Efficacy and safety of parecoxib in the treatment of acute renal colic: a randomized clinical trial

PURPOSE: Although nonselective nonsteroidal anti-inflammatory drugs (nsNSAIDs) and opioids are effective treatments for acute renal colic, they are associated with adverse events (AEs). As cyclooxygenase-2 selective NSAIDs may provide a safer alternative, we compared the efficacy and safety of parecoxib versus an nsNSAID in subjects with acute renal colic. MATERIALS AND METHODS: Phase IV., multicenter, double-blind, noninferiority, active-controlled study: 338 subjects with acute renal colic were randomized to parecoxib 40 mg i.v. plus placebo (n = 174) or ketoprofen 100 mg IV plus placebo (n = 164). 338 subjects with acute renal colic were randomized to parecoxib 40 mg IV (n = 174) or ketoprofen 100 mg IV(n = 164) plus placebo. Subjects were evaluated 15, 30, 45, 60, 90 and 120 minutes after treatment start and 24 hours after discharge. Primary endpoint was the mean pain intensity difference (PID) at 30 minutes by visual analog scale (VAS) (per-protocol population). An ANCOVA model was used with treatment group, country, and baseline score as covariates. Non-inferiority of parecoxib to ketoprofen was declared if the lower bound of the 95 percent confidence interval (CI) for the difference between the two groups excluded the pre-established margin of 10 mm for the primary endpoint. RESULTS: Baseline demographics were similar. The mean (SD) mPID30 min was 33.84 (24.61) and 35.16 (26.01) for parecoxib and ketoprofen, respectively. For treatment difference (parecoxib-ketoprofen) the lower bound of the 95 percent CI was 6.53. The mean change from baseline in VAS 30 minutes after study medication was ~43 mm; AEs were comparable between treatments. CONCLUSIONS: Parecoxib is as effective as ketoprofen in the treatment of pain due to acute renal colic, is well tolerated, and has a comparable safety profile.

Validando o SIR: um melhor índice prognóstico para pacientes com metástases cerebraistratados com cirurgia estereotática / Validating the SIR: a better prognostic score index for patients with brain metastases treated with stereotactic radiosurgery

Objetivo: Validar o SIR (score index for survival in patients with brain metastasis treated with stereotatic radiosurgery) [índice de escore paraavaliar a sobrevida de pacientes com metástases cerebrais tratadoscom radiocirurgia estereotática], uma classificação elaborada paramelhor prever o prognóstico de pacientes com metástases cerebraistratados com radiocirurgia, reavaliar a sobrevida dos pacientes e revisara literatura médica. Métodos: Foram analisados dados de 100 pacientes com metástases cerebrais tratados com radiocirurgia estereotática um uma única instituição, entre julho de 1993 e fevereiro de 2002. Os fatores prognósticos e índices estudados foram: idade, índice de desempenho de Karnofsky, estado da doença extracraniana, número de lesões cerebrais, volume da maior lesão, tipode tumor primário, tratado ou não tratado com radioterapia cerebral total,SIR e RPA (Recursive Partitioning Analysis – classificação por análiserecursiva fragmentada). As curvas atuariais de sobrevida de Kaplan-Meier foram calculadas e comparadas. Os modelos Cox – completo e de eliminação retrógrada – foram utilizados para identificar os fatores prognósticos e índices, associados à sobrevida. Resultados: Ao analisar as curvas de sobrevida de Kaplan-Meier, o índice de desempenho de Karnofsky, o estado da doença extracraniana, o volume da maior lesão cerebral, a RPA e o SIR mostraram correlação significativa com o prognóstico. Aplicando os modelos de Cox, observou-se significância para índice de desempenho de Karnofsky (p < 0,0001) e volume da maior lesão (p = 0,0182), assim como para o SIR e paraa RPA, quando testados individualmente (p < 0,0001 e p = 0,0002). Contudo, testando SIR e RPA conjuntamente, só o SIR alcançou significância estatística independente (p < 0,0001). Conclusão: Ao reavaliar nossa casuística, a classificação SIR mostrou maior precisão do que a RPA para prever o tempo de sobrevida de pacientes com metástases cerebrais tratados com radiocirurgia.

Objective: The aim of this paper is to validate the score index forsurvival in patients treated with stereotactic radiosurgery, using aclassification prepared to better evaluate the prognosis of patientswith brain metastasis submitted to stereotactic surgery, re-evaluatingsurvival of patients and reviewing the medical literature. Methods:Data from 100 patients with brain metastases treated with stereotacticradiosurgery at a single institution, between July 1993 and February2000, were retrospectively analyzed. The prognostic factors andscores studied were age, Karnofsky performance status, extracranialdisease status, number of brain lesions, volume of the largest lesion,primary tumor type, treated or not with whole brain radiation therapy,SIR, and RPA. Kaplan-Meier actuarial survival curves for subsets werecalculated and compared by log-rank test. Complete and backwardelimination Cox models were utilized to identify the prognostic factorsand scores independently associated with survival. Results: Karnofskyperformance status, extracranial disease status, volume of the largestbrain lesion, RPA, and SIR were significantly correlated with prognosisin Kaplan-Meier survival analysis. Applying Cox models, significancewas observed for KPS and volume of the largest lesion (p < 0.0001and p = 0.0182, respectively), as well as for SIR and RPA when testedindividually (p < 0.0001 and p = 0.0002, respectively). However, whentesting SIR and RPA together, only SIR reached independent statisticalsignificance (p < 0.0001). Conclusion: SIR classification demonstrateda better accuracy in predicting survival time than RPA. SIR was testedin other centers, showing superior accuracy and applicability than theRPA, thus validating this score.

Radioterapia em adenocarcinoma de pâncreas / Radiotherapy for pancreatic cancer

OBJETIVO: Avaliar retrospectivamente a sobrevida dos pacientes portadores de adenocarcinoma de pâncreas tratados no Serviço de Radioterapia do Hospital Israelita Albert Einstein, comparando os resultados com a literatura, e apresentando proposta de conduta. MÉTODOS: Entre abril de 1993 e agosto de 1999, 40 pacientes com adenocarcinoma de pâncreas foram admitidos para radioterapia neste Serviço. Destes, 25 haviam sido submetidos a procedimento cirúrgico radical com ressecçäo do tumor e em 15 o tumor näo havia sido ressecado (näo operados, biopsiados apenas ou submetidos a intervençöes cirúrgicas paliativas). RESULTADOS: A sobrevida actuarial mediana para toda amostra foi de 14,8 meses, sendo as probabilidades de sobrevida em 12 e 24 meses, 70 por cento e 22,2 por cento, respectivamente. A sobrevida actuarial mediana para o grupo de pacientes que tiveram o tumor ressecado foi de 21,4 meses e para o grupo de pacientes com tumor näo ressecado, 16,1 meses, sendo a probabilidade de sobreviver 12 e 24 meses de 76 por cento e 32 por cento no primeiro grupo e 60 por cento e 0 por cento no segundo (p=0,0156). CONCLUSÖES: Os nossos resultados säo semelhantes aos descritos na literatura médica atual. Há necessidade de introduzir novas drogas ativas para o tratamento destes tumores e a radioterapia intra-operatória tem que ser melhor explorada