To assess the efficacy and safety of palonosetron versus ondansetron in the prevention of chemotherapy-induced nausea and vomiting (CINV) in pediatric patients receiving moderately (MEC) or highly emetogenic chemotherapy (HEC)

Four cycles of 10 mc/kg palonosetron was compared to three 150 mc/kg doses of ondansetron on day 1 of chemotherapy, and 20 mc/kg palonosetron was compared to three 150 mc/kg doses of ondansetron on day 1 of chemotherapy. The intervention assignment was stratified based on the age of the participant and the emetogenicity of the chemotherapy. The efficacy of antiemetic regimens was evaluated through the proportion of patients who achieved complete response (CR) (no vomiting, retching, or use of rescue drugs) during the acute phase (0–24 hours post chemotherapy) of chemotherapy on day 1. Safety was evaluated through the number of adverse events reported.

• N = 493   
• AGE RANGE = 2.1 months–16.9 years
• MEAN AGE = 8.21 years
• MALES: 53.1%, FEMALES: 46.9%
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: No specific type of cancer required for inclusion
• OTHER KEY SAMPLE CHARACTERISTICS: MEC or HEC

• SITE: Multi-site   
• SETTING TYPE: Not specified    
• LOCATION: United States, South America, and Europe

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Pediatrics

• Double-blind, double-dummy, phase-III study

• Episodes of CINV, retching, and rescue medications used were documented in a daily diary kept by the patient/caregiver.  
• Adverse events were measured through physical examination, vital signs, laboratory assessments, and 12-lead electrocardiograms. The severity of all adverse events was rated mild, moderate, or severe based on the Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.

Twenty mc/kg palonosetron resulted in a significantly higher proportion of patients who achieved CR (no vomiting, retching, or use of antiemetic rescue medication) on day 1 of chemotherapy compared to those who received ondansetron (p = 0.0022). No difference existed in the proportion of CR on day 1 of chemotherapy for those who received 10 mc/kg palonosetron compared to ondansetron. Adverse events were reported in 80% (n = 134) of patients who received 10 mc/kg palonosetron, 69% (n = 113) of those who received 20 mc/kg palonosetron, and 82% (n = 134) of those who received ondansetron. Adverse events attributed to palonosetron were headache (n = 4), infusion site pain (n = 1), and cardiac issues (n = 5).

Compared to ondansetron, 20 mc/kg palonosetron resulted in significantly greater control of CINV and minimal adverse events in pediatric patients receiving MEC or HEC.

To evaluate the immediate and short-term effects of relaxation training with the Yoga in Daily Life program on anxiety in patients with breast cancer

Patients were randomized to standard physiotherapy or standard physiotherapy plus the relaxation program after surgery for breast cancer. Physiotherapy was provided for one week. The experimental group also had one-hour group sessions daily in groups of three for one week. The program involved relaxation breathing exercises, visualization, and body scan, providing progressive muscle relaxation techniques. Those in the experimental group were given audiocassettes with instructions for home practice and were asked to do this daily for another three weeks.

• N = 32  
• AGE: All patients were over 40; further information was not provided.
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Patients with breast cancer having just undergone initial surgery

• SITE: Single site  
• SETTING TYPE: Multiple settings    
• LOCATION: Slovenia

• PHASE OF CARE: Active antitumor treatment

• Single blind RCT

• State Trait Anxiety Scale
• Patient diary of use of relaxation at home

There was significant reduction in anxiety in the experimental group (p < .01), while mean anxiety level in the control group remained essentially the same. State anxiety levels were significantly lower after physiotherapy and relaxation training in the experimental group compared to controls one hour after physiotherapy (p = .038).

Visualization and progressive muscle relaxation as provided in this program may help reduce anxiety after surgery among patients with breast cancer.

• Small sample (< 100)
• Risk of bias (no blinding)
• Risk of bias (no appropriate attentional control condition)
• Measurement/methods not well described
• Other limitations/explanation: Single blind only. There is no information about how often patients did the program at home after hospital discharge.

Relaxation therapy including visualization and progressive muscle relaxation as accomplished in this program may be helpful for patients to reduce anxiety. This study has limitations and does not provide strong support for effectiveness; however, these are very low-risk types of interventions that may be helpful to some patients.

To determine effectiveness of GM-CSF impregnated gauze in preventing and healing acute radiation-induced dermatitis

The study took place from November 1981 to March 1998. Group A (n = 37) was comprised of patients treated from 1981 to 1993 and received steroid creams (e.g., Betamethasone) as prophylaxis to radiation-induced dermatitis. Group B (n = 24) was comprised of patients treated from 1993 to 1998 and received steroid creams from the start of treatment and, following 20 Gy of radiation, also recieved GM-CSF impregnated gauze. Dressings were applied twice daily, 12 hours apart, for the rest of their treatment, while steroid cream was applied once a day, intermediately. The same doctors and technicians treated all patients during this time interval and were evaluated using a standard protocol. Findings from both groups were analyzed retrospectively.

• The study sample was comprised of 61 female patients.
• Median age of the sample was 74 years, with a range of 38–84 years.
• Patients had a diagnosis of invasive squamous cell carcinoma of the vulva.

The study took place at a university hospital in Greece.

The study used a retrospective design.

• Patients were examined clinically twice a week to estimate the cutaneous reactions to the groin areas, vulva, perineum, and labiocrural folds.
• Radiation dermatitis was classified in four grades using Radiation Therapy Oncology Group/European Organisation for Research and Treatment of Cancer (RTOG/EORTC) toxicity scoring.
• Pain was classified into four grades according to the subjective scale of Subjective Objective Management Analytic grading system.

Group B had overall lower subjective pain results (p = 0.0014). Those who had received the GM-CSF had overall less severe skin toxicity by RTOG/EORTC grading (p = 0.008).

GM-CSF impregnated gauze can be effective in preventing and healing radiation-induced dermatitis and in reducing the interruption intervals in radiation therapy for vulvar carcinomas.

• The sample size is small, with less than 50 patients.
• The study used a nonrandomized, retrospective design. Small non-randomized study, retrospective study, Low accumulation of participants:12 years of study for group A (37 patients)
• Group A had 12 years of study and Group B had 5 years of study.
• The study did not specify the breakdown of stage and grade of cancers in each group, and a wide range of patient characteristics in body mass were included.
• The study did not specify number of patients per group who had surgery before radiation, required a boost dose, required pelvic radiation, or had a treatment break.
• No explanation/validation of the SOMA pain grading system was provided.

To compare effectiveness of pegfilgrastim given as a prophylactic single-fixed dose versus daily filgrastim for incidence of febrile neutropenia (FN), severe neutropenia, treatment delays, and dose reductions in high-risk breast cancer patients receiving adjuvant dose dense chemotherapy. The secondary aim was to evaluate the impact of both granulocyte–colony-stimulating factors (G-CSFs) on patients’ overall survival (OS).

All patients treated with E-T-CMF received G-CSF in each cycle of chemotherapy. Patients randomized to receive ET-CMF received G-CSF only during intensified phase of CMF treatment; patients randomized to receive E-CMF-DOC or E-CMF-PAC received G-CSF during the intensified phase of epirubicin and CMF treatment. G-CSF was arbitrarily chosen by physicians. Patients received either single fixed dose of pegfilgrastim 6 mg on the next day after chemotherapy completion or daily administration of filgrastim 5 mcg/kg per day on days 2-7 of each cycle (compliance for filgrastim was more than 90% of cycles).

• N = 1,058 (529 filgrastim; 529 pegfilgrastim)  
• MEAN AGE = 52.3 years
• AGE RANGE = 22–79 years
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Postoperative high-risk patients with breast cancer receiving sequential chemotherapy with epirubicin, pacitaxel, or docetaxel, and CMF supported by G-CSF.
• OTHER KEY SAMPLE CHARACTERISTICS: No difference in menopausal status, higher % of patients had positive estrogen/progesterone status, no difference in tumor size, number of positive nodes, 92% completed treatment in filgrastim arm/95.3% in pegfilgrastim arm. Eligible patients came from sample of 2,123 participants in randomized trials: ACTR N12609001036202 (HE10/00) (reported in: Fountizilas, G et al. [2008]. Postoperative dose-dense sequential chemotherapy with epirubicin, paclitaxel and CMF in patients with high-risk breast cancer: Safety analysis of the Hellenic Cooperative Oncology Group randomized phase III trial HE 10/00. Annals of Oncology, 19(5):853–860). ACTRN12610000151033 (HE 10/05) and 989 participants in an observational study (protocol HE 10/08).
• INCLUSION CRITERIA: Exposure to pegfilgrastim or nonexposure (i.e., filgrastim) during treatment with dose-dense sequential chemotherapy E-T-CMF and E-CMF-DOC or E-CMF-PAC
• EXCLUSION CRITERIA: Patients treated with ET-CMF; patients whose supportive care switched from pegfilgrastim to filgrastim and vice versa throughout the period they received chemotherapy, as well as those who received pegfilgrastim on the same day as chemotherapy

• SITE: Multisite
• SETTING TYPE: Unknown
• LOCATION: Greece

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Elder care

• Retrospective cohort study with matched sampling using data from prior prospective randomized phase III trials and an observational study

Data endpoints were rates of FN, severe (grade 3 or 4) neutropenia, dose reduction, and treatment delay. FN was defined as body temperature > 38.2 °C and neutrophil count < 0.5 × 10⁹/L. Severe (grade 3 or 4) neutropenia was assessed according to standard NCI criteria. Dose reduction was defined as any reduction greater than 10% of the dose planned based on the protocol assigned, and treatment delay was defined as chemotherapy administration with more than a two-day delay from the planned date.

No difference in rates of febrile neutropenia comparing filgrastim and pegfilgrastim arms existed. A significant increase in rates of severe neutropenia, treatment delays, and dose reduction in patients receiving prophylaxis with filgrastim was reported. More than half of the total episodes of febrile neutropenia occurred during the first four cycles of chemotherapy. No difference in overall survival between the two groups existed.

This retrospective study with matched sampling using data taken from a former prospective study of high-risk patients with breast cancer receiving postoperative dose dense sequential epirubicin, paclitaxel, and CMF matched samples found that those patients receiving pegfilgrastim had reduced incidence and risk for FN, dose delay, and dose reduction compared to filgrastim. No difference was found in reducing rates of neutropenia.

• Risk of bias (no random assignment)
• Unintended interventions or applicable interventions not described that would influence results
• Measurement/methods not well described
• Questionable protocol fidelity
• This study was not designed for the purpose of evaluating neutropenia as a secondary analysis with post hoc matching. 
• Unknown sampling technique and methods for patient selection were poorly described. 
• Retrospective data were from two randomized trials evaluating breast cancer treatment regimens ACTR N12609001036202 (HE 10/00) - ACTRN12610000151033 (HE 10/05) and one observational study (protocol HE 10/08). 
• Treatment dose of filgrastim two to seven days compared to pegfilgrastim could be considered unequal dosing/timing support for neutropenia prophylaxis. 
• Selection bias with G-CSF chosen arbitrarily by physician
• Several different chemotherapy regimens had no data for incidence of grades of neutropenia or FN specific to the type of regimen comparing filgrastim versus pegfilgrastim.
• No data existed for sequelae of FN events or infectious events.

Pegfilgrastim 6 mg 24 hours after chemotherapy is more effective in reducing incidence/risk of FN, dose delay, and dose reduction compared to filgrastim 5 mcg/kg/d on days two through seven in high-risk patients with breast cancer receiving postoperative adjuvant sequential chemotherapy regimens with epirubicin, paclitaxel, or docetaxel and CMF. Prospective randomized, controlled trials are needed to validate these results and to determine specific treatment regimens/population where pegfilgrastim or filgrastim dose/timing may be more effective in preventing FN.

Medical records for 250 patients referred for lymphedema treatment during the first two years of the program were analyzed. Data from the charts of 138 patients were included if their affected arms were larger than their unaffected arms at baseline and one-year and follow-up measurements were available. Pre- and post-volumetric measurements were compared, and the correlation with age; body mass index; and type of surgery, chemotherapy, and radiotherapy was determined. Treatment was stratified on the basis of the treatment modality used for breast cancer management. The therapy could include all four components of CDT or some components could be omitted at the discretion of the therapists. Fifty-five percent of patients received all four components; 32% received manual lymphatic drainage (MLD) alone; and 13% with mild lymphedema received instructions and counseling for the home program, which included self-administered lymph drainage and exercises. All patients received compression wraps during the intensive phase. Data from 250 patients was reviewed, and 138 were included in the final analysis.

Mean age of the study sample was 54.3 years.

The study took place at an outpatient lymphedema clinic staffed by two certified Vodder therapists in Winnipeg, Canada.

Circumference was measured from the wrist to the axilla every 4 cm.

Complete decongestive therapy and MLD with exercises were associated with a significant reduction in lymphedema volume. The mean affected arm pretreatment volume was 2,929 ml, with a range of 1,474–5,879. The normal arm range volume was 1,320–4,299 with mean volume 2,531 ml. The mean difference at base line was 398 ml. The number of MLD or CDT sessions was related to mastectomy (versus lumpectomy) and chemotherapy. One year after treatment an absolute volume reduction of 188 ml to 2,741 ml was found.

• The study had a risk of bias because of no randomization or control group.
• The study is retrospective.
• The components could not be qualified.

Researchers analyzed the medical records for 250 patients referred for lymphedema treatment during the first two years of the program and included 138 in the final analysis. Patients were included if their affected arms were larger than their unaffected arms at baseline and one-year follow-up measurements were available. Pre- and postvolumetric measurements were compared. The correlation with age, body mass index, and type of surgery, chemotherapy, and radiotherapy was determined. Treatment was stratified on the basis of the treatment modality used for breast cancer management. The therapy could include all four components of complete decongestive therapy (CDT) or only some components were omitted at the discretion of the therapists. Fifty-five percent of patients received all four components and 32% manual lymph drainage (MLD) alone. Thirteen percent with mild lymphedema received instructions and counseling for the home program, which included self-administered lymph drainage and exercises. All patients received compression wraps during the intensive phase.

The mean age of patients in the sample was 54.3 years.

The study was conducted at an outpatient lymphedema clinic staffed by two certified Vodder therapists in Winnipeg.

Circumference was measured from the wrist to axilla.  

CDT and MLD with exercises were associated with a significant reduction in lymphedema volume. The mean affected arm pretreatment volume was 2,929 ml (range 1,474–5,879). The normal arm volume range was (1,320–4,299) with a mean volume of 2,531 ml. The mean difference at baseline was 398 ml. The number of MLD or CDT sessions was related to mastectomy (versus lumpectomy) and chemotherapy. After one year, absolute volume was reduced by 188 ml to 2,741 ml.

The study examines CDT and its components for a variety of patient needs and supports modifications of components of CDT and individualization of care.

• The study was not randomized. 
• No control group was provided for the study.
• Research relied on retrospective studies. 
• The components could not be qualified.

Evidence supports a need for expert therapists.

To investigate through a systematic review what topical treatments are currently advocated to manage acute skin reactions, including creams, ointments, and dressings, and what evidence there is to support the use of these treatments

Databases used were  MEDLINE and Cochrane Central Register of Controlled Trials. Keywords searched radiation therapy, epidermis, acute skin reactions, and therapy. Studies were included if they

• Were written in the English language
• Were controlled trials
• Provided information about the post-radiation acute skin reactions
• Had patients who were eligible for treatment.

No exclusion criteria were identified in the article.

Total references retrieved, evaluation method, and comments on the literature used were not reported.
 

• The final number of studies included in the review was 17, 15 studies in which an agent was used and 2 studies with washing only.
• The total sample size across studies was 1,968 participants, with a range of 10–194 participants in one arm and 39–366 participants in an entire study.
• Radiation sites included breast, head and neck, pelvic, chest, and abdomen.

Patients were undergoing active treatment.

• Washing: Significant decrease in itching, erythema, and desquamation was found in the group that washed with soap and water. A higher incidence of moist desquamation was found in the no washing group (33%) as compared to the washing with soap and water group (14%). 
• Aloe vera: One study showed a benefit at higher cumulative doses. Another showed no difference in maximum severity or time to onset of grade 2 radiodermatitis. Still another showed a detriment in that dry desquamation was higher in the aloe vera arm (70%) as compared to topical aqueous cream (41%). 
• Biafine (trolamine): Two studies showed no significant decrease in skin reaction when comparing no treatment, Aquaphor, Lipiderm, and Biafine. A third study showed a decrease in grade 2 or greater skin reaction, pain, and treatment interruptions. 
• Hyaluronic acid: Two studies showed a significant benefit (i.e., decreased severity and delayed onset of radiodermatitis) among patients receiving hyaluronic acid as compared to a placebo or unidentified control. 
• Corticosteroids: Of two randomized, double-blinded studies using corticosteroid cream as a prophylaxis, the study by Bostrom et al. found a 25% compared to 60% incidence of grade IV radiation dermatitis (corticosteroid vs. emollient). The second study did not find significant results in favor of corticosteroid. Another study showed no significant difference between a corticosteroid cream and a placebo. Still another study showed a significant difference between a corticosteroid cream and clobetasone, but most of the patients in both arms experienced moderate-to-maximum skin reactions. 
• Sulcrafate: A randomized study in head and neck cancer found no difference in erythema, but found a higher incidence of moist desquamation in the topical sulcrafate prophylaxis group. A large (N = 357) randomized study in head and neck (n = 107), breast (n = 229), and anorectal (n = 30) cancer by found no significant difference among the topical sulcrafate, topical aqueous cream, and no cream groups. Another study (N = 44) found a significant reduction in grade 2 radiodermatitis and more rapid healing in the topical sulcrafate group among patients with breast cancer. A different study (N = 39) compared topical sorbolene and sorbolene plus sulcrafate to manage grade 3 or greater skin toxicity and found no differences between the two groups. Another study showed no benefit of using oral sulcrafate as a prophylactic agent for late reaction in prostate cancer. A final study showed no benefit of using oral sulcrafate as a prophylactic agent in preventing skin reactions in head and neck cancer. 
• Barrier film: A study compared No-Sting barrier film to topical sorbolene as prophylaxis for moist desquamation among patients with breast cancer, showed a significant benefit. Another study  (N = 50 ) examined the use of Dermofilm in reducing pain and irritation. “Favorable” results were reported, but a larger study was recommended.
• Anti-microbials: No study results were found. The authors cautioned against using antimicrobials as a prophylactic agent related to our knowledge of drug resistance. 
• Dressings: One study examined healing after radiation treatment among 18 patients and found the mean healing time was 13 days. There was no comparison arm. Another study compared the use of sliver leaf nylon dressings applied to the perineum of 15 patients with anal or gynecologic cancers to historic controls. Patients who received the silver leaf nylon dressings had significantly reduced incidence of grade 3 and 4 reactions. A different study (N = 60) showed a higher incidence of radiodermatitis in the sulcrafate arm among patients with head and neck cancer.  Another study (N = 44) showed a significant benefit to breast cancer patients. One very small study (N = 15) showed a benefit of using sliver leaf nylon dressings to reduce grade 3 and 4 radiodermatitis of the perineum among anal and gynecologic cancers.

Washing with soap and water consistently demonstrated a benefit. The evidence for the use of aloe vera is mixed with one study showing harm. Biafine did not demonstrate a benefit nor a harm. Hyaluronic acid showed a benefit. Corticosteroid showed mixed results, with one study showing favorable results, two showing no increased benefit, and one study showing mixed results. Most of the evidence on topical sulcrafate shows no increased benefit in preventing and managing radiodermatitis. Dermofilm, a barrier film, showed a significant benefit in reducing moist desquamation among patients with breast cancer in one small study.

Additional studies with a larger sample and a blinded randomized controlled design are needed.

The aim of the study was to evaluate the efficacy of Vitamin E for the prevention of chemotherapy-induced peripheral neuropathy.

Patients who were to receive taxane or platinum-based chemotherapy were randomized to receive placebo or vitamin E 300 mg by mouth twice daily. Treatment was begun within four days of the first chemotherapy treatment and continued throughout treatment and for one month beyond completion of chemotherapy. Patient assessments were conducted at baseline, prior to each chemotherapy treatment, and at one and six months after chemotherapy.

• The total sample consisted of 189 participants, 82% female and 18% male.
• Sixty-one percent of the total sample were older than age 50 years.
• Participants had multiple tumor types. Breast cancer was most common (61%).
• Ninety-four percent were Caucasian. 
• Fifty-eight percent were receiving taxane and the rest were receiving a platinum-based compound.
• Patients were excluded if anticoagulatns, opiods, anticonvulsants, or other treatments were used for neuropathic pain.
   

The study was conducted at multiple outpatient locations that were part of the North Central Cancer Treatment Group.

Phase of care

• Active antitumor treatment

The study had a double blind,  randomized, placebo-controlled trial design.

• NCI-CTCAE, version 3.0
• Symptom experience diary
• Neuropathic-specific questions
   

 No significant differences were noted between groups regarding study outcomes.

The findings do not demonstrate an effect of Vitamin E oral supplements on peripheral neuropathy from chemotherapy.

• Measurement and methods were not well described.
• Measurement validity and reliability was questionable.
• Use and frequency of the patient diary are not well described.
• There were no objective measures of neuropathy. 
• No recognized self-report questionnaire was used.

 Findings do not support the use of Vitamin E to prevent chemotherapy-induced peripheral neuropathy. Nurses can guide patients regarding the evidence in this area.

To examine the efficacy and safety of fentanyl buccal tablets (FBT) for treating breakthrough pain in patients with cancer

A dose titration of FBT was administered a maximum of four times. If ineffective, FBT was titrated to the next dose. In this double-blind study, nine tablets were prescribed, six being BTP and three a placebo. One tablet was taken per episode of breakthrough pain.

• N = 136  
• AGE = 20 years or older
• KEY DISEASE CHARACTERISTICS: Cancer-related pain
• OTHER KEY SAMPLE CHARACTERISTICS: Japanese study

• SITE: Multi-site    
• SETTING TYPE: Inpatient    
• LOCATION: Hospitals in Japan

• PHASE OF CARE: Late effects and survivorship
• APPLICATIONS: Elder care and palliative care 

Double-blinded, placebo-controlled study

• Self-recorded pain diary using an 11-point Numeric Rating Scale (NRS)
• Questionnaire of subjects' impression of FBT

A significant difference was observed between the treatment groups and the primary endpoint. The mean was 2.4 for FBT treatment and 2 for the placebo. Regarding the effectiveness of FBT in the questioner survey, 22 and 56 subjects responded that analgesic onset of FBT occurred within 15 or within 15–30 minutes postadministraion.

In this study, FBT was well-tolerated in patients with cancer and was shown to relieve breakthrough pain in patients receiving around-the-clock opioids.

• Among the subjects who started effective dose titration, no effective dose was identified for 28 if the subjects, and 10 subjects did not receive a sufficient effect for breakthrough pain.
• Patients who did not complete the diary were still included.

FBT may be useful in cancer-related breakthrough pain with around-the-clock dosing of opioids.

To determine the extent to which pegfilgrastim reduces the risk of febrile neutropenia (FN) in Japanese women with early-stage breast cancer receiving docetaxel and cyclophosphamide (DC) chemotherapy

Pegfilgrastim at 3.6 mg or a placebo was administered subcutaneously on day 2 (at least 24 hours after DC chemotherapy) of a 21-day cycle. The study compared the incidence of FN between the pegfilgrastim and placebo cohorts. The incidence of FN during the first cycle of chemotherapy, incidence of hospitalization related to FN, incidence of grade 4 neutropenia, and percentage of patients who received antibiotics as a result of FN also were tracked.

• N = 346
• MEDIAN AGE = 50–51 years (range = 26–69 years)
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Stages I–III primary invasive breast cancer
• OTHER KEY SAMPLE CHARACTERISTICS: Not applicable

• SITE: Multi-site  
• SETTING TYPE: Not specified  
• LOCATION: Japan

• PHASE OF CARE: Active antitumor treatment

Randomized, double-blinded, controlled trial using pegfilgrastim versus a placebo

FN was defined as an absolute neutrophil count < 500 and an axillary temperature at or above 37.5°C on the same day or the following day. Complete blood counts were checked on days 1, 2, 8, 11, and 15 during cycle 1 and on days 1, 2, 8, and 11 of subsequent cycles. Axillary body temperature was measured daily.

Patients treated with pegfilgrastim experienced a significantly lower incidence of FN (1.2%) compared to those who received a placebo (68.8%; p < 0.001). The measurement of secondary endpoints also revealed significant differences between the two groups. None of the patients in the pegfilgrastim group required hospitalization for FN whereas 6.9% of the placebo group did (p < 0.001). Patients who received pegfilgrastim were significantly less likely to require antibiotics to treat FN (0.6%) than those in the control group (56.6%; p < 0.001). During the first chemotherapy cycle, only one patient (0.6%) in the pegfilgrastim cohort developed FN compared to greater than half (57.8%) of the placebo group (p < 0.001). Only 4% of the pegfilgrastim group developed grade 4 neutropenia during chemotherapy whereas all of the placebo group developed this grade (p < 0.001).

Previous studies demonstrated the value of pegfilgrastim in significantly reducing FN in European and North American patients with breast cancer receiving chemotherapy with docetaxel. This study confirmed the efficacy of pegfilgrastim (using a dose of 3.6 mg) for use in Japanese female patients with breast cancer receiving DC chemotherapy. These results suggest that additional studies should be designed to determine if the lower pegfilgrastim dose of 3.6 mg is not inferior to the standard 6 mg dose.

• Findings not generalizable
• Other limitations/explanation: This study used pegfilgrastim at 3.6 mg, not the 6 mg that is the standard dose in the United States and Europe. The authors chose 3.6 mg for their study population because this dose has been demonstrated to be effective in reducing the incidence of FN following docetaxel, doxorubicin, and cyclophosphamide chemotherapy in Japanese patients.

The focus of this study was to demonstrate pegfilgrastim's efficacy in female Japanese patients with breast cancer, and it used a smaller pegfilgrastim dose than is commonly prescribed in the United States or Europe. Additional study is warranted to determine the appropriate dosage of pegfilgrastim for this particular population.