RESOURCE TYPE: Expert opinion

Unable to discern any information about scope or evidence used in this article. Expert opinion.

Recommendations for the management of low-grade diarrhea include symptomatic treatment with hydration (oral) and electrolyte replacement. Prednisone 1 mg/kg can be used as necessary followed by a four-week taper. For high-grade diarrhea, patients should be treated with high-dose IV steroids (methylprednisolone 2 mg/kg) one or two times per day, which should be tapered for improvement of symptoms over four weeks, and IV hydration with electrolyte replacement. For symptoms that improve after five to seven days, or for relapse after steroid taper, infliximab 5 mg/kg once every two weeks is suggested as an alternative immunotherapy.

Limited clinical experience with managing irAEs exists because of immune checkpoint inhibitors therapy and because only patients with non-small cell lung cancer were considered.

Additional studies need to be conducted to determine the best management practice for gastrointestinal side-effect management with immune-checkpoint blocking antibodies across a variety of cancer types.

STUDY PURPOSE: To evaluate the literature with the reported use of identifying arm and breast lymphatics using the axillary reverse mapping (ARM) procedure, and the utility of using ARM with sentinel lymph node biopsy (SLNB) and axillary lymph node dissection (ALND), as well as the oncologic safety of its use, by reviewing ARM lymph node metastasis and the convergence of SLN and ARM nodes

TYPE OF STUDY: General review/\"semi\" systematic

• FINAL NUMBER STUDIES INCLUDED: N (studies) = 15 studies
• TOTAL PATIENTS INCLUDED IN REVIEW = 747 (566 ALND studies, 181 SLNB studies)
• SAMPLE RANGE ACROSS STUDIES: 12–143 patients
• KEY SAMPLE CHARACTERISTICS: Patients undergoing ALND or SLNB for breast cancer were included in the study; however, varying inclusion criteria existed between studies.

PHASE OF CARE: Diagnostic

The identification rates of ARM nodes and lymphatics during ALND ranged from 17%–91% and for SLNB, 38%–50%. The applicability in the clinical setting is questionable, given the low rates of ARM/lymphatics identification during both procedures. The broad ranges in ARM/lymphatic identification necessitates improvement in the procedure through standardization of procedure protocols. Metastatic involvement was reported higher in ARM nodes in patients with cancer burden that is extensive in the axilla (0%–43%) and in patients with SLN/ARM node convergence (up to 64%); therefore, further study to understand the connectivity of breast and arm lymphatics is necessary to improve the rate of clinical applicability with the ARM procedure. The outcome measure of lymphedema incidence with or without the ARM procedure varied with no conclusive evidence. Length of follow-up, small follow-up samples, and differences in lymphedema measures and definitions made the outcome measure relative to lymphedema incidence unattainable.

• Limited number of studies included
• No quality evaluation
• Low sample sizes
• Knowledge regarding the most commonly reported times to onset of lymphedema was not evident by the length of follow-up reported in most of the studies.
• No standardization
• No evaluation of evidence
• The need for standardization of study protocols are necessary to facilitate treatment fidelity and overall rigor of the research.

The implications for nursing would be in the area of patient education, if and when the ARM procedure becomes a standard of care. For the present, nurses need to be knowledgeable of clinical trials involving ARM.

To examine the effects of guided imagery on patient distress and symptoms during radiotherapy.

Patients received instruction on guided imagery during the first few days of radiotherapy treatment and participated in sessions with a nurse immediately prior to radiotherapy treatments. Sessions lasted about 30 minutes and involved relaxation and breathing exercises with visualization of a calming experience and setting. Patients were provided with a CD for home practice. Study measures were performed at baseline and at the end of radiotherapy treatments. Pre- and postsession pulse, blood pressure, and thermal biofeedback measures were obtained.

• The study reported a sample of 66 women; only 11 remained for the final measures.
• Mean age was 57 years (range 28–77).
• All patients had breast cancer and were undergoing active radiotherapy. Most were also receiving adjuvant chemotherapy and/or hormonal therapy.

• Single site
• Outpatient

A quasiexperimental design was used.

• Distress thermometer and visual analog scale (VAS) subscales
• EuroQol EQ-5D questionnaire
• Thermal biofeedback

EQ-5D subscale scores for anxiety and depression declined from a mean of 1.42 to 1.26 by the end of treatment (p = 0.01). There was a decline in overall distress scores (p = 0.04), but no significant changes occurred in depression, sleep, or fatigue scores. Patients showed immediate postsession reduction in respiratory rate and blood pressure but no significant differences in thermal biofeedback findings.

The findings suggest that relaxation and imagery can be helpful to patients during radiotherapy.

• The study had a small sample size, with less than 100 patients.
• The study had risks of bias due no control group, no blinding, and no random assignment.
• Patient withdrawals were 10% or greater.
• It is not known whether patients used the intervention between sessions.

Findings suggest that relaxation therapy and imagery can be helpful to patients during radiotherapy treatment; however, this study had substantial design limitations that limited the strength of the evidence. Relaxation and imagery, and particularly patients’ use of these techniques on their own, pose no patient risks and can be a practical intervention that is helpful to patients during active treatment.

To pilot a randomized trial examining the effectiveness of cognitive behavioral therapy (CBT) and aromatherapy massage (AM) in reducing emotional distress in patients with cancer and to compare the differences in effectiveness between the CBT and AM groups

Participants were randomized to one of two treatment groups: CBT or AM. The study did not explain how the CBT intervention was actually implemented, except to note that trained and accredited therapists delivered the therapy. The study listed the topics covered in the CBT sessions but did not describe the procedures, group-session format, etc. AM was described as standard massage with 20 essential oils, delivered by a trained aromatherapist, in a quiet room with minimal talking. Each group received one of these interventions along with “treatment as usual” (standard care). Both groups were offered, after study entry, up to eight one-hour sessions delivered over 10 weeks. Time interval between treatments was not delineated.

• The study reported on a sample of 36 patients (39 enrolled; 3 dropped out before postintervention assessment).
• Mean patient age was 52.5 years.
• The sample was 79% female (n = 31) and 21% male (n = 8).
• The sample was composed mostly of patients with breast and colorectal cancer but also included patients with lung or prostate cancer, lymphoma, and myeloma.
• The stage of disease and other characteristics, such as type of treatment, was unspecified. Also unspecified was whether participants were receiving pharmacologic treatment for emotional distress (anxiety or depression) or some other psychological support. Study participants were screened, by means of the Hospital Anxiety and Depression Scale (HADS), for anxiety and depression. The initial cut score was 8. (An initial cut score of 8–10 is considered borderline for anxiety or depression.) Four months after study initiation, the cut score was increased to 11. (A cut score of 11 or higher is considered clinically significant.) The demographics of the CBT and AM groups were similar except in regard to gender: The CBT group contained only one male; seven males were in the AM group. In both groups, the total sample size was too small to allow researchers to detect significance differences.

• Single site
• Outpatient setting
• An urban teaching hospital, recruited from outpatient oncology clinics, in London, England

Patients were undergoing multiple phases of care.

The study, a pilot, was a randomized, single-blind, prospective, repeated-measure clinical trial with no control group. Measures were collected at baseline and at three and six months postintervention.

• Hospital Anxiety and Depression Scale (HADS): For screening and participant eligibility
• At baseline: Treatment preferences and beliefs about effectiveness and satisfaction with either CBT or AM
• Profile of Mood States Short Form (POMS-SF): Total mood disturbance score (TMS), summed from six subscales
• Psychological Outcomes Profiles (PSYCHLOPS): Six-point Likert scale to assess distress, duration, and impact of two patient-derived problem areas
• EuroQol: A health-related quality-of-life measure
• Client event recall: Asking patients about their experience with the therapy
• Consultation and Relational Empathy (CARE) measure: To quantify each patient’s perception of relational empathy with the therapist

The study was drastically underpowered, with too small a sample to allow researchers to draw meaningful conclusions. The study produced no statistically significant findings.

• With low recruitment (8%), a protracted period (two years, but still called a pilot?), and an underpowered design that lacked a strong conceptual grounding and rationale, this study produced no meaningful conclusions and suggested no direct application to practice.
• Both therapies, AM and CBT, were well received and posed no risk of harm.
• To treat the \"whole patient,\" nonpharmacologic interventions should be offered, when possible, to patients with cancer.

• The study had a small sample size, with less than 100 participants.
• The study had risks of bias due to no control group and as the result of sample characteristics.
• Findings are not generalizable.
• The study used nonrandom (convenience) sampling with a low accrual rate.
• Screening criteria changed four months into the trial, but data do not differentiate participants (defined only as patients with HADS greater than 8).
• Rationale for sampling time points is unclear (e.g., why should researchers expect an effect three to six months after AM?).
• Time between last treatment (AM or CBT) and three-month sampling is not noted, so relating outcomes to intervention is difficult.
• Participants were allowed to select the  number of therapy sessions to attend, which is certainly a weakness.
• Whether CBT was delivered in a group format cannot be ascertained.

AM may be beneficial as a treatment for short-term anxiety. This poorly designed and controlled pilot study offers no other immediate nursing implication.

To evaluate the efficacy and safety of palonosetron for management of chemotherapy-induced nausea and vomiting (CINV) in pediatric patients

Prior to every chemotherapy cycle, patients were randomized to receive either 0.25 mg palonosetron 30 minutes before chemotherapy or 8 mg/m² IV ondansetron every 8 hours. Patients or guardians used a self-administered questionnaire to record emetic events and intensity of nausea during the next seven days. They also were asked to record secondary effects of palonosetron.

• The study involved 50 cycles of chemotherapy.
• The actual number of patients was not reported.
• The study consisted of 16% patients aged 72 months or less and 84% of patients between 72 months and 16 years.
• The study group was 69% male and 31% female.
• Patients had multiple types of cancer, with the most frequent diagnosis being osteosarcoma. 
• Chemotherapy regimens included etoposide, ifosfamide, cisplatin, carboplatin, epirubicin, cyclophosphamide, adriamycin, or irinotecan.
• Study participants who had received previous chemotherapy ranged from 42%–88%. Those who had experienced CINV with previous chemotherapy ranged from 36%–80%.

The study was conducted at a single site in Mexico.

All patients were in active treatment and pediatric.

This was a randomized, single-blind comparative study.

The authors developed a questionnaire for patients to record emesis and nausea intensity. Nausea was defined as absent, mild (decrease in oral intake), or intense (no oral intake).

• Complete control of nausea and vomiting was reported in a significantly higher proportion of cycles with palonosetron during the first three days (p < 0.001); however, on day 4, a higher percentage of cycles with ondansetron reported complete control (p = 0.002).
• From days 4–7, a higher proportion of cycles with palonosetron were associated with less nausea, but these differences were not statistically significant.
• Reduction in nausea was greater in patients older than 72 months (p = 0.000).
• As used in this study, treatment with palonosetron cost $111 USD, compared to $250–$284 USD for the ondansetron regimen.
• No clinically significant adverse effects were reported.

Palonosetron appears to be safe and effective in pediatric patients. A regimen with single-dose palonosetron may be less expensive than multiple-dose ondansetron.

• No appropriate control group was included.
• The study was not designed as a true crossover trial, and analysis was done by chemotherapy cycle, rather than by patient.
• Age groupings for subgroup analysis were very broad, given the maximum age inclusion criteria.
• Actual individual patient demographics were not clear in this report.
• Nausea was defined according to oral intake, rather than the actual experience of the symptom. Although actual symptoms may be difficult to evaluate in very young children, many patients of the age groups would be expected to be able to express actual symptoms.
• Although analysis was done according to prevalence of complete control, complete control as used in this study was not defined.
• No adherence to diary documentation was reported.

Palonosetron may be effective in this population, and single-dose palonosetron regimens may be a cost-effective alternative to multiple-day treatments. Improved symptom measurement methods in pediatric patients are worth exploring.

To compare the efficacy and tolerability of the granisetron transdermal delivery system (GTDS) to palonosetron for the control of chemotherapy-induced nausea and vomiting (CINV) following moderately emetogenic chemotherapy (MEC)

Eligible patients were randomized to either the granisetron group (GP) or palonosetron group (PG). The GP group received transdermal granisetron (one patch, seven days) for the first chemotherapy cycle and palonosetron (IV 0.25 mg/day, one day) for the second chemotherapy before receiving MEC in two consecutive cycles. The PG received palonosetron for cycle 1 and granisetron for cycle 2. Granisetron was applied 24–48 hours prior to the start of chemotherapy in both groups and left in place for seven days. IV injection of palonosetron 0.25 mg was given 30 minutes prior to chemotherapy on day 1. Both groups received dexamethasone (IV 10 mg) within 30 minutes before chemotherapy on day 1. All subjects were followed for a total of 15 days. Patient diaries were used to record the following: emetic episodes, use of rescue medications, patch adhesion, and severity of nausea (which was evaluated daily until day 4) by the CTCAE. Adverse events and vital signs were also recorded.

• N =188   
• AGE = 29–83 years
• MALES: 59.3% GP, 65% PG  
• FEMALES: 40.7% GP, 35% PG
• CURRENT TREATMENT: Chemotherapy
• OTHER KEY SAMPLE CHARACTERISTICS: Receiving MEC combining 5-fluorouracil/leucovorin with Irinotecan (FOLFIRI) or oxaliplatin (FOLFOX) in two consecutive chemotherapy cycles

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

PHASE OF CARE: Active antitumor treatment

Multicenter, randomized, open-label, cross-over, active-controlled, phase IV study

• Complete response in acute and delayed phases—no emesis and no use of rescue medication
• Functional Living Index-Emesis (FLI-E)

The GTDS cycles showed noninferiority to palonosetron cycles during the acute phase. Complete responses were achieved by 75% of patients in the GTDS cycles and 80% in the palonosetron cycles. There was no significant difference in complete response rate of acute phase after the first cycle and the second cycle between the GP group and PG group (p = 0.405, p = 0.074).  Similar proportions of compete response were noted during the overall period of 0–72 hours. In both groups, small portions of patients had severe nausea during the acute phase (3 of 175 in the GTDS cycle and 1 of 175 of the palonosetron cycle). Satisfaction scores were measured by FLI-E and were equal in both groups for patients in the PG group, but in the GP group, patients' scores were lower in the palonosetron cycle versus GTDS. There were no differences in adverse events between the groups.

This study demonstrated that the granisetron transdermal delivery system is noninferior to palonosetron for relieving CINV in patients receiving MEC. Patients' satisfaction was higher with the GTDS than with palonosetron.

The GTDS is noninferior to palonosetron for patients receiving MEC. This may be a valuable option for patients who are unable to swallow pills or who have impaired absorption.

To assess the use of Traumeel S for the prevention and  treatment of mucositis. To replicate a previous study that showed benefit in using Traumeel S.

Patients were entered into COG Cancer Registry and identified by number. Study medications were identified by number only. Traumeel S and a placebo identical in appearance and taste were provided by Heel (company that makes Traumeel S). Patients were assigned by block randomization to receive Traumeel S or placebo (1:1). Participants were stratified by TBI (yes/no), allogeneic versus autologous transplant, and by COG institution versus Israeli institution. A pharmacist drew up the solution into an oral syringe, and patients were instructed to rinse the mouth vigorously, maintain it in their mouth, and then swallow. The medication was administered five times per day. Patients were instructed to be NPO for 30 minutes after the medication. Any type of analgesia was allowed, and the doses were normalized to morphine equivalents. Treatment began on the day before transplant and ended when patients met the completion criteria and no later that the 20th day post-transplant.

The study was comprised of 195 patients, age 3 to 25 years.

MALES (%) 62.6 (56 in Traumeel S group, 70 in placebo group), FEMALES (%) 37.4 (44 in Traumeel S group, 30 in placebo group).  

KEY DISEASE CHARACTERISTICS: ALL (55 patients), AML (36 patients), CNS tumor (11 patients), lymphoma (26 patients), solid tumor (37 patients), hemoglobinopathy (13 patients), other (8 patients), and missing (4 patients)

OTHER KEY SAMPLE CHARACTERISTICS: Median age in Traumeel S group = 12 years (range 3 to 24). Median age in placebo group = 11 years (age range 3 to 25)

SITE: Mutli-site

SETTING TYPE: Inpatient setting

PHASE OF CARE: Active treatment

CLINICAL APPLICATIONS: Pediatrics (and to age 25), palliative care

International, multi-center, double-blind, placebo-controlled, randomized clinical trial.

• Three-grade modified Walsh Scale for mucositis    
• Five-grade World Health Organization oral toxicity scale
• Amount of narcotic equivalents per day
• Number of days of parenteral nutrition
• Number of days of nasogastric feeding
• National Cancer Institute Common Terminology of Adverse Events v. 3.0

No statistical significance between the placebo group and the Traumeel S group on chemotherapy-induced mucositis. Also, no statistically significant difference in narcotic use or days of total parenteral nutrition or nasogastric feeding.

Traumeel S is not a useful complementary medication for the prevention and treatment of oral mucositis.

Multiple centers with variable data collectors and a high non-compliance rate may have impacted this study.

Complimentary and alternative medicine (CAM) is an important topic for our patients, and it is important to study these therapies. There was no mention of adverse outcomes from using Traumeel S, but there was also not a benefit in this study. It is important to help our patients use their financial resources wisely and to invest their energies into treatments that are beneficial.

To evaluate the efficacy of an internet-based psychological intervention in reducing post-traumatic stress symptoms (PTSS) and anxiety

This study included cognitive-based therapy that included two Internet-based, 45-minute writing sessions per week (10 writing sessions total) with standardized text messaging and instructions. It included two modules, one to reproduce the cancer-related event and then another to build coping strategies. Treatment was provided by two trained psychologists via Internet messaging. Outcomes were assessed by several tools (listed under Measurement Instruments) and then analyzed.

• N = 20  
• MEAN AGE = 27.3 years (SD = 4.8 years)
• MALES: 30%, FEMALES: 70%
• KEY DISEASE CHARACTERISTICS: Long-term survivors of pediatric cancer; cancer diagnosis before patients were 19 years old
• OTHER KEY SAMPLE CHARACTERISTICS: Mean time since diagnosis = 13.8 years; education < 11 years (15%), high school 12–13 years (85%); types of cancer included leukemia (40%), lymphoma (30%), central nervous system tumor (20%), soft tissue sarcoma (5%), and germ cell tumor (5%); history of relapse = 20%

• SITE: Single-site    
• SETTING TYPE: Outpatient    
• LOCATION: Germany

• PHASE OF CARE: Late effects and survivorship
• APPLICATIONS: Pediatrics

Single-arm pilot study with a pre/post three-month follow-up design

• Post-traumatic stress Diagnostic Scale (PDS) 
• Hospital Anxiety and Depression Scale (HADS) 
• Short Form of the Fear of Progression and Relapse Questionnaire (FOP-SF) 
• Sociodemographic and medical information

Twenty participants completed the intervention. PTSS scores and anxiety/fear of progression/relapse significantly declined by the end of intervention. There was a significant decrease in symptoms of depression. All effects were sustained at three months postintervention except depression.

Internet-based psychological interventions (Onco-STEP) are an innovative way to address psychological late-term effects in young adult long-term survivors of pediatric cancer, specifically improving PTSS scores and anxiety. It also may help to reduce the fear of progression or relapse and symptoms of depression.

• Small sample (< 30)
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Risk of bias (no appropriate attentional control condition)  
• Risk of bias(sample characteristics)
• Key sample group differences that could influence results
• Findings not generalizable
• Subject withdrawals ≥ 10%
• Other limitations/explanation: Dropout rate 28.6%; single-arm pilot study with no control group; subjects were recruited from a former study; mostly female

Although this was a small study, it demonstrates an innovative way to reach young adult survivors and assist them with their psychological needs. As nurses, we need to be open to new methods of assessment and intervention for psychosocial care in various populations.

To evaluate the safety and initial efficacy of endoscopic ultrasound-guided celiac plexus neurolysis (EUS-CPN) in patients with painful unresectable pancreatic cancer

All patients enrolled in the study received the EUS-CPN procedure once. As per protocol, patients were placed in left lateral position under either general anesthesia with propofol or IV deep sedation with midazolam, according to the patient’s personal preference.  If the patient was found to have unresectable disease and the fine-gauge needle aspiration findings were consistent with pancreatic cancer, CPN was performed under EUS guidance.  All procedures were performed by a single endosonographer. The 22-gauge injection needle was inserted into the targeted central position, advanced to the celiac trunk, and injected bupivacaine 1% and then a single injection of 10–15 ml of absolute alcohol. Each patient was monitored closely for two hours post-procedure in order to identify any immediate complications such as hypotension, tachycardia, pain enhancement, or paraplegia. Each patient was called 48 hours post-procedure to monitor for late effects such as diarrhea, hypotension, fever, or paraplegia.

• N = 32  
• AGE RANGE: 37–68 years
• MEAN AGE: 56.93 years
• MALES:  69%, FEMALES: 31%
• KEY DISEASE CHARACTERISTICS: All had diagnosis of inoperable pancreatic body-tail cancer without prior chemotherapy and presented with pain that necessitated opioid analgesia.
• OTHER KEY SAMPLE CHARACTERISTICS: Their visual analog scale (VAS) pain score was greater than 3 at the time of endoscopy, and diagnosis of pancreatic cancer was confirmed by cytopathological examination.

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

• PHASE OF CARE: Multiple phases of care
• APPLICATIONS: Elder care, palliative care

• Prospective cohort study of patients undergoing EUS-CPN for local advanced pancreatic adenocarcinoma without prior chemotherapy and pain requiring opioid analgesia
• Conducted at a tertiary medical center

• Assessment of pain and quality of life
  • Before the procedure, the Brief Pain Inventory-Short Form (BPI-SF) and the Functional Assessment of Cancer Therapy-General (FACT-G) (version 4) were administered to each patient. The BPI-SF evaluates the presence of pain using a 0–10 VAS to report average pain, minimum and maximum pain, and response to painkillers over the seven-day period preceding the intervention. The BPI-SF also evaluated the relationship of pain to activities such as walking, working, sleeping, social relations, and enjoyment of life. The FACT-G questionnaire evaluated physical well-being, social/family well-being, emotional well-being, and functional well-being. Each patient’s present health status was evaluated by means of self-reported VAS (0–100).
• Follow-up
  • Pain and quality of life were re-evaluated at the two-week follow-up visit (two weeks post-procedure). The BPI-SF and FACT-G were administered again, and any change in opioid daily usage was documented. Pain improvement was defined as a decrease of 2 or more points in pain score as compared to the index value without concurrent increase in oral opioid intake.

Each participant had one session of EUS-CPN performed. No complications or side effects were noted. Overall, the average pain decreased by 2 or more points in 28 of 32 patients (87.5%). Physical, emotional, and functional well-being scores were improved after the procedure. Family and social support did not change after the procedure. Pain relief experienced with use of medication after the EUS-CPN intervention (90%) did not significantly increase compared to prior (80%). The rate of pain alleviation, defined as a decrease of 2 or more points in pain score, was 75% in short-term follow-up. All BPI-SF measures of effects of pain showed improvement after EUS-CPN, including walking, general activity, working, sleeping, and enjoyment of life.

The FACT-G quality of life questionnaire showed physical, functional, and emotional well-being improved after EUS-CPN, as well as subjective appreciation of life. Functional status, work capability, sleeping, and enjoyment of leisure activities improved. Difficulties in physical status such as lack of energy, poor physical condition, and feeling ill were improved. No differences were found in coping with the disease (i.e., hopefulness and satisfaction with one’s own behavior), acceptance of the disease, enjoyment of life, or fulfillment at work.

This study demonstrated that EUS-CPN provides a safe and effective method of short-term pain management in patients with inoperable pancreatic body-tail cancer. Diminishing pain resulted in improvements in the areas of functional status, sleeping, and quality of life. Acceptance of the illness and enjoyment of life did not change.

These results would have increased substantiation with further research that included longer-term follow-up as well as investigation into multiple doses with a control group for further comparison to determine more explicitly the results demonstrated here and the relational cues to the intervention (as opposed to simply having a different subjective experience at the date of the two-week follow-up visit).

• Small sample (less than 100)
• Risk of bias (no control group)
• Risk of bias (no random assignment)
• Risk of bias (no appropriate attentional control condition)
• Other limitations/explanation: Excluded patients receiving any cancer therapy other than painkillers

These findings present an area for further nursing attention and related research. With no adverse effect noted during or post-procedure, this presents an opportunity for further research to determine comparison of results when a control group is implemented, increased frequency/doses of the intervention, and follow-up that continues at similar intervals but for a longer time (as appropriate with increased exposure to the intervention at regular intervals).

To identify the most effective dose of palonosetron when combined with fixed doses of dexamethasone in patients receiving chemotherapy of emetogenicity level 3 or 4 on the National Comprehensive Cancer Network (NCCN) 2004 guidelines

Patients were randomly assigned to receive a single IV dose of palonosetron of 0.075, 0.25 or 0.75 mg over 30 seconds administered 30 minutes before the first dose of chemotherapy on day one. Daily episodes of vomiting, severity of nausea, and patient satisfaction were recorded daily in patient diaries. Care providers recorded the use of rescue medications. All patients received 8 mg IV dexamethasone 45 minutes prior to the palonosetron. Patients had to be hospitalized for the first two days. Follow-up assessment was done on days 6–10 and days 14–20.

• The study consisted of 204 participants.
• The average age 61.4 years.
• The majority of participants were female (56.9%).
• The most common cancer types were non-small cell lung cancer (NSCLC), breast cancer, and small cell lung cancer.
• The most common chemotherapeutic agents used on day one were carboplatin, paclitaxel, cyclophosphamide, epirubicin, and doxorubicin.
• All patients had Eastern Cooperative Oncology Group (ECOG) performance statuses of 1 or 2.

The study was conducted at multisite, inpatient settings in Japan.

All patients were in active treatment.

This was a randomized, double-blind trial.

• Patient diaries were used to record nausea severity via a Likert-type scale.
• Complete response (CR) was defined as no emetic episodes and no use of rescue medication in the first 24 hours.

• CR rates in the acute phase were 85.1%, 82.4%, and 92.8%, respectively for the 0.075-, 0.25-, and 0.75-mg palonosetron dose groups.
• No significant dose response was found.
• For nausea in the delayed phase, no clinically relevant dose response was found and CR rates for delayed nausea ranged from 62.7%–71%.
• The most commonly reported events were headache and constipation. Neither prevalence nor severity appeared to be palonosetron-dose related.
• In patients who received a combination of anthracyclines and cyclophosphamide, the CR rates for delayed and overall phases of care appeared to be somewhat dose related.

Palonosetron in single doses from 0.075 to 0.75 mg appeared to be well tolerated. Optimal dosages for prevention and management of chemotherapy-induced nausea and vomiting (CINV) in these patients remain unclear.

• The authors concluded that higher palonosetron doses are indicated; however, the study results did not support this conclusion.
• Either a single emesis or what could amount to intractable emesis appears to have counted as a single episode. This approach, while useful for the purpose of analysis, does not seem realistic and appropriate.
• The method of rating severity of nausea was not well described.
• Patient compliance with diary recordings and missing data were not discussed.

The optimal dosage of palonosetron in patients who are receiving moderately emetogenic chemotherapy (MEC) remains unclear. A range of doses appears to be well tolerated.