The objective of the study was to evaluate tunneled pleural catheters for efficacy of palliation and the rate and predictors for spontaneous pleurodesis.

The study was a retrospective review of all patients (no matter who or where inserted) with at least tunneled pleural catheter inserted at a single institution from September 2007 to September 2009. Catheters were placed by pulmonologists, interventional radiologists, and thoracic surgeons in interventional radiology or bedside. All catheters were placed by Seldinger technique, unless during a video-assisted thoracoscopic procedure (VATs).

A total of 418 tunneled pleural catheters were placed. Forty-two patients had additional contralateral pleural catheters, 13 patients had an additional ipsilateral pleural catheter, and 4 patients had both a contralateral and secondary ipsilateral catheter.

• The study reported on a sample of 355 patients.
• The median age was 63 years, with a range of 16-90 years.
• Of the sample, 42% were males and 58% were females.
• Of the sample, 106 patients (30%) had lung cancer, 62 (17%) had breast cancer, 36 (10%) had gynecologic cancer, 24 (7%) had urologic cancer, 21 (6%) had upper gastrointestinal cancer, 18 (5%) had sarcoma, 18 (5%) had lower gastrointestinal cancer, 18 (5%) had hepatobiliary, and 52 (15%) had other disease.
• Two hundred fifty-three patients (61%) had right effusions, and 165 patients (39%) had left effusions.
• Sixty-nine patients (17%) had undergone previous procedures, and 349 patients (83%) had undergone no previous procedures.
• One hundred and ten patients (26%) had loculated pleural effusions, and 308 patients (74%) had simple, non-loculated pleural effusions.

The single-site study was conducted in both the inpatient and outpatient settings. Two hundred sixty-one patients (62%) were treated in interventional radiology, 107 patients (26%) were treating in the operating room, 37 patients (9%) were treated at the bedside, and 13 patients (3%) were treated in a clinic.

• Patients were undergoing long-term follow-up care.
• The study has clinical applicability for end-of-life and palliative care.
   

The study was a retrospective review.

• Radiographic evaluation of effusions pre- and post-catheter placement
• Computed tomography (CT) scan preferred; chest x-ray when CT not available
• Measured presence/absence of pleural fluid and presence/absence of spontaneous pleurodesis     
• Dyspnea was measured as “absence of symptoms” and “no need for subsequent effusion-directed drainage,” but the exact instrument or method of measurement was not described.
   

Median survival in this series from the time of the first catheter insertion was 3.7 months (range 2.9-4.5 months, confidence interval 95%). Median follow-up was 2.4 months, with a range of 1.0-6.4 months. Three hundred eighty of 418 catheters inserted (91%) did NOT need additional effusions-directed therapies. The successful palliation rate in patients who lived longer than 30 days was 89% (28 of 322 insertions). Spontaneous pleurodesis was achieved in 110 catheters (26%), and accounting for those who died, the probability of successful pleurodesis during the study time was 34%. The catheter complication rate was 4.8% (20 catheters; 5 grade II, 15 grade III).

• Tunneled pleural catheters were considered more cost-effective than talc pleurodesis for patients living less than six weeks. They had complication rates of 4.8% and were less severe than with talc pleurodesis (severe respiratory distress in 1%-9%).
• High rate of palliation (91%) was evidenced by no need for additional interventions for relief of symptomatic pleural effusions.
• The spontaneous pleurodesis rate of 26% is lower than other tunneled catheter studies.

•  No appropriate control group
•  Lack of a definitive symptom assessment scale
•  Lack of control for insertion operator, location, indication, or phase of disease.
   

Tunneled pleural catheters offer an alternative method of pleural drainage and may even induce spontaneous pleurodesis in patients with symptomatic malignant pleural effusions. The process of placing the catheter is minimally invasive, is associated with a low complication rate, and allows for rapid recovery of patients with limited life expectancy. More than 90% of patients receiving this therapy experienced symptomatic relief that did not require additional interventions for treatment of pleural effusions. This therapy option for management of symptomatic pleural effusions may be suggested by nurses familiar with the management of malignant pleural effusions. Studies addressing specific symptom relief would be valuable to validate the effectiveness of this intervention.

To evaluate the effectiveness of palonosetron versus granisetron in standard triplet antiemetic therapy

The regimens used were IV palonosetron or granisetron on day 1 in additional or oral aprepitant (125 mg on day 1 and 80 mg/day on days 2–3), IV dexamethasone 12 mg on day 1 and 8 mg/day on days 2–4. No other antiemetics were used. Patients were randomly assigned to the palonosetron or granisetron regimen. Patients recorded nausea daily in a diary. Rescue medication of metoclopramide, domperidone, or dexamethasone was used as needed.

• N = 827   
• MEDIAN AGE = 63 years
• MALES: 74.6%, FEMALES: 25.4%
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: All patients had solid tumors and were to receive a cisplatin-based highly emetogenic chemotherapy (HEC) regimen. Multiple tumor types existed; lung cancer was most frequent.

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

• PHASE OF CARE: Active antitumor treatment

• Double-blind, randomized, phase-III trial

• Complete control defined as no emesis, no use of rescue medication, and only mild nausea
• Total control defined as no emesis, no use of rescue medication, and no nausea

CR for delayed phase were higher with palonosetron (67.2% versus 59.1%, p = 0.014). Complete and total control rates were higher with palonosetron, in the delayed phase (p < 0.03).

The use of palonosetron as the 5HT3 in triplet antiemetic therapy was associated with somewhat greater chemotherapy-induced nausea and vomiting (CINV) control in the delayed phase and, as a result, in the overall phase.

• Evaluation was done only in the first cycle of chemotherapy.

Palonosetron was associated with a slightly higher proportion of patients having better CINV control in the delayed phase compared to granisetron. Further analysis is warranted to evaluate the actual cost benefit of different 5HT3 selections.

To investigate the safety and efficacy of fluvoxamine to treat anxiety and depression in patients with gynecologic cancer

For eight weeks patients were treated with escalating doses:

• Week 1: 25 mg once daily
• Week 2: 50 mg once daily
• Week 3: 50 mg twice daily
• Week 4: 50 mg three times daily
• Week 5 and onward: Dosing varied according to each patient's condition. 

Subjects were evaluated at two, four, six, and eight weeks.

• The study reported on a sample of 10 female patients.
• Median patient age was 53 years, with a range of 33–66 years.
• All patients had gynecologic cancers and were diagnosed at least two weeks prior to study entry.
• All patients had a HADS score of at least 11, indicating clinically relevant conditions. Mean HADS score was 19.
• Five patients had a diagnosed adjustment disorder, and five patients had major depression.

• Single site
• Setting not specified
• Japan

Patients were undergoing active antitumor treatment.

Prospective trial design 

• Hospital Anxiety and Depression Score (HADS)
• Short Form 36 Health Survey (SF-36)

Compared to HADS anxiety and depression scores at baseline, the scores were significantly lower after four weeks of treatment (p < 0.05) and remained significantly lower. After eight weeks, researchers noted significant improvements in SF-36 scores for vitality, mental health, and emotional role functioning (p < 0.05). No adverse effects of treatment were reported.

Fluvoxamine treatment of patients with gynecologic cancer who had clinically relevant anxiety and depression appears to reduce anxiety and depression. The small study sample precludes firm conclusions.

• The sample size was small, with fewer than 30 participants.
• The study had risks of bias because it had no control group, no blinding, and no random assignment.
• All patients had, at baseline, significant depression and anxiety, so findings cannot be generalized to patients with levels of these symptoms that are not clinically relevant. The follow-up period was only eight weeks; longer-term safety and efficacy are unknown.

Fluvoxamine as provided appeared to be effective in management of clinically relevant anxiety and depression in women with gynecologic cancer. Studies of anxiety and depression are often done with patients who do not have clinically significant problems in these areas at baseline, often making findings nonsignificant. This study provided some support for effective use of medication in patients with clinically relevant levels of anxiety and depression. The sample was very small, and the study design had multiple risks of bias. To determine which groups of patients can benefit from treatment, larger, well-designed trials are warranted.

To evaluate the safety and efficacy of the addition of aprepitant in patients receiving carboplatin-based chemotherapy after initial doublet-based antiemetics in the first chemotherapy cycle

In the first cycle of chemotherapy, patients were receiving doublet therapy, consisting of a 5-HT₃ and dexamethasone. In the second cycle, patients received aprepitant and reduced dexamethasone, as in standard triplet regimens. Patients completed daily questionnaires regarding vomiting frequency, nausea scoring, and food intake for five days of each cycle.

• N = 63   
• MEAN AGE = 66 years
• AGE RANGE = 44–81 years
• MALES: 79.4%, FEMALES: 20.6%
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: Tumor types were not stated, but 11.1% had brain metastases and 71.4% had a stage IV disease.

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

• PHASE OF CARE: Active antitumor treatment

• Observational

• Evaluation of complete response (CR) rates (no vomiting and no rescue antiemetics)
• Common Terminology Criteria for Adverse Events (CTCAE), version 3.0

The overall (p < 0.001) and delayed phase (p < 0.001) CR rates were better in the second cycle with the addition of aprepitant. No difference existed in the CR rates in the acute phase. Fewer patients in the second cycle required rescue antiemetics (p = 0.006). The proportion of patients who had grade 2 or higher nausea was less in the cycle with aprepitant (p = 0.013).

The addition of aprepitant significantly improved CINV control.

• Small sample (< 100)
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Experience of CINV in the first cycle could have influenced experiences in cycle 2 and beyond.

This study showed that the addition of an NK₁ as salvage for patients on MEC who did not have complete control in initial chemotherapy cycles was associated with improved CINV control, particularly in the delayed phase.

To explore the extent to which peritoneal dialysis (PD) patients are affected by constipation, how many laxatives they use on a regular basis, and barriers to managing constipation when their dietary fiber is increased.

In stage 1, the investigators established current bowel habits and laxative use. In stage 2 (N = 23), fiber intake was increased by 6 to 12 g per day using a dietary fiber supplement, partially hydrolyzed guar gum (PHGG). Finally, in stage 3 (N = 17), patients' daily diet was modified to include foods naturally high in fiber, aiming for 6 to 12 g per day more than their current intake, and bowel habits and laxative use were monitored.

A stool-and-laxative recording diary was sent to 126 PD patients. Forty-six reported using laxatives. All respondents using laxatives were invited to use a soluble dietary fiber supplement for four weeks, followed by dietary advice to see whether they could achieve the same effect using high-fiber foods.

• The study reported on a sample of 23 PD patients using laxatives.
• Patients were included in the study if they had received PD at home for at least three months.

United Kingdom

This was a descriptive study with a three-stage audit and intervention project.

A stool-and-laxative diary was used to measure number of bowel movements per day.

• In stage 1, a recording diary was sent to 126 patients with PD. Seventy patients returned the diary, and 46 reported using laxatives.
• In stage 2, 23 of 46 patients entered the intervention stage. Seventeen succeeded in replacing prescribed laxatives with the fiber supplement. All 23 patients successfully increased fiber and reduced laxative use within a four-week period.
• In stage 3, 17 patients were asked to increase dietary fiber by modifying their daily food intake. Sixteen tried to increase their intake of high-fiber foods; of them, 8 succeeded. However, only two patients were able to reduce their fiber supplement intake.

Fiber supplementation may be as effective as laxative treatment in preventing constipation. In addition, fiber supplementation was preferred by patients in this study, as many felt it improved bowel habits without the side effects of stimulant laxatives.

Fiber supplements cost much more than standard laxatives.

• The sample size was small.
• Only eight patients tried to increase their dietary fiber intake, limiting the value of the study. 
• The fiber supplement was used as a thickening and stabilizing agent. It helped renal patients on fluid restriction because psyllium and methyl cellulose require a lot of fluids to be effective. In addition, PHGG has negligible potassium and phosphate. This is not transferable to patients with cancer unless they are in renal compromise.
• The research design had flaws.
• The study did not compare the use of bulk-forming fiber or dietary with soluble fiber.
• A subjective patient-preferred questionnaire was administered. No tool was presented for patient outcomes assessed, which can be subjective for the clinicians evaluating the study.

Eight hundred mg vitamin E was diluted with corn oil (volume = 2 mL). Patients swished for at least 30 seconds then spat it out. The control group received corn oil only. Subjects did not rinse mouths for 30 minutes after spitting out the solution. Forty-five cycles of the study drug were administered (one cycle: four patients, two cycles: five patients, three cycles: one patient, four cycles: four patients, six cycles: five patients; vitamin E = 22 cycles, placebo = 23 cycles).

• N = 16
• AGE: Pediatric patients aged 6–18 years
• KEY SAMPLE CHARACTERISTICS: Planned chemotherapy for two identical cycles of doxorubicin-containing chemotherapy with doxorubicin at least 60 mg/m². Patients had chemotherapy regimens with one to three treatment sets consisting of two to six doxorubicin-containing chemotherapy cycles.

• Randomized, controlled, double-blind N-of-1 Bayesian analysis study

• Oral Mucositis Assessment Scale (OMAS) days 7, 10, 14, and 17 of each cycle
• Visual analog scale (VAS) score for pain and difficulty swallowing
• World Health Organization (WHO) scale in diary by participant or parent
• Amount of opioid analgesia
• Topical oral analgesia
• IV hydration
• Total parenteral nutrition
• Episodes of febrile neutropenia
   

Compliance was 84% with no statistically significant findings. Vitamin E was not associated with reduction in pain VAS scores or swallowing difficulty. WHO mucositis scores were similar for vitamin E and placebo cycles. No differences for the additional secondary outcomes between vitamin E and placebo cycles were found. Authors noted that vitamin E should not be used in this context. N-of-1 study design was found to be a potentially effective design method.
 

• Small study
• Data collection issues
• No significant findings
• The order in which the placebo and vitamin E cycles were administered is unclear.
   

PHASE OF CARE: Active antitumor treatment

Cryotherapy or low-level laser therapy may be offered to cooperative children receiving chemotherapy or HSCT conditioning with regimens associated with a high rate of mucositis. Keratinocyte growth factor (KGF) may be offered to children receiving HSCT conditioning with regimens associated with a high rate of severe mucositis. However, KGF use merits caution as there was a lack of efficacy and significant toxicity data as well as a lack of long-term follow-up data in pediatric cancers. No other interventions were recommended for oral mucositis prevention in children.

• Cryotherapy: Weak recommendation with moderate to quality evidence
• Low-level laser therapy: Weak recommendation with high-quality evidence
• KGF: Weak recommendation with high-quality evidence

No keywords, inclusion criteria, or exclusion criteria were stated in the article.

Although some information was missing in this study, the decision making process and results of the evidence review were well-described. The inclusion of a description of research gaps, summarized in a table, showed the comprehensiveness of this review.

To evaluate prophylactic colony-stimulating factors (CSFs) given concurrently with or after initiation of chemotherapy prior to the development of neutropenia compared with placebo or no therapy in patients with cancer undergoing chemotherapy or hematopoietic stem cell transplantation (HSCT)

The standard Quality of Reporting of Meta-Analyses (QUOROM) guidelines were used to guide the search.

DATABASES USED: Electronic searches of Ovid MEDLINE from 1966–April 24, 2007; EMBASE from 1980–April 26, 2007; and  the Cochrane Central Register of Controlled Trials Register (CENTRAL) through the second quarter of 2006 were performed. The pharmaceutical manufacturers of granulocyte CSFs (G-CSFs) and granulocyte macrophage CSFs (GM-CSFs) also were contacted.

INCLUSION CRITERIA: Patients randomly were assigned to CSFs or to placebo or no therapy. CSFs were given concurrently with or after initiation of chemotherapy or conditioning for stem cell transplantation but before neutropenia developed. Chemotherapy or conditioning regimens or other supportive care was not planned to systematically differ between study groups.

FINAL NUMBER STUDIES INCLUDED = 148 RCTs

TOTAL PATIENTS INCLUDED IN THE REVIEW: 16,839 participants or cycles; 8,474 randomly were assigned to CSF and 8,365 to placebo or no treatment.

KEY SAMPLE CHARACTERISTICS: The RCTs included adult or pediatric patients with cancer undergoing chemotherapy or HSCT. The results were analyzed at the study level, not at the patient level.

Compared with the control, prophylactic CSFs did not significantly affect

• Overall all-cause mortality (7.6 % rate in the CSF group and 8.0% in the control group)
• Risk for infection-related mortality (3.1% rate in the CSF group and 3.8% in the control group).

Compared with the control, prophylactic CSFs significantly reduced

• Documented infections by 15%
• Microbiologically documented infections by 14%
• Clinically documented infections by 25%
• Episodes of febrile neutropenia by 29%
• Duration of febrile neutropenia by a mean difference of 1.38 days
• Duration of fever by a mean difference of 0.45 days
• Time to absolute neutrophil count (ANC) of 500 cells/mcL or more by a mean difference of 3.79 days
• Time to ANC of 1,000 cells/mcL or more by a mean difference of 5.03 days
• Duration of parenteral antibiotic therapy by a mean difference of 1.81 days
• Duration of hospitalization by a mean difference of 2.41 days.

The median rate of febrile neutropenia in the placebo groups was 44.2% versus 25.3% in the CSF groups.

The use of G-CSFs had a greater effect than the use of GM-CSFs on reducing documented infections and febrile neutropenia, but all-cause mortality and infection-related mortality did not differ.

The purpose of this study was to examine colony-stimulating factors (CSFs) given to children with cancer prophylactically after initiation of chemotherapy prior to the development of febrile neutropenia.

OVID MEDLINE (January 1966 to July 2003) and EMBASE (January 1980 to July 2003) databases were searched. The search was limited to randomized, controlled trials (RCTs) that included children 18 years and younger. References were hand searched for relevant literature, and conference proceedings from meetings of the American Society of Hematology, American Society of Clinical Oncology, Society Internationale Oncologie Pediatric, and the American Society of Pediatric Hematology/Oncology from January 2001 to January 2003 were reviewed. Manufacturers of G-CSF and GM-CSF were contacted.

16 RCTs. Five studies evaluated GM-CSF, and 11 examined G-CSF.

1,183 children, 592 of whom were randomized to CSF and 591 to the control arm.

In children with cancer:

• CSFs reduced the rate of febrile neutropenia by 20%.
• CSFs reduced hospitalization duration by two days.
• CSFs reduced the documented infection rate by 22%.
• CSFs reduced the duration of neutropenia by four days.
• CSFs reduced the rate of amphotericin use by 50%.
• CSFs were not associated with a reduction in infection-related mortality.
• CSFs were not associated with a difference in duration of parenteral antibiotics.
• CSFs were not associated with a difference in the duration of chemotherapy delay.

The rates of febrile neutropenia in all of the included studies were 39% or higher, so the researchers concluded that prophylactic CSFs should be used in children with cancer who are receiving chemotherapy with an anticipated rate of febrile neutropenia 40% or higher. No explicit measurement of quality of life exists, but researchers hypothesize that decreasing hospitalization and febrile neutropenia would contribute to improved quality of life.

To assess whether perioperative intravenous flurbiprofen axetil reduces postmastectomy pain syndrome

Patients were randomized to receive either 50 mg of flurbiprofen axetil 15 minutes before surgical incisions and six hours after or 5 ml of intralipid as a control. All patients were receiving unilateral breast surgeries and lymph node dissections for breast cancer. All patients received the same anesthesia protocol for postoperative patient-controlled analgesia with fentanyl for 48 hours. Pain and opioid dose were recorded at two, six, 12, 24, and 48 hours after surgery. Chronic pain assessments were done by telephone at two, four, six, and 12 months after surgery.

• N = 60
• MEAN AGE = 49.9 years
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Breast cancer
• OTHER KEY SAMPLE CHARACTERISTICS: All patients received chemotherapy, and none received radiation therapy.

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

• PHASE OF CARE: Active antitumor treatment

Double-blinded, randomized, controlled trial

• 11-point Numeric Rating Scale (NRS) for pain

About a third of patients had mild to moderate pain two months after surgery with an average score of 0.77. Pain scores at all time points after surgery were lower in the flurbiprofen group (p < 0.02). These differences were most pronounced at two, four, and six months. The incidence of pain also was consistently lower in the flurbiprofen group at all time points and significantly lower at two, four, and six months (p < 0.02).

Perioperative infusion with flurbiprofen axetil was associated with the the reduced incidence and severity of chronic postmastectomy pain during the first year.

• Small sample (< 100)
• Unintended interventions or applicable interventions not described that would influence results
• Measurement validity/reliability questionable
• Other limitations/explanation: The single NRS used for pain measurement was limited. No information was provided about analgesic use during the follow-up period.

Although there were limitations, the results of this study were promising, and it was possible that perioperative flurbiprofen could be beneficial in reducing chronic postmastectomy pain by reducing inflammatory mechanisms. Additional research in this area is warranted.