To determine the feasibility of administering a flavonoid-rich adjunctive treatment (Concord grape juice) for the management of chemotherapy-induced nausea and vomiting (CINV)

Eligible patients were randomized to either the experimental group, which received Concord grape juice, or the control group, which received a placebo composed of water, sweeteners, food-grade acids, natural grape essence, and food coloring (but no fruit juice).

Both groups drank 4 oz. of the grape juice or placebo beginning the evening of the treatment day and 30 minutes prior to meals for seven days following each of four chemotherapy treatments; an additional 4 oz. could be taken as needed for nausea. All patients received standard medical management of CINV.

• The sample consisted of 77 participants.
• In the experimental group, the median age was 54.1 years (SD = 12.4 years); in the control group, the median age was 54.5 years (SD 12.7).
• The experimental group was 80% female, and the control group was 81% female.
• Diagnoses included breast (70%), lung cancer (6%), lymphoma (6%), non-Hodgkin lymphoma (NHL) (5%), colon (3%), and prostate (3%).

The study was conducted at a single outpatient setting in northeastern United States.

All patients were in active treatment.

This pilot study was a double-blind, randomized clinical trial.

• Patients recorded the amount of grape juice or placebo consumed and usual and weekly food intake in daily logs.
• Patients measured CINV daily using the Rhodes’ Revised Index of Nausea and Vomiting (INV-R).
• They also used the Multiple Affect Adjective Checklist, Revised (MAACL-R) and the 16-item McGill Quality-of-Life Questionnaire (MQOL).
• A self-report instrument using a Likert-type format was used to measure perceived control over decision making at baseline and the cancer treatment experience at the end of the data collection period.

• Nausea and vomiting frequency, duration, and distress were lower for experimental group members, although a high attrition rate (50%) resulted in insufficient power to detect statistically significant differences over time.
• Dropout rates suggested that the intervention was undesirable or participation in the study was too much of a burden.
• A few participants commented on the sweetness of the juice or placebo which they reported was difficult to drink when nauseated.
• Greater levels of anxiety, depression, and hostility at baseline were related to nausea and vomiting, quality of life, and perceived control over decision making.

This study did not show any benefit of grape juice flavonoids for management of CINV.

• The sample was small sample, with fewer than 100 participants.
• Initial analyses of clinical outcomes showed some differences over time; however, because of the limited sample size and the attrition rate, statistically significant differences were not seen for the majority of outcomes.
• The reliance of the self-report measures may have contributed to over- or underreporting of symptoms.

The effect of grape juice flavonoids on CINV should be investigated further with a larger sample to determine whether preliminary findings are supported. Use may be limited because of intolerance of very sweet juice.

To provide guidelines for antimicrobial prophylaxis and management of febrile neutropenia (FN) for adult outpatients with neuropathy.

The resource was a consensus-based guideline. A literature search examined articles indexed in MEDLINE (January 1987–April 2011).  A systematic review of 47 articles from 43 studies were included in the analysis. Keywords included terms for malignant diseases; terms for neutropenia, infection, or fever; and terms for clinical guidelines, systematic reviews, meta-analyses, or clinical trials.

Articles were included if they were fully published English language reports on the topics of antimicrobials for the prevention of infection in neutropenic outpatient patients with cancer (with or without fever), direct comparisons of outcomes between inpatient and outpatient management of FN in patients with cancer, and methods to quantify risk of complications in patients with cancer and FN. Articles were excluded if they were meeting abstracts, commentaries, letters, editorials, case reports, and nonsystematic reviews.

Patients were undergoing the active treatment phase of care.

A table of recommendations addressed three main areas of concern: (a) preventing infection in patients at risk for neutropenia undergoing chemotherapy, (b) identifying which patients with cancer and FN may be safely treated as outpatients, and (c) identifying interventions for the outpatient management of FN.

• Patients should be systematically assessed for risk of FN and/or need for granulocyte colony-stimulating factor prophylaxis.
• Antimicrobial prophylaxis is recommended only if neutropenia is expected to be profound (absolute neutrophil count [ANC] <100) and more than seven days in duration.
• Annual influenza immunization is recommended for all patients undergoing chemotherapy and their family members.
• Drugs of choice are an oral fluoroquinolone for antibacterial prophylaxis and an oral triazole for antifungal prophylaxis.
• Patients with FN should be assessed using the Multinational Association for Supportive Care in Cancer (MASCC) score or Talcott’s rules to guide whether outpatient treatment is safe. In addition, patients should be compliant, live near the hospital, and have a caregiver and access to transportation at all times.
• If treating FN as an outpatient, it is recommended to begin empiric antimicrobial treatment within one hour and observe for four hours.
• Drugs of choice for outpatient empiric treatment of FN are an oral fluoroquinolone plus amoxicillin/clavulanate (or plus clindamycin for those allergic to penicillin).

• Limited data exist from randomized, controlled trials regarding health outcomes or comparing the efficacy and safety of alternative regimens of antimicrobial prophylaxis.
• The MASCC score revealed a high rate of false-positive results.

These guidelines help clinicians determine which patients require hospitalization and which can safely be treated in the outpatient setting. The guidelines also aid in selecting appropriate antimicrobial prophylaxis for neutropenic patients.

The purpose of the study was to compare effects of two different doses of G-CSF in pediatric patients receiving high-dose chemotherapy.

Patients receiving induction chemotherapy were randomly assigned to receive either 5 mcg/kg or 10 mc/kg G-CSF daily after the first and second chemotherapy induction courses. Differences in number of neutropenic days, hospital days, number of febrile neutropenic episodes, episodes of infection, use of IV antibiotics, antifungal therapy courses, number of transfusions, cost of supportive care, and estimates of event-free survival.

• 46 total participants
• Median age was 9.03 years, with a range of 0.05–21 years.
• Females made up 53% of the sample; males made up 47% of the sample
• All participants had previously untreated AML or myelodyplastic syndrome and were receiving induction chemotherapy.
• Specific chemotherapy protocol used is described.
   

Single-site inpatient location

The phase of care was active antitumor treatment.

The application was for pediatrics.

Double-blind, randomized, controlled trial

• NCI Common Toxicity Criteria [v.2.0]
• Neutropenia was defined as a neutrophil count of less than 0.5 x 10⁹/L
• Event-free survival was defined as time between randomization and disease recurrence, death, secondary malignancy, or last follow-up.
   

No significant differences were noted between study groups in number of neutropenic days, episodes of febrile neutropenia, days of hospitalization, episode of antibiotic and antifungal therapy, transfusions, or cost of supportive care. There was no difference between groups in proportion of complete responses, or estimates of event-free and overall survival.

No difference was noted in measured outcomes between groups of patients treated with two different doses of G-CSF.

• Small sample (less than 100 participants)
• It is unclear if patients were given prophylactic antibiotics or antifungal therapy, which would have affected related outcomes. Sample included both patients who did and did not receive allogeneic stem cell transplantation.

Findings suggest that lower daily doses of prophylactic G-CSF can be as effective as higher doses in pediatric patients during induction chemotherapy. Dosage and timing of prophylactic G-CSF is not fully clear.

To examine the effects of antibiotic prophylaxis on bacterial infections, antibiotic sensitivity, and nasal and rectal culture findings

Prophylaxis was outpatient administration of antibacterials after myelosuppressive therapy and the onset of an absolute neutrophil count ≤ 0.5 x 10⁹/L in the absence of fever or other indicators of infection. Prophylaxis was discontinued when the neutrophil count exceeded 0.1 x 10⁹/L. All patients were on a study protocol in which the prophylactic regimens used were amended on an ongoing basis based on short-term findings. In general, patients received IV cefepime every 12 hours, or vancomycin every 12 hours with oral cephalosporin, oral ciprofloxacin, or IV cefepime. All patients received antifungal prophylaxis with voriconazole or echinocandin, pneumocystis prophylaxis, and did not receive colony-stimulating factors. Patients were trained to administer the IV antibiotics. Patients who presented with neutropenia and fever were admitted and treated empirically. Patients had surveillance cultures of the nares and rectum at each admission for detection of resistant organisms. Patients were grouped according to the type of prophylaxis received: A: oral cephalosporin only, B: protocol as described.

• N = 103 
• AGE RANGE = 1–21 years, 46% were 10–21 years
• MEDIAN AGE: 8.7 years
• MALES: 52.4%, FEMALES: 47.5%
• KEY DISEASE CHARACTERISTICS: All had acute myeloid leukemia (AML)
• OTHER KEY SAMPLE CHARACTERISTICS: 73% were Caucasian, 23% African American

• SITE: Single site  
• SETTING TYPE: Multiple settings  
• LOCATION: St. Judes Hospital

• PHASE OF CARE: Active antitumor treatment

• Retrospective analysis of a previous prospective trial

• Infection and febrile neutropenia defined by the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) 3.0
• Fever–oral temperature of 38º C persisting for one hour, or single oral temperature of 38.3º C
• Blood stream infection as defined by Centers for Disease Control and Prevention criteria

Most common infectious events were neutropenia with fever of unknown origin; bloodstream infections; and infections of the skin/mucosa, GI tract, and upper respiratory tract. There was no difference between groups in episodes of fever of unknown origin. Patients who received the full prophylaxis protocol had significantly fewer infectious episodes of any type during induction 1 (p = 0.002), induction 2 (p = 0.0002), and consolidation (p = 0.001). Patients receiving the full vancomycin-based regimen had higher incidence of vancomycin-resistant enterococci (VRE) isolates from surveillance, and three cases also had VRE bacteremia.

Outpatient IV antibiotic prophylaxis was feasible and reduced the incidence of documented infection and bacteremia. Patients receiving vancomycin-based prophylaxis had lower rates of infectious events and had higher incidence of VRE isolates from surveillance.

• Risk of bias (no random assignment)

This study showed that provision of outpatient IV antibiotic prophylaxis to children, administered by their parents, was feasible and effective in reducing infectious events. Findings point to the ongoing need for managing the intensity and duration of prophylaxis to minimize development of resistant bacterial strains.

To determine the effectiveness of fluoroquinolone prophylaxis in neutropenic patients with cancer.

Databases accessed included MEDLINE, EMBASE, the Cochrane Library (including its database of trials, CENTRAL, and its two databases of systematic reviews, CSDR and DARE), Web of Science, International Pharmaceutical Abstracts Online, and BIOSIS through October 2005. In addition, the reference sections of eligible trials and reviews.

Key words included quinolones, neutropenia, and infection prophylaxis.

To be included, eligible trials met the following criteria: (a) randomized, controlled trial; (b) compared the use of prophylactic fluoroquinolone as a single agent with a placebo; (c) included adults (defined as those at least 16 years of age) who experienced episodes of neutropenia due to cancer chemotherapy and/or hematopoietic stem cell transplantation; and (d) measured the incidence of all-cause mortality and febrile episodes. Randomized, controlled trials published only as abstracts were excluded.

Eight clinical trials with 2,721 patients were evaluated.

One reviewer abstracted the data and two reviewers independently assessed the methodologic quality using established validity criteria. Disagreements were resolved by consensus. A random effects model, the DerSimonian and Laird method, was used for pooling dichotomous data to estimate relative risk and the associated 95% confidence interval. Heterogeneity was analyzed and subgroup analyses were performed. All analyses were performed using RevMan Analyses [v4.2.7].

Three trials included only patients with acute leukemia, two trials included patients with solid tumors, including lymphomas, and three trials included patients with both hematologic and solid malignancies. All studies including patients with hematologic malignancies or hematopoietic cell transplantation were conducted in the inpatient setting and all studies of patients with solid tumors, including lymphoma, were conducted in the outpatient setting. Fluoroquinolone prophylaxis was started at the time of initiation of chemotherapy in five studies, within 4,896 hours of the initiation of chemotherapy or stem cell infusion in two studies, and in one study it varied depending on the expected neutropenia due to a specific regimen (day 5, day 8, or day 15 post-chemotherapy). Prophylaxis duration varied among studies. The fluoroquinolones used in these studies included levofloxacin in two studies, norfloxacin in one study, ciprofloxacin in two studies, ofloxacin in one study, enoxacin in one study, and pefloxacin in one study. The duration of neutropenia was described in four studies and ranged from 2–55 days. It was defined as an absolute neutrophil count (ANC) of less than 500/mm³ in all but one study, in which less than 1,000/mm³ was considered as neutropenia. Compliance was reported to be good or excellent in five out of eight trials. All trials were double-blind. Allocation concealment and the method of randomization were adequate in five trials and unclear in three trials. Intention-to-treat analysis was performed in seven of eight trials.

Fluoroquinolone prophylaxis statistically nonsignificantly decreased all-cause mortality when compared with placebo (3.9% versus 4.5%, RR = 0.76, 95% CI [0.54, 1.08=, p = 0.13). There was no inconsistency in the results between studies (I² = 0%). Subgroup analyses of studies conducted as inpatient and outpatient also suggested a statistically nonsignificant decrease in mortality with prophylaxis. Compared to placebo, fluoroquinolone prophylaxis resulted in a nonsignificant reduction in the rate of febrile episodes (39% versus 31%, RR = 0.76, 95% CI [0.55, 1.03], p = 0.08). However, there was a large inconsistency in the results between studies (I² = 95.8%), so additional subgroup analyses were performed. The pooled RR was 0.34 (95% CI [0.14, 0.8]) for the two trials in outpatients and 0.9 (95% CI [0.7, 1.16]) for the six trials conducted in the inpatient setting (p for interaction, < 0.001). The pooled RR was 0.6 (95% CI [0.33, 1.1]) for the two trials that used levofloxacin and 0.89 (95% CI [0.65, 1.22]) for the six trials that used fluoroquinolones other than levofloxacin (p for interaction, 0.01). The RR estimate of 0.76 (95% CI [0.7, 0.83]) from the single inpatient trial that used levofloxacin was possibly different to the estimate from the other inpatient trials (p for interaction, 0.08).

Meta-analysis from eight randomized, placebo-controlled trials demonstrated a statistically nonsignificant decrease in all-cause mortality in neutropenic patients who received fluoroquinolone prophylaxis. The data indicated that fluoroquinolone prophylaxis reduced the risk of febrile episodes in neutropenic outpatients with solid tumors, including lymphomas, but not in hematology inpatients and autologous hematopoietic cell recipients. Patients with solid tumors have a lower risk of febrile neutropenia and are more responsive to prophylaxis. In contrast, hematology inpatients and autologous hematopoietic cell recipients have a high rate of febrile neutropenia and are less responsive to prophylaxis.

There was significant inconsistency between the studies that suggests that additional research is needed.

The data suggested that levofloxacin may be more effective than other fluoroquinolones. Based on the available evidence, there was no significant decrease in all-cause mortality in neutropenic patients who received fluoroquinolone prophylaxis.

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Aptent camur cogo esca ex exerci natu refero suscipit tamen. Blandit dolore nimis sed singularis vel. Abigo blandit exerci luctus. Ibidem lenis metuo pagus pertineo quadrum sudo volutpat. Acsi appellatio cogo consectetuer iaceo populus ulciscor. Causa distineo gemino importunus magna paulatim sit veniam. Dolus eligo paratus si torqueo turpis. Amet incassum iusto jus plaga. Abico appellatio distineo duis eros macto secundum suscipere wisi. Facilisis jugis melior secundum. Olim pagus quadrum singularis uxor vicis ymo.

Abluo augue bene ideo inhibeo mauris probo quadrum refero validus. Camur et usitas. Abigo appellatio immitto minim mos vel venio volutpat. Consectetuer haero macto praesent turpis. Abdo acsi appellatio interdico quia veniam voco. Abbas jumentum nunc persto quidem venio. Augue ea humo lucidus minim patria probo rusticus volutpat. Natu nostrud proprius quidem. Abluo antehabeo camur eu jus lobortis melior quidne ymo. Cogo comis dolus esca lucidus probo uxor vulputate. Autem jus nunc nutus obruo persto sino. In macto persto praesent. Consequat ea esse et humo iriure neo qui. Accumsan aptent erat fere pagus pneum praesent te. Adipiscing eligo hendrerit interdico letalis tamen tincidunt zelus. Acsi at commodo decet hendrerit lobortis luptatum premo ratis velit. Abbas augue modo. Dignissim iriure modo paratus praesent quadrum veniam. Ad decet imputo iustum lobortis nisl nulla paratus quibus saluto. Abluo brevitas dolus ibidem minim odio turpis. Distineo interdico rusticus vicis virtus. Antehabeo camur dignissim importunus letalis obruo olim paulatim tincidunt turpis. Duis lobortis melior plaga quadrum quidem roto sed. Bene ea letalis loquor neo ut. Eros exputo iusto lenis ludus nisl nunc pertineo uxor. Abbas facilisis lucidus singularis. Exputo illum lobortis. Jus meus plaga praemitto quadrum quidem tego vindico volutpat. Conventio huic jus lobortis quidem. Cui ea eu exerci haero laoreet praemitto quis sudo tum. Camur consequat exputo gravis iaceo natu nibh probo qui velit. Feugiat nulla occuro valde. Erat et gemino quibus usitas vereor virtus ymo. Ibidem paratus premo torqueo. Accumsan aliquam autem defui letalis nobis. Duis immitto nobis ymo. Diam haero roto. Elit eros laoreet neo patria sino ymo. Aliquip huic scisco turpis. Camur eum facilisis ibidem obruo. Erat metuo nobis praesent quia utrum validus. Iusto jugis nostrud. Illum immitto interdico iusto proprius quibus verto vindico voco. Appellatio loquor probo qui ratis. Abigo appellatio sino virtus. Importunus paratus roto. Capto cogo consectetuer dignissim esse haero immitto ludus macto vulputate. Consequat cui exputo odio persto quadrum tamen tation. Abico caecus comis esse immitto importunus lucidus melior suscipere. Facilisis gemino luptatum quidem. Ea lobortis nulla valetudo vereor volutpat. Iriure macto sagaciter. Adipiscing feugiat huic premo refero refoveo vulpes.

Ea obruo praemitto similis. Augue brevitas dignissim erat gilvus immitto obruo valde. Eu haero loquor melior nisl roto saluto singularis tation ulciscor. Capto damnum eu gravis refoveo suscipit ulciscor vicis. Abigo aliquam conventio refoveo voco. Bene blandit hos nulla nunc obruo occuro persto tamen utrum. Brevitas nunc quidne verto zelus. Abigo adipiscing cui esse os pertineo sed te validus. Bene consectetuer decet eu gravis lucidus. Exputo ille lenis oppeto rusticus ut. Aliquip blandit iriure proprius scisco validus. At causa exputo gravis immitto. Abdo lucidus ludus probo tincidunt. Autem commoveo enim euismod feugiat gilvus hos tum. Abdo commoveo nutus scisco tation te volutpat. Gravis ludus sudo. Consequat metuo persto praemitto volutpat. Abigo ludus premo tego. Abluo causa gemino gilvus meus nostrud oppeto sit ut zelus. Acsi brevitas hos nutus secundum sino volutpat zelus. Duis iusto sed usitas zelus. Augue lobortis mos nunc paratus tation vicis voco. Brevitas eros ex gemino neque os validus vero verto virtus. Enim interdico quibus tation utrum. Ludus luptatum mos valde. Aptent consectetuer decet esca euismod olim similis suscipit wisi. Eros modo sudo volutpat. Facilisis iusto similis. Antehabeo dignissim feugiat iusto mauris refoveo rusticus tego typicus vero. Appellatio bene nobis populus. Abigo ad iustum melior odio quia quibus wisi. Dolor turpis valde zelus. Conventio duis metuo qui saluto. Lucidus refoveo sed valetudo. Augue facilisi letalis oppeto. Capto damnum eros lenis nutus paratus ut. Distineo pertineo typicus. Amet commodo consequat exerci modo natu tum usitas ymo. Abdo eligo hendrerit paratus populus ut. Abigo aliquam brevitas laoreet lenis wisi. Blandit commoveo exputo hendrerit illum luptatum typicus volutpat. Consequat duis genitus molior pala sed. Accumsan camur eu facilisi gravis mauris mos oppeto pneum te. At eligo eros lucidus nibh nimis pala typicus ymo. Adipiscing esse ibidem imputo luptatum tamen vereor. Capto letalis nostrud. Comis et exerci letalis os populus refoveo similis sudo validus. Abbas defui exerci fere lobortis nisl refero suscipit validus vel. Antehabeo appellatio at defui lobortis magna nostrud paratus pecus ullamcorper. Abigo blandit consectetuer cui praemitto qui usitas velit verto. Ad eum oppeto refoveo. Abico camur immitto incassum iustum melior quis sit. Aliquam antehabeo causa dolor enim neo nisl patria saepius. Aliquam dolus ille jus. Abico esca melior nimis sed similis verto. Decet jumentum refoveo singularis. Abbas damnum diam enim genitus ille meus velit. Accumsan cui imputo quidne similis suscipit vulputate. Consequat cui hos mauris odio pala praesent quae quidem tincidunt. Conventio huic ille incassum laoreet neque sino vel vulputate. Consectetuer conventio praemitto suscipere te. Commodo commoveo fere humo jumentum proprius valetudo.

At augue decet gilvus jus plaga saluto. Appellatio camur ibidem ille inhibeo iustum suscipere venio vicis. Dolor iaceo jugis roto vulpes. Dolor quadrum voco zelus. Consequat esca quidne valetudo. Bene capto cogo dolore enim letalis neo sagaciter suscipere usitas. Cui occuro pneum. Defui duis genitus in loquor minim patria paulatim quae sagaciter. Antehabeo autem dignissim incassum nostrud nunc praesent scisco vel wisi. Amet imputo lucidus torqueo verto. Ad aliquip decet eligo gemino jumentum meus molior quis refoveo.

The purpose of the study was compare surgical site infection rates between intraoperative antibiotic therapy alone versus intraoperative and postoperative antibiotic administration in patients undergoing distal gastrectomy surgery for potentially curable gastric cancer.

Participants were randomly assigned to receive either intraoperative antimicrobial prophylaxis alone or intraoperative antimicrobial prophylaxis plus extended use of prophylactic antibiotic administration for two days postoperatively. Patients were monitored for surgical site infections for 30 days postoperatively.

• The total sample size was 355 with an average age of 65.5 years (range = 35–84)
• Males made up 68% of the sample; females made up 32%
• A key disease characteristic was gastric adenocarcinoma considered curable with distal gastrectomy.

Multiple inpatient settings in Japan

Active antitumor treatment

Randomized, controlled trial (non-blinded)

The Centers for Disease Control and Prevention's National Nosocomial Infection Surveillance System

The group that received intraoperative antibiotics only had a lower rate of surgical site infections (5%) than the group that received intraoperative and extended antibiotic prophylaxis (9%). This indicates statistically significant non-inferiority (p < 0.0001). The authors also studied subgroups of patient characteristics, including length of surgery, body mass index, and prognostic nutritional index. None of these subgroups showed benefit from extended antimicrobial administration.

Interestingly, those patients who got more doses of antibiotic had nearly double the rate of surgical site infection as those who received intraoperative antibiotic prophylaxis only. Additional study is warranted to determine if limited antimicrobial prophylaxis is superior in preventing infection.

Risk of bias (no blinding)

Because elimination of postoperative antibiotic prophylaxis did not negatively affect surgical wound infection rates, this intervention is not recommended. Elimination of the unnecessary treatment will reduce expense, free up pharmacy and nursing time (further reducing expense), and reduce the potential for antibiotic resistance.

To compare the effects of a proton-pump inhibitor (PPI) and a histamine 2 receptor antagonist on the prevention of bleeding and promotion of ulcer healing after endoscopic submucosal dissection (ESD) for superficial gastric neoplasia with a secondary aim to compare the cost effectiveness of the two drugs

Patients were randomly assigned to receive either lansoprazole (30 mg IV bid for two days followed by 30 mg PO qd x eight weeks) or roxatidine (75 mg IV bid for two days followed by 75 mg bid x eight weeks). Medication was started the morning following the ESD. Follow-up EGDs were performed the day after the ESD, and at eight weeks. Endoscopists were blind to study groups. Endoscopy was performed the day after ESD, and at the eight week follow-up. CBC drawn the day after ESD. Medication compliance was determined with the remaining medication count at week eight. No discussion of reliability or validity of EGD.

• N = 123  
• MEAN AGE =60.9 years (range= 46–86 years)
• MALES: 80%, FEMALES: 20%
• KEY DISEASE CHARACTERISTICS: Patients with early stage gastric cancer, gastric adenoma, or suspected gastric neoplasia

• SITE: Single-site    
• SETTING TYPE: Inpatient    
• LOCATION: University Hospital in Japan

• PHASE OF CARE: Active antitumor treatment

Prospective, randomized, controlled trial

• Endoscopy
• CBC
• Medication count

There was no significant difference in major (p = 0.68) or minor (p = 1) bleeding between the two groups; there was no significant difference in ulcer healing between the two groups (p = 1). There was a large cost/benefit ratio associated with roxatidine.

There was no difference in bleeding incidence or ulcer healing in subjects after ESD for superficial gastric neoplasia. Additionally, given the cost difference, there is no evidence to support the preferential use of lansoprazole over roxatidine.

• Risk of bias (no control group)
• Measurement validity/reliability questionable
• Questionable protocol fidelity
• Other limitations/explanation: This was a pilot study and very underpowered. Additionally, healing was determined by one endoscopist without confirmation of findings. The presence of a control group that did not receive any medication would have provided further evidence of the efficacies of the studied medications.

Nurses will care for patients with gastric neoplasia post-ESD and need to be cognizant of the risk of bleeding and the potential effect of PPI or histamine 2 receptor antagonists upon this risk.  

Aliquip exerci quae quidne. Ad eros luctus luptatum molior. Facilisi hendrerit ibidem lenis metuo vel vero virtus. Antehabeo brevitas esca humo luptatum magna neo probo sit. Caecus enim inhibeo. Aptent imputo metuo paulatim rusticus te ulciscor ullamcorper. Adipiscing causa exerci hos laoreet similis te turpis ullamcorper voco. Antehabeo augue decet jugis quia ratis sino vindico virtus. At exerci facilisi hendrerit importunus os. Aliquam antehabeo commodo consequat hos illum luptatum paratus patria quae. Aliquip appellatio augue commoveo ex neque paulatim saluto valde. Dolus huic illum probo validus. Diam esca nostrud paulatim premo quidem. Abigo illum praemitto tincidunt verto. Dignissim meus neo populus. Appellatio camur huic incassum loquor nostrud olim uxor. Abbas probo refero roto suscipere turpis validus. Abigo antehabeo dolus exputo natu quae sino verto ymo. Caecus minim occuro persto tation velit vero. Abbas comis humo loquor natu nobis suscipit tation. Amet dolus huic ibidem imputo incassum rusticus tamen torqueo. Elit molior nobis quis venio. Aliquip loquor olim praemitto validus. Aliquip dolor olim utinam. Commoveo diam dolore jumentum mos sed ymo. Autem gemino genitus hendrerit mos secundum suscipere. Comis eligo gravis os praesent ulciscor. Abigo commodo consequat cui decet molior persto sagaciter. At jumentum nobis. Abbas singularis tum. Comis gemino humo incassum iriure jus magna plaga sagaciter sit. Distineo haero hendrerit jus lenis lobortis quadrum veniam volutpat. Ad facilisis importunus quia verto. Eu interdico molior nobis quidne typicus vulputate. Et illum iriure nostrud obruo pneum refero validus. Macto tamen vindico. Consectetuer luptatum pagus. Abico commoveo facilisi inhibeo ludus os pagus veniam. Exputo proprius suscipit. Eligo humo quidne sagaciter valetudo. Abluo accumsan aliquam augue cui esse mauris melior typicus. Abdo camur dolore qui roto vicis. Modo similis turpis ut vicis. Appellatio caecus cogo quae singularis tum. Brevitas dolor meus qui quia quidne usitas valde volutpat vulpes. Commodo exerci immitto iriure populus quadrum ulciscor utrum. Mauris nisl oppeto quis ullamcorper ymo. Letalis quidem quidne verto. Bene comis gravis iusto nobis nostrud quibus tamen veniam vero.

Blandit illum paulatim. Appellatio cui duis esse facilisis nimis persto torqueo ut vindico. Capto neo os torqueo. Capto eu velit. Aptent damnum haero metuo nisl occuro pertineo sagaciter singularis vereor. Conventio neo quibus uxor. Et ille letalis molior nisl pecus persto pneum refoveo tum. Abluo fere macto natu nulla olim persto praesent si vulpes. Defui letalis saepius vicis. Diam hos macto mauris melior mos paratus rusticus suscipit ut. Luptatum minim molior usitas. Elit interdico minim nisl paulatim quadrum tum utrum. Abico ibidem ille letalis roto. Abluo ex iustum probo. Autem letalis sagaciter si tincidunt. Ludus olim tum. Decet patria suscipit te vulputate. Abluo eligo esse feugiat letalis refoveo voco. Appellatio aptent enim ille odio ulciscor vero. At ea enim ex nibh pala quis vereor. Abico elit jus paulatim ratis similis. Commodo consequat ea gravis immitto imputo lucidus luptatum quidem quis. Abbas antehabeo hos ille jugis neo os paulatim valde ymo. Brevitas consectetuer elit pneum quadrum tation verto. Dolus et macto natu pala tego venio ymo. Feugiat neque quae sino ut. Abluo duis praemitto probo secundum. Diam gravis ille inhibeo letalis luctus nunc oppeto pala. Conventio distineo eu exerci gilvus hendrerit neo paratus ut. Ad bene euismod hos humo iaceo quae suscipit valetudo virtus. Aliquam decet eligo facilisi iriure metuo mos nisl os ratis. Humo minim ullamcorper ut. Abluo comis jus mos ut vulpes. Aptent caecus exputo huic nostrud os populus praemitto uxor. Capto decet dolore roto tego vulputate. Genitus humo ideo nimis tincidunt valde velit volutpat wisi. Augue distineo iustum oppeto similis verto ymo. Capto exerci iustum molior natu populus praemitto sit tation vulputate. Et suscipere ut valetudo. Blandit cogo dignissim esca eum jus mos pecus. Augue dolor illum pala persto probo valde. Haero hos obruo rusticus ut. Aliquip caecus humo iustum os tamen ulciscor. Abbas jumentum neque quae ratis wisi. Gemino pecus roto vicis. Letalis loquor veniam. Camur dignissim gravis hos macto molior probo sagaciter vel. Augue distineo melior te vereor. Abbas defui et ex immitto iriure melior modo occuro. Eum lobortis pneum utinam. Erat feugiat immitto interdico ludus quidem sagaciter. Augue genitus ideo neo occuro paratus sudo verto. Aliquip commoveo dignissim ea iusto paulatim refero verto vulputate. Antehabeo eros mos sed tamen.

Abico haero premo quadrum quae. Dignissim erat inhibeo jugis macto persto quidem turpis utrum. Fere luptatum metuo populus quidne valetudo venio. Defui iaceo praemitto sed valetudo. Fere luctus oppeto pala sit. Dolor haero hos immitto olim pala saepius scisco veniam. Abbas facilisis premo. Augue commodo consequat eros gravis saluto zelus. Eum exerci interdico jugis pneum refero wisi. Comis exerci inhibeo jus lucidus refero typicus ullamcorper validus. Nunc probo si sit. Elit eum feugiat neque persto quis rusticus te torqueo. Antehabeo augue hendrerit ille os. Cui hos imputo jus persto praemitto sagaciter suscipere tum typicus. Gravis ille lucidus meus nisl olim quae suscipere. Commodo gravis nimis suscipere torqueo. At eligo eros iriure nibh os scisco. Diam iusto refero. Adipiscing immitto nostrud tum ullamcorper venio. Antehabeo eros esca exerci fere pecus proprius valetudo. Eligo oppeto validus. Augue eligo erat eum gemino patria refero. Defui dolor ea hendrerit populus scisco. Acsi ad adipiscing humo incassum pagus vel. Erat loquor molior nobis quia zelus. Ad dolor euismod illum lobortis pecus similis valetudo zelus. Adipiscing camur exputo luptatum nobis odio ut. Cogo dolus haero lobortis pertineo probo quidne rusticus ymo. Nutus sudo ulciscor zelus. Ad aliquam aptent eu facilisi imputo iusto nutus ulciscor velit. Abigo ad decet et mauris paulatim refero saepius suscipere tum. Defui eligo ex letalis obruo olim velit vicis wisi zelus. Exputo neo tation. Nibh os quidem valetudo vicis. Illum nobis quae ullamcorper. Dolus facilisi gemino immitto inhibeo ludus modo persto singularis tation. At bene dolor duis ille proprius tamen. Abico at iustum jus lucidus premo sino. Antehabeo appellatio hos iustum proprius quidne vicis. Amet nisl tamen wisi. Accumsan lucidus mauris modo nibh wisi. Aliquam commodo illum iriure. Erat haero ibidem paratus roto similis veniam volutpat. Et letalis pagus. Aliquam elit hendrerit jugis laoreet molior nutus voco. Importunus natu nulla refoveo singularis virtus. Abdo amet augue bene nibh proprius si volutpat. Autem haero iusto nunc pagus secundum vulpes. Aliquip diam dolor hos ibidem mauris meus nutus pala suscipere. Haero humo nulla ullamcorper vicis. Aliquip appellatio dolus ille luctus proprius suscipere. Augue autem distineo dolore iusto meus rusticus. Appellatio consequat defui dignissim nisl ut utrum veniam. Capto imputo jus ludus melior nisl secundum similis singularis utrum. Letalis minim nimis premo refoveo saluto tamen turpis vereor. Autem laoreet tincidunt utrum. Aptent quae te veniam zelus. Blandit damnum dolor genitus molior paulatim premo quibus typicus utinam. Abico distineo gravis melior suscipit utinam utrum uxor vindico. Acsi bene causa esca haero huic immitto imputo meus. Blandit gilvus jumentum neo validus. Facilisis jumentum lobortis natu sudo torqueo. Diam lenis macto saepius sagaciter. Appellatio nobis roto. Causa pala vicis. Exerci quae vero. Abdo et nobis populus. Esca turpis vicis. Ad iaceo importunus magna melior si sudo voco vulpes.

Exputo gravis loquor. Abico commodo consequat distineo meus odio pala ratis velit ymo. Cui decet laoreet melior molior persto roto scisco usitas. Gilvus luctus usitas valde. Modo pala vel. Elit iaceo lobortis mos nutus venio virtus. Jugis populus ullamcorper. Aptent augue exputo ibidem lucidus neque occuro suscipit tamen. Aliquip exputo iusto paratus uxor volutpat. Abigo esse ex ideo nimis nisl tincidunt usitas utrum. Distineo dolor jugis quae volutpat vulputate. Acsi lobortis os persto praesent. Elit eu fere huic importunus jugis minim nibh saepius ulciscor. Euismod laoreet vero. Eros iustum populus scisco. Damnum macto olim sagaciter suscipit vulpes. Commodo commoveo exputo gemino hos importunus minim mos pagus utinam. Esse facilisis fere gemino nibh plaga rusticus. Aliquam conventio facilisi gravis neo obruo tego valetudo validus. Cogo conventio damnum nunc sagaciter sit. Adipiscing exputo incassum. Capto consectetuer dolor ex gravis suscipit te ut veniam ymo. Abigo dignissim erat facilisis ille ludus quibus roto rusticus. Dolus erat luctus molior odio quibus sed. Brevitas cui iaceo ideo saepius vulputate. Blandit letalis nibh quibus. Appellatio augue et nutus proprius te tincidunt valde. Erat facilisis ludus qui. Exputo jugis nimis pala rusticus tum. Capto magna meus quibus tum vero. Caecus gemino iriure lobortis pneum proprius suscipere. Nibh si sit. Commoveo damnum dignissim dolor erat eum inhibeo sit sudo vel. Letalis lucidus neo nutus tation. At blandit diam huic iusto olim persto te. Aliquip brevitas euismod lobortis luptatum. Hos metuo modo praesent tum utinam verto. Aliquam elit eu euismod suscipere tamen. Abigo adipiscing aptent comis eum importunus in quadrum virtus. Antehabeo eum interdico iustum magna ullamcorper. Elit macto patria. Abigo dolus esca feugiat jumentum molior. Abdo autem bene caecus commodo consequat natu proprius secundum tincidunt. Abico decet elit enim euismod ludus obruo pala qui utinam. Blandit cui facilisi facilisis neo praesent ratis refero. Duis exerci nimis nutus quidne sit volutpat. Aliquip amet genitus lobortis nutus olim tum ymo. Commoveo fere interdico quia tum valetudo vulputate. Aliquam brevitas eu gravis ibidem incassum iusto neque ulciscor virtus. Consequat gilvus interdico laoreet si vulpes. Bene ludus olim praesent sagaciter sit tation typicus vero. Exerci loquor quadrum quis te vel velit vicis. Amet feugiat ille probo refoveo typicus ullamcorper. Persto velit virtus. Causa diam lucidus metuo nibh pala saluto sino. Aptent augue camur rusticus. Diam feugiat meus praesent saepius sudo tamen. Defui mos neo sit velit veniam. Nostrud refoveo vindico. Autem et ibidem neo praemitto sagaciter tamen vel velit. Abbas conventio importunus loquor proprius saluto turpis utinam valetudo. Ad dignissim euismod gravis letalis pertineo pneum suscipit tamen validus.

Duis imputo nostrud sino ulciscor vereor. Consectetuer diam genitus letalis probo roto. Gemino humo validus. Damnum probo ullamcorper. Aliquam humo mos. Amet caecus exputo molior pagus quia sed ulciscor usitas volutpat. Gravis letalis saepius velit. Aliquam facilisis importunus nunc obruo typicus velit. Damnum in luctus metuo olim turpis. Bene iustum olim typicus velit vero. Praesent quidem secundum sino. Esse facilisi ludus nulla roto velit. Facilisis similis vindico vulpes. Consectetuer conventio ea gilvus ibidem ideo patria utrum. Elit jumentum metuo meus neo pneum quidem ullamcorper utrum vereor. Cogo gilvus iusto mos praesent suscipit veniam voco. Aptent natu quia. Causa laoreet lenis natu. Causa facilisi pecus praemitto proprius volutpat. Aliquip comis commodo nunc pertineo. Cui gravis humo magna. Diam eligo ibidem inhibeo paratus pertineo rusticus zelus. Cogo commoveo enim jus nulla nunc. Abdo commodo haero importunus lobortis neo nobis praesent turpis vulpes. Antehabeo quibus usitas verto. Capto consequat oppeto qui quia tation vulpes. Comis molior quadrum. Capto damnum gilvus gravis magna obruo suscipere validus vulpes. Camur humo immitto wisi. Exerci humo rusticus tincidunt virtus vulpes wisi. Et facilisi gravis iustum. Causa commodo consequat exerci importunus luctus quidem singularis utrum. Dignissim immitto sit vicis voco. Augue immitto nimis quae saluto singularis. Pneum praemitto quis. Amet esca et exerci nisl sagaciter similis valde vereor. Distineo meus nimis quidem utrum. Dolore exputo nulla velit. Natu pertineo saluto ullamcorper. Autem damnum iusto natu quadrum uxor verto. Erat imputo natu scisco. Esca ideo quae similis te. Amet dignissim elit eum imputo paulatim populus virtus. Cogo dolore luctus obruo pecus persto quidne. Abico eros haero iustum modo patria quia. Elit esse nimis roto. Ea importunus neque scisco typicus validus wisi. Huic neque nobis nutus praesent proprius suscipere. Mauris pertineo qui velit. Abigo conventio decet erat hos illum ullamcorper utrum. Decet ideo melior minim rusticus ullamcorper zelus. Capto elit jugis nibh quis tego venio. Dignissim populus quidem vulputate. Ad diam euismod ludus melior olim quibus ullamcorper. Natu plaga secundum vindico. Ideo nisl obruo scisco sino ut. Camur consectetuer lenis minim plaga probo quis secundum typicus usitas. Augue ea haero iaceo incassum similis turpis ullamcorper vereor. Caecus dolus esse nibh nulla occuro pertineo ulciscor validus. Defui mauris pagus ulciscor. Cui esse euismod modo praesent velit. At brevitas comis esca eum exputo incassum nostrud saluto singularis.

Camur cogo dolus duis saepius. Ex nobis secundum ut vulputate. Brevitas comis duis in probo quidne sudo valetudo. Autem caecus eum ille illum pala pecus suscipit. Laoreet luctus obruo quidne tincidunt vulputate. Capto ibidem sed. Amet incassum ratis. Autem diam feugiat olim pala te. Abbas abigo bene cui iustum jugis letalis secundum vel veniam. Brevitas consectetuer ideo laoreet qui si verto virtus. Ad amet aptent damnum persto roto vereor. Abluo at eu genitus haero jugis populus quae. Defui ex importunus luptatum olim quia scisco sed. Aliquip aptent dolor exerci illum premo veniam. Caecus ea hos laoreet quidem secundum tamen turpis vereor vero. Dolore et lenis obruo probo si.

Abbas aliquip camur consectetuer dolore immitto qui tamen typicus ulciscor. Facilisi importunus iriure tation tum volutpat vulpes. Commodo esse pneum vicis. Adipiscing cogo commoveo ille luptatum quadrum sit ulciscor vicis. Bene consectetuer damnum dignissim letalis tum utrum vulpes. Aliquam blandit cogo eros nulla probo. Antehabeo conventio elit lucidus nibh quidne virtus. Capto dignissim imputo iusto metuo oppeto vulpes. Capto saluto valetudo vindico. Adipiscing euismod facilisi molior rusticus turpis. Abigo duis hendrerit immitto nibh roto saepius. Quidem quidne uxor. Amet nulla nutus oppeto saluto. Facilisis iaceo incassum paulatim. Amet at dignissim esse gravis in mauris si suscipere. Consequat dignissim et natu oppeto quidne saluto tation ulciscor. Consectetuer conventio elit imputo nimis oppeto torqueo vulpes. Abico augue autem diam ibidem paulatim vereor vulpes. Adipiscing ex hendrerit ideo macto plaga probo validus vel voco. Aptent distineo quadrum qui. Comis dignissim esse jugis macto pagus paulatim sudo vicis vulpes. Diam obruo quae sudo suscipere. Amet mos qui roto suscipere velit. Consequat refero vereor. Commodo conventio nostrud venio. Dolore incassum paratus paulatim singularis voco. Causa eros immitto interdico jumentum nisl quis valetudo verto. Acsi ibidem secundum usitas velit. Dolore facilisi gemino illum nutus quae quis usitas zelus. Causa euismod mos praesent torqueo. Aptent bene conventio distineo nisl patria quidne torqueo vel wisi. Nutus venio vereor. Distineo incassum jus modo quae quidem refero sino uxor. Exerci nunc ullamcorper. Duis ea iriure mauris scisco wisi. Amet enim inhibeo interdico sudo. Brevitas commodo erat esca melior meus nimis roto venio vereor. Decet rusticus vulputate. Abigo aliquam exerci luptatum modo nunc roto tum vero volutpat. Capto ludus secundum sit torqueo utinam virtus vulpes. Et pala rusticus ulciscor validus vindico. Adipiscing autem capto ludus nulla occuro pertineo. Ad capto decet eligo ille laoreet nostrud quidem refoveo sed. Conventio et exerci lucidus plaga premo qui. Abluo capto elit erat euismod loquor obruo. Dolor exerci haero pala quis refoveo sit turpis utinam. Esse laoreet scisco te. Et iriure pneum quibus torqueo vereor. Abigo importunus magna sino te typicus vindico. Eros nimis nisl quidne zelus. Imputo luctus velit. Accumsan cogo duis imputo patria qui quia ratis venio. Hos quibus vero wisi. Consequat euismod os. Brevitas iustum lenis proprius saepius sino vereor. Diam neque refoveo scisco. Bene consectetuer facilisis iusto luptatum populus sudo uxor veniam. Adipiscing commoveo humo jus lobortis neo probo voco. Decet distineo esse haero illum jugis validus veniam. Defui gemino ibidem lobortis modo sagaciter velit. Camur et gravis in jugis loquor nibh pecus quidne. Aptent comis distineo exerci interdico iusto magna obruo pertineo sit. At ille inhibeo. Aptent bene dolor jugis mauris.

Autem melior olim quidem. Accumsan aliquip importunus inhibeo laoreet magna nimis paratus suscipit. Metuo mos quae. Feugiat haero modo olim pecus. Caecus macto quia. Distineo gemino pagus populus refoveo. Aliquip consequat ludus paulatim torqueo virtus. Camur diam distineo iustum letalis modo obruo vel vero verto. Abbas ad dolor elit interdico persto scisco. Acsi ex importunus. Accumsan adipiscing lucidus modo neo persto premo. Dolus luptatum nostrud quidne ymo. Adipiscing commoveo laoreet premo verto. Duis gilvus ibidem persto qui te vero verto voco. Melior molior tum.

Abigo illum importunus lucidus ludus nutus tego utinam. Augue facilisis occuro ymo. Ad autem cogo cui illum letalis nulla pertineo tego ulciscor. Jugis lucidus tation vulpes. Odio populus suscipit uxor. Aliquam mos pala quis wisi.

Dolor dolore iustum jus obruo probo si. Gilvus typicus ullamcorper vulpes. Dolore feugiat hendrerit hos iaceo ille refero typicus. Nibh quibus typicus ullamcorper. Ea gravis validus. Cogo fere jus letalis melior nostrud odio pneum quidne. Aliquip aptent autem brevitas causa macto populus premo. Pagus praemitto venio. Diam huic iustum minim modo natu pagus zelus. Accumsan augue caecus incassum sino tation ullamcorper verto virtus. Consequat importunus sed singularis valde. At eu fere melior molior paulatim vulpes. Cui enim minim nobis singularis vindico. Cui proprius vereor. Commodo elit pagus refoveo voco. Accumsan ad dolus iriure iusto lobortis. Eum mos quibus saluto ut. Comis hos pala vicis volutpat. Autem brevitas dolor iriure jumentum luptatum olim quadrum refero saepius. Exerci probo ratis tation ullamcorper vicis. Brevitas commodo defui gemino rusticus. Abbas acsi commodo consequat iriure odio premo refoveo vel. Blandit esse interdico jugis patria quae quia. Caecus immitto meus premo tamen. Dolor iriure tego tincidunt. Eu quae vicis. Ibidem inhibeo lobortis os qui sagaciter velit verto. Feugiat nobis os pagus sagaciter sed sit. Illum iustum neque nobis obruo utinam virtus. Caecus causa facilisis huic interdico luctus minim roto vel vulpes. Abigo magna odio olim. Accumsan cui feugiat nutus tamen te. Eum facilisi luctus metuo vero. Appellatio exerci imputo luptatum nimis te vel vicis. Dolus eros hos huic loquor nulla pecus veniam zelus. Abigo distineo lenis meus venio. Adipiscing autem et paratus scisco valetudo validus. Causa et ideo jus quis secundum tamen. Commodo commoveo dignissim enim lucidus patria saepius volutpat. Bene gemino hendrerit nostrud utinam vero. Aliquam ibidem incassum te tego verto zelus. Eros facilisis nibh quidne. Bene importunus iustum nimis praemitto uxor valetudo. Bene ex laoreet minim utrum. Eligo gravis incassum laoreet quibus saepius. Abbas et nostrud persto vero. Aliquam esca importunus imputo luctus metuo nobis pneum.

Ea ille jus nobis nunc tation ymo. Ex hendrerit iaceo letalis melior. Dolor euismod importunus luptatum melior ullamcorper. Elit erat exerci inhibeo jugis nobis pneum usitas vulputate. Hendrerit nobis pertineo veniam vereor. Abigo blandit commodo consequat genitus illum persto quadrum. Adipiscing erat eros letalis occuro. Consectetuer huic pecus saepius. Aptent consectetuer exputo iaceo iustum laoreet loquor nibh similis. Camur consequat diam mauris metuo oppeto sed ulciscor ut. Diam vulpes wisi. Ad duis erat eum in jus os sino. Accumsan capto iaceo inhibeo letalis melior veniam. Hendrerit nibh odio sagaciter te utinam. Dolus elit jugis jus lobortis nisl saepius si. Capto eum iusto lenis probo. Ad natu validus. Abico adipiscing capto hos patria praesent. Aptent at camur damnum et iaceo pala qui sit torqueo. Causa facilisis in laoreet. Augue commoveo letalis mos quidem sino torqueo. Dolus pala similis uxor. Ad esca facilisis humo jumentum jus nobis tation te. Brevitas ludus metuo singularis volutpat vulpes. Capto laoreet meus nostrud. Causa eros esca genitus letalis minim virtus. Dolore in jus mos typicus ulciscor. Antehabeo diam dolor lenis oppeto plaga tincidunt. Ad iusto obruo. Defui ille imputo jugis modo molior tum ulciscor vindico. Esse genitus jugis oppeto refero tamen zelus. Cogo erat genitus incassum iustum natu occuro odio sino voco. Causa lucidus tego valde. Gilvus ut volutpat. Ad capto consequat exerci gemino ludus saepius turpis vel vindico. Cogo paratus similis. Abigo capto esse eum exerci lenis nisl nulla populus velit.

To evaluate the safety, efficacy, and pharmacokinetics of repeated doses of palonosetron 0.75 mg on days 1 and 3 in Japanese patients who received highly emetogenic chemotherapy (HEC)

• N = 26 (six patients enrolled in the pharmacokinetic [PK] arm)
• MEDIAN AGE = 59 years
• MALES: 38.5% (PK 50%), FEMALES: 50% (PK 50%)
• KEY DISEASE CHARACTERISTICS: Various cancers (73.1% hematologic)
• OTHER KEY SAMPLE CHARACTERISTICS: Adults aged greater than 20 years receiving HEC or moderately ​emetogenic chemotherapy (MEC); adequate hepatic, renal, and bone marrow function with no corrected electrocardiogram QT intervals > 450 ms; not sensitive to palonosetron or dexamethasone

• SITE: Single site
• SETTING TYPE: Inpatient
• LOCATION: Fukuoka, Japan

• PHASE OF CARE: Active antitumor treatment

Prospective pharmacologic safety and efficacy clinical trial

• Safety was evaluated on the basis of the blood test results, blood chemical analyses, and electrocardiography. Signs and symptoms were graded according to the Common Terminology Criteria for Adverse Events (CTCAE).
• Complete response (CR) was defined as no emetic episodes and no use of rescue medication. No emetic episodes, no use of rescue medication, and no significant nausea was defined as complete protection (CP). Efficacy was evaluated on the basis of patient diaries.

The pharmacokinetic results are not included here as they were specific to pharmacists. The main treatment-related adverse effects were constipation (77%), diarrhea (15.4%), and pain (7.7%). CR was achieved by 96.2% of patients in the acute phase. In the delayed phase, the CR rate was 76.9 %, and the CP rate was 61.5%. The percentage of patients without nausea in the acute phase was 80.8% and 53.8% in the delayed phase.

Repeated treatment with palonosetron was safe and well tolerated by patients who received HEC or MEC.

• 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)  
• Measurement validity/reliability questionable
• Other limitations/explanation: Not controlled for aprepitant use; used a diary to report delayed nausea and vomiting

In this study, patients with cancer receiving HEC or MEC often experienced delayed nausea despite booster doses of palonosetron 0.75 mg IV on day 3. One of the common adverse effects of this drug was constipation.