To determine whether the effect of ketamine on postoperative pain can be enhanced and prolonged if ketamine is administered IM in repeated and escalating subanesthetic doses before surgery; to determine if administration of ketamine as specified can reduce consumption of analgesia

Patients were randomized to receive a placebo (saline) or ketamine.

• The first 40 patients (consecutive) received one injection 3–4 hours before surgery. Group K1 received one ketamine injection.
• The next 40 patients received two injections, one injection 11–20 hours before surgery and another 3–4 hours before surgery. Group K2 received two ketamine injections.
• The last 40 patients received three injections, one injection 17–18 hours before surgery, one at 11–12 hours before surgery, and another 3–4 hours before surgery. Group K3 group received three ketamine injections.

Postoperatively, for two days, all patients received IV morphine, by means of patient-controlled analgesia (PCA), to control pain for as long as requested. PCA was initiated in the postanesthesia care unit. The PCA consisted of a bolus of 1.5 mg morphine. After a morphine dose, a patient could not access another dose for seven minutes.

• The sample was composed of 120 patients.
• Mean patient age was 43–47 years. Mean age varied by injection group.
• The sample included 69 males and 51 females.
• The sample included 42 cases of abdominal tumor, 25 cases of bowel tumor, and 53 cases of bone or muscle tumor.

• Single site
• Inpatient
• Israel
   

• Phase of care: end-of-life care
• Clinical applications: end-of-life and palliative care

Double-blind, placebo-controlled randomized controlled trial

• Numeric Rating Scale (NRS), a 0–10 scale of pain intensity, which patients completed every 15 minutes during the first postoperative hour and every 30 minutes until discharge from the PACU    
• Overall satisfaction, measured by means of a subjective response, before the patient's discharge, from the surgeon
• Adverse-event questionnaire
   

Group K2's mean 48-hour score (P = 0.0004) and group K3's mean 48-hour score (P = 0.046) were lower than the corresponding scores of the placebo groups. Compared to the placebo groups, patients in K2 and K3 used less morphine. PCA use was approximately 50% less than PSA use in placebo-group counterparts (P < 0.05). Ketamine at 25 mg caused dizziness for two minutes.

Two or three injections of ketamine before surgery for cancer attenuated postoperative pain and decreased opioid requirements for 48 hours after surgery.

• The study was conducted at one site only.
• The study assessed patients for 48 hours only.
• Patients were randomized for ketamine use but not for the number of doses received.
• Different types of surgery can be expected to yield different levels of postoperative pain.

Ketamine injections before cancer surgery may attenuate postoperative pain. Ketamine can be associated with dizziness and other side effects.

To determine the effectiveness and safety of a disseminated community-based exercise program for cancer survivors who completed cancer treatment.

Twice weekly over a period of 12 weeks, YMCA personal trainers supervised groups of seven to 14 study participants during 90-minute exercise sessions at 13 YMCA sites. Study measures were administered at baseline and after the 12-week exercise program. The standardized protocol included aerobic warm-up (10 minutes), resistance training (50 minutes), and community building time (e.g., sharing personal experiences, didactic and experiential training in breathing, relaxation, stress management, and nutrition). Precautions or contraindicated movements were noted for each participant, and resistance training was individualized. YMCA personal trainers had at least one year of personal training experience and received a specialized 16-hour group training by a cancer rehabilitation physical therapist. Additional training to address emotional issues for participants and trainers was provided by a licensed clinical psychologist with expertise in cancer survivorship. Participants and immediate family received access to YMCA facility branches and were encouraged to exercise outside of the sessions.

• In total, 187 patients (17.6% male, 82.4% female) with both pre- and postintervention data were included. 
• Mean age was 57.7 years (standard deviation [SD] = 10.3)
• Patients had mixed cancers (55.5% breast cancer, 7.5% lymphoma, and 5% leukemia and prostate cancers).
• Mean time since diagnosis was 5.6 months (SD = 6.9 months).
• Eligibility included being off cancer treatment for longer than 90 days, with no evidence of active disease. Medical clearance was required to participate in the exercise program.  
• Of the patients, 97.3% were Caucasian and non-Hispanic/non-Latino, 63.6% had completed four-year college or graduate school education, and 49.7% reported working full- or part-time for pay.

• Multisite (13 YMCA sites as part of LIVESTRONG Exercise and Thrive [E & T] Program)
• Community
• Western Washington State

Patients were undergoing long-term follow-up postcancer treatment.

This was a prospective pre/post (nonrandomized) study design.

Validated patient-reported outcomes measures included

• Health-related quality of life: Short Form 36 Health Survey (SF-36), version 2
• Fatigue: Fatigue Symptom Inventory (FSI)
• Insomnia: Three items were developed for this study, rated from rarely or never (0) to nearly every day (4) for: “Does it take you more than half an hour to fall asleep at night?” “Do you wake during sleep and have difficulty falling back to sleep?” and “Do you wake earlier than you want in the morning and are you unable to get back to sleep?”
• Physical activity level: SF-36, version 2, physical component summary
• Physiologic measures:  six-minute walk test, resting heart rate, blood pressure, one repetition maximum test (upper and lower body strength), and sit and reach test (flexibility)
• Muscle and joint problems: Muscle and Joint Measure with subscales assessed (1) muscle aches or stiffness (myalgias); (2) joint pain; (3) stiffness or swelling (arthralgias) and muscle cramps; and (4) muscle weakness
• Social support:  brief seven-item measure used in the Enhancing Recovery in Coronary Heart Disease Patients (ENRICHD) study (study testing a psychosocial intervention on patients with postacute myocardial infarction)
• Injuries and/or lymphedema during classes:  Assessment was developed for the study using yes/no response items, including: “During your participation in E & T did you have any injuries?” and “As far as you know did you have any swelling or lymphedema that developed during E & T?” For those participants responding positive to the lymphedema question, subsequent questions were asked to determine if the lymphedema symptoms developed before or during the E & T program and (if lymphedema developed during the program) if the symptoms were a flare-up of existing lymphedema or a new site of lymphedema.
• Program evaluation: Five items were developed for the study, including: “How satisfied are you with your participation in the program overall?,” “Were the staff leading the program competent and knowledgeable?,” and “How easy or difficult was it for you to participate in the program?.”

The study indicated that the community-based exercise program has important beneficial effects on physiologic, symptom, and quality of life health outcomes for cancer survivors and is safe to implement. Findings suggested that the program is helpful for improving fatigue, insomnia, physical function, overall musculoskeletal symptoms, mental health, social support, and physical activity in cancer survivors. Average baseline insomnia ratings of 1.63 (SD = 0.93) differed significantly from postintervention ratings of 1.43 (SD = 0.85) (p < 0.001).  Additionally, the exercise program indicated notable improvements in physiologic measures (blood pressure, upper and lower body strength, walking endurance, and flexibility).

Community-based exercise groups for cancer survivors of mixed diagnoses and ages, who have completed active treatment, have physiologic and psychosocial benefits and appear to be safe. Because the participants self-selected to be part of the study and were screened for their ability to participate, findings cannot be generalized to the larger cancer survivor population.

• The study had a risk of bias due to no control group, no blinding, no random assignment, no appropriate attentional control condition, and the sample characteristics*.
• Participant withdrawals were 10% or greater.
• * Measurement validity/reliability was questionable. Findings were not generalizable. The intervention was expensive, impractical, and/or training needs. Participants were 82.4% female and non-Hispanic (Caucasian); the ethnic and racial homogeneity of the sample limited the generalizability of the findings. More than half of the participants had a breast cancer diagnosis. Self-referral and convenience sampling provided a population of participants who were motivated to self-initiate participation in an exercise program. Several measures were developed for the study, including the measure of insomnia; thus, there was a lack of previous established reliability and validity. Although access to the YMCA was provided to participants, the intervention was expensive in terms of participant time and effort, and personal trainers required special cancer-related training and one year of personal training experience. Having the intervention delivered to groups offsets the cost to a certain degree. Thirty-four of of 221 participants were excluded from the analysis because data were only available at one time point; there was a 15% withdrawal rate.

Survivors may benefit from participating in a community-based exercise program tailored to meet their individual needs as a survivor; however, exercise programs should be preceded by consultation with health care providers. Additional nursing research is needed to determine the effect of resistance training and other exercise protocols in more diverse cancer survivor populations.

Databases searched were MEDLINE and Index Medicus, EMBASE, CINAHL, CancerLIT, Allied and Complementary Medicine Database (AHMED), PsycINFO, CISCOM, Cochrane Database, and Database of Abstracts and Reviews of Effects (DARE).

The search yielded 27 studies from 1974–2003, only one of which was a randomized controlled trial (RCT). Authors analyzed only the RCT.

Results of one RCT documented effectiveness of hypnotherapy in treating symptoms in terminally ill adult cancer patients.

The lack of well-designed studies to be analyzed calls for further research, involving effectively designed studies, to establish the effectiveness of hypnotherapy.

The purpose of the study was to study the effect of administration of primary prophylactic (PPG) colony-stimulating factory and duration of administration on the occurrence of chemotherapy-induced neutropenia hospitalization in older adult patients with breast cancer.

The study sample included women older than age 66 years. Women with stage 0 were excluded because stage 0 does not require chemotherapy, and women with stage 4 were excluded because stage 4 palliative therapy is very different from standard first-course administration.

The SEER data from 16 registries (1994–2002) was used. The outcome of interest was neutropenia hospitalizations defined as ICD9 code 288.0X in the first, third or sixth months after the first course of chemotherapy.  Administration of G-CSF had to be initiated within five days after the first course of chemotherapy as primary prophylaxis. G-CSF was defined according to procedures codes.

• The total sample was 10,441 patients aged 66 years and older.
• All participants were female
• All had stage l, ll, or lll breast cancer
• Patients had to be receiving chemotherapy with in six months of diagnosis.
• Neutropenia hospitalization had to occur within the first three or six months.
• Exclusion criteria: Chemotherapy initiation after six months.
   

Inpatient

Observational study

• End result Medicare data from 1994–2003
• Outcomes and treatment defined by ICD9 diagnosis and procedure codes
   

Administration of PPG-CSF during the first course of chemotherapy reduced neutropenia hospitalizations by 16% with in first three months and 17% within the first six months of chemotherapy. Hospitalization rates within the first three months of chemotherapy initiation were three times higher in women receiving less than five days of PPG-CSF compared to women receiving PPG-CSF for five or more days. Hospitalization rates within the first one and six months were also lower with longer PPG-CSF.

PPG-CSF use is associated with reductions in patient healthcare utilization.

• No controls.
• The study does not focus on incidence of neutropenia and, rather, worked on severity
• Many mild cases of neutropenia go unreported as ANC less than 2,000.
• Neutropenia hospitalization was taken as a dependant variable for the study and patients with mild neutropenia would not be taken as a part of the study,
• Retrospective data analysis only
   

PPG-CSF received during the first three months, particularly after five days of initiation of the therapy, and to be taken for at least five days, would reduce the risk of neutropenia hospitalization among older adult patients with breast cancer.

To determine the effect of repeated intravenous injection of a monoclonal antibody, directed at the inflammatory cytokine tumor necrosis factor (TNF), on the mood of patients diagnosed with treatment-resistant depression (TRD); to note the effects of the intervention on the levels of inflammatory cytokines and high-sensitivity C-reactive protein (hs-CRP) and concentrations of TNF

Patients were randomized to receive either placebo or infliximab infusions of 5 mg/kg at baseline and at weeks 2 and 6. Assessments of clinical and inflammatory status (hs-CRP, TNF, and its soluble receptors I and II) were conducted at baseline and at weeks 1–4, 6, 8, 10, and 12.

• The sample was composed of 60 participants; 30 were in the placebo group and 30 were in the infliximab group. 
• The age range of participants was 25–60 years.
• Of male participants, 33% were treated with infliximab and 33% were treated with placebo. Of female participants, 67% were treated with infliximab and 67% were treated with placebo.
• All participants were moderately resistant to treatment in the current episode, having depression of moderate severity as measured by the treatment resistance staging method and a self-report of symptoms of depression. Group assignment was stratified by gender and by hs-CRP level (< 2 or ≥ 2).
• Of all participants, 77% were white, 20% were black, and 97% were college-educated (that is, had a college education ranging from some college to the attainment of a graduate degree). The groups were evenly matched in terms of approximate age at the time of the diagnosis of major depression, number of episodes of major depression to date, and antidepressant trials in the current episode. Authors noted no significant differences in the two test groups.

• Single site
• Outpatient
• Emory University, Division of Digestive Diseases, Atlanta, Georgia

Transition phase after active treatment

Randomized double-blind placebo-controlled trial

• Self-report
• Hamilton Rating Scale for Depression (HRSD, which the authors referred to as HAM-D; clinical response defined as at least 50% reduction in HAM-D score) and the Clinical Global Impression-Severity (CGI-S) scale
• Measures of hs-CRP, TNF, and TNF soluble receptors I and II

There were no differences in HAM-D score changes over time between groups.  These scores declined significantly over time in both groups (p = 0.01). Subgroup analysis showed that, for patients with baseline hs-CRP concentration greater than 5 mg/L, those on infliximab had greater improvement in HAM-D scores (effect size = 0.41). Treatment response rates were not different between groups

Treatment with infliximab is not an effective intervention for treatment-resistant depression. However, as levels of hs-CRP increase, infliximab has greater effect. Antagonism of TNF is ineffective against treatment-resistant depression. More research is needed to determine inflammatory biomarkers in patients who may uniquely respond to immune-targeted therapies.

• The study had a small sample size, with fewer than 100 participants.
• The study had a risk of bias due to no control.

This study yields no results that can immediately be applied to practice. Nurse-researchers should consider constructing and implementing clinical trials aimed at exploring, developing, and understanding inflammatory biomarkers to identify immune-targeted therapeutic interventions.

The purpose of the study was to evaluate if prophylaxis with oral levofloxacin will reduce or delay the febrile neutropenic episodes in chemotherapy-induced neutropenia.

Patients enrolled were assigned randomly to receive 500 mg of levofloxacin orally once daily, or an identical-appearing placebo, starting on day 1 of chemotherapy. Prophylaxis was continued until neutropenia had resolved or fever was documented. Patients were examined daily for clinical signs of infection.

The primary end point of the study was the occurrence of fever, requiring empirical antibacterial therapy during neutropenia. Secondary end points were the type and number of documented infections, the use of parenteral antimicrobial agents during neutropenia, survival at the resolution of neutropenia, compliance, and tolerability.
 

• 80 adult patients made up the sample
• Female, 35%
• Male, 65%
• All had a diangosis of acute leukemia

Active treatment
 

Prospective, randomized, placebo-controlled, single-blinded study.

• Time to first fever requiring empiric antibiotic coverage
• In non-neutropenic patients, axillary temperature exceeded 101°F and, in neutropenic patients (absolute neutrophil count of less than 500/mm³), a single oral temperature of 101ºF or higher, or a temperature of 100°F or higher for more than one hour, was taken as a sign of infection or septicemia.
• Type and number of documented infections
• Survival at the resolution of neutropenia
• Compliance
   

Levofloxacin prophylaxis reduced the incidence of fever (17/25 patients (68%) compared to18/23 patients (78%) in placebo group; relative risk = 0.87; absolute difference in risk = 10%, p < 0.001) and reduced the incidence of microbiological proven infection (4/25 [16%] in the levofloxacin group compared to 7/23 [30.4%] in the placebo group; relative risk = 0.52; absolute difference in risk = 14.4%; p < 0.001). However, patients in the levofloxacin group were more likely to have a fever that lasted more than seven days (23%) compared with the control group (12.5%, p not stated).

This prospective study does not make a strong case for the use of levofloxacin to prevent neutropenic fever in patients with acute leukemia..

• The sample size was small (less than 100).
• The statistical analysis was not described. It appears that the study is not adequately powered to detect differences between the treatment groups.
• Levofloxacin prophylaxis was started on day 1 of chemotherapy in this study, rather than after the chemotherapy in anticipation of the chemotherapy nadir, which is the more common practice.
• The risk of antibiotic resistance is a concern which is not evaluated in this study.
• This study was conducted in Bangladesh and the authors stated the concern that the hospital environment was not hygienic, so the data may not be applicable to the hospital setting in other countries.
• The statistical analyses do not appear adequate to use the data to make any definitive recommendations about levofloxacin prophylaxis.
   

This study suggests that levofloxacin may reduce fever and infection in patients with acute leukemia. There is a concern regarding antibiotic resistance with the use of prophylactic antibiotics.

To assess the effectiveness of a group mindfulness-based stress reduction program on fatigue severity and life quality measures in women with breast cancer

The intervention was a standard mindfulness-based stress reduction program consisting of mindfulness skills, meditation, relaxation, and yoga. The program was provided in a group setting once weekly over an eight-week period. Patients randomly were assigned to the intervention or control group, which received no intervention. Patients were excluded from the analysis if they did not want to continue to participate in the intervention or missed more than two sessions.

• N = 24  
• MEAN AGE = 43.6 years (range = 30–55 years)
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: All patients had breast cancer and were receiving chemotherapy.
• OTHER KEY SAMPLE CHARACTERISTICS: None provided

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

• PHASE OF CARE: Active antitumor treatment

Randomized, controlled, trial 

• Fatigue Severity Scale (FSS)
• Global Quality of Life in Cancer Patients (GLQ-C30)
• Life Quality in Breast Cancer (QLQ-BR23)

Role, emotional function, social function, and cognitive function improved over time in both groups. Pain and fatigue declined over time in both groups (p < 0.001). There was a significant effect of group assignment over time with greater improvements in the intervention group for fatigue and pain (p < 0.001) as well as multiple areas of functioning.

Mindfulness-based stress reduction may be helpful in the management of fatigue among women receiving treatment for breast cancer.

• Small sample (< 30)
• Risk of bias (no blinding)
• Risk of bias (no appropriate attentional control condition)
• Other limitations/explanation: No information was provided regarding adherence to sessions or drop-outs during the study.

Mindfulness-based stress reduction may be helpful for patients with cancer in the management of fatigue and some aspects of quality of life. Additional research involving the use of therapy interventions provided in groups should include appropriate group and attention control conditions because these factors can be expected to have an effect on perceived symptom severity.

To examine the effects of an integrated yoga program in reducing frequency and intensity of nausea and vomiting in chemotherapy-naïve patients with early stage breast cancer 

Patients were randomly assigned to receive either a yoga intervention or a supportive therapy intervention. Patients in the yoga group received both supervised and home practice of yoga sessions for 60 minutes daily, starting prior to chemotherapy. These patients received supervised initial training, audio and videocassettes for home use, and a supervised home visit. Patients in the control group received supportive therapy and coping preparation during hospital visits over a complete course of chemotherapy. Both interventions were initiated prior to the first chemotherapy cycle. The yoga instructor was trained in counseling and facilitated both groups. 

• The study consisted of 62 participants. The yoga intervention group had 28 patients, and the supportive therapy intervention group had 34 patients.
• Patients ranged in age from 30–70 years.
• All patients had at least a high school education.
• Patients were chemotherapy naïve with recently diagnosed, operable stage II or III breast cancer with a treatment plan that included surgery followed by adjuvant chemotherapy or both adjuvant chemotherapy and radiation therapy.
• Patients had Zubrod’s performance statuses of 0–2.
• Patients were excluded from the study if they had a medical condition that was likely to interfere with treatment; major psychiatric, neurologic, or autoimmune disorders; known metastases; a history of intestinal obstruction; or a known sensitivity to antiemetics.

Patients were recruited from a comprehensive cancer care center in India.

Patients maintained diaries to record episodes of vomiting and duration of nausea, and, at the fourth cycle, they completed the Morrow Assessment of Nausea and Emesis (MANE), State-Trait Anxiety Index (STAI), Beck Depression Inventory (BDI), Functional Living Index-Cancer (FLIC), and a symptom checklist questionnaire.

• The severity of post-chemotherapy vomiting was mild to moderate in both groups.
• The nausea severity was moderate to severe for the control group and mild to moderate for the yoga group.
• Frequency and intensity of nausea were lower in the yoga group. In addition, intensity of anticipatory nausea and vomiting was lower in the yoga group compared to the control group.
• A positive correlation was found between MANE scores and anxiety, depression, and distressful symptoms.

The yoga intervention was effective in reducing the frequency and intensity of nausea and the intensity of anticipatory nausea and vomiting in women with early stage breast cancer.

• The antiemetics for the management of delayed emesis were not based on guidelines or consensus statements.
• Participants in the control group were offered supportive therapy and coping less frequently than the yoga intervention group. In addition, the yoga group started the intervention earlier than the control group, closer to the time of surgery and radiation than chemotherapy.
• With the overlap of physical symptoms of cancer, the BDI and STAI in cancer populations have limitations.

To examine whether the post hoc analysis presented here confirms the original findings of the APF530 phase III trial, that APF530 is an alternative to palonsetron for preventing acute and delayed chemotherapy-induced nausea and vomiting (CINV) after moderately emetogenic chemotherapy (MEC) and highly emetogenic chemotherapy (HEC)

In the original study, patients were randomized 1:1:1 to receive APF530 500 mg subcutanous plus placebo IV, APR530 250 mg subcutaneous and palonosetron 0.25 mg plus placebo. The first objective was to establish noninferiority of APF530. For the second cycle, the placebos were dropped, and individuals who had been randomized to the palonsetron were randomly assigned to either 250 or 500 mg of APR530.

• N = Original study: 1,341 patients, secondary analysis: 1,299 patients (609 in the MEC group and 690 in the HEC group). Forty-two patients were dropped because they were reclassified as receiving regimens now considered less emetogenic than MEC. Of the remaining subjects, almost 50% were reclassified from MEC to HEC or HEC to MEC.  
• MEAN AGE = 60.3 years (MEC group), 53.4 years (HEC group)
• MALES: 24.8%, FEMALES: 75.2%
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: The most common tumors were lung, ovarian, and breast.

• SITE: Multi-site   
• SETTING TYPE: Multiple settings    
• LOCATION: International study—United States, Europe, India

ACUTE PHASE OF CARE: Active antitumor treatment

Secondary analysis of a randomized, controlled study

Complete response (CR) was measured by no emetic episodes and no use of rescue medications during the acute and delayed phases of CINV after cycle one. Noninferiority was established if the confidence interval for the difference in CR was greater than 15%.

The results of this secondary analysis did not find significance difference between APF530 and palonsetron for acute and delayed CINV in patients receiving HEC and MEC regimens. There were no notable differences in the results of this study and the original analysis, except they found numerically higher CR rates in patients receiving MEC and lower CR rates in patients receiving HEC for all study arms.

The post hoc analysis presented here confirms the original findings of the APF530 phase III trial, that APF530 is an alternative to palonsetron for preventing acute and delayed CINV after MEC and HEC.

Post hoc analysis

The results of this study will not change the current use of slow-release granisetron (noninferior to palonsetron) for acute and delayed CINV after HEC and MEC, but confirms previous knowledge with new ASCO emetogenicity criteria.

To compare two dose levels of AFP530 and palonosetron in preventing acute and delayed chemotherapy-induced nausea and vomiting (CINV) after moderately emetogenic chemotherapy (MEC) or highly emetogenic chemotherapy (HEC)

Eligible patients were 18 years of age or older with a confirmed malignancy scheduled to receive single-day MEC or HEC defined by the Hesketh algorithm. Patients were stratified according to their chemotherapy emetogenicity (MEC or HEC) and randomized 1:1:1 to receive APF530 at 250 mg subcutaneously (granisetron 5 mg) plus a placebo IV; APF530 at 500 mg subcutaneously (granisetron 10 mg) plus a placebo IV; or palonosetron IV at 0.25 mg plus a placebo subcutaneously prior to chemotherapy. After cycle 1, all patients were invited to continue in the study. If they consented, they were rerandomized to maintain blinding, but only patients who received IV palonosetron in cycle 1 were actually randomized 1:1 to receive APF530 at 250 or 500 mg subcutaneously for less than or equal to three subsequent cycles. Efficacy measures were determined from patient diaries in which patients recorded emetic episodes, rescue medications, and the severity of nausea for each 24-hour period after chemotherapy.

• N = 1,396 (653 received MEC, 742 received HEC)
• MEAN AGE RANGE = 54.8–58.1 years 
• MALES: 27.2%–12.25%, FEMALES: 62.8%–87.75% (across treatment arms and emetogenicity strata)
• KEY DISEASE CHARACTERISTICS: 63.3%–69.5% patients with breast cancer receiving MEC; 25.4%–32.8% patients with lung cancer; and 25.4%–27.6% patients with breast cancer receiving HEC
• OTHER KEY SAMPLE CHARACTERISTICS: Greater than half of the patients received prior chemotherapy. Eastern Cooperative Oncology Group performance statuses were greater than or equal to 2.

• SITE: Multi-site    
• SETTING TYPE: Not specified    
• LOCATION: 103 centers in the United States, Poland, and India

• PHASE OF CARE: Active antitumor treatment

Prospective, multicenter, randomized, double-blinded, double-dummy, parallel-group, phase 3 trial

• Efficacy measures were determined from diaries in which patients recorded emetic episodes, rescue medications, and the severity of nausea for each 24-hour period after chemotherapy.

The original analysis under the Hesketh criteria for emetogenicity demonstrated that AFP530 at 250 and 500 mg subcutaneously was noninferior to palonosetron as assessed by complete response (CR) in the control of acute CINV after MEC (CR rates of 74.8% and 76.9%, respectively, versus 75% for palonosetron). The result was similar for patients receiving HEC with acute CR rates of 77.7% and 81.3% for APF530 at 250 mg and 500 mg, respectively, versus 80.7% for palonosetron. APF530 at 500 mg subcutaneously also was noninferior to palonosetron in preventing delayed CINV after MEC with a CR rate of 58.5% versus 57.2% for palonosetron. The superiority of APF530 at 250 or 500 mg subcutaneously versus palonosetron at 0.25 mg IV in preventing delayed CINV after HEC in cycle 1 was not determined. However, CR rates were similar for APF530 at 500 mg subcutaneously and palonosetron at 0.25 mg IV. In a post hoc analysis, patients receiving chemotherapy regimens whose antiemetic risk had been revised according to the updated antiemetic practice guidelines (notably cyclophosphamide plus anthracyclines [reclassified from MEC to HEC] and carboplatin-based regimens [reclassified from HEC to MEC]) were reclassified at the request of the U.S. Food and Drug Administration. The results of this reanalysis showed no notable statistic or clinical difference in response rates between APF530 and palonosetron.

A single, subcutaneous APF530 injection offered a convenient alternative to palonosetron for preventing acute and delayed CINV after MEC or HEC with similar safety profiles.

• Measurement/methods not well described
• Other limitations/explanation: Patient diaries and ratings were not clearly described. Chemotherapy was single-day only, and nausea and vomiting was measured for only a 24-hour period.

Single-dose APF530 subcutaneously was noninferior to palonosetron at 0.25 mg IV for controlling acute CINV in patients who received single-day MEC or HEC as determined by CR. This provides another option for antiemetic chemotherapy premedication. Because of changing emetic classifications, antiemetic study interpretation can be a complicated process. The findings of this study cannot be generalized to multiday chemotherapeutic regimens because multiday chemotherapeutic regimens were not included in the design of the study.