Evaluate moderate intensity exercise programs for patients with breast cancer and their effect on several immune indicators as well as on fatigue, depression, and quality of life

Lab was obtained at week 0 and 12 and analyzed. Quality of life, fatigue, and depression were evaluated before and after the exercise program using tools mentioned. Patients were assigned to one of three groups. All were provided education. Group one did supervised exercise consisting of 45 minutes per day three times per week and brisk walking for 30 minutes per day three times per week. Group two did brisk walking for 30 minutes per day three times per week. Group three received education only. Patients wrote down their progress, and groups two and three were interviewed over the phone once a week. Arm circumference was measured to control for lymphedema at zero, one, two, and three months.

• N = 58
• AGE: 18–65 years
• MALES: 0%, FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Breast cancer, completed surgery, radiation, chemotherapy, post-menopausal, had not smoked in past year, absence of physical condition that would hinder exercise, cognitive capacity
• OTHER KEY SAMPLE CHARACTERISTICS: Patient demographics, age at diagnosis, type of operation, time after diagnosis, axillary dissection, sentinel lymph node biopsy, operation side, number of chemotherapy cycles, number of radiation treatments, body mass index

• SITE: Single site    
• SETTING TYPE: Outpatient    
• LOCATION: Outpatient clinic for oncology and support unit of Ege University Tulay Aktas Oncology Hospital

PHASE OF CARE: Transition phase after active treatment

Prospective, randomized controlled study

• European Organisation for Research and Treatment of Cancer Quality of Life C30
• Brief Fatigue Inventory (BFI)
• Beck Depression Inventory (BDI)

Demographics were similar among the three groups. Exercise groups had a statistically significant decrease in some of the biomarkers, while the education group had a statistically significant increase in monocyte chemoattractant protein 1 levels. Functional score and global health score in both exercise groups increased.  Depression score was reduced in the supervised exercise group (p < .05). However, no significant differences were seen between groups after the intervention.

Significant changes in biomarkers were found at the end of 12 weeks, and improvements were seen in quality of life and depression in the supervised  and unsupervised exercise groups.

• Small sample (< 100)
• Findings not generalizable
• Intervention expensive, impractical, or training needs
• 12-week exercise program often is difficult for individuals
• Unclear if the home walking group adhered to the exercise program

Nurses encouraging patients with breast cancer to stay physically active and adopt a moderate exercise program is important to improve quality of life and help with symptoms of depression.

To determine the efficacy of royal jelly on oral mucositis in patients receiving chemotherapy and radiation

Patients were divided into two groups. All patients received benzydamine hydrochloride and nystatin rinses. In the experimental group, royal jelly was swished orally for 30 seconds and then swallowed twice per day for a total of 1 g per day. Patients could not eat or drink within 30 minutes of using the royal jelly. Both groups used the mouthwash protocol or mouthwash protocol plus royal jelly until mucositis was resolved. All participants and assessors were blinded to group. Oral mucosa was divided into five sites—labial mucosa, buccal mucosa, gingivae, tongue, and soft and hard palates—and the mucositis score was determined daily by a trained researcher for each site until no further evidence of mucositis existed.

• N = 103  
• AGE = 52.25 years
• MALES: 47%, FEMALES: 53%
• KEY DISEASE CHARACTERISTICS: Multiple types of cancer
• OTHER KEY SAMPLE CHARACTERISTICS: Multiple stages of cancer, chemotherapy types, and chemotherapy cycles

• SITE: Single site    
• SETTING TYPE: Outpatient    
• LOCATION: Turkey

• PHASE OF CARE: Active antitumor treatment

• Prospective, randomized clinical trial

• World Health Organization criteria for mucositis

No statistical difference was seen in mucositis severity at the beginning of the study between the two groups. For grade 1 mucositis, the mean number of days to healing in the royal jelly group was 1.1 days, and in the control group it was 2.7 days (U = 64; p = 0.0001). For grade 2 mucositis, the mean number of days to healing in the control group was 5.8 days, and in the experimental group it was 3 days (U = 77; p = 0.0001). For grade 3 mucositis, those in the experimental group had a faster healing time than those in the control group (U = 59; p = 0.005).

The addition of royal jelly to a mouthwash protocol with benzydamine and nystatin rinses significantly decreased the healing time for grade 1, 2, and 3 oral mucositis.

• Risk of bias (no random assignment)
• Other limitations/explanation: Random assignment was not described in the study

Royal jelly should be considered as an additional intervention to promote the healing of oral mucositis caused by chemotherapy and radiation. Royal jelly, in addition to a mouthwash protocol consisting of a benzydamine and nystatin rinse, effectively reduced the number of days to complete healing of oral mucositis. The sample in this study included a wide variety of cancer types as well as a wide range of types of chemotherapy and number of chemotherapy cycles.

To evaluate the feasibility of a cognitive rehabilitation intervention for persistent post-treatment cognitive issues in survivors of breast cancer and to conduct a substudy to garner preliminary data related to the use of quantitative electroencephalography (qEEG) to assess changes in cognitive function

Five weekly, manualized, two-hour sessions were provided to five cohorts of four to nine participants. The last cohort participated in the qEEG substudy. Two difficulty levels of in-class cognitive training and three levels of homework exercises were designed to build skills in the targeted areas of attention, executive function, and memory. Participants were encouraged to do four 20-minute sessions of homework exercises per week and log their time. Participants received a training manual workbook, CDs for auditory exercises, answer keys, and a stopwatch. In-class education focused on a specified targeted area and instructions on coping strategies to minimize anxiety (such as deep breathing, relaxation, pacing, and countering negative thoughts). Goal attainment was discussed during the group sessions to facilitate setting individual short-term and long-term goals. Neurocognitive testing, self-report instruments, and the qEEG (substudy) were administered at baseline (T0), within one week (T1), and at two (T2), and four (T3) months after completing the intervention.

• N = 27 (8 in substudy)  
• MEDIAN AGE = 54.1 years (SD = 6.3 years)
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Breast cancer survivors within 18 months to five years after initial treatment completion who reported persistent cognitive issues that interfered with daily activities. Ongoing endocrine therapy and HER2-targeted adjuvant therapy were allowed. Inclusion requirements: 18–75 years old and stages 0–III breast cancer.
• OTHER KEY SAMPLE CHARACTERISTICS: Participants primarily were Caucasian, married, and well-educated (mean 16.4 years of education). The majority received chemotherapy (89%), radiation (63%), or endocrine therapy (67%). Exclusion criteria included untreated depression, psychiatric disorders, and disorders of the central nervous system (CNS) (i.e., CNS cancer, CNS treatment with intrathecal chemotherapy, surgery, radiotherapy, traumatic brain injury, seizures, intellectual disabilities, substance abuse disorder).

• SITE: Single-site    
• SETTING TYPE: Outpatient    
• LOCATION: University of California, Los Angeles, United States

• PHASE OF CARE: Late effects and survivorship

Prospective trial

• CNS Vital Signs Computerized Testing Platform
  • Finger tapping dominant, finger tapping nondominant
  • Shifting attention test
  • Stroop reaction time
  • Continuous performance test
  • Symbol digit test
• Hopkins Verbal Learning Test, Revised (HVLT-R) (total recall, delayed recall)
• Brief Visuospatial Memory Test, Revised (BVMT-R)
• Trail Making Tests (TMT) A and B
• Paced Auditory Serial Addition Test (PASAT) Trial 1
• Judgment of Line Orientation (JLO) test
• Patient’s Assessment of Own Functioning Inventory (PAOFI)
• Beck Depression Inventory, Second Edition (BDI-II)
• Spielberger State-Trait Anxiety Inventory (STAI)
• Resting quantitative electroencephalography (qEEG)

PAOFI totals and memory complaint scores decreased between T0 and T1 (p = .031 and p = .009, respectively) and were maintained at T3 (p < .0001 in both). Decreases in high-level cognitive functions (PAOFI scale) were demonstrated at T3 (p = .005). Significant short- and long-term improvements were observed for the symbol digit, Stroop reaction time, and trail A tests (p < .05). Meaningful improvement by a reliable change index (RCI) occurred for 19% of patients (n = 5) between T0 and T1, and 30% of patients (n = 8) by T3. RCI improvement (in ≥ 2 of 16 tests) predominantly occurred for verbal learning and memory (HVLT-R), processing speed (symbol digit), and divided attention (shifting attention test). Absolute alpha power increase (qEEG) was associated with PAOFI improvements at T1 (p = .014). Change in alpha power correlated with change in PAOFI memory subscale at T1 (p = .021) and T2 (p = .004). Correlation also was noted with the PAOFI HLC subscale at T2 (p = .030) and T3 (p = .048).

This study's results demonstrated the feasibility of this cognitive rehabilitation intervention and preliminary evidence for the improvement of subjective and objective cognitive function. Larger randomized, controlled trials are necessary to further determine efficacy. Preliminary results supported the potential use of qEEG as a measure of change in cognitive function. An additional randomized, controlled trial is underway.

• Small sample (< 30)
• Risk of bias (no control group)
• Findings not generalizable
• Other limitations/explanation: Sample primarily was Caucasian, married, and well-educated. Results may not be generalizable to other demographics.

Cognitive rehabilitation interventions appear to be promising. Nurses should maintain an awareness of research results in this area and consider suggesting appropriate clinical trials to eligible survivors.

To determine the efficacy of a cognitive-behavioral intervention for treating insomnia in survivors of breast cancer.

Participants were assigned to either a multicomponent intervention with stimulus control, sleep restriction, and sleep education and hygiene or a control intervention with sleep education and hygiene. Participants attended four weekly treatment group sessions (the first session was two hours and the other three were one hour) followed by two weekly 15- to 30-minute individual telephone sessions. Outcomes measures were sleep-onset latency, wake-after-sleep onset, total sleep time, time in bed, sleep efficiency, and sleep quality.

• The study was comprised of 34 participants in the multicomponent intervention and 38 in the control group.
• Participants were women older than 18 years with a diagnosis of stage I, II, or III breast cancer and with insomnia of at least three months' duration.

The study was conducted in university and medical center classrooms.

Patients were undergoing the follow-up phase of care.

This was a randomized, controlled trial.

• Daily sleep diary
• Actiwatch®

After the intervention, based on daily sleep diaries, both groups improved in sleep-onset latency, wake-after-sleep onset, total sleep time, time in bed, sleep efficiency, and sleep quality. A between-group difference existed for time in bed. Wrist actigraph data showed significant pre- to postintervention changes for sleep-onset latency, wake-after-sleep onset, total sleep time, and time in bed. When compared to the control group, the multicomponent intervention group rated overall sleep as more improved.
 

A nonpharmacologic intervention is effective in the treatment of insomnia in survivors of breast cancer.

• The study used a selective sample:  the women were primarily white, well educated, and, on average, were diagnosed with cancer six years previously.
• Recruitment was via an advertisement and support groups; therefore, participants were more motivated to receive treatment.
• Space was required for group meetings.
• Actigraphs incurred a cost.
• The study required a Master’s level clinical nurse specialist in psychiatric-mental health nursing trained in the delivery of the intervention.

Participants were randomized to receive either benzydamine HCl oral rinse, containing 0.15% benzydamine oral rinse (1.5 mg/ml benzydamine) or placebo, which identical in appearance and taste consisting of the vehicle only (approximately 10% alcohol by volume, menthol, peppermint oil, clove oil, and other flavoring agents).

Patients were to rinse with 15 ml of solution for two minutes, 4–8 times daily, before and during radiation therapy (RT) and for two weeks after completion of RT. If burning or stinging occurred, dilution of the rinse with water at 1:1 or 1:2 was allowed.  

Patients were evaluated before RT, twice weekly during RT, at the end of RT, and 2–3 weeks after RT.

• The sample consisted of 172 patients, with 84 receiving benzydamine and 88 receiving placebo.
• Patients ranged in age from 18–80 years old.
• Patients had been diagnosed with head and neck cancer and were scheduled to receive at least 5000 cGy RT via megavoltage treatment. Patients were eligible if at least two oral sites were included in RT.
• Patients were excluded if they had Karnofsky performance status of less than 80%, known hypersensitivity to benzydamine or typical nonsterioidal anti-inflammatory drugs, had residual oral or pharyngeal mucositis from previous RT or chemotherapy, or were already on RT and had taken experimental drugs within 30 days of study start.

The study was conducted at 16 centers in North America (15 in the United States and 1 in Canada).

• Mucositis assessment involved evaluating 14 anatomic areas for erythema, pseudomembrane, and ulceration using a 4-point scale ranging from 0–3.
• Pain in the mouth or throat and pain during meals was assessed on a 7-point categorical self-rating scale ranging from 0–6.

Benzydamine produced a 26.3% reduction in mean mucositis area under the curve (AUC) compared with placebo for overall 0–5000 cGy (p = 0.009).

Pain also decreased as evidenced by a delay in use of concomitant systemic analgesics. Mouth pain showed a 25.8% reduction in AUC (p = 0.064) versus placebo, and throat pain showed a 22.5% reduction in AUC (p = 0.064).

Pain during meals was not effectively reduced.

Benzydamine was not effective in reducing more severe mucositis in patients receiving high, single, daily RT regimens of 220 cGy per day or more.

• The study is limited because of the small sample size.
• The intervention is not approved by the U.S. Food and Drug Administration.
• The decrease in pain was not statistically significant.

To determine the impact of repeated dosing with doxepin rinse over the course of one week in patients with oral mucositis

Patients were instructed to rinse the oral cavity for 1 minute with 5 mL doxepin suspension (5 mg/mL) and then spit it out. Patients were to continue using the rinse as needed, 3–6 times per day, for the following week until their second visit and assessment. Standard of care for mucositis also was used during this time. Subjects used diaries to record analgesic use and mouth rinses.

• The study reported on 9 patients, 3 women and 6 men, with a median age of 41 years.
• Patients were receiving radiation therapy, chemotherapy, hematopoietic stem cell transplantation (HSCT), or a combination of these for head and neck cancer.
• All patients had painful oral mucositis.

The study was conducted at a single site, outpatient setting in Canada.

This was a nonrandomized, unblinded, uncontrolled, open-label study.

• Data was compiled in Microsoft Excel. Statistical analysis was conducted using SAS 9.0 for Windows. Frequencies, medians, and ranges were used to report subject characteristics.
• Oral pain was graded using a visual analog scale (VAS) (0 = no pain, 10 = worst pain). Oral pain when eating and without function was graded prior to oral rinse and at 5 minutes, 15 minutes, 1 hours, 2 hours, 3 hours, and 4 hours following doxepin rinse.
• A VAS was used to report the taste of the rinse, discomfort, and fatigue.
• An Oral Mucositis Assessment Scale (OMAS) was used.
• Patients were asked to record in a diary estimates of their average pain up to four hours after using the rinse.

Statistically significant reductions in pain scores were reported for two hours following doxepin rinse during the initial visit (p < 0.05). Patients recalled that their pain significantly dropped within 5 minutes of rinsing over the week of repeated dosing (p < 0.05). At the follow-up visits, subjects reported statistically significant pain reduction 5 minutes after doxepin rinsing (p < 0.05). No changes were reported in systemic analgesics used during the study week despite the increasing severity of mucositis. No significant differences were found in mucositis scores over time.

Doxepin rinsing in addition to usual oral care produced reduced intensity of pain levels but no apparent difference in mucositis severity. No firm conclusions can be drawn from this extremely small sample.

• The sample size was small.
• Risk of bias exists because this was not a randomized, controlled, blinded study
• The standard care protocol, which also was used for oral care, was not described.

The doxepin rinse was well tolerated, and the results warrant a larger, randomized, controlled clinical trial.

To understand the prevalence of humidified high-flow nasal oxygen (HHFNOx) use at the authors’ institution, and to investigate characteristics related to HHFNOx initiation, discontinuation, and consistency with patient goals of care

In this retrospective study, the characteristics of HHFNOx—Optiflow™—use, including malignancy diagnosis, underlying cardiopulmonary disease, reason for HHFNOx initiation (hypoxia/dyspnea), duration of HHFNOx therapy, reported HHFNOx impact, reason for discontinuation (stable, declined, or expired), and patient outcome were analyzed (discharge/code status). Patients who used the HHFNOx device—Optiflow™—since 2008 were identified via the institution’s database search. Of the 353 patients identified, 183 were randomly selected for analysis. Objective (documented patient comfort and SaO2 on the device, and “step up” and “step down” grading to other oxygen support devices) and subjective (recorded patient and clinician impressions of tolerability) outcomes, oxygen saturation (SaO2), and oxygen interventions pre and post HHFNOx were examined.

• N = 183   
• MEDIAN AGE = 67 years
• AGE RANGE = 20–95 years
• MALES: Not specified, FEMALES: Not specified
• CURRENT TREATMENT: Not applicable
• KEY DISEASE CHARACTERISTICS: The population includes the following malignancies: hematologic (29%), lung (17%), gastrointestinal (15%), sarcoma (6%), head/neck/CNS tumors (5%), breast (4%), and other tumors (24%)
• OTHER KEY SAMPLE CHARACTERISTICS: HHFNOx was used in the intensive care unit (ICU) in 72% of cases and otherwise in the hospital ward alone or in the post-ICU stay.

• SITE: Single site   
• SETTING TYPE: Inpatient    
• LOCATION: Memorial Sloan Kettering Cancer Center in New York, NY

• PHASE OF CARE: Multiple phases of care
• APPLICATIONS: Palliative care 

• Retrospective

• Oxygen saturation (SaO2) percentile range subsets (e.g., 60s, 70s, and so forth)
• Recorded patient and clinician impressions of tolerability to HHFNOx
• Documented SaO2 
• “Step up” and “step down” grading to other oxygen support devices
• Documented reasons for initiation or discontinuation of HHFNOx
• Documented outcome (discharge, vitals, code status)

• Forty-one percent improved while on HHFNOx, 44% remained stable, and 15% declined.
• Subjective reports by the patients were well-documented as well as tolerated with seldom complaints.
• The majority (66%) of patients appeared to benefit indirectly from HHFNOx as it acted as a “step up” or “step down” device between more intensive or invasive forms of ventilation and lower oxygenation.
• Recorded pre-and post-HHFNOx saturations were maintained within the normal range of 90%–100% SaO2.
• At time of data abstraction, 44% of patients were alive, 33% died at the institution, and 22% died outside the institution. 
• Median time of HHFNOx was three days (range = 1–27 days).
• The majority of patients with DNR status pre (12%) or post (43%) HHFNOx died at the institution (78%).
• Full-code status patients (82%) were discharged either to home (82%) or to an outside facility (11%).

HHFNOx was effective in the stabilization or improvement of oxygen saturation in the majority of treated patients. Though HHFNOx devices are expensive, they are a more cost-effective oxygen delivery alternative because they may help prevent escalation to more invasive oxygenation (e.g., mechanical ventilation).

• Risk of bias (no control group)
• Risk of bias (no random assignment)
• Risk of bias (sample characteristics)
• Key sample group differences that could influence results
• The sample included patients with differing goals of care (e.g., curative versus palliative) which would have affected interpretation of effectiveness of the intervention. Distinction between treatment intents are, therefore, not clearly defined because of the limitation of the retrospective design of the study. No data recorded on oxygen support devices after discharge limits the understanding of the role of HHFNOx in discharge planning. Reporting and scoring of dyspnea were not available and, therefore, limits the ability to compare with other studies examining dyspnea and other symptoms. No measurement or report of symptoms of dyspnea exist.

HHFNOx seems well tolerated by various malignancies and clinical trajectories and generally safe. The study claims to be the only clinical description of HHFNOx device used exclusively in the cancer population. Users were able to benefit from high flow of oxygen delivery while still being able to eat and drink (as opposed to oxygen delivery via face mask or face tent).

To evaluate if the topical application RayGel (contains glutathione and anthocyanin) decreases radiation dermatitis

Both groups received instruction in standard skin care and used aloe vera gel and vitamin E after treatment. Gel or placebo was applied to breasts one to three hours prior to radiation therapy. The placebo was a water-based gel.

• The study sample was comprised of 30 female patients with breast cancer.
• Mean age was 54.9 years (SD = 8.3 years) in the placebo group and 62.5 years (SD =12.2 years) in the RayGel group.
• Average treatment was 180–200 cGy per day.

The study used a prospective, placebo-controlled design.

• Skin reactions were evaluated using modified Radiation Therapy Oncology Group skin toxicity scoring.
• The breast was divided in to nine regions and then each region was assigned a grade (0–4). The score was calculated for each of the nine breast regions by multiplying the grade of skin reaction by the percentage of area within that region. The whole breast score was the sum of the nine regions. A separate score was calculated for the area with the worst degree of skin reaction.

Whole breast severity scores were lower with RayGel at 93.7% versus the placebo at 123%. The difference in the worst site score was not as pronounced; however, the RayGel Group was 14% less than that of the placebo group, at 39.2% and 45.5%, respectively. None of the findings were significant.

RayGel tended to be superior to the placebo, although significance could not be determined because of the small sample size.

• The sample size was small, with less than 50 participants.
• All patients were using aloe and Vitamin E; use of multiple topical treatments confounds results.
• Modified Radiation Therapy Oncology Group scoring is difficult to compare with other studies not using modified scoring.

The purpose of the study was to demonstrate the activity and safety of XM02 compared to filgrastim for the prevention of chemotherapy-induced neutropenia in patients with non-Hodgkin lymphoma.

Patients randomized in a 2:1 ratio of XM02 to filgrastim for the first cycle of chemotherapy (CHOP or R-CHOP [rituximab added per national guidelines and physician discretion]). All patients received XM02 in subsequent cycles, with a maximum of six cycles; three weeks per cycle. Subcutaneous injections given daily (5 mg/kg per day) for at least five days and a maximum of 14 days. Drug stopped with the absolute neutrophil count (ANC) of  10 x 10⁹/L or greater after nadir was reached (blood samples to evaluate ANC taken within 24 hours prior to start of chemotherapy and then daily from day 2 on in the first cycle and day 5 on in cycles 2–6 until day 15 or until ANC reached greater than 2.0 x10⁹/L). Body temperature measured daily until day 15 or until ANC reached greater than 2.0 x10⁹/L.

• 92 total patients were in the sample.
• Age ranged from 18-83 years.
• For women, were in the XM02 group and 12 were in the filgrastim group.
• For men, 31 were in the XM02 group and 17 were in the filgrastim group.
• Patients had aggressive NHL, defined as diffuse large B-cell lymphoma, mediastinal large B-cell lymphoma, follicular lymphoma grade 3, or anaplastic large cell lymphoma.
• Eligible patients had to be chemotherapy-naïve, have a life expectancy of six months or longer, an international prognostic index score of 3 or lower, an ANC greater than 15 x 10⁹/L, a platelet count greater than 100 x 10⁹/L, and adequate hepatic, cardiac, and renal function for the chemotherapy regimen.

Multiple inpatient and outpatient settings

Active treatment

Phase III, randomized, controlled trial

• Duration of severe neutropenia (DSN)    
• Febrile neutropenia    
• ANC
• Adverse events: musculoskeletal and connective tissue disorders (bone pain, arthralgia, back pain, musculoskeletal pain, jaw pain); general disorders and administration site conditions (pyrexia, fatigue, flu like illness); gastrointestinal (diarrhea); nervous system (HA), vascular (hot flush); and blood and lymphatic (anemia)
• Pharmacokinetics
   

XM02 was found to be pharmacokinetically similar to filgrastim and not statistically significantly different from filgrastim for febrile neutropenia (FN) in cycle 1 (11.1% for XM02 and 20.7% for filgrastim). ANC values in both groups reached a maximum at day 4 and decreased to a nadir on day 9 followed by an increase reaching a maximum on day 11, with a return to day 1 mean values reached on day 21 (similar to other filgrastim studies). Drug-related adverse events were not statistically different between XM02 and filgrastim.

The administration of G-CSFs for the prevention of chemotherapy-induced neutropenia and related adverse events has been proven effective in many trials. Use of XM02 has similar pharmacokinetics, safety, and efficacy compared to the established filgrastim. Other studies show greater efficacy with pegylated filgrastim that requires less dosing than the daily doses of filgrastim. The use of XM02 instead of filgrastrim does not seem favorable based on these results.

• Small sample size (less than 100 participants)
• This study was sponsored and funded by BioGeneriX AG, the manufacturer of XM02.
• Filgrastim was only compared to XM02 in the first chemotherapy cycle, then all patients received XM02; yet the results evaluated outcomes throughout the duration of all chemotherapy doses.
   

Based on this study alone, nurses can be aware that XM02 for patients 18 and older with aggressive NHL for the risk reduction of neutropenia and related adverse outcomes will be similarly effective to filgrastrim.

DATABASES USED: MEDLINE (1966–1996); the reference lists of retrieved articles also were reviewed.

• FINAL NUMBER STUDIES INCLUDED = 18 RCTs
• TOTAL PATIENTS INCLUDED IN REVIEW: 707
• KEY SAMPLE CHARACTERISTICS: Patients were undergoing chemotherapy for malignancy (primarily hematologic malignancies). Quinolone prophylaxis was compared with placebo (nine trials) or trimethoprim/sulfamethoxazole (nine trials). The article did not state whether patients received granulocyte colony-stimulating factors.

Without prophylaxis

• 82% of patients developed fever.
• 25% of patients developed gram-negative infections.
• 23% of patients developed gram-positive infections.
• 55% of patients developed any infection.

Compared with no prophylaxis, quinolone prophylaxis decreased the risk of

• Gram-negative infections by 79%
• Gram-negative bacteremia by 77%
• Microbiologically documented infections by 35%
• Total infections by 46%
• Fever by 15%.

Compared with trimethoprim/sulfamethoxazole prophylaxis, quinolone prophylaxis decreased the risk of

• Gram-negative infections by 70%
• Gram-negative bacteremia by 68%
• Microbiologically documented infections by 28%
• Total infections by 17%.

Quinolone prophylaxis did not affect the rate of

• Gram-positive infection or bacteremia
• Fungal infection
• Clinically documented infection
• Infection-related death.

The rate of quinolone-resistant gram-negative infections was 3.0%, and the rate of quinolone-resistant gram-positive infections was 9.4% among patients who received quinolone prophylaxis, but no data were provided regarding the rate of quinolone-resistant infections among the control group. Therefore, the effect of quinolone prophylaxis on the rate of quinolone-resistant infections is unknown.