Eleutherakis-Papaiakovou, E., Kostis, E., Migkou, M., Christoulas, D., Terpos, E., Gavriatopoulou, M., . . . Papadimitriou, C.A. (2010). Prophylactic antibiotics for the prevention of neutropenic fever in patients undergoing autologous stem-cell transplantation: results of a single institution, randomized phase 2 trial. American Journal of Hematology, 85, 863–867.
To demonstrate the use of prophylactic antibiotics to prevent fever in autologous stem cell transplantation recipients.
Researchers used antibiotics prophylactically (ciprofloxacin and vancomycin) to prevent ElE infections during the neutropenic stage of transplantation. Patients were randomly assigned to receive 500 mg of ciprofloxacin orally twice a day and 1000 mg of vancomycin intravenously (IV) daily or no prophylactic antibiotic use. Antibiotics were given on day 0 and continued until neutropenia resolution or the occurrence of a febrile event. Antibiotics were given to any patient who experienced a febrile event. All patients received lenogastrim three days after cyclophosphamide and until harvesting and also from posttransplant day 1 until the white blood cell (WBC) count was >10x103 µg/dL.
This was a randomized, controlled study.
Between cell reinfusion and bone marrow reconstitution, 71.3% of patients receiving prophylactic antibiotics developed neutropenic fever, compared with 91.2% of those receiving only supportive care (p < 0.001). Patients receiving the combination of ciprofloxacin and IV vancomycin had a significantly lower rate of bacteremias (5.6%) than those with no prophylaxis (35%) (p = 0.005). The cumulative hazard ratio (HR) of fever for randomized patients demonstrated a statistical benefit in favor of prophylactic antibiotics (HR = 2.43; 95% confidence interval [1.60, 3.49]; p < 0.001). There were no infection-related deaths in the sample. There were no differences between groups in duration of hospitalization. Median duration of treatment was six days. Patients were followed for one month in the study. Five patients developed severe skin rash attributed to antibiotics and discontinued treatment. There were no clear differences between groups in adverse effects, and no other effects were severe enough to warrant discontinuation of antibiotics.
This article showed that the prophylactic antibiotics oral ciprofloxacin and IV vancomycin help to prevent neutropenic fever after transplant but that their usage is not helpful in either decreasing the overall length of stay in the hospital or decreasing the risk of complication-related deaths.
Findings support the use of prophylactic antibiotic therapy for reducing the prevalence of febrile neutropenia in this group of patients.
Elad, S., Luboshitz-Shon, N., Cohen, T., Wainchwaig, E., Shapira, M. Y., Resnick, I. B., et al. (2011). A randomized controlled trial of visible-light therapy for the prevention of oral mucositis. Oral Oncology, 47(2), 125-130.
To assess the efficacy of a visible-light therapy device for the prevention of OM in HSCT patients.
All patients received preventive protocols that included prophylactic antivirals for those at risk for infection, cyclosporine as GVHD prophylaxis in allogeneic transplant patients, and standard topical antibacterial and antifungal prophylaxis with chlorhexidine, Nystatin, and saline rinses. Subjects were randomized to the study group (N = 10) who received broad band visible light (BBVLT) therapy starting on the first day of conditioning 5 times per week, continuing until at least day 21 if score was 0 on OMAS and WHO Scales. Subjects assigned to the placebo group received sham therapy using a similar device. Otherwise treatment was continued until day 28. Patients were evaluated daily, and oral mucosa was evaluated weekly by the research team.
The study was comprised of 19 patients, age 24.5 - 66 years.
Males (%): 53, Females (%): 47
Key Disease Characteristics: Leukemia, lymphoma, five patients listed as other (2 active Rx, 3 Placebo).
Other Key Sample Characteristics: Adult patients receiving myeloablative and non-myeloablative conditioning regimens with chemo + or - TBI and prophylaxis. Examined prior to treatment to confirm intact mucosal lining. Karnofsky score greater than 60.
Site: Single site
Setting Type: Not specified
Location: Hadassah University Medical Center - Department of Bone Marrow Transplantation
Phase of Care: Active treatment
Randomized, placebo controlled and double blinded
There was a statistically significant difference in both the frequency of patients with no mucositis and the severity of the mucositis based on the WHO and OMAS scales at visit three only (p = 0.02) . Other than that, there were no statistically significant differences in frequency or severity of mucositis between the two groups. There was no significant difference in narcotic consumption between the two groups. Satisfaction was highly rated in both groups.
There were significantly better mucositis scores and lower pain levels in the treatment group at one week post-HSCT. Treatment was well tolerated with no adverse events related to the study device. The conclusion is that the BB-VLT device is safe and effective in the prevention of oral mucositis in HCST patients.
Small sample <30
Costly treatment, though less so than lasers. Significant differences were seen at only one time point.
Needs further study, though device appears easy to use and safe. BBVLT therapy may be a less costly alternative to laser treatments, and the device used could be operated by patients themselves for self care. Larger studies in this area are warranted.
Einhorn, L., Rapoport, B., Navari, R., Herrstedt, J., Brames, M., Einhorn, L.H., . . . Brames, M.J. (2017). 2016 updated MASCC/ESMO consensus recommendations: Prevention of nausea and vomiting following multiple-day chemotherapy, high-dose chemotherapy, and breakthrough nausea and vomiting. Supportive Care in Cancer, 25, 303–308.
RESOURCE TYPE: Consensus-based guideline
PROCESS OF DEVELOPMENT: A literature search for papers published between January 1, 2009, and January 6, 2015, related to high-dose chemotherapy, multiple-day chemotherapy regimens, and breakthrough nausea and vomiting
DATABASES USED: PubMed
INCLUSION CRITERIA: Clinical trials, systematic reviews, stem cell transplantations (SCTs), patients with germ cell tumors
EXCLUSION CRITERIA: Other studies
PHASE OF CARE: Active antitumor treatment
Few studies related to the prevention of acute and delayed CINV in patients receiving high-dose and multiple-day chemotherapy regimens and for breakthrough nausea and vomiting. Little evidence related to the control of nausea exists.
Aprepitant should be added to two-drug antiemetic regimens in patients receiving high-dose and multiple-day cisplatin regimens to prevent acute and delayed CINV. Olanzapine is recommended for breakthrough CINV.
Einhorn, L., H., Grunberg, S., M., Rapoport, B., Rittenberg, C., & Feyer, P. (2011). Antiemetic therapy for multiple-day chemotherapy and additional topics consisting of rescue antiemetics and high-dose chemotherapy with stem cell transplant: Review and consensus statement. Supportive Care in Cancer, 19, S1-S4.
To evaluate topics related to nausea and vomiting, specifically antiemetic therapy in high-dose chemotherapy with stem cell transplant and the use of rescue antiemetic for refractory emesis, with the intention of developing a consensus statement
Recommendations were rated using the Multinational Association of Supportive Care in Cancer (MASCC) and European Society for Medical Oncology (ESMO) levels of confidence for evidence strength rating.
Patients were in active treatment.
Patients receiving multiple-day cisplatin should receive a 5-HT3 receptor antagonist plus dexamethasone for acute nausea and vomiting and dexamethasone for delayed nausea and vomiting. Because emesis in progress is difficult to control, include maximally effective antiemetics in first-line prophylactic antiemetic regimens so that rescue therapy will not be necessary. No clear evidence was provided on the most effective management of breakthrough or refractory CINV, and it is recommended that maximal prophylactic antiemetics are the best current approach.
The authors concluded that control of nausea and vomiting with high-dose chemotherapy remains a problem and more evidence is needed to aid researchers in making guideline decisions as to how to best manage CINV using modern antiemetics. Limited evidence is available for management of breakthrough and refractory CINV.
Einhorn, L.H., Brames, M.J., Dreicer, R., Nichols, C.R., Cullen, M.T., Jr., & Bubalo, J. (2007). Palonosetron plus dexamethasone for prevention of chemotherapy-induced nausea and vomiting in patients receiving multiple-day cisplatin chemotherapy for germ cell cancer. Supportive Care in Cancer, 15(11),1293-1300.
To evaluate the safety and efficacy of palonosetron plus dexamethasone for patients receiving multiple-day, highly emetogenic chemotherapy (HEC)
Patients received 0.25 mg IV palonosetron as an infusion 30 minutes before chemotherapy on days 1, 3, and 5 plus dexamethasone 20 mg IV on days 1 and 2, 8 mg orally twice daily on days 6 and 7, and 4 mg orally twice daily on day 8. Given the high receptor-binding affinity and prolonged half-life of palonosetron, this study involved alternate day dosing (days 1, 3, and 5 rather than days 1-3) combined with a standard dexamethasone regimen for multiple-day, cisplatin-based chemotherapy.
The study consisted of 41 patients with germ cell tumors.
This was a nonrandomized trial.
The following data was collected.
Eigentler, T.K., Hassel, J.C., Berking, C., Aberle, J., Bachmann, O., Grunwald, V., . . . Gutzmer, R. (2016). Diagnosis, monitoring and management of immune-related adverse drug reactions of anti-PD-1 antibody therapy. Cancer Treatment Reviews, 45, 7–18.
RESOURCE TYPE: Expert opinion
PHASE OF CARE: Active antitumor treatment
Review article
Literature review of common anti-PD-1 checkpoint pathway inhibitors/antibody therapy adverse events. No evidence of quality review provided.
Research is needed on the management of anti-PD-1 checkpoint pathway inhibitors/antibody therapy toxicities.
Eguchi, K., Honda, M., Kataoka, T., Mukouyama, T., Tsuneto, S., Sakamoto, J., & Saji, S. (2014). Efficacy of corticosteroids for cancer-related fatigue: A pilot randomized placebo-controlled trial of advanced cancer patients. Palliative and Supportive Care. Advance online publication.
To investigate the effectiveness of corticosteroids for the treatment of fatigue in patients with advanced cancer
Patients were randomized to receive 16 mg methylprednisolone or placebo orally twice daily for seven days. Study assessments for quality of life levels were done at baseline, day 3, and day 8. Fatigue and appetite loss were evaluated daily.
Double-blinded, placebo-controlled, randomized, controlled trial
Fatigue and appetite loss improved in both groups. On day 5, appetite was significantly better with steroid use (p = 0.011). There were no significant differences in adverse events between the groups.
The findings of this study demonstrate that this oral steroid may be helpful for anorexia, but it was not effective for reducing cancer-related fatigue.
Oral corticosteroids may improve loss of appetite in patients with advanced cancer. However, steroids were not shown to be helpful in managing the cancer-related fatigue in this study.
Eghbali, M., Yekaninejad, M.S., Varaei, S., Jalalinia, S.F., Samimi, M.A., & Sa'atchi, K. (2016). The effect of auricular acupressure on nausea and vomiting caused by chemotherapy among breast cancer patients. Complementary Therapies in Clinical Practice, 24, 189–194.
To determine if the use of auricular acupressure is effective in relieving nausea and vomiting in patients with breast cancer who are receiving chemotherapy
Random assignment of patients: The experimental group received standard antiemetics for chemotherapy-induced nausea and vomiting (CINV) and auricular acupressure (AA) for five days. The control group received standard antiemetics only. Acute and delayed CINV was measured with the Morrow questionnaire daily for five days after receiving chemotherapy. The questionnaire has 16 items measured with a 7-degree Likert-type scale. Patients self-reported. For the second cycle of chemotherapy, the groups were switched.
PHASE OF CARE: Active antitumor treatment
Crossover clinical trial
Morrow (Moro) questionnaire
The use of auricular acupressure was shown to help alleviate CINV when used along with standard antiemetics in patients with breast cancer receiving moderate to high-risk emetogenic chemotherapy.
Auricular acupressure is a safe, noninvasive, easy, patient-administered, nursing-centered, nonpharmacologic treatment and was shown to lower the number and intensity of nausea in both the acute and delayed phases of treatment.
Eghbali, A., Taherkhanchi, B., Bagheri, B., & Sadeghi Sedeh, B. (2016). Effect of chewing gum on oral mucositis in children undergoing chemotherapy: A randomized controlled study. Iranian Journal of Pediatric Hematology and Oncology, 6(1), 9–14.
To study the effects of salivary stimulation using chewing gum on oral mucositis (OM) in children undergoing chemotherapy
Patients were randomized to a control group or experimental group. Control patients were given a mouth rinse of nystatin, diphenhydramine, and aluminum three times per day. The test group received the same mouth rinse plus sugar-free chewing gum six times per day for 15 days. The gum was chewed for about 30 minutes.
Prevalence of grade 1 (p < 0.05) and grade 2 (not significant) OM was lower in children who chewed the gum. Grade 3 mucositis was slightly higher among those chewing gum. No difference existed between groups in prevalence of grade 4 mucositis.
Chewing gum for salivary stimulation may help reduce inflammation with low grades of mucositis but shows no overall benefit for more severe mucositis.
Chewing sugar-free gum to increase salivary stimulation is a low-risk intervention that may help in low-grade mucositis cases but appears to have no overall efficacy in reducing the prevalence or severity of mucositis in children receiving chemotherapy. Further research regarding the potential role of salivary stimulation for the prevention or management of OM would be beneficial.
Egerer, G., & Geist, M.J. (2011). Posaconazole prophylaxis in patients with acute myelogenous leukaemia—Results from an observational study. Mycoses, 54(Suppl. 1), 7–11.
200 mg of oral posaconazole was started three times daily on patients on the first day after their chemotherapy ended. Treatment was started prophylactically and was independent of a specific cycle of chemotherapy (i.e., some patients started after cycle 1, some started after cycle 2). A total of 76 chemotherapy cycles were included among these 40 patients.
A single site in Heidelberg, Germany.
Active treatment
Retrospective, observational study.
23 patients enrolled in the study developed pneumonia, with 13 being possible invasive fungal disease and 1 being proven aspergillosis. Single-agent posaconazole as prophylaxis was interrupted in 25 of the 40 enrolled patients due to various causes; one patient was unable to swallow due to mucositis, two developed adverse reactions. One third of the patients (25 cycles of the 76 studied) had systemic therapy of different types started during the study time period because of signs and symptoms of fungal infection or due to adverse events.
Based on the findings of the study, posaconzole may show promise for prevention of fungal infection in the immunocompromised patient, although it cannot be relied on as monotherapy for all patients due to the limitations of it being only PO and the use of other systemic anti-fungal prophylaxis. More studies are needed with posaconazole to determine its effectiveness as sole prophylaxis.
Some patients included were receiving additional prophylactic treatment other than posaconazole, making it hard to determine which drug was the most effective in prevention of invasive fungal infection.
Posaconazole may be an effective treatment prophylactically for fungal infection if patients are able to take oral medications, but further studies are needed to determine how effective it can be. The fact that it only comes as an oral product limits the population that may benefit.