,” and “catheter was useful.” When combined, 628 of the 657 patients (95.6%) experienced some degree of improvement in their symptoms, although the magnitude of improvement cannot be determined. Serious complications were rare. The most common complications were cellulitis (32 of 935, 3.4%) and obstruction or clogging (33 of 895, 3.7%) or unspecified malfunction of the catheter (11 of 121, 9.1%). The quality of the studies was low, as evaluated by the GRADES system.
Authors suggest that TIPC may improve symptoms for patients with MPE.
Based on the low-quality evidence in the form of the case studies, evidence is insufficient to demonstrate the effectiveness of TIPCs.
More rigorous studies need to be conducted to establish evidence with respect to dyspnea.
Joyce, J., & Herbison, G.P. (2015). Reiki for depression and anxiety. Cochrane Database of Systematic Reviews, 4, CD006833.
Studies reviewed did not ensure that patients studied had depression or anxiety, so validity of examining impact of Reiki intervention on these problems is questionable. Two of the three studies had high risk of bias. No studies showed a statistically significant benefit.
There is insufficient evidence to evaluate efficacy of Reiki for anxiety and depression.
The evidence regarding effects of Reiki for anxiety or depression is insufficient to draw any conclusions. If Reiki is to be seen as a serious option for treatment, well-designed research to investigate effects is needed.
Jørgensen, K.J., Gøtzsche, P.C., Dalbøge, C.S., & Johansen, H.K. (2014). Voriconazole versus amphotericin B or fluconazole in cancer patients with neutropenia. Cochrane Database of Systematic Reviews, 2014(2).
PHASE OF CARE: Active antitumor treatment
A trial comparing voriconazole to liposomal amphotericin B as an empirical treatment for suspected fungal infection in neutropenic patients with cancer in which 6.8% of the patients died showed a significant benefit of using liposomal amphotericin B over voriconazole. No benefits were found between antifungal agents in the other two trials evaluated.
For the empirical treatment of patients with cancer who are immunosuppressed, liposomal amphotericin B is significantly more effective than voriconazole. Voriconazole and fluconazole did not have different outcomes in patients undergoing allogeneic HCT who were given either of these antifungal agents prophylactically. Treatment of aspergillosis comparing voriconazole with amphotericin B was not investigated.
Overall, there were so few trials comparing these antifungal agents (though large sample sizes) that except for one finding, results were inconclusive. These trials also could not be pooled for analysis due to their heterogeneity in study design.
For treatment of suspected fungal infections (neutropenic fever without overt fungal infection), liposomal amphotericin B is recommended. Careful evaluation for side effects of visual disturbances, dyspnea, and hypokalemia is critical.
Jordan, K., Roila, F., Molassiotis, A., Maranzano, E., Clark-Snow, R. A., Feyer, P., & MASCC/ESMO. (2011). Antiemetics in children receiving chemotherapy. MASCC/ESMO guideline update 2009. Supportive Care in Cancer, 19(Suppl 1), 37-42.
To provide a consensus statement derived from published articles as well as expert opinion about antiemetic therapy in children younger than 18 years
This resource is a guideline, developed by the Multinational Association of Supportive Care in Cancer (MASCC) and European Society of Medical Oncology (ESMO).
A panel of 23 oncology professionals determined the level of evidence and confidence according to EMSO and MASCC criteria. Between 2004 and June 2009, eight articles were published regarding 5-HT3 receptor antagonists (RAs) in pediatric populations (two regarding safety issues, four dose-finding or -optimizing studies, and two comparative studies), four articles reported on the NK1 RA aprepitant (one randomized study, two case reports, and one study on the liquid formulation of aprepitant), and two miscellaneous studies looked at the impact of an antiemetic pump and the value of metopimazine when added to ondansetron. Recommendations were classified using the MASCC level of scientific confidence and consensus.
Pertinent information from the published literature from 2004 to June 2009 was retrieved and reviewed for the creation of this guideline.
Database searched was Medline.
Search keywords were antiemetics, chemotherapy-induced emesis, children, neoplasms, nausea, vomiting, serotonin antagonists, neurokinin 1 receptor antagonists, phenothiazines, butyrophenones, cannabinoids, corticosteroids, and metoclopramide.
No inclusion criteria were identified.
Articles were excluded if they were review articles or addressed emesis not caused by chemotherapy.
Children receiving chemotherapy should receive a 5-HT3 RA and dexamethasone for antiemetic prophylaxis both in highly emetogenic and moderately emetogenic chemotherapy. A significant lack of well-designed randomized studies exist to evaluate the problem of chemotherapy-induced emesis in children. Optimal dosing in children and management of delayed and anticipatory CINV in children is not yet clear. Investigation is needed regarding the potential role of NK1 RAs and the 5-HT3 RAs palonosetron and transdermal granisetron for future consideration in pediatrics.