Les nausées et les vomissements induits par la chimiothérapie (NVIC) nuisent à la qualité de vie tant des adultes que des patients pédiatriques atteints d’un cancer (Dupuis, Milne-Wren, Cassidy ...et al., 2010; Farrell, Brearley, Pilling et Molassiotic, 2013; Russo, Cinausero, Gerratana et al., 2014; Hinds, Gattuso, Billups et al., 2009; Sommariva, Pongiglione, et Tarricone, 2016). Les vomissements et les haut-le-cœur sont des symptômes qui s’évaluent objectivement, alors que la nausée est subjective et plus difficile à mesurer. En général, l’intensité de la nausée chez les adultes peut être décrite à l’aide d’échelles d’évaluation visuelle analogique ou qualitative. Il existe à cette fin des instruments validés et recommandés par des spécialistes du domaine, comme celui de la Multinational Association of Supportive Care in Cancer (en ligne : www.mascc.org) (Hesketh, Gralla, du Bois et Tonato, 2016).
To develop an evidence-based guideline for the empiric management of pediatric fever and neutropenia (FN).
The International Pediatric Fever and Neutropenia Guideline Panel is a multidisciplinary and ...multinational group composed of experts in pediatric oncology and infectious disease as well as a patient advocate. The Panel was convened for the purpose of creating this guideline. We followed previously validated procedures for creating evidence-based guidelines. Working groups focused on initial presentation, ongoing management, and empiric antifungal therapy. Each working group developed key clinical questions, conducted systematic reviews of the published literature, and compiled evidence summaries. The Grades of Recommendation Assessment, Development, and Evaluation approach was used to generate summaries, and evidence was classified as high, moderate, low, or very low based on methodologic considerations.
Recommendations were made related to initial presentation (risk stratification, initial evaluation, and treatment), ongoing management (modification and cessation of empiric antibiotics), and empiric antifungal treatment (risk stratification, evaluation, and treatment) of pediatric FN. For each recommendation, the strength of the recommendation and level of evidence are presented.
This guideline represents an evidence-based approach to FN specific to children with cancer. Although some recommendations are similar to adult-based guidelines, there are key distinctions in multiple areas. Implementation will require adaptation to the local context.
We validated different approaches to symptom assessment for pediatric cancer patients based on the Symptom Screening in Pediatrics Tool (SSPedi) for self-report (SSPedi and mini-SSPedi), proxy-report ...(proxy-SSPedi), and structured dyadic-report (co-SSPedi). The objective was to compare co-SSPedi scores vs proxy-report (proxy-SSPedi) and self-report (SSPedi or mini-SSPedi) scores for pediatric patients receiving cancer treatments.
This was a single-center, randomized crossover study enrolling English-speaking dyads of pediatric patients with cancer or hematopoietic cell transplant recipients 4-18 years old and their guardians. Dyads were randomized to first complete the dyadic-report (co-SSPedi) or self-report (patients: SSPedi or mini-SSPedi) and proxy-report (guardians: proxy-SSPedi). Dyads then crossed over to the alternate approach. Primary analysis compared total SSPedi scores between randomized groups.
We enrolled 420 dyads that were randomized to co-SSPedi first (n = 213) or proxy-SSPedi and self-report SSPedi first (n = 207). Mean total SSPedi scores (± standard deviation) were co-SSPedi (9.6 ± 7.1), proxy-SSPedi (9.7 ± 7.5; P = .950 for comparison vs co-SSPedi), and self-report SSPedi (9.7 ± 8.2; P = .981 for comparison vs co-SSPedi). Co-SSPedi scores were significantly different from proxy-SSPedi for feeling disappointed or sad, feeling cranky or angry, feeling tired, mouth sores, and changes in taste. Co-SSPedi scores were significantly different from self-report SSPedi scores for problems with thinking or remembering things, feeling tired, mouth sores, tingly or numb hands or feet, and diarrhea.
Total co-SSPedi scores were not significantly different compared with proxy-report or self-report scores, although there were differences in specific symptom scores. If different reporter types are used during clinical implementation, specifying reporter type will be important. The study was registered at clinicaltrials.gov (NCT #05012917). Symptoms are common and frequently severely bothersome in pediatric patients with cancer and hematopoietic cell transplant (HCT) recipients (1). To measure the extent of bothersome symptoms, the Symptom Screening in Pediatrics Tool (SSPedi) suite of symptom assessment tools was developed for pediatric patients receiving cancer treatments and currently consists of multiple validated instruments. SSPedi was developed for self-report by patients 8-18 years of age (2,3). Mini-SSPedi was developed for self-report by patients 4 to 7 years of age (4). Proxy-SSPedi was developed for proxy-report by guardians of pediatric patients 2-18 years of age (5). These 3 instruments can be categorized as either self-report (SSPedi or mini-SSPedi) or proxy-report (proxy-SSPedi).
Purpose To update the ASCO guideline for antiemetics in oncology. Methods ASCO convened an Expert Panel and conducted a systematic review of the medical literature for the period of November 2009 to ...June 2016. Results Forty-one publications were included in this systematic review. A phase III randomized controlled trial demonstrated that adding olanzapine to antiemetic prophylaxis reduces the likelihood of nausea among adult patients who are treated with high emetic risk antineoplastic agents. Randomized controlled trials also support an expanded role for neurokinin 1 receptor antagonists in patients who are treated with chemotherapy. Recommendation Key updates include the addition of olanzapine to antiemetic regimens for adults who receive high-emetic-risk antineoplastic agents or who experience breakthrough nausea and vomiting; a recommendation to administer dexamethasone on day 1 only for adults who receive anthracycline and cyclophosphamide chemotherapy; and the addition of a neurokinin 1 receptor antagonist for adults who receive carboplatin area under the curve ≥ 4 mg/mL per minute or high-dose chemotherapy, and for pediatric patients who receive high-emetic-risk antineoplastic agents. For radiation-induced nausea and vomiting, adjustments were made to anatomic regions, risk levels, and antiemetic administration schedules. Rescue therapy alone is now recommended for low-emetic-risk radiation therapy. The Expert Panel reiterated the importance of using the most effective antiemetic regimens that are appropriate for antineoplastic agents or radiotherapy being administered. Such regimens should be used with initial treatment, rather than first assessing the patient's emetic response with less-effective treatment. Additional information is available at www.asco.org/supportive-care-guidelines and www.asco.org/guidelineswiki .
Antiemetics: ASCO Guideline Update Hesketh, Paul J; Kris, Mark G; Basch, Ethan ...
Journal of clinical oncology,
08/2020, Letnik:
38, Številka:
24
Journal Article
Recenzirano
To update the guideline to include new anticancer agents, antiemetics, and antiemetic regimens and to provide recommendations on the use of dexamethasone as a prophylactic antiemetic in patients ...receiving checkpoint inhibitors (CPIs).
ASCO convened an Expert Panel and updated the systematic review to include randomized controlled trials (RCTs) and meta-analyses of RCTs published between June 1, 2016, and January 24, 2020. To address the dexamethasone and CPI question, we conducted a systematic review of RCTs that evaluated the addition of a CPI to chemotherapy.
The systematic reviews included 3 publications from the updated search and 10 publications on CPIs. Two phase III trials in adult patients with non-small-cell lung cancers evaluating a platinum-based doublet with or without the programmed death 1 (PD-1) inhibitor pembrolizumab recommended that all patients receive dexamethasone as a component of the prophylactic antiemetic regimen. In both studies, superior outcomes were noted in the PD-1 inhibitor-containing arms. Other important findings address olanzapine in adults and fosaprepitant in pediatric patients.
Recommendations for adults are unchanged with the exception of the option of adding olanzapine in the setting of hematopoietic stem cell transplantation. Dosing information now includes the option of a 5-mg dose of olanzapine in adults and intravenous formulations of aprepitant and netupitant-palonosetron. The option of fosaprepitant is added to pediatric recommendations. There is no clinical evidence to warrant omission of dexamethasone from guideline-compliant prophylactic antiemetic regimens when CPIs are administered to adults in combination with chemotherapy. CPIs administered alone or in combination with another CPI do not require the routine use of a prophylactic antiemetic.Additional information is available at www.asco.org/supportive-care-guidelines.
Abstract
Background
Bacteremia and other invasive bacterial infections are common among children with cancer receiving intensive chemotherapy and in pediatric recipients of hematopoietic stem cell ...transplantation (HSCT). Systemic antibacterial prophylaxis is one approach that can be used to reduce the risk of these infections. Our purpose was to develop a clinical practice guideline (CPG) for systemic antibacterial prophylaxis administration in pediatric patients with cancer and those undergoing HSCT.
Methods
An international and multidisciplinary panel was convened with representation from pediatric hematology/oncology and HSCT, pediatric infectious diseases (including antibiotic stewardship), nursing, pharmacy, a patient advocate, and a CPG methodologist. The panel used the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach to generate recommendations based on the results of a systematic review of the literature.
Results
The systematic review identified 114 eligible randomized trials of antibiotic prophylaxis. The panel made a weak recommendation for systemic antibacterial prophylaxis for children receiving intensive chemotherapy for acute myeloid leukemia and relapsed acute lymphoblastic leukemia (ALL). Weak recommendations against the routine use of systemic antibacterial prophylaxis were made for children undergoing induction chemotherapy for ALL, autologous HSCT and allogeneic HSCT. A strong recommendation against its routine use was made for children whose therapy is not expected to result in prolonged severe neutropenia. If used, prophylaxis with levofloxacin was recommended during severe neutropenia.
Conclusions
We present a CPG for systemic antibacterial prophylaxis administration in pediatric cancer and HSCT patients. Future research should evaluate the long-term effectiveness and adverse effects of prophylaxis.
This clinical practice guideline presents recommendations for systemic antibacterial prophylaxis administration in pediatric cancer and hematopoietic stem cell transplantation patients. The recommendations were developed by an international panel based on the results of a systematic review of 114 randomized trials.
Several randomized controlled trials (RCTs) have demonstrated that dexrazoxane reduces anthracycline cardiotoxicity in adults, but use in children has been hindered by lack of direct evidence of ...cardioprotection and concerns regarding second malignant neoplasms (SMNs). This study aimed to systematically review the evidence regarding dexrazoxane in children.
We searched Medline, Embase, the Cochrane Library, and abstracts for RCTs and nonrandomized studies (NRSs) that compared dexrazoxane to no cardioprotection among children. We combined findings using random-effects models. All statistical tests were two-sided.
Eleven eligible publications reported results from five RCTs (1254 patients), and 15 publications reported results from 12 NRSs (3385 patients). Dexrazoxane did not impact clinical cardiotoxicity in RCTs because of a low cardiotoxic event rate (three events among all patients) but was associated with a reduction in subclinical cardiotoxicity. Among NRSs, dexrazoxane was associated with a reduction in clinical cardiotoxicity (relative risk (RR) = 0.29, P = .001) and clinical+subclinical cardiotoxicity (RR = 0.43, P < .001). Among RCTs, 17 of 635 (2.7%) patients treated with dexrazoxane developed an SMN compared with seven of 619 (1.1%) who did not receive dexrazoxane (RR = 2.37, P = .06). Two RCTs that used concurrent etoposide reported an increased risk of acute myeloid leukemia, while one that used cranial radiation reported an increased risk of brain tumors. Event-free survival did not differ (P = .91).
Dexrazoxane is associated with a statistically significant risk reduction for most cardiotoxic outcomes. Dexrazoxane is associated with a statistically borderline increase in SMNs, possibly because of an interaction with concurrent cancer therapies. The decision to use dexrazoxane in children should balance the risks of cardiotoxicity and SMNs specific to each treatment protocol.
To describe treatment failure and mortality rates with different antibiotic regimens and different management strategies for empirical treatment of fever and neutropenia (FN) in pediatric patients ...with cancer and hematopoietic stem-cell transplantation (HSCT) recipients.
We conducted a systematic review and performed searches of MEDLINE, Embase, PubMed, and Cochrane Central Register of Controlled Trials. Studies were included if pediatric patients had cancer or were HSCT recipients and the intervention was related to the management of FN. Strategies synthesized were monotherapy versus aminoglycoside-containing combination therapy; antipseudomonal penicillin monotherapy versus fourth-generation cephalosporin monotherapy; inpatient versus outpatient management; oral versus intravenous antibiotics; and addition of colony-stimulating factors.
Of 11,469 citations screened, 68 studies randomly assigning 7,265 episodes were included. When compared with monotherapy, aminoglycoside-containing combination therapy did not decrease treatment failures (risk ratio, 1.13; 95% CI, 0.92 to 1.38; P = 0.23), and no difference in mortality was observed. Antipseudomonal penicillin and fourth-generation cephalosporin monotherapy were associated with similar failure and mortality rates. Outpatient management and oral antibiotics were safe in low-risk FN with no infection-related mortality observed in any patient and no significant differences in outcomes compared with inpatient management and intravenous therapy. Therapeutic colony-stimulating factors were associated with a 1.42-day reduction in hospitalization (95% CI, 0.62 to 2.22 days; P < .001).
There were a moderate number of pediatric randomized trials of FN management. Monotherapy for high-risk FN and outpatient and oral management for low-risk FN are effective strategies. These findings will provide the basis for guideline recommendations in pediatric FN.
Purpose To update a clinical practice guideline (CPG) for the empirical management of fever and neutropenia (FN) in children with cancer and hematopoietic stem-cell transplantation recipients. ...Methods The International Pediatric Fever and Neutropenia Guideline Panel is a multidisciplinary and multinational group of experts in pediatric oncology and infectious diseases that includes a patient advocate. For questions of risk stratification and evaluation, we updated systematic reviews of observational studies. For questions of therapy, we conducted a systematic review of randomized trials of any intervention applied for the empirical management of pediatric FN. The Grading of Recommendation Assessment, Development and Evaluation approach was used to make strong or weak recommendations and to classify levels of evidence as high, moderate, low, or very low. Results Recommendations related to initial presentation, ongoing management, and empirical antifungal therapy of pediatric FN were reviewed; the most substantial changes were related to empirical antifungal therapy. Key differences from our 2012 FN CPG included the listing of a fourth-generation cephalosporin for empirical therapy in high-risk FN, refinement of risk stratification to define patients with high-risk invasive fungal disease (IFD), changes in recommended biomarkers and radiologic investigations for the evaluation of IFD in prolonged FN, and a weak recommendation to withhold empirical antifungal therapy in IFD low-risk patients with prolonged FN. Conclusion Changes to the updated FN CPG recommendations will likely influence the care of pediatric patients with cancer and those undergoing hematopoietic stem-cell transplantation. Future work should focus on closing research gaps and on identifying ways to facilitate implementation and adaptation.