Editorial
Studies on lung cancer management in routine practice
Estudos sobre a abordagem clínica no cancro do pulmão
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Hespanhol, B. Parente, A. Araújo, J. Cunha, A. Fernandes, M.M. Figueiredo, R. Neveda, M. Soares, F. João, H. Queiroga" "autores" => array:10 [ 0 => array:2 [ "nombre" => "V." "apellidos" => "Hespanhol" ] 1 => array:2 [ "nombre" => "B." "apellidos" => "Parente" ] 2 => array:2 [ "nombre" => "A." "apellidos" => "Araújo" ] 3 => array:2 [ "nombre" => "J." "apellidos" => "Cunha" ] 4 => array:2 [ "nombre" => "A." "apellidos" => "Fernandes" ] 5 => array:2 [ "nombre" => "M.M." "apellidos" => "Figueiredo" ] 6 => array:2 [ "nombre" => "R." "apellidos" => "Neveda" ] 7 => array:2 [ "nombre" => "M." "apellidos" => "Soares" ] 8 => array:2 [ "nombre" => "F." "apellidos" => "João" ] 9 => array:2 [ "nombre" => "H." 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They collected information about 9767 patients with a significant increase in the number of cases from 2000 (634 cases) to 2010 (1284 cases). Collected data include demographic characteristics, smoking habits, performance status, histology, stage, treatment strategy. Survival, specific mortality and causes of death were not reported. There was an increase of adenocarcinoma histological type as well as more lung cancers in women. The authors observed also over time a significant increase of combined therapeutic modalities.</p><p id="par0010" class="elsevierStylePara elsevierViewall">This type of study is important because it allows determining how thoracic oncology is practiced in specific settings or countries without selection of the patients according to trials criteria. It may somehow give a picture how guidelines or recent studies results are implemented in the daily practice. In the present report, the authors consider to have included about one third of the total number of lung cancer diagnosed in their catchment area. In comparison, registries have the advantage to include all the cases of the area without any selection but information about individual patients is often limited.</p><p id="par0015" class="elsevierStylePara elsevierViewall">Other studies performed with unselected patients population are <span class="elsevierStyleBold">implementation studies</span> where a specific treatment or approach is assessed in routine practice. This very important information is often lacking in the literature, particularly concerning guidelines. We have conducted a few implementation studies to determine if the results that are obtained with a given treatment in routine practice are consistent with those reported by the clinical trials. We assessed in advanced non-small cell lung cancer by such an approach the MIP (mitomycin<span class="elsevierStyleHsp" style=""></span>+<span class="elsevierStyleHsp" style=""></span>ifosfamide<span class="elsevierStyleHsp" style=""></span>+<span class="elsevierStyleHsp" style=""></span>cisplatin) regimen as first-line chemotherapy<a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">2</span></a> and docetaxel<a class="elsevierStyleCrossRef" href="#bib0015"><span class="elsevierStyleSup">3</span></a> and pemetrexed<a class="elsevierStyleCrossRef" href="#bib0020"><span class="elsevierStyleSup">4</span></a> as salvage chemotherapy. The results that we obtained in all those retrospective studies showed similar activities than those reported in clinical prospective trials, suggesting their generalizability for routine practice if medical contra-indications are respected.</p><p id="par0020" class="elsevierStylePara elsevierViewall">French authors have used a similar approach based on <span class="elsevierStyleBold">unselected cohorts</span> as in the Northern Portugal study. This study, called KPB-CPHG, has been prospectively performed in general hospitals. Two cohorts have been follow up, one in 2000 and the other one in 2010 with the respective participation of 137 and 104 centres that have included 5667 and 7051 patients<a class="elsevierStyleCrossRefs" href="#bib0025"><span class="elsevierStyleSup">5–8</span></a>. They observed that over ten years, lung cancer characteristics have changed with more women, more never-smokers, and more adenocarcinomas. That observation is similar to the presently reported. In the French study, survival was also registered and results with the first cohort were published, showing an overall 10.4% 5-year survival. The impact of treatment strategy has also been assessed with better survival when patients were treated.</p><p id="par0025" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleBold">Registries</span> can also provide interesting information. They have the advantage to deal with large number of patients but the number of collected data is usually limited, precluding in-depth analysis. The SEER (for Surveillance, Epidemiology and End Results) registry is widely used for purposes as the study of lung cancer in women<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">9</span></a>, the influence of hospital volume on survival after resection for lung cancer<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">10</span></a>, the effect of race on invasive staging and surgery in non-small-cell lung cancer<a class="elsevierStyleCrossRef" href="#bib0055"><span class="elsevierStyleSup">11</span></a>, the role of postoperative radiotherapy<a class="elsevierStyleCrossRef" href="#bib0060"><span class="elsevierStyleSup">12</span></a>, or the management of stage III and IV NSCLC<a class="elsevierStyleCrossRef" href="#bib0065"><span class="elsevierStyleSup">13</span></a>. Other good registries are also available in the United Kingdom, Scandinavia and the Netherlands, allowing performing similar studies.</p><p id="par0030" class="elsevierStylePara elsevierViewall">An important question is <span class="elsevierStyleBold">the level of evidence</span> of the study reported in the present issue of the Portuguese Journal of Pulmonology. Whatever implementation, cohort or registries studies, all deal with unselected patients’ population, contrary to clinical trials. In term of evidence-based medicine, randomised clinical trials are considered as the best level of evidence<a class="elsevierStyleCrossRefs" href="#bib0070"><span class="elsevierStyleSup">14,15</span></a>, followed by prospective studies with a control group, comparative studies with historical controls, prospective cohorts without control group, retrospective studies and case reports. If this is true from a scientific point of view (internal validity) because randomisation minimises the risk of bias, it is less true for external validity. Indeed, the patients selected for trials are often a small part of the whole group of patients which we have to treat. Patients which are compromised by conditions such as poor performance status, organ failures, other severe diseases, or old age, are often excluded for trials but not for routine treatment. In fact, results of clinical trials should be confirmed by studies conducted in the context of the daily practice where patients do not receive the recommended therapy only in case of medical contra-indication to its administration. Those studies of which methodology should be better defined are the best level evidence for generalizability (<span class="elsevierStyleBold">external validation</span>). A similar approach should be recommended for practice guidelines. Indeed, a lot of guidelines are today published but none have been so far validated by implementation studies.</p><p id="par0035" class="elsevierStylePara elsevierViewall">Today, the performance of a prospective clinical trial has become very complicated and expansive. A lot of bureaucratic rules and a high cost have led to a considerable reduction of the number of academic trials. Most of the randomised clinical trials testing drugs are conducted by the pharmaceutical industry for registration purposes. A new role for academic research is to develop external validation in unselected patients’ population, allowing generalisation of the registered treatment. Otherwise, the drug prescription should be restricted to the criteria and conditions with which the registration studies were performed.</p><p id="par0040" class="elsevierStylePara elsevierViewall">Today, the external validation studies are mainly published in the national medical press and often in the native language. Indeed, an important parameter that has to be considered in such studies is the influence of the social security system (including rules for reimbursement) and of the local health care organisation. This is a barrier for publication in the journal with good impact factors, which are highly biased in favour of the native English-speaking world. Taking all those elements in consideration, studies like that presently reported can have major care impact, particularly if survival is taken into account and correlated with treatment administered over time. They also should allow validation of guidelines in the daily practice.</p></span>" "pdfFichero" => "main.pdf" "tienePdf" => true "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0005" "bibliografiaReferencia" => array:15 [ 0 => array:3 [ "identificador" => "bib0080" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Cancro do pulmão no norte de Portugal: um estudo de base hospitalar" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:6 [ 0 => "V. Hespanhol" 1 => "B. Parente" 2 => "A. Araújo" 3 => "J. Cunha" 4 => "A. Fernandes" 5 => "M.M. 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| Year/Month | Html | Total | |
|---|---|---|---|
| 2024 November | 6 | 6 | 12 |
| 2024 October | 28 | 32 | 60 |
| 2024 September | 34 | 25 | 59 |
| 2024 August | 49 | 31 | 80 |
| 2024 July | 67 | 31 | 98 |
| 2024 June | 55 | 37 | 92 |
| 2024 May | 43 | 29 | 72 |
| 2024 April | 49 | 33 | 82 |
| 2024 March | 36 | 26 | 62 |
| 2024 February | 47 | 20 | 67 |
| 2024 January | 21 | 27 | 48 |
| 2023 December | 24 | 24 | 48 |
| 2023 November | 25 | 32 | 57 |
| 2023 October | 28 | 34 | 62 |
| 2023 September | 25 | 34 | 59 |
| 2023 August | 22 | 24 | 46 |
| 2023 July | 21 | 26 | 47 |
| 2023 June | 31 | 16 | 47 |
| 2023 May | 44 | 25 | 69 |
| 2023 April | 30 | 16 | 46 |
| 2023 March | 60 | 24 | 84 |
| 2023 February | 38 | 20 | 58 |
| 2023 January | 20 | 13 | 33 |
| 2022 December | 28 | 20 | 48 |
| 2022 November | 66 | 34 | 100 |
| 2022 October | 36 | 28 | 64 |
| 2022 September | 29 | 37 | 66 |
| 2022 August | 38 | 41 | 79 |
| 2022 July | 35 | 47 | 82 |
| 2022 June | 19 | 31 | 50 |
| 2022 May | 39 | 41 | 80 |
| 2022 April | 26 | 31 | 57 |
| 2022 March | 38 | 49 | 87 |
| 2022 February | 40 | 29 | 69 |
| 2022 January | 41 | 44 | 85 |
| 2021 December | 32 | 36 | 68 |
| 2021 November | 29 | 45 | 74 |
| 2021 October | 30 | 40 | 70 |
| 2021 September | 24 | 34 | 58 |
| 2021 August | 17 | 22 | 39 |
| 2021 July | 18 | 29 | 47 |
| 2021 June | 20 | 31 | 51 |
| 2021 May | 28 | 32 | 60 |
| 2021 April | 52 | 37 | 89 |
| 2021 March | 31 | 29 | 60 |
| 2021 February | 45 | 19 | 64 |
| 2021 January | 25 | 22 | 47 |
| 2020 December | 24 | 15 | 39 |
| 2020 November | 33 | 19 | 52 |
| 2020 October | 29 | 21 | 50 |
| 2020 September | 59 | 21 | 80 |
| 2020 August | 47 | 23 | 70 |
| 2020 July | 73 | 23 | 96 |
| 2020 June | 72 | 14 | 86 |
| 2020 May | 74 | 20 | 94 |
| 2020 April | 63 | 13 | 76 |
| 2020 March | 52 | 15 | 67 |
| 2020 February | 44 | 21 | 65 |
| 2020 January | 60 | 15 | 75 |
| 2019 December | 50 | 23 | 73 |
| 2019 November | 62 | 11 | 73 |
| 2019 October | 63 | 19 | 82 |
| 2019 September | 57 | 24 | 81 |
| 2019 August | 87 | 13 | 100 |
| 2019 July | 105 | 14 | 119 |
| 2019 June | 133 | 14 | 147 |
| 2019 May | 168 | 15 | 183 |
| 2019 April | 114 | 22 | 136 |
| 2019 March | 132 | 14 | 146 |
| 2019 February | 132 | 5 | 137 |
| 2019 January | 141 | 25 | 166 |
| 2018 December | 68 | 7 | 75 |
| 2018 November | 19 | 2 | 21 |
| 2018 October | 40 | 8 | 48 |
| 2018 September | 16 | 8 | 24 |
| 2018 August | 37 | 29 | 66 |
| 2018 July | 60 | 19 | 79 |
| 2018 June | 56 | 19 | 75 |
| 2018 May | 97 | 25 | 122 |
| 2018 April | 128 | 20 | 148 |
| 2018 March | 139 | 21 | 160 |
| 2018 February | 34 | 10 | 44 |
| 2018 January | 73 | 15 | 88 |
| 2017 December | 85 | 17 | 102 |
| 2017 November | 47 | 19 | 66 |
| 2017 October | 31 | 19 | 50 |
| 2017 September | 43 | 22 | 65 |
| 2017 August | 33 | 15 | 48 |
| 2017 July | 20 | 13 | 33 |
| 2017 June | 36 | 18 | 54 |
| 2017 May | 34 | 15 | 49 |
| 2017 April | 13 | 3 | 16 |
| 2017 March | 16 | 5 | 21 |
| 2017 February | 13 | 3 | 16 |
| 2017 January | 14 | 8 | 22 |
| 2016 December | 18 | 9 | 27 |
| 2016 November | 13 | 5 | 18 |
| 2016 October | 7 | 8 | 15 |
| 2016 September | 8 | 5 | 13 |
| 2016 August | 8 | 4 | 12 |
| 2016 July | 4 | 8 | 12 |
| 2016 April | 12 | 4 | 16 |
| 2016 March | 21 | 8 | 29 |
| 2016 February | 18 | 11 | 29 |
| 2016 January | 23 | 9 | 32 |
| 2015 December | 29 | 9 | 38 |
| 2015 November | 24 | 9 | 33 |
| 2015 October | 27 | 11 | 38 |
| 2015 September | 30 | 6 | 36 |
| 2015 August | 26 | 12 | 38 |
| 2015 July | 27 | 4 | 31 |
| 2015 June | 18 | 3 | 21 |
| 2015 May | 28 | 7 | 35 |
| 2015 April | 25 | 5 | 30 |
| 2015 March | 21 | 6 | 27 |
| 2015 February | 15 | 3 | 18 |
| 2015 January | 31 | 9 | 40 |
| 2014 December | 21 | 13 | 34 |
| 2014 November | 26 | 8 | 34 |
| 2014 October | 26 | 19 | 45 |
| 2014 September | 19 | 24 | 43 |
| 2014 August | 10 | 12 | 22 |
| 2014 July | 20 | 8 | 28 |
| 2014 June | 32 | 8 | 40 |
| 2014 May | 39 | 16 | 55 |
| 2014 April | 32 | 20 | 52 |
| 2014 March | 62 | 21 | 83 |
| 2014 February | 35 | 19 | 54 |
| 2014 January | 52 | 33 | 85 |
| 2013 December | 75 | 44 | 119 |
| 2013 November | 101 | 35 | 136 |
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