RESUMO
BACKGROUND: Many studies have compared real-world clinical outcomes of immunotherapy in patients with metastatic non-small cell lung cancer (NSCLC) with reported outcomes data from pivotal trials. However, any differences observed could be only limitedly explored further for causation because of the unavailability of individual patient data (IPD) from trial participants. The present study aims to explore the additional benefit of comparison with IPD. METHODS: This study compares progression free survival (PFS) and overall survival (OS) of metastatic NSCLC patients treated with second line nivolumab in real-world clinical practice (n = 141) with IPD from participants in the Checkmate-057 clinical trial (n = 292). Univariate and multivariate Cox proportional hazards models were used to construct HRs for real-world practice versus clinical trial. RESULTS: Real-world patients were older (64 vs. 61 years), had more often ECOG PS ≥ 2 (5 vs. 0%) and were less often treated with subsequent anti-cancer treatment (28.4 vs. 42.5%) compared to trial patients. The median PFS in real-world patients was longer (3.84 (95%CI: 3.19-5.49) vs 2.30 (2.20-3.50) months) and the OS shorter than in trial participants (8.25 (6.93-13.2) vs. 12.2 (9.90-15.1) months). Adjustment with available patient characteristics, led to a shift in the hazard ratio (HR) for OS, but not for PFS (HRs from 1.13 (0.88-1.44) to 1.07 (0.83-1.38), and from 0.82 (0.66-1.03) to 0.79 (0.63-1.00), respectively). CONCLUSIONS: This study is an example how IPD from both real-world and trial patients can be applied to search for factors that could explain an efficacy-effectiveness gap. Making IPD from clinical trials available to the international research community allows this.
Assuntos
Carcinoma Pulmonar de Células não Pequenas , Neoplasias Pulmonares , Humanos , Carcinoma Pulmonar de Células não Pequenas/tratamento farmacológico , Imunoterapia , Neoplasias Pulmonares/tratamento farmacológico , Nivolumabe/uso terapêutico , Modelos de Riscos Proporcionais , Estudos Retrospectivos , Ensaios Clínicos como AssuntoRESUMO
BACKGROUND: The growing number of cancer survivors and treatment possibilities call for more personalised and integrated cancer care. Primary care seems well positioned to support this. We aimed to assess the effects of structured follow-up of a primary care team after a cancer diagnosis. METHODS: We performed a multicentre randomised controlled trial enrolling patients curatively treated for breast, lung, colorectal, gynaecologic cancer or melanoma. In addition to usual cancer care in the control group, patients randomized to intervention were offered a "Time Out consultation" (TOC) with the general practitioner (GP) after diagnosis, and subsequent follow-up during and after treatment by a home care oncology nurse (HON). Primary outcomes were patient satisfaction with care (questionnaire: EORTC-INPATSAT-32) and healthcare utilisation. Intention-to-treat linear mixed regression analyses were used for satisfaction with care and other continuous outcome variables. The difference in healthcare utilisation for categorical data was calculated with a Pearson Chi-Square or a Fisher exact test and count data (none versus any) with a log-binomial regression. RESULTS: We included 154 patients (control n = 77, intervention n = 77) who were mostly female (75%), mainly diagnosed with breast cancer (51%), and had a mean age of 61 (SD ± 11.9) years. 81% of the intervention patients had a TOC and 68% had HON contact. Satisfaction with care was high (8 out of 10) in both study groups. At 3 months after treatment, GP satisfaction was significantly lower in the intervention group on 3 of 6 subscales, i.e., quality (- 14.2 (95%CI -27.0;-1.3)), availability (- 15,9 (- 29.1;-2.6)) and information provision (- 15.2 (- 29.1;-1.4)). Patients in the intervention group visited the GP practice and the emergency department more often ((RR 1.3 (1.0;1.7) and 1.70 (1.0;2.8)), respectively). CONCLUSIONS: In conclusion, the GRIP intervention, which was designed to involve the primary care team during and after cancer treatment, increased the number of primary healthcare contacts. However, it did not improve patient satisfaction with care and it increased emergency department visits. As the high uptake of the intervention suggests a need of patients, future research should focus on optimizing the design and implementation of the intervention. TRIAL REGISTRATION: GRIP is retrospectively (21/06/2016) registered in the 'Netherlands Trial Register' (NTR5909).
Assuntos
Neoplasias da Mama , Clínicos Gerais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Satisfação do Paciente , Atenção Primária à Saúde , Estudos RetrospectivosRESUMO
Several observational studies suggested that gut microbiome-affecting-medication impairs the effectiveness of immunotherapy in patients with metastatic non-small-cell lung cancer (NSCLC). We postulated that if the effectiveness of immunotherapy is affected by drug-related changes of the microbiome, a stronger association between the use of co-medication and overall survival (OS) will be observed in patients treated with immunotherapy as compared to patients treated with chemotherapy. In a retrospective matched cohort study, immunotherapy patients were matched (1:1) to patients treated with chemotherapy in the pre immunotherapy era. The association between the use of antibiotics, opioids, proton pump inhibitors, metformin and other antidiabetics on OS was assessed with multivariable cox-regression analyses. Interaction tests were applied to investigate whether the association differs between patients treated with immuno- or chemotherapy. A total of 442 patients were studied. The use of antibiotics was associated with worse OS (adjusted Hazard Ratio (aHR) 1.39, p = 0.02) independent of the type of therapy (chemotherapy or immunotherapy). The use of opioids was also associated with worse OS (aHR 1.33, p = 0.01). The other drugs studied showed no association with OS. Interaction term testing showed no effect modification by immuno- or chemotherapy for the association of antibiotics and opioids with OS. The use of antibiotics and opioids is similarly associated with worse outcomes in both chemotherapy and immunotherapy treated NSCLC patients. This suggests that the association is likely to be a consequence of confounding rather than disturbing the composition of the microbiome.
Assuntos
Carcinoma Pulmonar de Células não Pequenas/mortalidade , Interações Medicamentosas , Microbioma Gastrointestinal , Imunoterapia/mortalidade , Neoplasias Pulmonares/mortalidade , Idoso , Antibacterianos/administração & dosagem , Carcinoma Pulmonar de Células não Pequenas/tratamento farmacológico , Carcinoma Pulmonar de Células não Pequenas/imunologia , Carcinoma Pulmonar de Células não Pequenas/patologia , Feminino , Seguimentos , Humanos , Neoplasias Pulmonares/tratamento farmacológico , Neoplasias Pulmonares/imunologia , Neoplasias Pulmonares/patologia , Masculino , Pessoa de Meia-Idade , Prognóstico , Inibidores da Bomba de Prótons/administração & dosagem , Estudos Retrospectivos , Taxa de SobrevidaRESUMO
OBJECTIVES: This study describes the initiation of the Dutch Lung Cancer Audit for Lung Oncology (DLCA-L) and reports the first results of three years of clinical auditing. METHODS: The initiation, dataset, and data quality of the DLCA-L are described. For the analyses, all patients registered from 2017 to 2019 were included. Descriptive statistics were used to assess the first outcomes of the DLCA-L, including results from quality indicators, patient- and tumor characteristics, and the real-world use of immunotherapy. RESULTS: The DLCA-L was initiated after the surgery and radiotherapy audit for lung cancer. In total, 33.788 NSCLC patients and 4.293 SCLC patients were registered in the DLCA-L from 2017 to 2019. Seventy-three (97 %) Dutch hospitals participated in the DLCA-L in 2019. The registry became nation-wide in 2020. The data quality improved over the years, with complete cases in 90 % of the NSCLC patients. In total, 15 quality indicators were established based on DLCA-L data to improve processes and clinical outcomes. An example of these quality indicators was brain imaging at diagnosis of stage III NSCLC patients, which increased from 80 % in 2017 to 90 % in 2019 and hospital variation was reduced. The DLCA-L provided data on immunotherapy use in stage IV NSCLC (nâ¯=â¯4.415) patients. These patients had a median age of 67 years and 11 % of the patients had an ECOG PSâ¯≥â¯2. The number of patients treated with immunotherapy in different hospitals varied between 2 patients to 163 patients per hospital. CONCLUSION: The DLCA-L has become a valuable and complete data source with national coverage in 2020. A high number of registered patients and limited missing data resulted in better insights into hospital processes and outcomes of lung cancer care. Quality indicators were, with success, used to establish improvements and minimize hospital variation. The DLCA-L also provides hospitals real-world information on the use of (systemic) therapies.
Assuntos
Carcinoma Pulmonar de Células não Pequenas , Neoplasias Pulmonares , Idoso , Carcinoma Pulmonar de Células não Pequenas/epidemiologia , Carcinoma Pulmonar de Células não Pequenas/terapia , Hospitais , Humanos , Imunoterapia , Neoplasias Pulmonares/epidemiologia , Neoplasias Pulmonares/terapia , Sistema de RegistrosRESUMO
OBJECTIVE: Phase III studies of checkpoint inhibitors changed the therapeutic landscape for lung cancer. In 2015 the Dutch Society of Chest Physicians (NVALT) introduced a national immunotherapy registry for patients with lung cancer; quality standards for hospitals were implemented. At population level we studied clinical benefit in daily practice and in patients who are underrepresented in phase III trials. MATERIALS AND METHODS: From the initial introduction of checkpoint inhibitors in the Netherlands patients were centrally registered. Educational programs and quality control were provided under supervision of NVALT. The largest immunotherapy providing hospitals were compared to hospitals who provided less checkpoint inhibitors as marker of experience. Patients characteristics, treatment and side effects, response rate and survival were studied. RESULTS: A total of 2676 patients were registered, 2302 with follow up data were evaluated. Between October 2015 and December 2017 a gradual increase from 12 to 30 qualified hospitals showed no major toxicity differences. Toxicity led to a hospital admission rate of 9.1 with an average duration of 10.4 days. Overall tumor response was 21.8 % and median overall survival 12.6 months. Overall survival was not significantly different for patients aged ≥ 75 years, those having brain metastases or selected auto-immune diseases before start checkpoint inhibitors compared to younger patients or those without, respectively. Survival outcomes were worse in patients with PS 2+, non-smokers, and patients who received any palliative radiotherapy (HR 2.1, 95 % CI 1.7-2.7; 1.3, 95 % CI 1.0-1.6 and 1.2, 95 % CI 1.1-1.4, respectively). CONCLUSIONS: Changes in the therapeutic landscape did not lead to major differences in quality of care between hospitals. Elderly patients, those with brain metastases or selected auto-immune disease underrepresented in clinical trials did not do worse on checkpoint inhibitors, except for those with PS 2 + .
Assuntos
Neoplasias Encefálicas/tratamento farmacológico , Carcinoma Pulmonar de Células não Pequenas/tratamento farmacológico , Inibidores de Checkpoint Imunológico/uso terapêutico , Imunoterapia/métodos , Neoplasias Pulmonares/tratamento farmacológico , Sistema de Registros/estatística & dados numéricos , Carcinoma de Pequenas Células do Pulmão/tratamento farmacológico , Adenocarcinoma de Pulmão/tratamento farmacológico , Adenocarcinoma de Pulmão/imunologia , Adenocarcinoma de Pulmão/patologia , Adulto , Idoso , Idoso de 80 Anos ou mais , Neoplasias Encefálicas/imunologia , Neoplasias Encefálicas/secundário , Carcinoma Pulmonar de Células não Pequenas/imunologia , Carcinoma Pulmonar de Células não Pequenas/patologia , Carcinoma de Células Escamosas/tratamento farmacológico , Carcinoma de Células Escamosas/imunologia , Carcinoma de Células Escamosas/patologia , Feminino , Seguimentos , Humanos , Neoplasias Pulmonares/imunologia , Neoplasias Pulmonares/patologia , Masculino , Pessoa de Meia-Idade , Países Baixos , Prognóstico , Carcinoma de Pequenas Células do Pulmão/imunologia , Carcinoma de Pequenas Células do Pulmão/patologia , Taxa de SobrevidaRESUMO
BACKGROUND: Individually tailored cancer treatment is essential to ensure optimal treatment and resource use. Treatments for incurable metastatic non-small cell lung cancer (NSCLC) are evolving rapidly, and decision support systems (DSS) for this patient population have been developed to balance benefits and harms for decision-making. The aim of this systematic review was to inventory DSS for stage IIIB/IV NSCLC patients. METHODS: A systematic literature search was performed in Pubmed, Embase and the Cochrane Library. DSS were described extensively, including their predictors, model performances (i.e., discriminative ability and calibration), levels of validation and user friendliness. RESULTS: The systematic search yielded 3531 articles. In total, 67 articles were included after additional reference tracking. The 39 identified DSS aim to predict overall survival and/or progression-free survival, but give no information about toxicity or cost-effectiveness. Various predictors were incorporated, such as performance status, serum and inflammatory markers, and patient and tumor characteristics. Some DSS were developed for the entire incurable NSCLC population, whereas others were specifically for patients with brain or spinal metastases. Few DSS had been validated externally using recent clinical data, and the discrimination and calibration were often poor. CONCLUSIONS: Many DSS have been developed for incurable NSCLC patients, but DSS are still lacking that are up-to-date with a good model performance, while covering the entire treatment spectrum. Future DSS should incorporate genetic and biological markers based on state-of-the-art evidence, and compare multiple treatment options to estimate survival, toxicity and cost-effectiveness.
Assuntos
Carcinoma Pulmonar de Células não Pequenas/terapia , Sistemas de Apoio a Decisões Clínicas , Neoplasias Pulmonares/terapia , Cuidados Paliativos/métodos , Carcinoma Pulmonar de Células não Pequenas/mortalidade , Técnicas de Apoio para a Decisão , Humanos , Neoplasias Pulmonares/mortalidade , PrognósticoRESUMO
OBJECTIVES: Real-world resource use and cost data on non-small cell lung cancer (NSCLC) are scarce. This data is needed to inform health-economic modelling to assess the impact of new diagnostic and/or treatment technologies. This study provides detailed insight into real-world medical resource use and costs of stage I-IV NSCLC in the Netherlands. MATERIALS AND METHODS: A random sample of patients newly diagnosed with NSCLC (2009-2011) was selected from four Dutch hospitals. Data was retrospectively collected from patient charts. This data included patient characteristics, tumour characteristics, treatment details, adverse events, survival and resource use. Resource use was multiplied by Dutch unit costs expressed in EUR 2012. Total mean costs were corrected for censoring using the Bang and Tsiatis weighted complete-case estimator. Furthermore, costs of adverse events, costs per phase of NSCLC management and costs of second opinions are presented. RESULTS: Data was collected on 1067 patients. Total mean costs for NSCLC diagnosis, treatment and follow-up are 28,468 during the study period and 33,143 when corrected for censoring. Adverse events were recorded in the patient charts for 369 patients (41%) and 82 patients (9%) experienced an adverse event of grade III or higher. For these patients, adverse event-related hospital admissions cost on average 2,091. Mean total costs are 1,725 for the diagnostic period, 17,296 for first treatment line, and 13,236 for each later treatment line. Costs of providing a second opinion are 2,580 per patient. CONCLUSIONS: Total mean hospital costs per NSCLC patient are 33,143 for the total duration of the disease. Ignoring censoring in our data underestimates these costs by 14%. Main limitations of the study relate to the short follow-up time, staging difficulties and missing data. Its main strength is that it provides highly detailed, real-world data on the costs of NSCLC.
Assuntos
Carcinoma Pulmonar de Células não Pequenas/economia , Neoplasias Pulmonares/economia , Idoso , Idoso de 80 Anos ou mais , Carcinoma Pulmonar de Células não Pequenas/diagnóstico , Carcinoma Pulmonar de Células não Pequenas/epidemiologia , Carcinoma Pulmonar de Células não Pequenas/terapia , Análise Custo-Benefício , Feminino , Custos de Cuidados de Saúde , Humanos , Neoplasias Pulmonares/diagnóstico , Neoplasias Pulmonares/epidemiologia , Neoplasias Pulmonares/terapia , Masculino , Pessoa de Meia-Idade , Modelos Econômicos , Países Baixos , Estudos RetrospectivosRESUMO
BACKGROUND: Care processes for patients with NSCLC can vary by provider, which may lead to unwanted variation in outcomes. Therefore, in modern health care an increased focus on guideline development and implementation is seen. It is expected that more guideline adherence leads to a higher number of patients receiving optimal treatment for their cancer which could improve overall survival. OBJECTIVE: The aim of this study was to evaluate variations in treatment patterns and outcomes of patients with NSCLC treated in different (types of) hospitals and regions in the Netherlands. Especially, variation in the percentage of patients receiving the optimal treatment for the stage of their disease, according to the Dutch national guideline of 2004, was analyzed. METHODS: All patients with a histological confirmed primary NSCLC diagnosed in the period 2001-2006 in all Dutch hospitals (N = 97) were selected from the population-based Netherlands Cancer Registry. Hospitals were divided in groups based on their region (N = 9), annual volume of NSCLC patients, teaching status and presence of radiotherapy facilities. Stage-specific differences in optimal treatment rates between (groups of) hospitals and regions were evaluated. RESULTS: In the study period 43 544 patients were diagnosed with NSCLC. The resection rates for stage I/II NSCLC patients increased during the study period, but resection rates varied by region and were higher in teaching hospitals for thoracic surgeons (OR 1.5; 95%CI 1.2-1.9, p = 0.001) and in hospitals with a diagnostic volume of more than 50/year (OR 1.3; 95%CI 1.1-1.5, p = 0.001). Also the use of chemoradiation in stage III patients increased, though marked differences between hospitals in the use of chemoradiation for stage III patients were revealed. Differences in optimal treatment rates between hospitals led to differences in survival. CONCLUSION: Treatment patterns and outcome of NSCLC patients in the Netherlands varied by region and the hospital their cancer was diagnosed in. Though resection rates were higher in hospitals training thoracic surgeons, variation between individual hospitals was much more distinct. Hospital characteristics like a high diagnostic volume, teaching status or availability of radiotherapy facilities proved no guarantee for optimal treatment rates.
Assuntos
Carcinoma Pulmonar de Células não Pequenas/mortalidade , Carcinoma Pulmonar de Células não Pequenas/terapia , Hospitais/estatística & dados numéricos , Neoplasias Pulmonares/mortalidade , Neoplasias Pulmonares/terapia , Qualidade da Assistência à Saúde , Idoso , Carcinoma Pulmonar de Células não Pequenas/patologia , Terapia Combinada , Feminino , Humanos , Neoplasias Pulmonares/patologia , Masculino , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Países Baixos/epidemiologia , Pneumonectomia/estatística & dados numéricos , Guias de Prática Clínica como Assunto , Resultado do TratamentoRESUMO
Background. sequential chemotherapy can maintain dose intensity and preclude cumulative toxicity by increasing drug diversity. Purpose. to investigate the toxicity and efficacy of the sequential regimen of gemcitabine followed by paclitaxel in first line advanced stage non-small cell lung cancer (NSCLC) patients with good performance status (PS). Patients and methods. gemcitabine 1250 mg/m(2) was administered on day 1 and 8 of course 1 and 2; Paclitaxel 150 mg/m(2) on day 1 and 8 of course 3 and 4. Primary endpoint was response rate (RR), secondary endpoints toxicity and time to progression (TTP). Results. Of the 21 patients (median age 56, range 38-80 years; 62% males, 38% females) 10% (2/21) had stage IIIB, 90% (19/21) stage IV, 15% PS 0, 85% PS 1. 20% of patients had a partial response, 30% stable disease, 50% progressive disease. Median TTP was 12 weeks (range 6-52 weeks), median overall survival (OS) 8 months (range 1-27 months), 1-year survival was 33%. One patient had grade 3 hematological toxicity, 2 patients a grade 3 peripheral neuropathy. Conclusions. sequential administration of gemcitabine followed by paclitaxel in first line treatment of advanced NSCLC had a favourable toxicity profile, a median TTP and OS comparable with other sequential trials and might, therefore, be a treatment option for NSCLC patients with high ERCC1 expression.
RESUMO
The treatment of patients with locally advanced non-small cell lung cancer (stage III) has changed significantly in the past few years. Patients with a non-resectable stage IIIA/B tumour are given combined treatment consisting ofchemotherapy and radiotherapy. These can be administered sequentially or concurrently. It has been shown recently that concurrent chemoradiotherapy gives a survival advantage in comparison with sequential chemoradiotherapy. Cisplatin and etoposide are usually the drugs of choice for chemotherapy in patients with stage III cancer. A biologically effective dose of radiotherapy equivalent to 60-66 Gy, over a maximum of 6.5 weeks, should be given. Surgery is possible for a selected group of patients, provided a complete objective mediastinal response has been achieved after chemoradiotherapy and a complete resection appears to be technically feasible. It is recommended to apply this treatment in a research setting. High-dose concurrent chemoradiotherapy is advised as the standard treatment for stage III non-small cell lung cancer in patients in good physical condition.
Assuntos
Carcinoma Pulmonar de Células não Pequenas/terapia , Terapia Combinada , Neoplasias Pulmonares/terapia , Carcinoma Pulmonar de Células não Pequenas/tratamento farmacológico , Carcinoma Pulmonar de Células não Pequenas/mortalidade , Carcinoma Pulmonar de Células não Pequenas/radioterapia , Relação Dose-Resposta a Droga , Relação Dose-Resposta à Radiação , Esquema de Medicação , Humanos , Neoplasias Pulmonares/tratamento farmacológico , Neoplasias Pulmonares/mortalidade , Neoplasias Pulmonares/radioterapia , Estadiamento de Neoplasias , Indução de Remissão , Análise de Sobrevida , Resultado do TratamentoRESUMO
Selective pulmonary artery perfusion (SPAP) is a modality of regional chemotherapy first investigated in the 1950's. A number of studies in animal models documented pharmacokinetic superiority with high-dose local cytostatic drug concentrations when compared to intravenous administration. Blood flow occlusion of the pulmonary artery before or after drug injection results in further increase in local drug concentrations. Animal tumor models with sarcoma and coloncarcinoma confirm anti-tumour efficacy in cytostatic SPAP. In human investigations, feasibility and safety of chemotherapeutic SPAP in humans has been documented. Recent encouraging investigations of SPAP with gemcitabine and blood flow occlusion in a porcine model emphasize the need for further investigations in humans with pulmonary malignancies for safety and efficacy assessments.
Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Carcinoma Pulmonar de Células não Pequenas/tratamento farmacológico , Quimioterapia do Câncer por Perfusão Regional/métodos , Neoplasias Pulmonares/tratamento farmacológico , Artéria Pulmonar/efeitos dos fármacos , Animais , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Estudos de Viabilidade , Humanos , Injeções Intra-Arteriais , Fluxo Sanguíneo Regional/efeitos dos fármacos , Grau de Desobstrução Vascular/efeitos dos fármacosAssuntos
Neoplasias Pulmonares/complicações , Polissacarídeos/uso terapêutico , Tromboembolia/tratamento farmacológico , Trombose Venosa/tratamento farmacológico , Adulto , Gerenciamento Clínico , Progressão da Doença , Evolução Fatal , Feminino , Fondaparinux , Humanos , Neoplasias Pulmonares/tratamento farmacológico , Recidiva , Tromboembolia/etiologia , Trombose Venosa/etiologiaRESUMO
The present EORTC phase II feasibility study in stage IIIB (T4-N3) NSCLC was conducted to investigate whether an induction regimen with concurrent chemoradiotherapy followed by surgery after restaging by re-mediastinoscopy and/or fluorodeoxyglucose-positron emission tomography (FDG-PET) was feasible in a multicenter setting. Unfortunately, the study closed prematurely because of poor accrual. The combination of more stringent selection criteria, the incorrect prevailing view of Ethical Boards that a tri-modality approach is too toxic, competing studies in the participating centers and the fact that patients with N3 disease could only be enrolled if a re-mediastinoscopy could be performed, underlie the low accrual. Although this study illustrates that the conduct of a tri-modality study across Europe appeared to be difficult at that time, the number of centers with highly qualified and experienced specialists involved in this kind of multi-modality approaches is rapidly increasing. Future initiatives should, therefore, certainly be encouraged. Minimally invasive procedures such as EUS and EBUS should preferably be used for up-front mediastinal staging, mediastinoscopy with or without EUS should preferably be reserved for restaging, and especially right-sided pneumonectomies should be avoided. Though evident, the feasibility to complete this kind of studies within a reasonable time period is still a condition sine qua non.
Assuntos
Carcinoma Pulmonar de Células não Pequenas/cirurgia , Neoplasias Pulmonares/cirurgia , Carcinoma Pulmonar de Células não Pequenas/diagnóstico por imagem , Carcinoma Pulmonar de Células não Pequenas/tratamento farmacológico , Carcinoma Pulmonar de Células não Pequenas/patologia , Carcinoma Pulmonar de Células não Pequenas/radioterapia , Ensaios Clínicos Fase III como Assunto , Terapia Combinada , Fluordesoxiglucose F18 , Humanos , Neoplasias Pulmonares/diagnóstico por imagem , Neoplasias Pulmonares/tratamento farmacológico , Neoplasias Pulmonares/patologia , Neoplasias Pulmonares/radioterapia , Estadiamento de Neoplasias , Tomografia por Emissão de Pósitrons , Compostos Radiofarmacêuticos , Resultado do TratamentoRESUMO
BACKGROUND: The aim of this prognostic factor analysis was to investigate if a patient's self-reported health-related quality of life (HRQOL) provided independent prognostic information for survival in non-small cell lung cancer (NSCLC) patients. PATIENTS AND METHODS: Pretreatment HRQOL was measured in 391 advanced NSCLC patients using the EORTC QLQ-C30 and the EORTC Lung Cancer module (QLQ-LC13). The Cox proportional hazards regression model was used for both univariate and multivariate analyses of survival. In addition, a bootstrap validation technique was used to assess the stability of the outcomes. RESULTS: The final multivariate Cox regression model retained four parameters as independent prognostic factors for survival: male gender with a hazard ratio (HR) = 1.32 (95% CI 1.03-1.69; P = 0.03); performance status (0 to 1 versus 2) with HR = 1.63 (95% CI 1.04-2.54; P = 0.032); patient's self-reported score of pain with HR= 1.11 (95% CI 1.07-1.16; P < 0.001) and dysphagia with HR = 1.12 (95% CI 1.04-1.21; P = 0.003). A 10-point shift worse in the scale measuring pain and dysphagia translated into an 11% and 12% increased in the likelihood of death respectively. A risk group categorization was also developed. CONCLUSION: The results suggest that patients' self-reported HRQOL provide independent prognostic information for survival. This finding supports the collection of such data in routine clinical practice.
Assuntos
Carcinoma Pulmonar de Células não Pequenas/diagnóstico , Nível de Saúde , Qualidade de Vida , Adulto , Idoso , Europa (Continente) , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Prognóstico , Análise de Regressão , Análise de SobrevidaRESUMO
To assess the therapeutic activity of accelerated cisplatin and high-dose epirubicin with erythropoietin and G-CSF support as induction therapy for patients with stage IIIa-N2 non-small-cell lung cancer (NSCLC). Patients with stage IIIa-N2 NSCLC were enrolled in a phase II trial. They received cisplatin 60 mg m(-2) and epirubicin 135 mg m(-2) every 2 weeks for three courses combined with erythropoietin and G-CSF. Depending on results of clinical response to induction therapy and restaging, patients were treated with surgery or radiotherapy. In total, 61 patients entered from March 2001 to April 2004. During 169 courses of induction chemotherapy, National Cancer Institute of Canada (NCI-C) grade III/IV leucocytopenia was reported in 35 courses (20.7%), NCI-C grade III/IV thrombocytopenia in 26 courses (15.4%) and NCI-C grade III/IV anaemia in six courses (3.6%). Main cause of cisplatin dose reduction was nephrotoxicity (12 courses). Most patients received three courses. There were no chemotherapy-related deaths. Three patients were not evaluable for clinical response. Twenty-eight patients had a partial response (48.3%, 95% CI: 36-61.1%), 24 stable disease and six progressive disease. After induction therapy, 30 patients underwent surgery; complete resection was achieved in 19 procedures (31.1%). Radical radiotherapy was delivered to 25 patients (41%). Six patients were considered unfit for further treatment. Median survival for all patients was 18 months. Response rate of accelerated cisplatin and high-dose epirubicin as induction chemotherapy for stage IIIa-N2 NSCLC patients is not different from more commonly used cisplatin-based regimen.
Assuntos
Carcinoma Pulmonar de Células não Pequenas/tratamento farmacológico , Cisplatino/administração & dosagem , Epirubicina/administração & dosagem , Neoplasias Pulmonares/tratamento farmacológico , Adulto , Idoso , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Carcinoma Pulmonar de Células não Pequenas/patologia , Carcinoma Pulmonar de Células não Pequenas/radioterapia , Carcinoma Pulmonar de Células não Pequenas/cirurgia , Terapia Combinada , Intervalo Livre de Doença , Eritropoetina/administração & dosagem , Feminino , Fator Estimulador de Colônias de Granulócitos/administração & dosagem , Humanos , Neoplasias Pulmonares/patologia , Neoplasias Pulmonares/radioterapia , Neoplasias Pulmonares/cirurgia , Metástase Linfática , Masculino , Mediastino , Pessoa de Meia-Idade , Pneumonectomia , Análise de SobrevidaRESUMO
AIM: To define the best sequence of radiotherapy and chemotherapy for inoperable stage III non-small cell lung (NSCL) tumours. MATERIALS AND METHODS: A systematic review was performed on the clinical results of radiotherapy, combined or not with chemotherapy, for inoperable NSCL cancer stage III. The mean median survival time (MST) and mean overall survival (OS) percentages were derived for radiotherapy only, for sequential and for concurrent chemo-radiotherapy. RESULTS: The mean median survival duration +/- standard deviation for radiotherapy only was 10.4 +/- 1.8 months. For sequential chemo- and radiotherapy it was increased to 13.0 +/- 1.2 months. When radiotherapy in the sequential regimen was accompanied by chemotherapy, the mean median duration was 15.8 +/- 2.6 months. For concurrent radio-chemotherapy it was further increased to 16.4 +/- 2.7 months. The mean 2- and 3-year overall survivals for radiotherapy alone, sequential and concurrent radio-chemotherapy were 17.1 +/- 4.6 and 10, 23.8 +/- 6.3 and 18.5 +/- 7.0, and 32.5 +/- 8.7 and 25.7 +/- 6.3%, respectively. CONCLUSION: Concurrent chemo-radiotherapy demonstrated increased efficacy over sequential chemotherapy and radiotherapy and should be the treatment of choice. Further improvements may be obtained by optimising the conditions for concurrent chemo-radiotherapy.
Assuntos
Carcinoma Pulmonar de Células não Pequenas/tratamento farmacológico , Carcinoma Pulmonar de Células não Pequenas/radioterapia , Neoplasias Pulmonares/tratamento farmacológico , Neoplasias Pulmonares/radioterapia , Carcinoma Pulmonar de Células não Pequenas/patologia , Terapia Combinada , Fracionamento da Dose de Radiação , Esquema de Medicação , Humanos , Neoplasias Pulmonares/patologia , Metanálise como Assunto , Estadiamento de Neoplasias , Taxa de SobrevidaRESUMO
OBJECTIVE: To calculate the number of cervical mediastinoscopies that need not be carried out ifoesophageal endoscopic ultrasound and fine-needle aspiration biopsy (EUS-FNA) are included in the staging of patients with non-small-cell lung carcinoma (NSCLC). DESIGN: Retrospective, descriptive. METHOD: Patients referred to the St. Antonius Hospital in Nieuwegein, the Netherlands, with NSCLC from January to December 2003 routinely underwent EUS-FNA during the staging process. If mediastinal or distant metastases were found to be present then cervical mediastinoscopy was not carried out as the patient was not eligible for operation. If no metastases were demonstrated then cervical mediastinoscopy was carried out. The value of EUS-FNA was calculated. RESULTS: A total of 43 patients underwent EUS-FNA: 32 men and 11 women with an average age of 64 (range: 45-77). In 22 (51%) of them, cervical mediastinoscopy was not performed as EUS-FNA demonstrated malignant cells in the lymph nodes of the mediastinum or abdomen, in the left adrenal gland or in the primary tumour which had grown into the mediastinum. In 2 of the 21 other patients malignant cells were found on mediastinoscopy showing the EUS-FNA results in 2 of 43 patients (5%) to be false-negative. No complications occurred. CONCLUSION: Based on the findings from EUS-FNA, cervical mediastinoscopy was not performed in 51% of the patient group.
Assuntos
Biópsia por Agulha Fina/métodos , Carcinoma Pulmonar de Células não Pequenas/patologia , Endossonografia/métodos , Neoplasias Pulmonares/patologia , Estadiamento de Neoplasias/métodos , Idoso , Carcinoma Pulmonar de Células não Pequenas/diagnóstico por imagem , Feminino , Humanos , Neoplasias Pulmonares/diagnóstico por imagem , Metástase Linfática/diagnóstico por imagem , Metástase Linfática/patologia , Masculino , Mediastinoscopia , Pessoa de Meia-Idade , Estudos Retrospectivos , Sensibilidade e EspecificidadeRESUMO
Three patients, two Moroccan men aged 27 and 25 and a Turkish man aged 25, presented with haemoptysis caused by pulmonary aneurysm. The aneurysms had formed as a complication of Behçet's disease. Two of them were treated with high doses of corticosteroids. One man recovered and another died as a consequence of massive haemoptysis. The third man underwent emergency thoracotomy and pneumectomy due to massive haemoptysis. Postoperatively he was treated with cyclosporine resulting in full recovery. Behçet's disease is a multisystem vasculitis characterised by orogenital ulcerations and uveitis. In a minority of cases pulmonary aneurysms develop, often causing massive haemoptysis. Aneurysms are often accompanied by venous thrombosis. Treatment consists of immunosuppressive therapy. Nevertheless a considerable number of patients die following massive haemoptysis.
Assuntos
Aneurisma/complicações , Síndrome de Behçet/complicações , Hemoptise/etiologia , Artéria Pulmonar , Corticosteroides/uso terapêutico , Adulto , Aneurisma/etiologia , Síndrome de Behçet/mortalidade , Síndrome de Behçet/patologia , Evolução Fatal , Hemoptise/tratamento farmacológico , Humanos , Masculino , Embolia Pulmonar/complicações , Resultado do TratamentoRESUMO
Response rate and toxicity of second-line therapy with docetaxel (75 mg m(-2)) or docetaxel, irinotecan, and lenogastrim (60 mg m(-2), 200 mg m(-2), and 150 microg m(-2) day(-1), respectively) were compared in 108 patients with stage IIIb-IV non-small-cell lung cancer. Addition of irinotecan to docetaxel does not improve response rate, and increases gastrointestinal toxicity.