Febrile neutropenia: a prospective study to validate the Multinational Association of Supportive Care of Cancer (MASCC) risk-index score

Objective The objective of this study was to prospectively validate the Multinational Association of Supportive Care of Cancer (MASCC) risk-index score in an attempt to accurately predict on presentation with febrile neutropenia those cancer patients who are at low- or high-risk for development of serious medical complications during the episode.Patients and methods Patients who presented with febrile neutropenia during November 2000 and July 2002 were prospectively enrolled in the protocol. All patients were hospitalized until recovery or outcome of the event and were treated with broad-spectrum, empiric, intravenous antibiotic therapy. The MASCC risk-index score (based on seven independent factors present at onset of febrile neutropenia) was calculated in 64 patients with 80 febrile neutropenic episodes. Patients with a score of 21 were regarded as low risk; patients with a score of <21 were regarded as high risk.Results Of the 80 febrile neutropenic episodes, 58 were classified as low-risk and 22 as high-risk patients. Fifty-seven (98.3%) of the 58 low-risk patients recovered without complications, and three (13.6%) of the 22 high-risk patients did not develop medical complications. One low-risk patient developed a fungal infection but recovered completely in comparison to 11 high-risk patients (50%) who developed serious medical complications (p<0.001). None of the low-risk patients died. However, eight (36.4%) of the 22 high-risk patients died during the febrile neutropenic episode (p<0.001), six as a consequence of sepsis and two due to rapidly uncontrolled cancer.Conclusion We correctly predicted 98.3% of low-risk patients and 86.3% of high-risk patients. This study had a positive predictive value of 98.3% and a negative predictive value of 86.4% with both a sensitivity and specificity of 95%. The MASCC risk-index score correctly identifies low- and high-risk patients at presentation with febrile neutropenia.     

Darbepoetin alfa in lung cancer patients on chemotherapy: a retrospective comparison of outcomes in patients with mild versus moderate-to-severe anaemia at baseline

Goals Currently, there is some debate concerning the haemoglobin level at which treatment of anaemia with erythropoiesis-stimulating agents should be initiated in cancer patients on chemotherapy. We report several analyses of data from a phase III trial of darbepoetin alfa versus placebo, comparing outcomes for patients with mild and moderate-to-severe anaemia.Patients and methods Data were obtained from a phase III trial of darbepoetin alfa versus placebo in anaemic patients with lung cancer receiving chemotherapy (n=314). Outcomes were compared for patients with baseline haemoglobin 10–11 g/dl and <10 g/dl.Results Darbepoetin alfa significantly reduced transfusions compared with placebo, irrespective of haemoglobin level at treatment initiation. For patients with baseline haemoglobin <10 g/dl, 31% and 59% of those receiving darbepoetin alfa and placebo, respectively, required a transfusion from week 5 to the end of the treatment phase (P<0.038). For patients with baseline haemoglobin 10 g/dl, the proportions were 15% and 41%, respectively (P<0.001). Darbepoetin alfa also improved fatigue compared with placebo in both haemoglobin categories.Conclusions These findings show that initiating treatment at haemoglobin levels both <10 g/dl and 10–11 g/dl results in substantial clinical benefits, supporting the use of erythropoietic therapy also in patients with mild anaemia.J. Vansteenkiste is the beneficiary of the Amgen Fund in Supportive Cancer Care at the Catholic University, Leuven, Belgium.This work was supported by Amgen Inc., Thousand Oaks, California, USA     

High-risk populations for nasal carriage of methicillin-resistant Staphylococcus aureus

To determine the population at high risk of nasal carriage of methicillin-resistant Staphylococcus aureus (MRSA) on hospital patients admission, a nasal swab was taken from the following patients: (1) those aged 70 years or over (age 70), (2) non ambulatory receiving regular home visits by nurses and physicians (visiting), (3) residents of nursing homes (nursing home), (4) patients from other hospitals (another Hp), and (5) those scheduled for surgery (presurgery). Between March and July 2000, a total of 412 patients were admitted and 136 were enrolled. MRSA was isolated from 12 (8.8%) patients. The number of patients positive for MRSA in the five groups, age 70, visiting, nursing home, another Hp, and presurgery, were 3 of 68, 3 of 21, 2 of 3, 3 of 9, and 1 of 35, respectively. Multivariate analysis revealed that living in a nursing home [odds ratio (OR) = 32.82, P = 0.010] or coming from another hospital (OR = 14.55, P = 0.0043) were high risk factors with for nasal carriage of MRSA. Furthermore, patients ages were further divided into three categories, 79, 80–89, 90, and regarded as independent high risk factors (OR = 3.08, P = 0.043). The results were that advanced living in a age (80, 90), living in a nursing home or coming from another hospital are high risk factors of nasal carriage of MRSA on hospital admission.     

Severe community-acquired pneumonia in ICUs: Prospective validation of a prognostic score

Objective To determine predictors of intensive care unit (ICU) mortality in patients with community-acquired pneumonia (CAP), to develop a pneumonia-specific prognostic index, and to evaluate this index prospectively.Design Combined retrospective and prospective clinical study over two periods: January 1987–December 1992 and January 1993–December 1994.Setting Four medical ICUs in the north of France.Patients Derivation cohort: 335 patients admitted to one ICU were retrospectively studied to determine prognosis factors and to develop a pneumonia-specific prognostic index. Validation cohort: 125 consecutive patients, admitted to four ICUs, were prospectively enrolled to evaluate this index.Results In the derivation cohort, 16 predictors of mortality were identified and assigned a value directly proportional to their magnitude in the mortality model: aspiration pneumonia (–0.37), grading of sepsis 11 (–0.2), antimicrobial combination (–0.01), Glasgow score >12+mechanical ventilation (MV) (+0.09), serum creatinine 15 mg/l (+0.22), chest involvement shown by X-ray 3 lobes (+0.28), shock (+0.29), bacteremia (+0.29), initial MV (+0.29), underlying ultimately or rapidly fatal illness (+0.31), Simplified Acute Physiology Score 12 (+0.49), neutrophil count 3500/mm³ (+0.52), acute organ system failure score 2 (+0.64), delayed MV (+0.67), immunosuppression (+1.38), and ineffective initial antimicrobial therapy (+1.5). An index was obtained by adding each patient's points. According to a receiver operating characteristic curve, the cut-off value of this index was 2.5. In the validation cohort, an index of 2.5 could predict death with a positive predictive value of 0.92, sensitivity 0.61, and specificity 0.98.Conclusion This index, which performs well in classifying patients at high-risk of death, may help physicians in initial patient care (appropriateness of the initial antimicrobial therapy) and guide future clinical research (analysis and design of therapeutic trials).     

Body temperature alterations in the critically ill

Objective To determine the incidence of body temperature (BT) alterations in critically ill patients, and their relationship with infection and outcome.Design Prospective, observational study.Setting Thirty-one bed, medico-surgical department of intensive care.Patients Adult patients admitted consecutively to the ICU for at least 24 h, during 6 summer months.Interventions None.Results Fever (BT38.3°C) occurred in 139 (28.2%) patients and hypothermia (BT36°C) in 45 (9.1%) patients, at some time during the ICU stay. Fever was present in 52 of 100 (52.0%) infected patients without septic shock, and in 24 of 38 (63.2%) patients with septic shock. Hypothermia occurred in 5 of 100 (5.0%) infected patients without septic shock and in 5 of 38 (13.1%) patients with septic shock. Patients with hypothermia and fever had higher Sequential Organ Failure Assessment (SOFA) scores on admission (6.3±3.7 and 6.4±3.3 vs 4.6±3.2; p<0.01), maximum SOFA scores during ICU stay (7.6±5.2 and 8.2±4.7 vs 5.4±3.8; p<0.01) and mortality rates (33.3 and 35.3% vs 10.3%; p<0.01). The length of stay (LOS) was longer in febrile patients than in hypothermic and normothermic (36°C<BT<38.3°C) patients [median 6 (1–57) vs 5 (2–28) and 3 (1–33) days, p=0.02 and p=0.01, respectively). Among the septic patients hypothermic patients were older than febrile patients (69±9 vs 54±7 years, p=0.01). Patients with septic shock had a higher mortality if they were hypothermic than if they were febrile (80 vs 50%, p<0.01).Conclusions Both hypothermia and fever are associated with increased morbidity and mortality rates. Patients with hypothermia have a worse prognosis than those with fever.     

A validation study of the WHO analgesic ladder: a two-step vs three-step strategy

Goals of work The aims of the present study were to verify whether an innovative therapeutic strategy for the treatment of mild-moderate chronic cancer pain, passing directly from step I to step III of the WHO analgesic ladder, is more effective than the traditional three-step strategy and to evaluate the tolerability and therapeutic index in both strategies.Methods Patients aged 18 years or older with multiple viscera or bone metastases or with locally advanced disease were randomized. Pain intensity was assessed using a 0–10 numerical rating scale based on four questions selected from the validated Italian version of the Brief Pain Inventory. Treatment-specific variables and other symptoms were recorded at baseline up to a maximum follow-up of 90 days per patient.Results Fifty-four patients were randomized onto the study, and pain intensity was assessed over a period of 2,649 days. The innovative treatment presented a statistically significant advantage over the traditional strategy in terms of the percentage of days with worst pain 5 (22.8 vs 28.6%, p<0.001) and 7 (8.6 vs 11.2%, p=0.023). Grades 3 and 4 anorexia and constipation were more frequently reported in the innovative strategy arm, although prophylactic laxative therapy was used less in this setting.Conclusions Our preliminary data would seem to suggest that a direct move to the third step of the WHO analgesic ladder is feasible and could reduce some pain scores but also requires careful management of side effects.     

Medium-term effects of chemotherapy in older cancer patients

Purpose To address the lack of research in older cancer patients, the present study prospectively evaluated their cognitive functions across the first six months following diagnosis and chemotherapy.Patients and Methods A total of 77 younger (n=43, age < 60) and older (n=34, age 60) cancer patients with hematological disease or cancer of the intestinal tract took part in the study. Medium-term effects of chemotherapy were examined in these cancer patients by means of a battery of cognitive tests during baseline and six months after start of treatment.Results In contrast to baseline verbal learning, word fluency and memory capacity improved in all patients six months after start of treatment. A negative effect of age on cognitive functions could not be demonstrated. Additionally, depression was neither associated with medium-term effects of chemotherapy nor was it related to age.Conclusion The results suggest that chemotherapy has no negative effects on cognitive functions after the first six months following the onset of treatment. It was demonstrated that complete recovery of cognitive functions is independent of the patients age.     

The role of gallium-67 scintigraphy in diagnosing sources of fever in ventilated patients

Objective To evaluate the diagnostic value of gallium-67 scintigraphy in febrile ventilated patents by correlating the findings of⁶⁷Ga scintigraphy to sources of fever and pulmonary density, as determined by a comprehensive protocolized diagnostic evaluation.Design Prospective observational study.Patients Thirty-two intubated patients on mechanical ventilation for 3 days with fiver (38.3°C) and a new or progressive density on chest radiograph. Twenty patients (21 tests) had adult respiratory distress syndrome (ARDS).Intevention Diagnostic evaluation for fever included bronchoscopy with protected specimen brushing and (protected) bronchoalveolar lavage (BAL); computed tomography (CT) of sinuses; cultures of blood, urine, and central lines; and CT of the abdomen in high-risk patients.Measurements and results Uptake of⁶⁷Ga was reported as either focal or diffused pulmonary uptake and extrapulmonary uptake. The combined causes of fever were pneumonia (9), fibroproliferation of late ARDS (7), abdominal process (4), sinusitis (4), urinary tract infection (3), and others (6). Causes of the pulmonary densities were pneumonia (9), ARDS (13), atelectasis (7), congestive heart failure (3), and empyema (1). Marked and diffused pulmonary uptake was found only in patients with ARDS; however, it was not useful in discriminating those patients with pulmonary fibroproliferation as the sole cause of fever (p=0.167) from those with infection.⁶⁷Ga scintigraphy was inadequate for detecting pneumonia but valuable in identifying extrapulmonary sites of infection in patients with ARDS (p=0.021).Conclusions ⁶⁷Ga scintigraphy should be considered only as an adjunct diagnostic test in the febrile, ventilaged patients who has no obvious source of fever, despite a negative evaluation that includes testing for pneumonia, sinusitis, and urinary tract infection, conditions that are rarely detected by⁶⁷Ga scintigraphy.     

The respiratory variation in inferior vena cava diameter as a guide to fluid therapy

Objective To investigate whether the respiratory variation in inferior vena cava diameter (D_IVC) could be related to fluid responsiveness in mechanically ventilated patients.Design Prospective clinical study.Setting Medical ICU of a non-university hospital.Patients Mechanically ventilated patients with septic shock (n=39).Interventions Volume loading with 8 mL/kg of 6% hydroxyethylstarch over 20 min.Measurements and results Cardiac output and D_IVC were assessed by echography before and immediately after the standardized volume load. Volume loading induced an increase in cardiac output from 5.7±2.0 to 6.4±1.9 L/min (P<0.001) and a decrease in D_IVC from 13.8±13.6 vs 5.2±5.8% (P<0.001). Sixteen patients responded to volume loading by an increase in cardiac output 15% (responders). Before volume loading, the D_IVC was greater in responders than in non-responders (25±15 vs 6±4%, P<0.001), closely correlated with the increase in cardiac output (r=0.82, P<0.001), and a 12% D_IVC cut-off value allowed identification of responders with positive and negative predictive values of 93% and 92%, respectively.Conclusion Analysis of D_IVC is a simple and non-invasive method to detect fluid responsiveness in mechanically ventilated patients with septic shock.     

Reduction in expenditures on analgesics during one year of treatment of chronic tension headache with BoNT-A

Abstract The aim of this study was to investigate the impact of the use of botulinum toxin type A (BoNT-A; BOTOX; Allergan, Inc.; Irvine, CA) as preventive treatment of chronic tension-type headache (CTH) on analgesic use and expenditure.This was a prospective, single-center, 1-year, open-label study of the effect of BoNT-A treatment on acute analgesic use and expenditure in CTH patients.A structured headache questionnaire, which included questions about medication costs, was completed by CTH patients attending a specialist headache clinic in Rome prior to BoNT-A injections. Repeat injections were administered every 3 months for up to 1 year. Patients were required to complete the questionnaire prior to each injections cycle. A pharmacoeconomic analysis was performed at each assessment to determine the effect of BoNT-A treatment on analgesic use and expenditure. Three hundred questionnaire were distributed and 296 (98%) were completed. The study population consisted of 67.8% (201) females and 32.2% (95) males, with a mean age of 46.7±16.1 years.The economic evaluation of the pharmacologic treatment of CTTH was conducted on the 101 (34.12%) patients who gave complete information on posology. Pharmacoeconomic data analysis focused on the whole group using analgesics compared to those who self-prescribed and those who turned to health specialists before and after treatment with BoNT-A. Prior to treatment with BoNT-A the median monthly pharmaceutic expenditure per patient was euro (€) 24.30 for the whole group using analgesics, and € 34.93 and € 18.51 for the self-prescribers and the prescribed by specialist groups, respectively. Median monthly pharmaceutic expenditure decreased significantly for the whole group (p<0.001), the self-prescribers (p<0.01), and the prescribed by specialist group (p<0.002) (3rd month: € 13.3, 9.3, 7.2, respectively; 6th month: € 8.9, 9.0, 4.1, respectively; 9th month: € 5.7, 12.4, 3.0, respectively; 12th month € 4.1, 9.8, 3.4, respectively).BoNT-A treatment produced significant reductions in both analgesic use and expenditure. The data suggest that consultation with a specialist would be helpful in patients with CTTH. Cooperative studies on cost analysis of chronic daily headaches, including both CTTH and chronic migraine, comparing the economic cost package borne by patient and community both before and after treatment with BoNTA, are warranted. However, in the near future additional studies to compare clinical efficacy of BoNT-A in CTTH with its painkiller use/expenditure in the control of pain are needed in order to avoid any possible interference due to placebo effect.     

Alcoholic liver disease: Value of the left-to-right portal vein ratio in its sonographic diagnosis

A study group of 50 patients in whom the left portal vein diameter was equal to or greater than the right portal vein diameter (LPVDRPVD) was prospectively compared on ultrasonography with a control group of 50 patients with LPVD < RPVD. Clinical and laboratory data indicating chronic alcoholic liver disease (CALD) were observed with a significantly higher frequency in the study group than in the control group. It emerges from this study that LPVD RPVD represents a useful ultrasonographic sign of CALD, corresponding to a relative enlargement of the left hepatic lobe compared with the right.     

Variation of infected cell count in bronchoalveolar lavage and timing of ventilator-associated pneumonia

Objectives The aim of this study was to evaluate and compare the accuracy of the percentage of infected cells (%IC) in bronchoalveolar lavage (BAL) for ventilator-associated pneumonia (VAP) diagnosis according to its onset from the initiation of mechanical ventilation.Patients One hundred and eight patients admitted to a surgical ICU were retrospectively included (1999–2001). A total of 171 cases of VAP were diagnosed on clinical, biological, chest X-ray and BAL results (threshold 10⁴ cfu/ml).Results The %IC significantly decreased with the timing of VAP diagnosis: 12.2±12.1% for VAP occurring less than 7 days after the initiation of mechanical ventilation, 7.4±9.2% for VAP occurring between 7 and 15 days and 4.8±6.4% for VAP after 15 days (p=0.0002), despite the same number of elements and proportion of polymorphonuclear neutrophils in BAL. In addition, a relationship between the %IC and the pathogen responsible for VAP was observed for P. aeruginosa [higher for VAP <7 days than for VAP 7–15 days (p=0.01) and VAP >15 days (p=0.006)] and S. aureus [lower for VAP >15 days than VAP 7–15 days (p=0.04) and VAP <7 days (p=0.04)]. Furthermore, the %IC in BAL was lower in patients undergoing antimicrobial therapy than in patients without antibiotics (p=0.04). Three factors were independently associated with the %IC: quantitative culture of BAL (=0.42, p<0.0001), ongoing antimicrobial therapy (= –0.21, p=0.003) and onset of VAP (= –0.17, p=0.01).Conclusions A relationship between the %IC in BAL, duration of ventilation, quantitative culture of BAL and ongoing antimicrobial therapy has been proved in this study. The %IC for VAP diagnosis may not be accurate in patients with ongoing antibiotics and late onset infections (>7 days).Presented in part at the annual meeting of the European Society of Intensive Care Medicine, Barcelona, Spain, 29th September to 2nd October, 2002.     

Piperacillin-tazobactam and netilmicin as a safe and efficacious empirical treatment of febrile neutropenic children

Goals of work We evaluated piperacillin-tazobactam in association with netilmicin (TN) in the early empirical treatment of neutropenic children, as data are limited in number.Patients and method In 1996, an observational study was initiated to assess the efficacy and safety of this association, with a glycopeptide (TNG) if needed. The impact on the bacterial ecology of our unit was also observed. Children were treated for hematological malignancy or solid tumor between September 1996 and December 1998 and presented a febrile neutropenia.Results There were 148 evaluable febrile neutropenic episodes in 104 patients. Median age was 7 years, 55% of the episodes were fever of unknown origin, 22% were clinically documented and 23% microbiologically documented (27 bacteriemia). A glycopeptide was added in 67 episodes. The initial unmodified treatment was successful in 114 episodes (77%): 75/81 episodes in the TN group and 39/67 in the TNG group. For successful episodes, median treatment duration was 6 days. There were 22 febrile recurrences. These patients, as well as initial failures, always responded to a second-line treatment. One child was considered a failure because he developed a skin rash probably due to piperacillin-tazobactam and required another -lactamase.Conclusion This study suggests that piperacillin-tazobactam in association with netilmicin presents a satisfactory efficacy and a good tolerance as empirical therapy for febrile neutropenic children. It allowed us to maintain the bacterial ecology of our unit.     

Critically ill old and the oldest-old patients in intensive care: short- and long-term outcomes

Objective The purpose of this study was to examine characteristics and outcome of the old, very old and oldest-old ICU patientsDesign This is a cohort study.Setting The study was set in a ten-bed medical ICU in a university hospital.Participants There were 410 patients classified in three subgroups: old, 75–79 years (n=184; 44.4%), very old, 80–84 (n=137, 33.4%) and the oldest-old, 85 (n=91; 22.2%).Measurements Underlying medical conditions, organ dysfunction, severity of illness, length of stay, use of mechanical ventilation, therapeutic activity and nosocomial infections were recorded. Multivariate analysis was conducted to identify risk factors for ICU and long-term mortality.Results Characteristics at ICU admission did not differ among the three groups. ICU length of stay, therapeutic activity, mechanical ventilation and nosocomial infection(s) decreased with age. ICU survival rates for those below 75, 75–79, 80–84 and over 85 years were 80, 68, 75 and 69%, respectively; survival rates at 3 months were 54, 56 and 51%, respectively. APACHE II score [odds ratio (OR): 1.11] was identified as the only factor associated with ICU mortality, and age (OR: 2.17, for patients 85 years old and 1.82, for patients 80–84 years old) and limitation of activity before admission (OR: 1.74) as factors associated with long-term mortality.Conclusion In a population of patients 75 years old, very old age is not directly associated with ICU mortality. After ICU discharge, deaths occurred predominantly during the first 3 months: age and prior limitation of activity were associated with the risk of dying.An editorial regarding this article can be found in the same issue ()     

A comparison of dopamine,dobutamine and isoproterenol in the treatment of shock

Twelve patients in shock, defined as being present if the mean arterial blood pressure was less than 60 mm Hg, pulmonary arterial occlusion pressure was 15 mm Hg or greater, urine output was 20 ml or less for 2 consecutive hours, and there was clinical evidence of poor peripheral perfusion, underwent a comparative therapeutic trial with dopamine at 200 g · min^-1 and 400 g · min^-1 (2.5–5.5 g · kg^-1 · min^-1), dobutamine 250 g · min^-1 and 500 g · min^-1 (3.5–7 g · kg^-1 · min^-1) and isoproterenol 2 g · min^-1 and 4 g · min^-1 (0.025–0.055 g · kg^-1 · min^-1). Isoproterenol at 2 g · min^-1, produced a significant increase in pulse rate, cardiac output, left ventricular stroke work index and decrease in mean pulmonary blood pressure and pulmonary arterial occlusion pressure and at 4 g · min^-1 a significant increase in stroke volume, mixed venous oxygen tension and decrease in right atrial pressure and systemic vascular resistance was also observed. Dopamine at 200 g · min^-1 produced a significant increase in cardiac output, pulmonary arterial occlusion pressure and mixed venous oxygen tension and at 400 g · min^-1 a significant increase in pulse rate, mean arterial blood pressure mean pulmonary blood pressure, right ventricular stroke work index, right atrial pressure and pulmonary arterial occlusion pressure and decrease in arterial oxygen tension was also observed. Dobutamine at 250 g · min^-1 produced a significant increase in cardiac output, and at 500 g · min^-1 a significant increase in pulse rate, mixed venous oxgen tension and decrease in pulmonary arterial occlusion pressure.All agents increased pulse rate and cardiac output, although in the dosages chosen dopamine was the only agent do so with an increase in pulmonary arterial occlusion pressure and decrease in arterial oxygen tension. In patients in shock if an inotropic agent is considered necessary its pulmonary effect should be considered along with its effect on coronary and peripheral perfusion since dopamine may reduce arterial oxygenation.     

Prevalence of vertebral fractures in an urban population in Croatia aged fifty and older

Summary AIM OF THE STUDY: To establish the prevalence of vertebral fractures according to age groups, sex and vertebral level in a sample of a Croatian urban population aged 50. We also tried to establish how many people had been diagnosed with osteoporosis by their family physician. PARTICIPANTS AND METHODS: Lateral thoracic and lumbar spinal radiographs were obtained in 425 ambulatory people (156 men and 269 women) aged 50 and living in the community as a random sample of the City of Zagreb (Croatia) population. An interviewer-administered questionnaire was used to obtain information on prior traumatic vertebral fractures and whether the person had been diagnosed with osteoporosis. Vertebral fractures in the population sample were defined using the morphometric method proposed by McCloskey et al., and normal values of the ratios of dimensions in non-fractured vertebrae with the iterative algorithm described by Melton et al. RESULTS: The prevalence of individuals with vertebral fractures was 11.8% (15.8% of men and 9.7% of women), ranking Zagreb mid-scale among other European cities. The prevalence of individuals with vertebral fractures rose with age. Sixty-nine (1.24%) of 5525 analysed vertebrae had been fractured. The most common fractures were those of lower thoracic and upper lumbar vertebrae. The elderly tend to sustain multiple fractures. Forty-one (9.6%) people had been previously diagnosed as having osteoporosis. Extrapolation to the Croatian population implies that approximately 90,000 men and 77,000 women aged 50 have vertebral fractures. CONCLUSION: Vertebral osteoporotic fractures are common in the Croatian population aged 50; however, awareness of osteoporosis appears to be low.     

A phase II study of methylphenidate for the treatment of fatigue

Background Cancer-related fatigue (CRF) is one of the most distressing symptoms patients experience and is seen well after the completion of treatment. Methylphenidate (Ritalin) use includes the treatment of opiate-induced somnolence, depression, and reduced cognition. This phase II study was performed to evaluate the effects of methylphenidate on CRF.Patients and methods The criteria for the eligibility of patients included the following: a history of breast cancer, absence of disease for greater than 6 months but less than 5 years, a hemoglobin level of >12 g%, less than moderate depression on the Brief Zung Self-administered Depression Scale, and a score of 4 on the Brief Fatigue Inventory (BFI). Patients received methylphenidate, 5 mg, orally, twice daily, for 6 weeks, with a dose escalation on week 2 if the BFI score remained 4 and no significant toxicities were reported. A response was defined as a decrease in the BFI score of at least two points on weeks 4 and 6 as compared to baseline.Results Between May 2001 and May 2003, 37 patients were entered and treated. On weeks 4 and 6, 20 of 37 (54%) responded with a decreased BFI score greater than two points, averaging a decrease of 3.5. Although six patients (19%) withdrew due to adverse events, these were reported as grade 1.Conclusion This study suggests that women with breast cancer who are suffering from moderate to severe fatigue may benefit from methylphenidate.Presented in part at the 39th Annual Meeting of the American Society of Clinical Oncology, Chicago, IL, May 2003     

Multicenter,randomized trial of ramosetron plus dexamethasone versus ramosetron alone in controlling cisplatin-induced emesis

Goals To establish whether the combination of a corticosteroid (dexamethasone) and the newer serotonin-3 (5-HT₃) receptor antagonist ramosetron is superior to ramosetron alone in controlling cisplatin-induced emesis.Patients and methods A total of 283 patients aged 18–75 years with confirmed malignant disease who were scheduled to receive cisplatin 50 mg/m² with or without other antineoplastic agents were randomized to intravenous treatment with either ramosetron 300 g plus dexamethasone 20 mg (n=149) or ramosetron 300 g alone (n=134) given 30 min prior to cisplatin infusion. If vomiting occurred in the following 24 h, patients in both groups received an intravenous rescue dose of ramosetron 300 g. Subsequently, on days 2 and 3, treatment was continued orally with either ramosetron 100 g once daily plus dexamethasone 8 mg twice daily, or ramosetron 100 g once daily.Main results During the first 24 h after cisplatin infusion, significantly more patients receiving combination therapy had a complete response (no nausea or vomiting or requirement for rescue therapy) than those receiving ramosetron alone (68% vs 54%, respectively; P=0.034), and significantly fewer patients needed a rescue dose of ramosetron (22% vs 34%, respectively; P=0.032). In addition, the percentages of patients with no nausea and no vomiting were significantly greater in the ramosetron plus dexamethasone group than in the ramosetron-alone group at both 24 h and 72 h after cisplatin administration.Conclusions The antiemetic efficacy of ramosetron in cancer patients receiving highly emetogenic cisplatin chemotherapy is significantly enhanced by its use in combination with dexamethasone.This work is presented on behalf of the Philippines Nasea Study Group whose members are listed in the Appendix.     

Tuboovarian abscess caused by Candida glabrata in a febrile neutropenic patient

Deep-seated Candida infections are strongly associated with mortality and morbidity of patients, and need early diagnosis. The frequency of deep-seated fungal infection has recently been growing. We encountered a tuboovarian abscess caused by Candida glabrata after chemotherapy with an anticancer drug, methotrexate, in a febrile neutropenic patient. The susceptibilities to fluconazole and amphotericin B were 16 and 0.5µg/ml, respectively. Although combination therapy of fluconazole and amphotericin B was effective, left salpingectomy was laparoscopically performed because the left adnexal tumor continued to exist asymptomatically after 1 month.     

Postoperative education concerning the use of the upper limb,and exercise and treatment of the upper limb: cross-sectional survey of 105 breast cancer patients

In this retrospective survey we investigated the recall of breast cancer patients (n=105) 6 months after the operation concerning postoperative instructions on exercises for shoulder mobility, and instructions for oedema prevention and treatment, upper limb strength training and the use of the upper limb in daily activities. Patients also described the content in their own words and ranked the instructors who had mostly given this education. Operation type and length of hospital stay did not have any effect on the education recalled, but the age of the respondent had some effect (r=–0.23, p<0.05). The Wilcoxon signed ranks test showed that the most commonly reported item was instructions on shoulder movements (P<0.001). Patients reported that they had more instructions for using the upper limb in daily activities than instructions for strength training (P=0.002) and oedema prevention and treatment (P=0.001). Patients own comments were sometimes conflicting: Use the upper limb as before and you can even lift weights and You cannot drive a car or lift a weight over 3 kg for 6 weeks. Over half of the respondents named the physiotherapist or physiotherapy assistant as the person who had given them most of the instructions. A medical doctor was ranked in first place by 19% of the patients. Only half of the patients reported that they had some education after hospitalization. This study suggests that postoperative education of breast cancer patients is inconsistent and insufficient to provide knowledge for independent rehabilitation for future.