Pignol, J.P., Olivotto, I., Rakovitch, E., Gardner, S., Sixel, K., Beckham, W., . . . Paszat, L. (2008). A multicenter randomized trial of breast intensity-modulated radiation therapy to reduce acute radiation dermatitis. Journal of Clinical Oncology, 26, 2085–2092.
To determine if breast intensity-modulated radiation therapy (IMRT) can lead to significant reduction in radiation-induced skin toxicity
Participants randomly assigned to receive 50 Gy in 25 fractions to the whole breast using either standard RT or breast IMRT. Random assignment was stratified for use of boost and breast size. Standard skin care during the radiation treatment was similar between groups. Patients were assessed weekly during and up to six weeks after RT.
The study too place at two cancer centers in Canada.
The study used a phase III, double-blind, randomized, controlled trial design.
A lower proportion of patients experienced moist desquamation during or up to six weeks after radiation treatment with IMRT (31.2%) compared to 47.8% with standard treatment (p = 0.002). Multivariate analysis found IMRT (p = 0.003) and smaller breast size (p = 0.001) significantly associated with a decreased risk of moist desquamation. Breast IMRT (31.2%) significantly reduced the occurrence of moist desquamation compared to a standard wedged technique (47.8%) (p = 0.002).
IMRT was associated with reduced risk and prevalence of moist desquamation.
No information was given on what the standard skin care was during the radiation treatments, just that it was similar between sites.
Piet, J., Würtzen, H., & Zachariae, R. (2012). The effect of mindfulness-based therapy on symptoms of anxiety and depression in adult cancer patients and survivors: A systematic review and meta-analysis. Journal of Consulting and Clinical Psychology, 80, 1007–1020.
To evaluate current evidence regarding the effect of mindfulness-based therapy (MBT) on symptoms of anxiety and depression in patients with cancer
Multiple phases of care
Among nonrandomized studies, overall effect size for anxiety was 0.60 (Hedges’s g, p < 0.001) and 0.42 (p < 0.001) for depression. Among randomized controlled trials, effect size for anxiety was 0.37 and 0.44 (p < 0.001) for depression. Most studies used the Profile of Mood States scale or the State-Trait Anxiety Inventory. The range of Jadad quality scores was 0–4, with only six studies having scores greater than 2. This score indicates low quality. Heterogeneity among studies was moderate.
Findings demonstrate a low to moderately significant effect of MBT in reducing anxiety and symptoms of depression among patients with cancer. Heterogeneity among studies suggests that findings be viewed with caution.
MBT may benefit patients with cancer by reducing anxiety and symptoms of depression. The use of MBT appears to be feasible in cancer care. The low quality of studies in this analysis points to the need for well-designed research on the effects of MBT.
Pielichowski, W., Barzal, J., Gawronski, K., Mlot, B., Oborska, S., Wasko-Grabowska, A., & Rzepecki, P. (2011). A triple-drug combination to prevent nausea and vomiting following BEAM chemotherapy before autologous hematopoietic stem cell transplantation. Transplantation Proceedings, 43(8), 3107–3110.
To evaluate the efficacy of a triple-drug combination (palonosetron + aprepitant + dexamethasone) to prevent acute and delayed emesis after high-dose chemotherapy with BEAM (carmustine + etoposide + cytarabine + melphalan) before hematopoietic stem cell transplantation (HSCT) by comparison with historical control of patients treated with dexamethasone + ondansetron or dexamethasone + palonosetron
Triple drug antiemetic regimen (aprepitant 1 hour before chemotherapy [125 mg on day one and 80 mg on days 2 & 3] + 0.25 mg IV palonosetron 30 minutes before chemotherapy and 20 mg IV dexamtheasone 15 minutes before chemotherapy for day 1 and 12 mg daily for rest of chemotherapy regimen) was compared to data from historical control patients that received 32 mg ondansetron and IV dexamethasone daily during chemotherapy or palonosetron and dexamethasone (dexamethasone given as 20 mg IV day 1 and 12 mg daily for rest of chemotherapy regimen in all cases). Acute phase was defined as the first 24 hours after receiving chemotherapy, and delayed phase was definied as days 2–5.
The study was conducted at a single inpatient setting in Warsaw, Poland.
All patients were in active treatment.
This was a descriptive study with comparison to historical controls.
Patients treated with the triple-drug antiemetic combination showed higher response rates than those receiving palonosetron or ondansetron (+ dexamethasone) during both the acute and delayed phases in reduction of chemotherapy-induced nausea and vomiting (CINV).
Drawing conclusions based on the information provided in the study is difficult.
Although the study appeared to support the use of established CINV guidelines established by the National Comprehenaive Cancer Network (NCCN) and the American Society of Clinical Oncology (ASCO), the data in this study were of questionable significance because of the information provided and poor quality of the study.
Phillips, R.S., Friend, A.J., Gibson, F., Houghton, E., Gopaul, S., Craig, J.V., & Pizer, B. (2016). Antiemetic medication for prevention and treatment of chemotherapy-induced nausea and vomiting in childhood. Cochrane Database of Systematic Reviews, 2, CD007786.
STUDY PURPOSE: To update a previous systematic review regarding the effectiveness and adverse events of pharmacologic interventions used to control anticipatory, acute, and delayed nausea and vomiting in children younger than 18 years who are preparing to receive chemotherapy
TYPE OF STUDY: Meta-analysis and systematic review
PHASE OF CARE: Active antitumor treatment
APPLICATIONS: Pediatrics
Thirty-four studies using a range of antiemetic regimens produced a variety of outcomes. The majority of quantitative data related to the complete control (CC) of acute vomiting (27 studies). Adverse events were reported in 29 studies and nausea outcomes in 16 studies. Two studies assessed the use of dexamethasone with 5-HT3 antagonists for CC of vomiting (pooled risk ratio [RR] = 2.03, 95% confidence interval [CI] [1.35, 3.04]). Three studies compared 20 mcg/kg granisetron with 40 mcg/kg for CC of vomiting (pooled RR = 0.93, 95% CI [0.8, 1.07]). Three studies compared granisetron and ondansetron for CC of acute nausea (pooled RR = 1.05, 95% CI [0.94, 1.17], two studies), acute vomiting (pooled RR = 2.26, 95% CI [2.04, 2.51], three studies), delayed nausea (pooled RR = 1.13, 95% CI [0.93, 1.38], two studies), and delayed vomiting (pooled RR = 1.13, 95% CI [0.98, 1.29], two studies). Narrative synthesis suggests that 5-HT3 antagonists are more effective than older antiemetic agents, even when these agents are combined with a steroid. Cannabinoids are probably effective but produce frequent side effects.
This review provides evidence that knowledge of the most effective antiemetics to prevent chemotherapy-induced nausea and vomiting in pediatrics is incomplete and additional research is needed. This review also indicates that 5-HT3 antagonists are effective in patients receiving emetogenic chemotherapy and that granisetron or palonosetron may be better than ondansetron. Adding dexamethasone improves control of vomiting, although the risk-benefit profile of adjunctive steroid remains uncertain.
Overall, the evidence related to the treatment of chemotherapy-induced nausea and vomiting in pediatric populations receiving emetogenic chemotherapy is lacking and requires additional research, and 5-HT3 medications have been shown to be effective in small studies.
Phillips, R., Hancock, B., Graham, J., Bromham, N., Jin, H., & Berendse, S. (2012). Prevention and management of neutropenic sepsis in patients with cancer: Summary of NICE guidance. BMJ, 345, e5368.
The purpose of the article was to assess systemic reviews of best available evidence, including consideration of cost, management of neutropenic sepsis leading to avoidable deaths, and the lack of systems for urgent assessment and lack of institutional policies for managing neutropenic sepsis. Adults (aged 18 or older) with acute leukaemias, stem cell transplantations or solid tumors with expected neutropenia of 0.5 x 109/L or less post-chemotherapy were assessed.
This was an evidence-based guideline with a guideline summary process of development.
Inclusion criteria included adult patients receiving chemotherapy. Exclusion criteria included being younger than age 18 and a diagnosis of lymphoma.
The phase of care was active anti-tumor treatment
High-quality evidence based on systematic reviews/meta-analyses of randomized, controlled trials (RCTs), moderate quality evidence based on systematic reviews, experienced opinion of Guideline Development Group (GDG), and National Cancer Action Team referenced as experience and opinion sources. Low-level evidence includes observational studies.
High-quality evidence (systematic reviews/meta-analysies of RCTs):
Moderate quality evidence (systematic reviews):
Experienced opinion of Guideline Development Group (GDG):
Low level evidence (observational studies):
High-quality evidence exists for practice recommendations:
Phillips, R.S., Gopaul, S., Gibson, F., Houghton, E., Craig, J.V., Light, K., & Pizer, B. (2010). Antiemetic medication for prevention and treatment of chemotherapy induced nausea and vomiting in childhood. Cochrane Database of Systematic Reviews (Online), 9, CD007786.
To assess effectiveness, adverse events, and quality of life associated with pharmacologic interventions for control of anticipatory nausea and vomiting in children about to receive chemotherapy and for control of acute and delayed nausea and vomiting in children receiving chemotherapy
Databases searched were MEDLINE, Embase, LILACS, and Cochrane CENTRAL register of clinical trials to February or March 2008.
Search keywords included the specific names of all drugs used for nausea and vomiting, including cannabinoids. Extensive listing of terms and Medical Subject Heading (MeSH) terms were provided in appendices. Multiple terms were included for pediatric cases. MeSH Nausea, MeSH Vomiting and anticipatory vomiting, Cancer and associated terms, and Chemotherapy. Manual reference screening and author contact for further information also was used.
Studies were included in the review if they
Studies were excluded if they
Initial searching provided 844 references. Of these, 67 were identified for detailed screening. A final sample of 27 articles reporting on 28 trials was included. Evaluation included assessment of study quality and risk of bias.
A broad range of adverse events were reported for 5-HT3 RAs. Those reported most frequently were headache, sedation/somnolence, and abdominal pain. The main side effects reported with cannabinoids were drowsiness, dizziness, mood alteration, and increased appetite. Only a few studies reported side effects with metoclopramide or chlorpromazine.
This review concluded that knowledge of the most effective antiemetics to prevent chemotherapy induced nausea and vomiting in children is incomplete and imprecise. Nausea often was reported with different methods that were not validated. No information was available about delayed or anticipatory nausea. Conclusions from these trials were that 5-HT3 RAs appear to be more effective than older antiemetic agents, even when those agents are combined with steroids. Additionally, 5-HT3 RAs with dexamethasone were effective in patients who were to receive highly emetogenic chemotherapy, although the addition of steroids was unclear. Cannabinoids were found to probably be effective. Related side effects may be experienced as adverse by some patients but not others.
The following areas for research were identified.
Future research should incorporate the use of validated measures and examination of appropriate schedules and doses to deal with anticipatory and delayed symptoms.
Philip, J., Gold, M., Milner, A., Di Iulio, J., Miller, B., & Spruyt, O. (2006). A randomized, double-blind, crossover trial of the effect of oxygen on dyspnea in patients with advanced cancer. Journal of Pain and Symptom Management, 32(6), 541–550.
The objective of the study was to determine if patients preferred oxygen or air following 15-minute administration of both. Another aim of the study was to identify other factors that might impact the experience of dyspnea and the response to oxygen.
The study compared the response to oxygen and air in hypoxic and nonhypoxic patients. Patients were randomized to receive either oxygen or air at 4 L via nasal canula for 15 minutes. At the completion of 15 minutes, dyspnea intensity ratings and oximetry were repeated. Patients then spent 30 minutes without gas. Repeat measures were performed with a crossover to the other gas for 15 minutes. Measure of symptom intensity and oximetry were repeated, then the blinded patient and investigator designated the preferred gas.
The study reported on a sample of 51 patients. Dyspnea was related to the cancer in 47 patients (92%). In 29 of the 47 patients, cancer was the sole cause of dyspnea. In the remaining patients, dyspnea causes were from cancer complications, such as pneumonia (five patients), and cancer treatment, such as radiation pneumonitis. Fifteen patients (29%) had unrelated dyspnea causes, including 11 patients with chronic obstructive pulmonary disease.
Patients were eligible if
Patients were excluded if they
The study was conducted in two centers in Australia. Patients were recruited from inpatient and outpatient units.
Randomized, double-blind, crossover study
Twenty-seven patients (53%) were randomized to the air first arm and 24 patients (47%) to the oxygen arm. No significant difference was seen in VAS score improvement between the two types of gases (p = 0.622). No significant difference was seen in percentage of verbal ratings of improvement after first gas (p = 0.888) and after the second gas (p= 0.767). A significant difference was seen between the two gas types in mean increase in oxygen saturation (p < 0.001, air = 0.94%, oxygen = 5.43%) No significant correlation was seen between VAS score and oxygen saturation. Twenty-one patients (41%) preferred oxygen, 15 (29%) preferred air, and 15 (29%) had no preference. No significant difference (p = 0.357) was seen in patient preference for air or oxygen. In the subgroup of 17 hypoxic patients, mean change in VAS score did not differ significantly between air and oxygen (p = 0.812, air = 15.4 mm, oxygen = 13.3 mm), but mean oxygen saturation levels increased significantly more for oxygen than for air (p = 0.005, air = 2.7%, oxygen = 10.7%).
On average, patients improved symptomatically with both air and oxygen, and no significant difference was seen between the treatments. The subgroup of 17 hypoxic patients overall did not demonstrate a significant difference between air and oxygen, despite having improved oxygen saturations when administered oxygen. No major or minor flaws were noted in the study design. The authors designated clinically significant response to oxygen to be a preference for oxygen chosen by 60% of patients. If clinically significant improvement occurred at lower increments, this study may not have been adequately powered.
Air was not considered a placebo in this trial, but in fact a placebo effect may have been associated with air administration. Another possible explanation is that no differential response to either air or oxygen may be a result of mechanoreceptos stimulated by any gas administration. Patients who were dyspneic upon exertion but not dyspneic at rest were not eligible to enter the study. Eligible patients had to record a dyspnea VAS score of at least 30 mm. There may have been a different preference and response to the gases for exertional dyspnea.
Accruing 50 patients with dyspnea to this study took five years, which underscores the clinical fragility of patients who experience dyspnea and the difficulty in conducting research in this population. This evidence contradicts the findings of Bruera et al. (1993), who demonstrated that oxygen is beneficial to and preferred by patients with hypoxia.
Phianmongkhol, Y., Thongubon, K., & Woottiluk, P. (2015). Effectiveness of cognitive behavioral therapy techniques for control of pain in lung cancer patients: An integrated review. Asian Pacific Journal of Cancer Prevention, 16, 6033–6038.
STUDY PURPOSE: To synthesize the evidence regarding effectiveness of cognitive behavioral techniques (CBT) for pain in patients with lung cancer
TYPE OF STUDY: Systematic review
PHASE OF CARE: Late effects and survivorship
APPLICATIONS: Palliative care
The review included two studies that involved such interventions as distraction and relaxation and imagery rather than true CBT-approach interventions. No conclusions were drawn due to the lack of substantial evidence.
Very limited evidence exists regarding effects of CBT-type interventions for pain among patients with lung cancer.
This review showed there is little evidence to determine effectiveness of CBT for pain in patients with lung cancer.
Pham, H. P., Rogoza, K., Stotler, B., Duffy, D., Parker-Jones, S., Ginzburg, Y., . . . Schwartz, J. (2012). Granulocyte transfusion therapy in pediatric patients after hematopoietic stem cell transplantation: a 5-year single tertiary care center experience. Journal of Pediatric Hematology/Oncology, 34, e332–e336.
To determine the efficacy of granulocyte transfusion in neutropenic pediatric patients after undergoing hematopoietic stem cell transplantation (HSCT).
A retrospective observational review analysis was performed on all pediatric HSCT recipients between January 2005 and and January 2010 in a single center.
This was a retrospective observational review.
Data were analyzed using Fisher exact test for binary outcomes and the 2-tailed t test for continuous outcomes.
One hundred fifty-three granulocyte transfusions were administered to 16 pediatric HSCT recipients. Patients had bacterial infections (69%), fungal infections (19%), and combined infections (12%). Concurrent infections, mostly bacterial (60%), occurred. One adverse reaction of pulmonary toxicity was reported. The ANC of the stimulated products was significantly higher compared with the unstimulated products; however, neither the average number of granulocytes transfused by weight nor the outcomes difference were noticed between groups.
Granulocyte transfusion is safe in neutropenic and infected pediatric patients after HSCT. There was no difference in the outcomes between the groups that received stimulated products and those that received unstimulated products.
Recruiting pediatric patients for a randomized, controlled trial continues to be challenging.
Pfeil, A.M., Allcott, K., Pettengell, R., von Minckwitz, G., Schwenkglenks, M., & Szabo, Z. (2015). Efficacy, effectiveness and safety of long-acting granulocyte colony-stimulating factors for prophylaxis of chemotherapy-induced neutropenia in patients with cancer: A systematic review. Supportive Care in Cancer, 23, 525–545.
TOTAL REFERENCES RETRIEVED: 731 full publications and 108 Congress abstracts; duplicates were removed, leaving 700 items
PHASE OF CARE: Active antitumor treatment
Pegfilgrastim did not consistently show better efficacy or effectiveness in all studies, but the vast majority showed better efficacy and effectiveness compared to daily G-CSF, no upfront pegfilgrastim, no G-CSF or placebo in regards to CIN, febrile neutropenia (FN), chemotherapy dose reductions/delays, antibiotic use, and neutropenia-related hospitalizations. It is suggested that pegfilgrastim has an acceptable safety profile with similar AEs between pegfilgrastim and filgrastim.
Pegfilgrastim is currently being widely used in clinical practice, showing similar efficacy/effectiveness with acceptable safety profiles.
Limitations include the quality of the underlying studies. Some studies did not report number of patients receiving primary prophylaxis versus secondary prophylaxis, which may have led to underestimation of effectiveness. Studies were not consistent in their definitions of FN and CIN. Combined measures of effect are missing in the analysis.
Further studies in broader patient populations are needed to confirm. This review adds to the body of evidence that shows mixed findings regarding the question of whether pegfilgrastim use achieves better patient outcomes than daily filgrastim. It is also unclear if either of these has better results for primary or secondary prophylaxis.