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1.
Cochrane Database Syst Rev ; 12: CD013020, 2020 Dec 03.
Artigo em Inglês | MEDLINE | ID: mdl-33270906

RESUMO

BACKGROUND: Different bone-modifying agents like bisphosphonates and receptor activator of nuclear factor-kappa B ligand (RANKL)-inhibitors are used as supportive treatment in men with prostate cancer and bone metastases to prevent skeletal-related events (SREs). SREs such as pathologic fractures, spinal cord compression, surgery and radiotherapy to the bone, and hypercalcemia lead to morbidity, a poor performance status, and impaired quality of life. Efficacy and acceptability of the bone-targeted therapy is therefore of high relevance. Until now recommendations in guidelines on which bone-modifying agents should be used are rare and inconsistent. OBJECTIVES: To assess the effects of bisphosphonates and RANKL-inhibitors as supportive treatment for prostate cancer patients with bone metastases and to generate a clinically meaningful treatment ranking according to their safety and efficacy using network meta-analysis. SEARCH METHODS: We identified studies by electronically searching the bibliographic databases Cochrane Controlled Register of Trials (CENTRAL), MEDLINE, and Embase until 23 March 2020. We searched the Cochrane Library and various trial registries and screened abstracts of conference proceedings and reference lists of identified trials. SELECTION CRITERIA: We included randomized controlled trials comparing different bisphosphonates and RANKL-inihibitors with each other or against no further treatment or placebo for men with prostate cancer and bone metastases. We included men with castration-restrictive and castration-sensitive prostate cancer and conducted subgroup analyses according to this criteria. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data and assessed the quality of trials. We defined proportion of participants with pain response and the adverse events renal impairment and osteonecrosis of the jaw (ONJ) as the primary outcomes. Secondary outcomes were SREs in total and each separately (see above), mortality, quality of life, and further adverse events such as grade 3 to 4 adverse events, hypocalcemia, fatigue, diarrhea, and nausea. We conducted network meta-analysis and generated treatment rankings for all outcomes, except quality of life due to insufficient reporting on this outcome. We compiled ranking plots to compare single outcomes of efficacy against outcomes of acceptability of the bone-modifying agents. We assessed the certainty of the evidence for the main outcomes using the GRADE approach. MAIN RESULTS: Twenty-five trials fulfilled our inclusion criteria. Twenty-one trials could be considered in the quantitative analysis, of which six bisphosphonates (zoledronic acid, risedronate, pamidronate, alendronate, etidronate, or clodronate) were compared with each other, the RANKL-inhibitor denosumab, or no treatment/placebo. By conducting network meta-analysis we were able to compare all of these reported agents directly and/or indirectly within the network for each outcome. In the abstract only the comparisons of zoledronic acid and denosumab against the main comparator (no treatment/placebo) are described for outcomes that were predefined as most relevant and that also appear in the 'Summary of findings' table. Other results, as well as results of subgroup analyses regarding castration status of participants, are displayed in the Results section of the full text. Treatment with zoledronic acid probably neither reduces nor increases the proportion of participants with pain response when compared to no treatment/placebo (risk ratio (RR) 1.46, 95% confidence interval (CI) 0.93 to 2.32; per 1000 participants 121 more (19 less to 349 more); moderate-certainty evidence; network based on 4 trials including 1013 participants). For this outcome none of the trials reported results for the comparison with denosumab. The adverse event renal impairment probably occurs more often when treated with zoledronic acid compared to treatment/placebo (RR 1.63, 95% CI 1.08 to 2.45; per 1000 participants 78 more (10 more to 180 more); moderate-certainty evidence; network based on 6 trials including 1769 participants). Results for denosumab could not be included for this outcome, since zero events cannot be considered in the network meta-analysis, therefore it does not appear in the ranking. Treatment with denosumab results in increased occurrence of the adverse event ONJ (RR 3.45, 95% CI 1.06 to 11.24; per 1000 participants 30 more (1 more to 125 more); high-certainty evidence; 4 trials, 3006 participants) compared to no treatment/placebo. When comparing zoledronic acid to no treatment/placebo, the confidence intervals include the possibility of benefit or harm, therefore treatment with zoledronic acid probably neither reduces nor increases ONJ (RR 1.88, 95% CI 0.73 to 4.87; per 1000 participants 11 more (3 less to 47 more); moderate-certainty evidence; network based on 4 trials including 3006 participants). Compared to no treatment/placebo, treatment with zoledronic acid (RR 0.84, 95% CI 0.72 to 0.97) and denosumab (RR 0.72, 95% CI 0.54 to 0.96) may result in a reduction of the total number of SREs (per 1000 participants 75 fewer (131 fewer to 14 fewer) and 131 fewer (215 fewer to 19 fewer); both low-certainty evidence; 12 trials, 5240 participants). Treatment with zoledronic acid and denosumab likely neither reduces nor increases mortality when compared to no treatment/placebo (zoledronic acid RR 0.90, 95% CI 0.80 to 1.01; per 1000 participants 48 fewer (97 fewer to 5 more); denosumab RR 0.93, 95% CI 0.77 to 1.11; per 1000 participants 34 fewer (111 fewer to 54 more); both moderate-certainty evidence; 13 trials, 5494 participants). Due to insufficient reporting, no network meta-analysis was possible for the outcome quality of life. One study with 1904 participants comparing zoledronic acid and denosumab showed that more zoledronic acid-treated participants than denosumab-treated participants experienced a greater than or equal to five-point decrease in Functional Assessment of Cancer Therapy-General total scores over a range of 18 months (average relative difference = 6.8%, range -9.4% to 14.6%) or worsening of cancer-related quality of life. AUTHORS' CONCLUSIONS: When considering bone-modifying agents as supportive treatment, one has to balance between efficacy and acceptability. Results suggest that Zoledronic acid likely increases both the proportion of participants with pain response, and the proportion of participants experiencing adverse events However, more trials with head-to-head comparisons including all potential agents are needed to draw the whole picture and proof the results of this analysis.

2.
Zentralbl Chir ; 143(2): 193-204, 2018 Apr.
Artigo em Alemão | MEDLINE | ID: mdl-28946155

RESUMO

BACKGROUND: Patients with colorectal cancer are often affected by liver and lung metastases. Besides systemic therapies, lung metastasectomy is a suitable treatment option after complete resection of primary colorectal carcinoma and even concomitant liver metastases. MATERIAL AND METHODS: We have performed a systematical literature research of all studies published after 01. 01. 2010. Studies reporting on at least 100 patients undergoing lung metastasectomy after 01. 01. 2000 have been included in our final analysis. Operative data, survival data and prognostic factors have been extracted. RESULTS: Eleven study cohorts reporting on 2,891 patients could be included in the final analysis. Complete resection could be achieved in most cases and thoracic surgeons preferred subsegmental resections. Pathological examination revealed thoracic lymph node involvement in 2.3 to 18.2% of patients. The postoperative mortality varied from 0 to 0.5%. The median follow up ranged between 27.5 and 65.1 months. Pulmonary metastasectomy resulted in 5-year survival rates of 53 to 75.5% and 5-year progression-free survival rates of 33 to 50.9%. Intrathoracic recurrence occurred in 25.2 to 42.9% of patients with complete resection and five-year survival rates ranged from 49 to 75.5% after repeat pulmonary metastasectomy. Analysis of prognostic factors revealed that number, size and distribution of lung metastases are minor important prognostic factors. Moreover, current data suggest disadvantageous post-metastasectomy survival for patients with elevated pre-metastasectomy serum CEA level or intrathoracic lymph node metastases in comparison with the control groups. Nevertheless, even in these patients, lung metastasectomy might be a beneficial procedure. CONCLUSIONS: In patients with colorectal cancer and resectable isolated lung or combined liver and lung metastases pulmonary resection should be the treatment of choice. Pulmonary metastasectomy should be combined with thoracic lymph node resection to remove potential lymph node metastases. Repeat metastasectomy should be offered to patients suffering from isolated intrathoracic recurrence.


Assuntos
Neoplasias Colorretais , Neoplasias Pulmonares , Metastasectomia , Neoplasias Colorretais/patologia , Humanos , Estimativa de Kaplan-Meier , Neoplasias Pulmonares/secundário , Neoplasias Pulmonares/cirurgia , Pneumonectomia , Prognóstico
3.
Cochrane Database Syst Rev ; 12: CD006250, 2017 12 26.
Artigo em Inglês | MEDLINE | ID: mdl-29278410

RESUMO

BACKGROUND: The prevalence and incidence of pain and skeletal complications of metastatic bone disease such as pathologic fractures, spinal cord compression and hypercalcemia is high and an important contributor to morbidity, poor performance status and decreased quality of life. Moreover, pathologic fractures are associated with increased risk of death in people with disseminated malignancies. Therefore, prevention of pain and fractures are important goals in men with prostate cancer at risk for skeletal complications. OBJECTIVES: To assess the effects of bisphosphonates in men with bone metastases from prostate cancer. SEARCH METHODS: We identified studies by electronic search of bibliographic databases including the Cochrane Controlled Trials Register and MEDLINE on 13 July 2017 and trial registries. We handsearched the Proceedings of American Society of Clinical Oncology (to July 2017) and reference lists of all eligible trials identified. This is an update of a review last published in 2006. SELECTION CRITERIA: We included randomized controlled studies comparing the effectiveness of bisphosphonates in men with bone metastases from prostate cancer. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data and assessed the quality of trials. We defined the proportion of participants with pain response as the primary end point; secondary outcomes were skeletal-related events, mortality, quality of life, adverse events, analgesic consumption and disease progression. We assessed the quality of the evidence for the main outcomes using the GRADE approach. MAIN RESULTS: We included 18 trials reporting on 4843 participants comparing the effect of bisphosphonate administration to control regimens. PRIMARY OUTCOME: there was no clear difference in the proportion of participants with pain response (RR 1.15, 95% CI 0.93 to 1.43; P = 0.20; I2 = 0%; 3 trials; 876 participants; low quality evidence). In absolute terms, bisphosphonates resulted in a pain response in 40 more participants per 1000 (19 fewer to 114 more). SECONDARY OUTCOMES: bisphosphonates probably reduced the incidence of skeletal-related events in participants with prostate cancer metastatic to bone (RR 0.87, 95% CI 0.81 to 0.94; P = 0.27; I2 = 19%; 9 trials; 3153 participants; moderate quality evidence). In absolute terms, bisphosphonates resulted in 58 fewer SREs per 1000 (85 fewer to 27 fewer).We found no clinically relevant differences in mortality (RR 0.97, 95% CI 0.91 to 1.04; P = 0.43; I2 = 1%; 9 trials; 2450 participants; moderate quality evidence). In absolute terms, bisphosphonates resulted in 16 fewer deaths per 1000 (47 fewer to 21 more).Outcome definition of quality of life and the measurement tools varied greatly across trials and we were unable to extract any quantitative data for meta-analysis.Bisphosphonates probably increased the number of participants affected by nausea (RR 1.19, 95% CI 1.00 to 1.41; P = 0.05; I2 = 0%; 9 trials; 3008 participants; moderate quality evidence). In absolute terms, bisphosphonates resulted in seven more cases of nausea per 1000 (0 fewer to 14 more). Bisphosphonates probably increased the number of renal adverse events (RR 1.65, 95% CI 1.11 to 2.46; P = 0.01; I2 = 0%; 7 trials; 1794 participants; moderate quality evidence). In absolute terms, bisphosphonates resulted in 22 more renal adverse events per 1000 (4 more to 50 more). We found no clear difference in the number of participants with osteonecrosis of the jaw between groups (RR 1.92, 95% CI 0.75 to 4.90; P = 0.17; I2 = 0%; 5 trials; 1626 participants; very low quality evidence). In absolute terms, bisphosphonates resulted in seven more cases with osteonecrosis of the jaw per 1000 (2 fewer to 29 more). We observed no clinically relevant difference in the proportion of participants with decreased analgesic consumption (RR 1.19, 95% CI 0.87 to 1.63; P = 0.28; I2 = 37%; 4 trials; 416 participants). Statistical analysis revealed that bisphosphonates probably reduced the number of participants with disease progression (RR 0.94, 95% CI 0.90 to 0.98; P = 0.006; I2 = 0%; 7 trials; 2115 participants; moderate quality evidence). In absolute terms, bisphosphonates resulted in 36 fewer cases of disease progression per 1000 (71 fewer to 7 fewer).Findings of our predefined subgroup and sensitivity analyses were no different from those of the primary analyses. AUTHORS' CONCLUSIONS: Based on low quality evidence, there may be no clinically relevant difference in the proportion of men with pain response between bisphosphonates and control regimens in men with bone metastases from prostate cancer. Bisphosphonates probably decrease the number of skeletal-related events and disease progression. These benefits need to be weighed against the increased risk of renal impairment and nausea in men receiving bisphosphonates. Future studies should explicitly evaluate patient important outcomes such as quality of life and pain by using standardized and comparable assessment tools.


Assuntos
Conservadores da Densidade Óssea/uso terapêutico , Neoplasias Ósseas/tratamento farmacológico , Neoplasias Ósseas/secundário , Difosfonatos/uso terapêutico , Dor/tratamento farmacológico , Neoplasias da Próstata , Osteonecrose da Arcada Osseodentária Associada a Difosfonatos/epidemiologia , Conservadores da Densidade Óssea/efeitos adversos , Neoplasias Ósseas/mortalidade , Difosfonatos/efeitos adversos , Humanos , Rim/efeitos dos fármacos , Masculino , Náusea/induzido quimicamente , Dor/etiologia , Ensaios Clínicos Controlados Aleatórios como Assunto
4.
Geburtshilfe Frauenheilkd ; 77(6): 645-650, 2017 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-28769127

RESUMO

Breast carcinoma with pulmonary metastasis can be treated locally or systemically. Following primary tumour resection patients with isolated, completely resectable pulmonary nodules and definite functional operability can be offered lung metastasis resection. Following metastasectomy a median survival of 32 to 96.6 months can be achieved with corresponding five-year survival rates between 30.8 and 54.4%. The procedure is associated with a mortality rate of 0 to 3%. The most important independent prognostic factor for long-term survival is complete resection of all lung lesions. The configuration and pattern of metastasis as well as disease-free interval, hormone and HER2/neu receptor status also appear to influence prognosis, but are of lesser importance. Intrapulmonary recurrence of metastases may, after careful selection on a case-by-case basis, also be treated operatively. In some cases this is associated with a favourable long-term prognosis. Pulmonary metastasectomy should be the treatment of choice for selected patients with metastatic breast carcinoma.

5.
Z Orthop Unfall ; 155(5): 567-574, 2017 Oct.
Artigo em Alemão | MEDLINE | ID: mdl-28637066

RESUMO

Background Advanced soft tissue or osteosarcoma is often associated with lung metastases. Curative pulmonary metastasectomy is appropriate for patients with successfully resected primary cancer who show no evidence of extrapulmonary metastases, with proven functional operability and completely resectable metastases. Material and Methods Systematic literature research and qualitative analysis of studies on patients undergoing lung metastasectomy after resection of primary sarcoma published since 01.01.2010. We assessed operative findings, survival data and prognostic factors. Results Pulmonary metastasectomy results in a median postmetastasectomy survival of 8.76 to 69.9 months. Five year survival rates after metastasectomy vary between 21.7 and 56.8%. The patients' prognosis depends particularly on complete resection of all suspected metastases. Intrapulmonary recurrence could be treated by repeated resection, but this procedure requires careful decision for indication. Re-metastasectomy might result in a favourable outcome in selected cases. Conclusion Pulmonary metastasectomy should be considered as treatment of choice in selected patients with isolated lung metastases from osteosarcoma. Optimal indication might lead to an advantage in patients with metastasectomy of isolated lung metastases from soft tissue.


Assuntos
Neoplasias Ósseas/cirurgia , Neoplasias Pulmonares/secundário , Neoplasias Pulmonares/cirurgia , Metastasectomia/métodos , Osteossarcoma/secundário , Osteossarcoma/cirurgia , Sarcoma/secundário , Sarcoma/cirurgia , Neoplasias de Tecidos Moles/cirurgia , Progressão da Doença , Humanos , Neoplasias Pulmonares/patologia , Recidiva Local de Neoplasia/patologia , Recidiva Local de Neoplasia/cirurgia , Estadiamento de Neoplasias , Osteossarcoma/patologia , Prognóstico , Reoperação , Sarcoma/patologia , Neoplasias de Tecidos Moles/patologia
6.
Interact Cardiovasc Thorac Surg ; 22(3): 351-9, 2016 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-26678151

RESUMO

A best evidence topic in thoracic surgery was written according to a structured protocol. The question addressed was whether manual palpation of the lung is necessary in patients undergoing pulmonary metastasectomy. In total, 56 articles were found using the described search strategy. After screening these articles and their references, 18 publications represented the best evidence to answer the clinical question. No randomized controlled trial addressing the three-part question was available. The authors, journal, date and country of publication, patient group, study type, relevant outcomes and results of these papers were tabulated. The studies reported on 1472 patients with different primary cancers. The patients underwent more than 1630 pulmonary metastasectomies between 1990 and 2014 after the treatment of primary cancer. Almost three quarters of patients underwent open procedures like thoracotomy or sternotomy. Most frequently, helical CT with a slice thickness ranging between 1 and 10 mm was used for preoperative imaging. The sensitivity in detecting pulmonary nodules ranged from 34 to 97%. The corresponding sensitivity rates for PET-CT were 66-67.5 and 75% for high-resolution CT. The positive predictive value for lesions detected by helical CT varied from 47 to 96%. Helical CT reached a specificity between 54 and 93% in detecting pulmonary nodules. The surgeons identified more nodules by meticulous palpation than helical CT. It is noteworthy that up to 48.5% of these palpated nodules were benign lesions (false-positive). Patients with smaller imaged nodules, multiple imaged nodules or primary mesenchymal tumour are more likely to have occult pulmonary nodules. We conclude that not all palpable pulmonary nodules can be imaged preoperatively. Thoracotomy allows the manual palpation of the ipsilateral hemithorax and might be superior to video-assisted thoracic surgery regarding radical resection. However, not all palpable nodules are malignant, and the impact of non-resected pulmonary metastases on patient survival is not clearly evaluated.


Assuntos
Neoplasias Pulmonares/secundário , Neoplasias Pulmonares/cirurgia , Metastasectomia/métodos , Palpação , Pneumonectomia , Idoso , Benchmarking , Medicina Baseada em Evidências , Feminino , Humanos , Neoplasias Pulmonares/mortalidade , Masculino , Metastasectomia/efeitos adversos , Metastasectomia/mortalidade , Imagem Multimodal/métodos , Pneumonectomia/efeitos adversos , Pneumonectomia/mortalidade , Tomografia por Emissão de Pósitrons , Valor Preditivo dos Testes , Fatores de Risco , Cirurgia Torácica Vídeoassistida , Toracotomia , Tomografia Computadorizada Espiral , Resultado do Tratamento
7.
Hautarzt ; 66(1): 65-73, 2015 Jan.
Artigo em Alemão | MEDLINE | ID: mdl-25576143

RESUMO

Results of previous studies question the benefits of pulmonary surgery in patients with pulmonary metastases from malignant melanoma. A systematic literature search and analysis of articles published since 1 January 2000 was carried out to investigate the advantages of metastasectomy and alternative forms of therapy. Patients reached a median survival time of 17-40 months and 5-year survival rates between 18% and 39.4% after metastasectomy. Intrathoracic recurrence occurred in 30 % of patients but could be successfully treated with re-operations in some cases. Various monoclonal antibodies are currently available and achieve a median survival time of up to 17 months. Pulmonary metastasectomy is the treatment of choice in selected patients; however, in the future the benefits should be revalidated in comparison with pharmaceuticals of the current generation.


Assuntos
Neoplasias Pulmonares/secundário , Neoplasias Pulmonares/cirurgia , Melanoma/secundário , Melanoma/cirurgia , Recidiva Local de Neoplasia/mortalidade , Neoplasias Cutâneas/mortalidade , Medicina Baseada em Evidências , Humanos , Incidência , Neoplasias Pulmonares/mortalidade , Melanoma/mortalidade , Recidiva Local de Neoplasia/prevenção & controle , Pneumonectomia/mortalidade , Neoplasias Cutâneas/cirurgia , Taxa de Sobrevida , Resultado do Tratamento
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