Lg Clark

Colony-Stimulating Factors for Chemotherapy-Induced Febrile Neutropenia: A Meta-Analysis of Randomized Controlled Trials

PURPOSE Current treatment for febrile neutropenia (FN) includes hospitalization for evaluation, empiric broad-spectrum antibiotics, and other supportive care. Clinical trials have reported conflicting results when studying whether the colony-stimulating factors (CSFs) improve outcomes in patients with FN. This Cochrane Collaboration review was undertaken to further evaluate the safety and efficacy of the CSFs in patients with FN. METHODS An exhaustive literature search was undertaken including major electronic databases (CANCERLIT, EMBASE, LILACS, MEDLINE, SCI, and the Cochrane Controlled Trials Register). All randomized controlled trials that compare CSFs plus antibiotics versus antibiotics alone for the treatment of established FN in adults and children were sought. A meta-analysis of the selected studies was performed. RESULTS More than 8,000 references were screened, with 13 studies meeting eligibility criteria for inclusion. The overall mortality was not influenced significantly by the use of CSF (odds ratio [OR] = 0.68; 95% CI, 0.43 to 1.08; P = .1). A marginally significant result was obtained for the use of CSF in reducing infection-related mortality (OR = 0.51; 95% CI, 0.26 to 1.00; P = .05). Patients treated with CSFs had a shorter length of hospitalization (hazard ratio [HR] = 0.63; 95% CI, 0.49 to 0.82; P = .0006) and a shorter time to neutrophil recovery (HR = 0.32; 95% CI, 0.23 to 0.46; P < .00001). CONCLUSION The use of the CSFs in patients with established FN caused by cancer chemotherapy reduces the amount of time spent in hospital and the neutrophil recovery period. The possible influence of the CSFs on infection-related mortality requires further investigation.

Efficacy of bevacizumab (Bev) plus chemotherapy (CT) compared to CT alone in previously untreated locally advanced or metastatic non-small cell lung cancer (NSCLC): systematic review and meta-analysis.

OBJECTIVE To perform a systematic review and meta-analysis of all randomized controlled trials comparing the efficacy of chemotherapy (CT) plus Bevacizumab (Bev) versus CT alone in previously untreated locally advanced or metastatic non-small cell lung cancer (NSCLC). METHODS Several databases were searched, including MEDLINE, EMBASE, LILACS, and CENTRAL. The endpoints were overall survival (OS), progression-free survival (PFS) and side effects. We performed a meta-analysis (MA) of the published data, using a fixed effects model and an additional random effects model, when applicable. The results of the MA are expressed as hazard ratio (HR) or risk ratio (RR), with their corresponding 95% confidence intervals (CI95%). We analyzed the use of Bev in the doses of 7.5 mg/kg and 15 mg/kg. RESULTS The final analysis included 4 trials, comprising 2200 patients. The response rate was higher in patients who received the combination of CT plus Bev 7.5 mg/kg (RR=0.58; CI95%=0.46-0.74; p<0.00001) and Bev 15 mg/kg (RR=0.53; CI95%=0.45-0.63; p<0.00001) with moderate heterogeneity at dose of 15 mg/kg (Chi(2)=4.30, df=3 (P=0.23); I(2)=30%). The PFS length was longer in patients who received CT plus Bev 7.5 mg/kg (HR=0.78, CI95%=0.68-0.90; p=0.0005) and Bev 15 mg/kg (HR=0.72, CI95%=0.65-0.80; p<0.00001) with moderate heterogeneity (Bev 7.5 mg/kg: Chi(2)=1.43, df=1 (P=0.23); I(2)=30% and Bev 15 mg/kg: Chi(2)=7.43, df=3 (P=0.06); I(2)=60%). Differences in these end points remained in favor of CT plus Bev when made the analysis by random-effects model. Overall survival was longer in patients who received CT plus Bev 15 mg/kg (HR=0.89, CI95%=0.80-1.00; p=0.04), with moderate heterogeneity (Chi(2)=5.09, df=3 (P=0.17); I(2)=41%). The random-effects model analysis for this endpoint did not confirmed the difference seen in the fixed effects model analysis (HR=0.90, CI95%=0.76-1.07; p=0.23). Severe haematologic toxicities (grade>3), neutropenia and febrile neutropenia were more common among the patients that received Bev. CONCLUSION The combination of CT plus Bev increased the response rate and progression-free survival of patients with NSCLC. With respect to overall survival the benefits of Bev remains uncertain.

Ideal Vial Size for Bortezomib: Real-World Data on Waste and Cost Reduction in Treatment of Multiple Myeloma in Brazil

OBJECTIVES Single-size vials of drugs may be a source of waste and increase in treatment costs. Bortezomib, indicated for multiple myeloma (MM) treatment, is available in 3.5-mg vials, a quantity higher than the average dose commonly prescribed. This analysis aimed to demonstrate, through real-world data, which would be the optimal vial presentation for bortezomib in Brazil and quantify the reduction in medication waste related to this option. METHODS From November 2007 to October 2009 all patients with MM treated with bortezomib were identified via the Evidências database. Analysis of prescribed, dispensed, and wasted doses, their costs and projections of the ideal vial size were performed. RESULTS Thirty-five patients (mean body surface area of 1.73 m(2)) received 509 infusions in 131 cycles of treatment (average of 3.77 cycles per patient). The average dose prescribed was 2.1 mg per infusion (95% confidence interval [CI] 1.97-2.26) with average waste of 39.5% of the vial content (95% CI 35.35-43.76). The mean waste per patient per day was 1.38 mg (95% CI 1.24-1.52). If a 3-mg vial were available, the average drug waste per patient per day would be 0.88 mg (95% CI 0.74-1.03) or 36.2% less. With a 2.5-mg vial the waste would be 1.05 mg (95% CI 0.81-1.29) or 23.9% less. If two presentations were available (2.5 mg and 0.5 mg), the waste would be 0.52 mg (95% CI 0.4-0.63) or 62.5% less. Considering the price of the different vials to be proportional to the original 3.5-mg vial, the cost would be also reduced by the same rates described above. CONCLUSIONS A simple adjustment in vial size may reduce the waste of bortezomib by 36% to 62% and can also reduce the cost of treatment.

PCN166 TRAZTUZUMAB ON ADJUVANT BREAST CANCER TREATMENT: EVIDENCE SYNTHESIS AND A HEALTH TECHNOLOGY EVALUATION

RESULTS: A total of six systematic reviews (SR) were found and met our inclusion criteria. For the indolent indication: a) Wake et al. 2002 and Schulz et al. 2007 evaluated the treatment as first line or subsequent therapies; b) Vidal et al. 2009 and Aksoy et al. 2009 assessed the maintenance therapy; c) Cheung et al. 2007 evaluated: first line and subsequent therapies, maintenance and aggressive NHL; and d) Knight et al. 2004 evaluated aggressive NHL. Only three studies developed a meta-analysis (Vidal, Schulz and Aksoy). According to the SRs rituximab induced remission, improved overall survival and disease control. Twenty five HTAR were found: 5 indicated the analysis through inexistent links; 2 belonged to sites with content blocked to nonmembers; 2 related to other drugs; 3 indicated ongoing analysis; 3 related to other indications. Consequently, 10 reports met the survey criteria. Seven out of 10 published HTAR support the use of rituximab for indolent or aggressive lymphomas. There are three assessments which are not conclusive. CONCLUSIONS: Findings from systematic reviews suggest that rituximab offer better clinical outcomes to patients. Most of the Health Technology Assessment reports indicate rituximab as a costeffective alternative.

PCN18 Intermittent Versus Continuous Chemotherapy for First-Line Treatment of Unresectable Metastatic Colorectal Cancer (CCRm): Systematic Review and Meta-Analysis

INTERMITTENT VERSUS CONTINUOUS CHEMOTHERAPY FOR FIRST-LINE TREATMENT OF UNRESECTABLE METASTATIC COLORECTAL CANCER (CCRM): SYSTEMATIC REVIEW AND META-ANALYSIS Botrel TEA1, Paladini L2, Clark O1, Clark LGO1 1Evidências, Campinas, Brazil, 2Evidências, São Paulo, São Paulo, Brazil OBJECTIVES: To perform a systematic review and meta-analysis of all randomized controlled trials comparing efficacy of Intermittent versus continuous chemotherapy (CT) for first-line treatment of unresectable Metastatic Colorectal Cancer (CCRm). METHODS: Several databases were searched, including MEDLINE, EMBASE, LILACS, and CENTRAL. The primary endpoint was overall survival (OS). The data extracted from the studies were combined by using Hazard Ratio (HR) with their corresponding 95% confidence intervals (CI95%). RESULTS: Overall, 733 references were identified and screened. The final analysis included 4 trials comprising 1,827 patients analyzed. There was no statistically significant difference between the groups (Intermittent vs continuous chemotherapy) on the analysis of overall survival (fixed effect: HR 1.03, CI95% 0.92 to 1.16; p 0.56). No heterogeneity was detected on this analysis (Chi2 2.88, df 3 (P 0.41); I2 0%). CONCLUSIONS: Overall survival was similar between groups. The intermittent chemotherapy regimen provides better quality of life that the scheme is continued and probably cost saving.

PCN35 BUDGETARY IMPACT OF ORAL CHEMOTHERAPY: REAL-WORLD DATA ANALYSIS FROM PAYERS' PERSPECTIVES IN BRAZIL

PCN30 THE BURDEN OF MULTIPLE MYELOMA: ASSESSMENT ON OCCURRENCE, OUTCOMES AND COST USING A RETROSPECTIVE LONGITUDINAL STUDY BASED ON ADMINISTRATIVE CLAIMS DATABASE de Portu S, Fanin R, Patriarca F, Morsanutto A, Tosolini F, Esti R, Mantovani LG University Federico II, Naples, Italy, University of Udine, Udine, Italy, Friuli Venezia Giulia Regional Health Authority, Trieste, Italy OBJECTIVES: Multiple myeloma (MM) is a malignancy of plasma cells that results in an overproduction of light and heavy chain monoclonal immunoglobulins. Multiple myeloma imposes a significant economic and humanistic burden on patients and society. The present study is aimed to assess the burden of multiple myeloma in epidemiologic and economic terms. METHODS: A retrospective, naturalistic longi tudinal study on the occurrence, outcomes and cost of multiple myeloma using an administrative database was performed. We selected residents of a North-eastern Region of Italy, who had the multiple myeloma first hospital admission during the period 2001–2005, and we followed them up until December 31, 2006, death or transfers. Direct medical costs were quantified in the perspective of the Regional Health Service. RESULTS: out of a population if 1.2 million inhabitants, we enrolled 517 patients (52% female) leading to a crude incidence of 8.6/100.000 person-years. During the period of observation, 364 (70.4%) subjects died. Total health care costs per patients over the maximum of follow-up were a78,020 for the subjects younger than 70 years old and a23,096 in older group. CONCLUSIONS: The overall cost of MM is substantial, particularly in the first year after diagnosis and for hospital care. The natural history of the disease requires a great absorption of resources in the early phases after diagnosis and in the late stages of the disease. Multiple myeloma imposes a significant epidemiologic and economic burden to the healthcaresystem and society.