To compare the effectiveness of a new biosimilar colony-stimulating factor (CSF) compared to reference CSF medications

Data were obtained from medical records in a tertiary cancer center for women with breast cancer who had received TAC chemotherapy. The febrile neutropenia management protocol was the same in all cohorts. Outcomes were compared across cohorts of patients who had received the biosimilar filgrastim, reference filgrastim, and pegfilgrastim.

• N = 420
• MEDIAN AGE = 50 years 
• AGE RANGE = 25–76 years
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: All women had breast cancer.

• SITE: Single site  
• SETTING TYPE: Not specified  
• LOCATION: Portugal

• PHASE OF CARE: Active antitumor treatment

• Retrospective cohort comparison

• Febrile neutropenia (FN) defined at body temperature ≥ 38 C and ANC ≤ 500 cell/mcl
• ANC
• FN-related treatment delays, reductions, or terminations

FN episode rates were 16%, 9%, and 16% in the reference filgrastim, pegfilgrastim, and biosimilar groups respectively. ANC at the time of FN diagnosis was lower in the biosimilar group in comparison with reference filgrastim (p = 0.015), and FN episodes were more frequent in the biosimilar group compared to both other groups (p ≤ 0.02). There were more chemotherapy delays in the biosimilar group compared with pegfilgrastim (p = 0.04). There were no other differences between groups.

Findings suggest the need for ongoing studies to determine comparative efficacy of this biosimilar CSF for prevention of febrile neutropenia and related complications in patients receiving cancer treatment.

• Baseline sample/group differences of import
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Key sample group differences that could influence results
• There were differences among cohorts in age, extent of disease, and use of antibiotic prophylaxis, which could have influenced results.

There are a growing number of biosimilar CSF agents being produced, and it is not yet clear if there are important clinical differences in bioavailability and activity in the clinical setting. Nurses should be aware of patients who are receiving biosimilar agents and monitor them for signs of FN or infection. Ongoing research is needed to determine safety and efficacy of these newer CSF agents over time.

• FINAL NUMBER STUDIES INCLUDED = 7
• TOTAL PATIENTS INCLUDED IN REVIEW = 616
• KEY SAMPLE CHARACTERISTICS: Average age = 61–72 years; patients in advanced stage of diseases in palliative care; four studies examined lactulose, senna, co-danthramer, misrakasneham, and magnesium hydroxide with liquid paraffin; three studies evaluated methylnaltrexone

PHASE OF CARE: End of life care
 
APPLICATIONS: Palliative care

All of the studies investigated variables in laxative types, opioid doses, and frequency of stools. Outcome measures included change in frequency of bowel movements, ease of defection, relief of systemic and abdominal symptoms of constipation, change in quality of life, and the use of rescue laxatives. There were no significant cross-findings, except all participants required rescue laxatives despite the initiation of a constipation prevention regimen. In two studies of (288) participants using methylnaltrexone versus a placebo, a statistically significant difference favored the intervention of rescue-free laxation 4 hours and 24 hours after the first dose of methylnaltrexone. Thirty percent of those participants experienced adverse effects. One study of 33 participants with methylnaltrexone showed a statistical difference favoring higher doses. Adverse effects were similar.

There were no recommendations for optimal laxative management of constipation in palliative care patients.

There was little concrete evidence and too many variables across the studies. There was no information on how the search was conducted. It was very difficult to follow the evidence summary.

The effectiveness of laxatives and the optimum management of constipation in palliative care patients requires further investigation involving the measurement of standardized, clinically relevant outcomes in a clearly defined population.

To test the efficacy of group psychotherapy to reduce distress and improve spiritual well being among patients with advanced or terminal cancer

Groups of 8-10 patients were formed and then randomized to either meaning-centered group psychotherapy (MCGP) or supportive group psychotherapy (SGP) as an active control. Questionnaires were completed at baseline, after eight weeks of therapy, and two months after completion of the intervention. MCGP focused on helping people develop or increase meaning. SGP focused on coping by encouraging patients to share concerns, describe experiences and emotions, and offer support and advice to each other. Groups met weekly, and all were facilitated by a social worker or clinical psychologist and doctoral student. Facilitators only conducted one type of session, clinical supervision was done weekly, and group sessions were audiotaped for random review for fidelity of the intervention

• N = 127
• MEAN AGE = 58.3 years (range = 27 -91)
• MALES: 30%, FEMALES: 70%
• KEY DISEASE CHARACTERISTICS: Multiple tumor types.
• OTHER KEY SAMPLE CHARACTERISTICS: Predominantly Caucasian ethnicity, but did include African Americans and Hispanics, overall average years of education was 15.9.

• SITE: Single site  
• SETTING TYPE: Outpatient  
• LOCATION: New York

• PHASE OF CARE: End-of-life care
• APPLICATIONS: Palliative care

• Randomized parallel group trial

• Functional Assessment of Chronic Illness Therapy Spiritual Well Being Scale
• McGill QOL questionnaire
• Beck Depression Inventory
• Hospital Anxiety and Depression Scale
• Hopelessness Assessment in Illness Questionnaire
• Memorial Symptom Assessment Scale
• Mini Mental State Exam
• Functional Social Support Questionnaire

Depression declined over time in all participants, but showed a significant decline among those in the meaning centered psychotherapy group, for those who completed at least three sessions (p < 0.05). The number of those completing three sessions is not provided.  All other measures, except anxiety, also improved over time and improved more in the meaning-centered group. Within group change scores showed moderate effects in both MCGP (d = 0.54) and SGP (d = 0.39).

Both types of group therapy used here were associated with improvement in depression and quality of life measures. Results were somewhat stronger for the meaning-centered therapy group.

• Risk of bias (no control group)
• Risk of bias (no blinding)
• Unintended interventions or applicable interventions not described that would influence results
• Measurement validity/reliability questionable
• Subject withdrawals at 10% or greater 
• Other limitations/explanation: There was no complete control group, and the active control intervention used here could also have positive effects on outcomes measured. Patients completed a battery of repeated measures which could have resulted in fatigue and testing effects. Only 65%-70% completed at least one session. Sample included those without clinically relevant depression or anxiety, so there was limited opportunity for improvement. Medications used that could have affected outcomes are not stated. Those in the MCGP had higher distress at baseline.

Group psychotherapy can be helpful to patients with advanced cancer for depression and quality-of-life issues, and both meaning-centered and supportive interventions may be of benefit. There are a number of study limitations here which mitigate the strength of these findings. Nurses can consider and advocate for these types of interventions for appropriate patients.

TOTAL REFERENCES RETRIEVED: 179

• FINAL NUMBER STUDIES INCLUDED = 13 (in adults), 5 (in children)
• TOTAL PATIENTS INCLUDED IN REVIEW: 483 adults
• SAMPLE RANGE ACROSS STUDIES: 9–181 patients
• KEY SAMPLE CHARACTERISTICS: All had refractory pain.

PHASE OF CARE: End-of-life care
 
APPLICATIONS: Palliative care

There were five double-blind, randomized, controlled trials, six uncontrolled trials, and one case series in adults. These showed descreases in pain ratings with oral, subcutaneous, sublingual, and IV ketamine. Reduced pain was shown in 50%–90% of participants. Dosages varied greatly across studies. Common side effects were sedation, somnolence, sensory illusions, dissociative feelings, blurred vision, anorexia, abdominal pain, insobriety, and dream disturbances. At higher doses delirium, impaired motor function, amnesia, panic attacks, mania, insomnia, and elevated blood pressure have been reported. Studies in children involved 16 patients treated with IV ketamine.

In adults with chronic pain that is not controlled with opioids, ketamine appears to decrease opioid use and improve pain control. There is insufficient evidence to form any conclusions regarding its use in children.

Few studies, most of which had small samples, particularly among children

Ketamine may be promising for the management of refractory pain that is poorly responsive to opioids; however, its use is associated with a variety of side effects. In most cases for chronic pain, ketamine has been studied in patients with very limited life expectancies. There is very little evidence in children. Further research is needed to fully establish ketamine's usefulness for pain control. If ketamine is used, nurses need to be aware of potential side effects and should monitor patients for them. There is no current evidence to show that ketamine is superior to other therapies for pain.

Patients diagnosed with lung cancer were randomized to attend a nursing clinic offering interventions for breathlessness versus best supportive care. The intervention consisted of

• A detailed assessment of breathlessness, what hinders it, and what aids it
• Advice and support for patients and families on management of breathlessness
• Exploration of the meaning of breathlessness, disease, and their future
• Training in breathing control techniques, relaxation techniques, and distraction exercises
• Goal setting to complement breathing and relaxation techniques, to improve function and social activities, and to help develop coping skills
• Early identification of problems needing pharmacologic or medical intervention
• Clinic visits once a week up to eight weeks and not less than three weeks.

Control: received standard of care for breathlessness; best supportive care involved standard management and treatment available for dyspnea. Nurse specialists used and were taught the intervention in same way, using a practice guideline to ensure correct delivery of the intervention.

The study reported on a sample of 119 patients with lung cancer; the goal was to recruit 150 patients for 90% power. Data from 16 patients were lost because a center was dropped from the study. Final sample included 51 in the intervention group and 52 in the control group.

The study was conducted in nursing clinics in six hospital settings in London, United Kingdom.

The study design included randomization to either intervention or control group.

Outcome measures were conducted at baseline and at four and eight weeks.

• VAS measuring breathlessness at worst and at best and distress caused by breathlessness
• World Health Organization (WHO) performance status scale
• HAD
• Rotterdam symptom checklist

The intervention group improved significantly at eight weeks in 5 of 11 items assessed.

• Breathlessness at best
• WHO performance status
• Level of depression
• Physical symptom distress and breathlessness from Rotterdam symptom checklist

Final sample included 51 in the intervention group and 52 in the control group. Attrition: 16 patients died, and 28 withdrew. Reasons for withdrawal: 1 improved condition, 16 had deterioration, 4 were unhappy with the assigned treatment arm, and 7 were for unknown reasons. Survival of patients who withdrew was significantly worse than the intervention arm (hazard ratio = 2.5; p < 0.05). Survival of all who withdrew versus nonwithdrawals was also significantly worse (p < 0.01). Overall survival of the intervention and control groups was not different. At baseline, both groups had high level of distress caused by breathlessness and associated functional impairment.

Overall conclusion is that patients attending nursing clinics for breathlessness experienced improvements in breathlessness, performance status, and physical and emotional status.

The analysis was based on the assumption that missing data from patients who withdrew because of poor outcomes were assigned a lower change score .The findings would have been more credible if outcomes were actually assessed. The method assumed that patients were able to show a change in either direction on rating scales, but patients who were on the extreme could only go in one direction. As stated in the Corner et al. (1996) pilot study, the contribution of each component of the intervention is unknown. Are all components needed to achieve the same outcome, or was one aspect of the intervention most significant?

To investigate which approach, psychoeducation or support, provides the greatest benefit to patients with early-stage breast cancer

Women who had undergone surgery for breast cancer were randomly assigned to receive either a support group (SG) or psychoeducational group (PEG). The PEG intervention consisted of health education about breast cancer and side effects of treatments, stress management (including training and a DVR in progressive muscle relaxation), enhancing problem solving skills, and psychological support from research staff and other group members. Sessions were two hours weekly for five weeks. The SG intervention was part of routine care, consisted of three weekly two-hour sessions on topics women introduced for discussion. A surgeon, physical therapist, and a breast cancer survivor attended the group for 30 minutes each to provide information in a question and answer format. Study assessments were done at baseline, at 2 months, 6 months, and 12 months.

• N = 367  
• MEAN AGE = 54.75 years
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: All had breast cancer.  Most were stage T1 or T2.  More than 70% had radiotherapy, 50% had chemotherapy, and 60% had endocrine therapy. All had surgery.
• OTHER KEY SAMPLE CHARACTERISTICS: 67% were married, 38% were employed, and slightly more than 50% had more than a high school education.

• SITE: Multi-site  
• SETTING TYPE: Outpatient    
• LOCATION: Norway

• PHASE OF CARE: Transition phase after active treatment

• Randomized, controlled trial with active control

• Hospital Anxiety and Depression Scale
• Mini Mental Adjustment to Cancer scale
• Life Orientation Test, revised (measuring optimism and pessimism)

Ninety-seven percent of patients attended all sessions in both groups. Both groups showed significant decline in anxiety. With adjustment for baseline anxiety level, there were no differences in anxiety levels between groups after the intervention. Depression declined significantly in all patients over time, with no difference between groups. At various time points, there were differences in mental adjustment to cancer between optimists and pessimists, but these differences were not consistent, and there were no significant differences at 12 months. Within the first six months, there was greater decline in anxiety and depression among those in the PEG group.

Women in both groups showed reduced anxiety and depression over time. There were no differences in results between those receiving a support group versus a psychoeducational intervention except in the first 6 months. Psychoeducation may be more helpful in the short term at a time when patients are likely to have more distress.

• Risk of bias (no control group)
• Risk of bias (no blinding)
• Other limitations/explanation: Unclear if repeated measures could have created a testing effect. Content in both groups was similar, raising the question of whether these two interventions were substantially different from each other. Groups received a different number of sessions, which could have accounted for the few differences seen. 

Findings suggest that both psychoeducational and support group interventions can be beneficial to women dealing with breast cancer. In the short term, findings suggest that psychoeducation may yield some greater benefits, but there were no long-term differences based on the type of intervention provided. It may be beneficial to incorporate more psychoeducational components into routine support group and supportive interventions.

To examine the insurance data of cancer survivors to determine lymphedema prevalence and to assess the affect on specific clinical health outcomes and healthcare costs after the receipt of a pneumatic compression device (PCD) among the identified study group of cancer survivors with lymphedema

The researchers performed a retrospective analysis of health claims data from 2007–2013. D-identified administrative health claims data from deidentified Normative Health Information (dNHI) database (34 million insured) were used through OptumInsight. Researchers did not have access to the data but rather instructed Optum employees to cull the data.  

• ICD-9 codes were used to select patients with cancer.
• ICD-9 codes for lymphedema (457.0, 457.1, and 757.0) were sought among the patients with cancer.  
• The Healthcare Common Procedure Coding System (HCPCS) codes for a PCD, E0651, or E0652 were searched among patients with cancer and lymphedema.
• Every participant was required to have had 12 months of insurance coverage prior to the receipt of a PCD, which then carried through another 12 months.  
• Any patients who received a replacement pump were excluded.

• N = 1,065   
• AGE = 9.2% aged 19–44 years, 53.2% aged 45–64 years, and 37.6% aged 65 years or older
• MALES: 20%, FEMALES: 80%
• CURRENT TREATMENT: Not applicable
• KEY DISEASE CHARACTERISTICS: Patients with cancer with insurance for 12 months prior to and after the receipt of a PCD (index date). Baseline period was 12 months prior to receipt of the pump. Follow-up was 12 months after receipt of the pump.  
• OTHER KEY SAMPLE CHARACTERISTICS: Nineteen percent were obese.

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

A retrospective study of insurance data from 2007–2013. The researchers compared the rate of identified clinical healthcare outcomes and their costs in each setting for the year prior to the receipt of a PCD to the rates and costs after receipt of the PCD.

After the sample was identified, the affect of the receipt of the PCD was determined by searching for specific claims codes and their costs during the 12 months before and after receipt of the PCD. Specific health outcomes, such as hospitalization, outpatient visits, physical therapy, episodes of cellulitis, and courses of lymphedema physical therapy, were determined by the American Medical Association place of service codes, and the clinical costs were designated as lymphedema related if the primary or secondary diagnoses were ICD-9: 457.0, 457.1, 757.0. Total cost was the sum of the payments for lymphedema claims. Continuous variables were tested pre PCD minus post PCD with a paired t test.

• Prevalence: In 2007, a prevalence of lymphedema cancer survivors existed at 0.95% in the database. The prevalence rose to 1.243% in 2013.
• Health outcomes: While receipt of a PCD appeared to have no affect on the rate of hospitalizations for patients with lymphedema, it did appear to reduce the percentage of patients attending outpatient hospital visits (p < 0.0001) and the percentage of patients using physical therapy (p < 0.0001). In addition, the number of patients diagnosed with cellulitis decreased significantly (p < 0.0001).  
• Healthcare Costs: The total healthcare cost for patients with cancer-related lymphedema during the baseline year was $62,190 with inpatient costs accounting for $15,458, outpatient costs accounting for $21,222, and office visits accounting for $15,278. However, lymphedema-attributed costs were only 4% of the total, or $2,243. A significant decrease in total cost by 18% occurred in the 12-month period after receipt of the PCD (from $62,190 to $50,857) (p < 0.0001).

• A study of the sample database showed an increasing prevalence of cancer-related lymphedema.
• The healthcare outcomes data showed a reduction in the rate of hospitalizations, outpatient visits, physical therapy, and cellulitis as well as a significant healthcare cost reduction the year following the receipt of a PCD.

• Risk of bias (no control group)
• Findings not generalizable
• The stages of cancer are not known or accounted for, and some of the costs may reflect the burden of cancer care. 
• The burden of disease is greater at the onset of lymphedema than when the limb swelling stabilizes. Likewise, the reduction of physical therapy reflects perhaps that the patients had physical therapy and then received a PCD for maintenance. Having a pump does not necessarily mean patients use the pump.
• It is unknown if the patients received a compression garment. 
• Other codes could have been looked at, including 97140, manual lymph drainage. 
• Too many confounding variables exist, making the results nongeneralizable. 
• As the authors pointed out, inaccuracy in coding cannot be ruled out. The low obesity/overweight rate of 19% was below the national average, which is currently 68.8%.

Lymphedema prevalence among cancer survivors continues to be defined. Whether a PCD improved healthcare outcomes or reduced healthcare costs is unclear. Nevertheless, healthcare outcomes and costs were reduced. A PCD may benefit outcomes and reduce costs. Even with the limitations of this study, lymphedema needs to be diagnosed, treated early, and managed to reduce the disease burden.

To report the six-month follow-up effects of a mindfulness stress reduction training program on perceived stress, depression, anxiety, post-traumatic stress symptoms, positive states of mind coping, self-efficacy, and mindfulness among patients treated for cancer

Patients with a previous cancer diagnosis were recruited and randomized into an intervention group or a waiting list control group. Questionnaires were sent to participants directly by mail after randomization at three and six months. The waiting list participants were scheduled to participate in the intervention program after six months. The intervention involved eight-week, two-hour, weekly sessions of mindfulness training. The sessions consisted of experiential and group exercises. The training was an adaptation of the Jon Kabat-Zinn program of mindfulness-based stress reduction (MBSR) from the Stress Reduction and Relaxation Clinic at the Massachusetts Medical center in Shrewsbury. For details of the program, the authors refer to a previous publication.

• N = 71  
• MEAN AGE = 51.8 years (SD = 30–65 years)
• MALES: 1, FEMALES: 70
• KEY DISEASE CHARACTERISTICS: Study was open to patients with varying cancer diagnoses who were not undergoing current radiation or chemotherapy treatment. Fifty-four patients had been treated for breast cancer, 10 for gynecological cancer, five for lymphatic cancer, one for pancreatic cancer, and one for neck cancer.
• OTHER KEY SAMPLE CHARACTERISTICS: Ten patients were diagnosed within the last year, 39 within one to two years, and 22 more than two years ago. Thirty-nine patients had a bachelor’s degree and 30 had full- or part-time employment. Twenty-three participants used antidepressants.

• SITE: Not stated/unknown    
• SETTING TYPE: Outpatient    
• LOCATION: Stockhom, Sweden

• PHASE OF CARE: Transition phase after active treatment
• APPLICATIONS: Elder care

Randomized, controlled intervention and wait-list groups; random selection of participants was done consecutively using a random sequence of numbers indicating group assignment

• The SPSS software’s random selection was used for the sequence of numbers.
• Power calculations were conducted to decide the adequate number of participants.
• Perceived Stress Scale (PSS)
• Hospital Anxiety and Depression Scale (HADS)
• Impact of Event Scale Revised (IES-R)
• Positive States of Minds (PSOM)
• Coping Self-Efficacy Scale (CSES)
• Five-Facet Mindfulness Questionnaire (FFMQ)
• Meditation practice: The frequency of meditation practice before and during the study period was assessed with one question.  
• The intervention effect was analyzed using multivariate repeated measure analysis of covariance (MANCOVA).

Compared to participants in the control group, the intervention group showed a larger increase in mindfulness at the six-month follow-up. There were no differences in any other outcomes between the intervention and control groups. 60% of the participants reported regular meditation practice during the intervention period. Continued meditation practice was associated with a significant reduction in post-traumatic stress symptoms of avoidance. Change in psychological distress, positive states of mind, and coping self-efficacy did not show any significant differences between the control and intervention group. There were trends in a greater reduction of perceived stress. There was a significant change in the intervention group reporting increases in mindfulness. Postintervention, 38% of the participants in the intervention group continued to meditate regularly. Those in the intervention group who continued to mediate regularly after the intervention had a significant reduction in post-traumatic avoidance symptoms at the six-month follow-up (t = 2.5, p < .5). No other significant intervention effects on psychological outcomes were found.

The study indicates the need to better understand the mechanism behind the effects of MBSR and the potential modification of mindfulness interventions to promote a sustained benefit over time. Future studies should examine the potential of additional intervention tools to encourage postintervention meditation practice. The short-term positive effects of mindfulness training and the particular time when mindfulness intervention might have the most positive effects should be further studied.

• Small sample (< 100)
• Baseline sample/group differences of import
• Risk of bias (no blinding)
• Risk of bias (sample characteristics)
• Key sample group differences that could influence results
• Findings not generalizable
• Subject withdrawals ≥ 10%
• Other limitations/explanation: Many measurement tools

The lack of sustained, positive effects from mindfulness training suggests that booster sessions or tools for increasing postintervention adherence to mindfulness practice would be beneficial. Assisting patients in integrating mindfulness training into everyday life would benefit patients as the increased dispositional level of mindfulness moderates the influence of stress on both depression and perceived health.

STUDY PURPOSE: To provide a review of best evidence for chemotherapy-induced peripheral neuropathy (CIPN) treatments

TYPE OF STUDY: Systematic review

• FINAL NUMBER STUDIES INCLUDED = 13 
• TOTAL PATIENTS INCLUDED IN REVIEW = 685
• SAMPLE RANGE ACROSS STUDIES: 16–201

PHASE OF CARE: Active antitumor treatment

Interventions included were vitamin E, glutamine, goshajinkigan, alpha-lipoic acid, omega-3 fatty acids, acupuncture, massage therapy, acetyl L carnitine, and physical activity. All interventions showed mixed findings, with findings suggesting that acetyl L carnitine may worsen symptoms in patients receiving chemotherapy.

Limited evidence exists to show the effectiveness of integrative therapies for the prevention or treatment of CIPN.

• Limited number of studies included
• No quality evaluation
• Low sample sizes

Very limited evidence exists for effective interventions to prevent or manage CIPN. More research is needed in this area.

To determine whether pyridoxine can prevent hand-foot syndrome (HFS) in patients with cancer being treated with capecitabine

Eligible patients were randomized to receive either pyridoxine at a dose of 100 mg per day plus capecitabine-containing chemotherapy or a placebo plus capecitabine-containing chemotherapy. The placebo pills did not visually match the pyridoxine pills although they were similar. The primary investigator and the treating oncologist were blinded to treatment groups. The potency of the pyridoxine was not tested, but the drug came from multiple lots over the course of the study. Pyridoxine or placebo treatment was initiated on the first day of capecitabine treatment. Adherence was assessed by a phone call to patients during the third week of each treatment cycle as well as by pill counting. Data were collected by the treating oncologist after each cycle of chemotherapy for up to four cycles. Three topical agents that contained urea or lactic acid were not permitted to be used during the study, Aqua Care^® medicated calamine lotion (.3%), Dr. Scholl’s^® Smooth Touch deep moisturizing cream, and Dove^® moisturizing cream wash.

• N = 77  
• MEAN AGE = 54.1 years
• MALES: 38%, FEMALES: 62%
• KEY DISEASE CHARACTERISTICS: All patients were diagnosed with a cancer requiring capecitabine therapy and had never received capecitabine before.  
• OTHER KEY SAMPLE CHARACTERISTICS: Ethnicities included African American (53%), white (21%), Hispanic (18%), and Asian (7%). Inclusion criteria included age reater than 18 years old, an Eastern Cooperative Oncology Group score of 0–2, a life expectancy > 6 months, not taking vitamin B supplements, no prior HFS, no contraindication to chemotherapy, and adequate renal and liver function. Exclusion criteria included previous treatment for HFS, hypersensitivity to pyridoxine, immunosuppression or positive human immunodeficiency virusserology, and pregnancy or lactation.

• SITE: Single-site    
• SETTING TYPE: Not specified    
• LOCATION: John H. Stroger Jr. Hospital of Cook County, Chicago, IL (Hematology and Oncology Division)

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

Randomized, double-blinded, placebo-controlled trial

• The National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 3 toxicity grading criteria was used to grade HFS.

HFS developed in 26% of patients in the pyridoxine group (n = 38) and 21% patients in the placebo group (n = 39). In both groups, 16% developed grade 2 or 3 HFS. No significant differences in HFS grades were observed in the two arms of the study.

Based on a review of the study’s primary endpoints (e.g., HFS incidence, grade), there is no true benefit from using prophylactic vitamin B6 in patients with cancer receiving capecitabine-containing chemotherapy.

• Small sample (< 100)
• Risk of bias (sample characteristics)
• Key sample group differences that could influence results
• Other limitations/explanation: Low percentage of patients of Asian ethnicities; included patients who received doses of capecitabine that were lower than the standard dose, which might explain the lower incidence of HFS in the studied population

The results of this study demonstrated that administering pyridoxine (vitamin B6) to patients receiving capecitabine-containing chemotherapy did not lower the incidence or grade of HFS. Other strategies should be implemented to prevent capecitabine-induced HFS.