Consensus on diagnosis and management of non-metastatic castration resistant prostate cancer in Brazil: focus on patient, selection, treatment efficacy, side effects and physician's perception according to patient comorbidities

ABSTRACT Background: Non-metastatic castration resistant prostate cancer (M0 CRPC) has seen important developments in drugs and diagnostic tools in the last two years. New hormonal agents have demonstrated improvement in metastasis free survival in M0 CRPC patients and have been approved by regulatory agencies in Brazil. Additionally, newer and more sensitive imaging tools are able to detect metastasis earlier than before, which will impact the percentage of patients staged as M0 CRPC. Based on the available international guidelines, a group of Brazilian urology and medical oncology experts developed and completed a survey on the diagnosis and treatment of M0 CRPC in Brazil. These results are reviewed and summarized and associated recommendations are provided. Objective: To present survey results on management of M0 CRPC in Brazil. Design, setting, and participants: A panel of six Brazilian prostate cancer experts determined 64 questions concerning the main areas of interest: 1) staging tools, 2) treatments, 3) side effects of systemic treatment/s, and 4) osteoclast-targeted therapy. A larger panel of 28 Brazilian prostate cancer experts answered these questions in order to create country-specific recommendations discussed in this manuscript. Outcome measurements and statistical analysis: The panel voted publicly but anonymously on the predefined questions. These answers are the panelists' opinions, not a literature review or meta-analysis. Therapies not yet approved in Brazil were excluded from answer options. Each question had five to seven relevant answers including two non-answers. Results were tabulated in real time. Conclusions: The results and recommendations presented can be used by Brazilian physicians to support the management of M0 CRPC patients. Individual clinical decision making should be supported by available data, however, for Brazil, guidelines for diagnosis and management of M0 CRPC patients have not been developed. This document will serve as a point of reference when confronting this disease stage.

Estadiamentos pré-operatório e patológico do CPNPC: análise retrospectiva de 291 casos / Preoperative and pathological staging of NSCLC: retrospective analysis of 291 cases

OBJECTIVE: The objective of this study was to evaluate the accuracy of preoperative clinical staging with computed tomography in predicting the correct pathological stage. METHODS: Medical records of non-small cell lung cancer (NSCLC) patients treated, from 1990 to 2005 were reviewed. Clinical stage was based on routine preoperative clinical and imaging evaluation. Positron emission tomography was not routinely performed. Suspected lesions, that would preclude a surgical resection, were pathologically confirmed. The pathological stage was based on final postoperative or biopsy pathological assessment. A correlation table between clinical and pathological stages was generated. Cohen's kappa index, sensitivity, specificity, positive and negative predictive values and accuracy were calculated. RESULTS: Records of 291 patients were reviewed. Clinical stages Ia, Ib, IIa, IIb, IIIa, IIIb and IV were found respectively in 8.9 percent, 31.9 percent, 0.3 percent, 18.6 percent, 25.4 percent, 11 percent and 3.8 percent. Pathological staging was different from clinical staging in 33 percent (15 percent were upstaged and 18 percent downstaged). Sensitivity, specificity, positive and negative predictive values and accuracy for clinical staging were 78 percent, 69 percent, 82 percent, 64 percent and 67 percent, respectively. Cohen's kappa index was 0.574 (P < 0.001). CONCLUSION: Preoperative clinical staging presents limited efficacy for the correct staging of NSCLC patients from this sample of Brazilian population.

OBJETIVO: O objetivo do presente estudo foi avaliar a eficácia do estadiamento clínico pré-operatório com tomografia computadorizada com o estadiamento patológico. MÉTODOS: Entre 1990 e 2005, foram revisados retrospectivamente os prontuários dos pacientes com câncer de pulmão não-pequenas células (CPNPC). O estágio clínico foi baseado em exames pré-operatórios de imagem. Tomografia por emissão de pósitrons não foi incluída na rotina de exames pré-operatórios. Lesões suspeitas, que contra-indicassem a ressecção cirúrgica curativa, foram confirmadas patologicamente. O estágio patológico foi considerado aquele baseado na análise patológica pós-operatória ou em biópsia de lesão suspeita. Foi gerada uma tabela de correlação entre estágio clínico e patológico. Foram calculados o índice kappa de Cohen, a sensibilidade, a especificidade, o valor preditivo positivo e negativo, e a acurácia. RESULTADOS: 291 prontuários de pacientes foram revisados. Os estágios Ia, Ib, IIa, IIb, IIIa, IIIb e IV foram encontrados em 8,9 por cento, 31,9 por cento, 0,3 por cento, 18,6 por cento, 25,4 por cento, 11 por cento e 3,8 por cento, respectivamente. Estágio patológico foi diferente do estágio clínico em 33 por cento dos pacientes (15 por cento foram sobre-estadiados e 18 por cento sub-estadiados). Sensibilidade, especificidade, valor preditivo positivo e negativo, e acurácia foram 78 por cento, 69 por cento, 82 por cento, 64 por cento e 67 por cento, respectivamente. O índice kappa de Cohen foi de 0,574 (P < 0,001). CONCLUSÃO: O estadiamento clínico pré-operatório apresenta eficácia limitada no estadiamento dos pacientes com CPNPC.