Problema de Salud AUGE N°81
Cáncer de pulmón en persona de 15 años y más
Recomendación Dg3 – Juicio del Panel y Evidencia
Dg.3.En personas con diagnóstico de cáncer de pulmón, el Ministerio de Salud SUGIERE realizar un PET/CT por sobre no realizarlo.
Comentarios del Panel de Expertos:
►El PET/CT pudiera resultar negativo en una proporción de pacientes con compromiso mediastínico. Por lo que en pacientes con alto riesgo de compromiso mediastínico (por ejemplo: tumores centrales, histología previa de adenocarcinoma o de cáncer pulmonar de células pequeñas, o tumor mayor de 3 cm) con un PET/CT negativo, el equipo clínico debiera considerar métodos diagnósticos complementarios (biopsia con mediastinoscopía o por videotoracocospía).
El panel de expertos analizó y debatió cada uno de las preguntas de la “Tabla de la evidencia a la decisión”, considerando tanto la evidencia de investigación, experiencia clínica, conocimiento de gestión o experiencia de los pacientes. Una vez consensuada la postura del panel respecto a las preguntas, emitieron un juicio seleccionando la opción de respuesta que mejor representaba la opinión del conjunto (destacada con color). Finalmente cuando el panel emitió su juicio sobre todas las preguntas, se emitió la recomendación.
A continuación se presenta la “Tabla de la evidencia a la decisión” con el resumen de los juicios, la evidencia de investigación evaluada, consideraciones adicionales y comentarios planteados por el panel.
1.- ¿El problema es una prioridad?
| No | Probablemente no | Probablemente sí | Sí | Varía | No lo sé |
|---|
El problema ha sido definido como prioritario en el marco de las Garantías Explícitas en Salud (GES), régimen integral de salud que prioriza un grupo de patologías o problemas de salud, garantizando el acceso a tratamiento oportuno y de calidad.
2.- ¿Qué tan precisa es este test?
| Muy imprecisa | Imprecisa | Precisa | Muy precisa | Varía | No lo sé |
|---|
Precisa: En la mayoría de los casos, la prueba es capaz de diferenciar en forma confiable quienes padecen y no padecen la enfermedad o condición. Cabe considerar que la exactitud diagnóstica del PET/CT depende del estadio y el tamaño del tumor, siendo menos exacto en estadios más avanzados.
Evidencia de investigación
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PET/CT para etapificación del compromiso mediastínico en cáncer de pulmón. |
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Pacientes |
Personas mayores de 15 años con diagnóstico de cáncer pulmonar aparentemente localizado según resultados de biopsia. |
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Test |
PET/CT para etapificación del compromiso mediastínico. |
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Comparación |
No realizar PET/CT |
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Impacto diagnóstico |
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Desenlaces |
Efecto |
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Morbilidad o mortalidad |
No se identificaron estudios evaluando el impacto del test, por lo que el desenlace se estimó este en base a su exactitud diagnóstica, y de las consecuencias esperadas a partir de cada resultado. |
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Exactitud diagnóstica |
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Gold standard |
Biopsia |
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Desenlaces |
Efecto por 1000 pacientes testeados (IC 95%) Prevalencia hipotética 30%* |
Certeza de la evidencia (GRADE)** |
Mensajes clave en términos sencillos |
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Sensibilidad: 77,4% (IC 95% de 65,3 a 86,1%) |
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Compromiso mediastínico correctamente detectado (verdaderos positivos) |
232 (196 a 258) |
⊕⊕◯◯1,2,3 Baja |
La etapificación mediastínica mediante PET/CT podría diagnosticar correctamente a 232 de 300 pacientes con compromiso mediastínico, pero la certeza de la evidencia es baja. |
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Compromiso mediastínico correctamente descartado (verdaderos negativos) |
631 (597 a 655) |
⊕⊕◯◯1,2,3 Baja |
La etapificación mediastínica mediante PET/CT podría descartar correctamente a 631 de 700 pacientes sin compromiso mediastínico, pero la certeza de la evidencia es baja. |
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Metástasis mediastínica incorrectamente detectada (falsos positivos) |
69 (45 a 103) |
⊕⊕◯◯1,2,3 Baja |
La etapificación mediastínica mediante PET/CT podría clasificar equivocadamente a 69 de 700 pacientes sin compromiso mediastínico, pero la certeza de la evidencia es baja. |
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Metástasis mediastínica incorrectamente descartada (falsos negativos) |
68 (42 a 104) |
⊕⊕◯◯1,2,3 Baja |
La etapificación mediastínica mediante PET/CT podría no detectar a 68 de 300 pacientes con compromiso mediastínico, pero la certeza de la evidencia es baja. |
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IC: Intervalo de confianza del 95%.
GRADE: grados de evidencia del GRADE Working Group.
*La prevalencia corresponde al promedio aproximado de prevalencia de los estudios (679/2328).
** Certeza de exactitud diagnóstica.
1 Se decidió no disminuir la certeza de la evidencia por inconsistencia, ya que existen razones clínicas que la justifican (Diferentes estadios clínicos o tipo histológico).
2 Se disminuyó un nivel de certeza de evidencia por riesgo de sesgo, ya que la selección de pacientes en 11 estudios [9, 14, 16, 23, 33, 35, 48, 58, 63, 66, 75] era dudosa, en seis estudios no estaba claro si la interpretación del test fue ciega del gold standard [16, 23, 48, 58, 66, 75], en un estudio no está claro si el gold standard fue aplicado a todos los pacientes [75] y en 7 estudios [11, 16, 35, 52, 53, 63, 75] el seguimiento era insuficiente.
3 Se disminuyó un nivel de certeza por imprecisión debido al intervalo de confianza amplio.
Fecha de elaboración de la tabla: Agosto, 2018
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Búsqueda y Síntesis de Evidencia
Búsqueda y síntesis de evidencia de efectos deseables e indeseables
3.- ¿Qué tan significativos son los efectos deseables anticipados?
| Triviales | Pequeños | Moderados | Grandes | Varía | No lo sé |
|---|
Grandes: El panel de expertos de la Guía estimó que los efectos deseables de «realizar un PET/CT» en comparación a «no realizarlo» son grandes, considerando la evidencia, experiencia clínica, conocimiento de gestión o experiencia de las personas con la condición o problema de salud. El principal beneficio del PET/CT sería la disminución de cirugías innecesarias en los casos de verdaderos negativos.
Evidencia de investigación
Se estima que en una población compuesta de 300 pacientes con compromiso mediastínico y 700 personas sin compromiso mediastínico:
– La etapificación mediastínica mediante PET/CT podría diagnosticar correctamente a 232 de 300 pacientes con compromiso mediastínico, pero la certeza de la evidencia es baja.
– La etapificación mediastínica mediante PET/CT podría descartar correctamente a 631 de 700 pacientes sin compromiso mediastínico, pero la certeza de la evidencia es baja.
Referencias
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15. Cerfolio RJ, Bryant AS, Ojha B, Eloubeidi M. Improving the inaccuracies of clinical staging of patients with NSCLC: a prospective trial. The Annals of thoracic surgery. 2005;80(4):1207-13; discussion 1213-4.
16. Harders SW. LUCIS: lung cancer imaging studies. Danish medical journal. 2012;59(11):B4542.
17. Al-Sarraf N, Gately K, Lucey J, Wilson L, McGovern E, Young V. Lymph node staging by means of positron emission tomography is less accurate in non-small cell lung cancer patients with enlarged lymph nodes: analysis of 1,145 lymph nodes. Lung cancer (Amsterdam, Netherlands). 2008;60(1):62-8.
18. Ceylan N, Doğan S, Kocaçelebi K, Savaş R, Çakan A, Çağrici U. Contrast enhanced CT versus integrated PET-CT in pre-operative nodal staging of non-small cell lung cancer. Diagnostic and interventional radiology (Ankara, Turkey). 2012;18(5):435-40.
19. Hu M, Yu JM, Liu NB, Liu LP, Guo HB, Yang GR, Zhang PL, Xu XQ. [Significance of dual-time-point 18F-FDG PET imaging in evaluation of hilar and mediastinal lymph node metastasis in non-small-cell lung cancer]. Zhonghua zhong liu za zhi [Chinese journal of oncology]. 2008;30(4):306-9.
20. Tasci E, Tezel C, Orki A, Akin O, Falay O, Kutlu CA. The role of integrated positron emission tomography and computed tomography in the assessment of nodal spread in cases with non-small cell lung cancer. Interactive cardiovascular and thoracic surgery. 2010;10(2):200-3.
21. Ohnishi R, Yasuda I, Kato T, Tanaka T, Kaneko Y, Suzuki T, Yasuda S, Sano K, Doi S, Nakashima M, Hara T, Tsurumi H, Murakami N, Moriwaki H. Combined endobronchial and endoscopic ultrasound-guided fine needle aspiration for mediastinal nodal staging of lung cancer. Endoscopy. 2011;43(12):1082-9.
22. Jeon TY, Lee KS, Yi CA, Chung MP, Kwon OJ, Kim BT, Shim YM. Incremental value of PET/CT Over CT for mediastinal nodal staging of non-small cell lung cancer: Comparison between patients with and without idiopathic pulmonary fibrosis. AJR. American journal of roentgenology. 2010;195(2):370-6.
23. Lee BE, von Haag D, Lown T, Lau D, Calhoun R, Follette D. Advances in positron emission tomography technology have increased the need for surgical staging in non-small cell lung cancer. The Journal of thoracic and cardiovascular surgery. 2007;133(3):746-52.
24. Carnochan FM, Walker WS. Positron emission tomography may underestimate the extent of thoracic disease in lung cancer patients. European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery. 2009;35(5):781-4; discussion 784-5.
25. Xu N, Wang M, Zhu Z, Zhang Y, Jiao Y, Fang W. Integrated positron emission tomography and computed tomography in preoperative lymph node staging of non-small cell lung cancer. Chinese medical journal. 2014;127(4):607-13.
26. Lee AY, Choi SJ, Jung KP, Park JS, Lee SM, Bae SK. Characteristics of Metastatic Mediastinal Lymph Nodes of Non-Small Cell Lung Cancer on Preoperative F-18 FDG PET/CT. Nuclear medicine and molecular imaging. 2014;48(1):41-6.
27. Uesaka D, Demura Y, Ishizaki T, Ameshima S, Miyamori I, Sasaki M, Fujibayashi Y, Okazawa H. Evaluation of dual-time-point 18F-FDG PET for staging in patients with lung cancer. Journal of nuclear medicine : official publication, Society of Nuclear Medicine. 2008;49(10):1606-12.
28. Ventura E, Islam T, Gee MS, Mahmood U, Braschi M, Harisinghani MG. Detection of nodal metastatic disease in patients with non-small cell lung cancer: comparison of positron emission tomography (PET), contrast-enhanced computed tomography (CT), and combined PET-CT. Clinical imaging. 2010;34(1):20-8.
29. Halpern BS, Schiepers C, Weber WA, Crawford TL, Fueger BJ, Phelps ME, Czernin J. Presurgical staging of non-small cell lung cancer: positron emission tomography, integrated positron emission tomography/CT, and software image fusion. Chest. 2005;128(4):2289-97.
30. Kasai T, Motoori K, Horikoshi T, Uchiyama K, Yasufuku K, Takiguchi Y, Takahashi F, Kuniyasu Y, Ito H. Dual-time point scanning of integrated FDG PET/CT for the evaluation of mediastinal and hilar lymph nodes in non-small cell lung cancer diagnosed as operable by contrast-enhanced CT. European journal of radiology. 2010;75(2):143-6.
31. Kim DW, Kim WH, Kim CG. Dual-time-point FDG PET/CT: Is It Useful for Lymph Node Staging in Patients with Non-Small-Cell Lung Cancer?. Nuclear medicine and molecular imaging. 2012;46(3):196-200.
32. An YS, Sun JS, Park KJ, Hwang SC, Park KJ, Sheen SS, Lee S, Lee KB, Yoon JK. Diagnostic performance of (18)F-FDG PET/CT for lymph node staging in patients with operable non-small-cell lung cancer and inflammatory lung disease. Lung. 2008;186(5):327-36.
33. Yang W, Zhang Y, Fu Z, Yu J, Sun X, Mu D, Han A. Imaging of proliferation with 18F-FLT PET/CT versus 18F-FDG PET/CT in non-small-cell lung cancer. European journal of nuclear medicine and molecular imaging. 2010;37(7):1291-9.
34. Shinya T, Rai K, Okumura Y, Fujiwara K, Matsuo K, Yonei T, Sato T, Watanabe K, Kawai H, Sato S, Kanazawa S. Dual-time-point F-18 FDG PET/CT for evaluation of intrathoracic lymph nodes in patients with non-small cell lung cancer. Clinical nuclear medicine. 2009;34(4):216-21.
35. Lee JW, Kim BS, Lee DS, Chung JK, Lee MC, Kim S, Kang WJ. 18F-FDG PET/CT in mediastinal lymph node staging of non-small-cell lung cancer in a tuberculosis-endemic country: consideration of lymph node calcification and distribution pattern to improve specificity. European journal of nuclear medicine and molecular imaging. 2009;36(11):1794-802.
36. Kuo WH, Wu YC, Wu CY, Ho KC, Chiu PH, Wang CW, Chang CJ, Yu CT, Yen TC, Lin C. Node/aorta and node/liver SUV ratios from (18)F-FDG PET/CT may improve the detection of occult mediastinal lymph node metastases in patients with non-small cell lung carcinoma. Academic radiology. 2012;19(6):685-92.
37. Sanli M, Isik AF, Zincirkeser S, Elbek O, Mete A, Tuncozgur B, Elbeyli L. Reliability of positron emission tomography-computed tomography in identification of mediastinal lymph node status in patients with non-small cell lung cancer. The Journal of thoracic and cardiovascular surgery. 2009;138(5):1200-5.
38. Perigaud C, Bridji B, Roussel JC, Sagan C, Mugniot A, Duveau D, Baron O, Despins P. Prospective preoperative mediastinal lymph node staging by integrated positron emission tomography-computerised tomography in patients with non-small-cell lung cancer. European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery. 2009;36(4):731-6.
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46. Nomori H, Mori T, Ikeda K, Kawanaka K, Shiraishi S, Katahira K, Yamashita Y. Diffusion-weighted magnetic resonance imaging can be used in place of positron emission tomography for N staging of non-small cell lung cancer with fewer false-positive results. The Journal of thoracic and cardiovascular surgery. 2008;135(4):816-22.
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60. Kim YN, Yi CA, Lee KS, Kwon OJ, Lee HY, Kim BT, Choi JY, Kim SW, Chung MP, Han J, Kim TS, Chung MJ, Shim YM. A proposal for combined MRI and PET/CT interpretation criteria for preoperative nodal staging in non-small-cell lung cancer. European radiology. 2012;22(7):1537-46.
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2. Pak K, Park S, Cheon GJ, Kang KW, Kim IJ, Lee DS, Kim EE, Chung JK. Update on nodal staging in non-small cell lung cancer with integrated positron emission tomography/computed tomography: a meta-analysis. Annals of nuclear medicine. 2015;29((Pak K., ilikechopin@daum.net; Kim I.-J., injkim@pusan.ac.kr) Department of Nuclear Medicine and Biomedical Research Institute, Pusan National University Hospital, Busan, South Korea):409-19.
3. Schmidt-Hansen M, Baldwin DR, Hasler E, Zamora J, Abraira V, Roqué I, Figuls M. PET‐CT for assessing mediastinal lymph node involvement in patients with suspected resectable non‐small cell lung cancer. Cochrane Database of Systematic Reviews. 2014;11(11):CD009519.
4. Shen G, Hu S, Deng H, Jia Z. Diagnostic value of dual time-point 18 F-FDG PET/CT versus single time-point imaging for detection of mediastinal nodal metastasis in non-small cell lung cancer patients: a meta-analysis. Acta radiologica (Stockholm, Sweden : 1987). 2015;56(6):681-7.
5. Shen G, Lan Y, Zhang K, Ren P, Jia Z. Comparison of 18F-FDG PET/CT and DWI for detection of mediastinal nodal metastasis in non-small cell lung cancer: A meta-analysis. PloS one. 2017;12(3):e0173104.
6. Zhao L, He ZY, Zhong XN, Cui ML. (18)FDG-PET/CT for detection of mediastinal nodal metastasis in non-small cell lung cancer: a meta-analysis. Surgical oncology. 2012;21(3):230-6.
7. Maziak DE, Darling GE, Inculet RI, Gulenchyn KY, Driedger AA, Ung YC, Miller JD, Gu CS, Cline KJ, Evans WK, Levine MN. Positron emission tomography in staging early lung cancer: a randomized trial. Annals of internal medicine. 2009;151(4):221-8, W-48.
8. Fischer BM, Mortensen J, Hansen H, Vilmann P, Larsen SS, Loft A, Bertelsen AK, Ravn J, Clementsen P, Høegholm A, Larsen KR, Dirksen A, Skov BG, Krasnik M, Højgaard L, Lassen U. Multimodality approach to mediastinal staging in non-small cell lung cancer. Faults and benefits of PET-CT: a randomised trial. Thorax. 2011;66(4):294-300.
9. Yang W, Fu Z, Yu J, Yuan S, Zhang B, Li D, Xing L, Zhao D, Mu D, Sun X, Fang Y, Huang Y, Huange Y, Li W. Value of PET/CT versus enhanced CT for locoregional lymph nodes in non-small cell lung cancer. Lung cancer (Amsterdam, Netherlands). 2008;61(1):35-43.
10. Hu M, Han A, Xing L, Yang W, Fu Z, Huang C, Zhang P, Kong L, Yu J. Value of dual-time-point FDG PET/CT for mediastinal nodal staging in non-small-cell lung cancer patients with lung comorbidity. Clinical nuclear medicine. 2011;36(6):429-33.
11. Billé A, Pelosi E, Skanjeti A, Arena V, Errico L, Borasio P, Mancini M, Ardissone F. Preoperative intrathoracic lymph node staging in patients with non-small-cell lung cancer: accuracy of integrated positron emission tomography and computed tomography. European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery. 2009;36(3):440-5.
12. Usuda K, Sagawa M, Motono N, Ueno M, Tanaka M, Machida Y, Matoba M, Kuginuki Y, Taniguchi M, Ueda Y, Sakuma T. Advantages of diffusion-weighted imaging over positron emission tomography-computed tomography in assessment of hilar and mediastinal lymph node in lung cancer. Annals of surgical oncology. 2013;20(5):1676-83.
13. Iskender I, Kapicibasi HO, Kadioglu SZ, Sevilgen G, Tezel C, Kosar’ A, Atasalihi A, Kir A. Comparison of integrated positron emission tomography/computed tomography and mediastinoscopy in mediastinal staging of non-small cell lung cancer: analysis of 212 patients. Acta chirurgica Belgica. 2012;112(3):219-25.
14. Kim BT, Lee KS, Shim SS, Choi JY, Kwon OJ, Kim H, Shim YM, Kim J, Kim S. Stage T1 non-small cell lung cancer: preoperative mediastinal nodal staging with integrated FDG PET/CT–a prospective study. Radiology. 2006;241(2):501-9.
15. Cerfolio RJ, Bryant AS, Ojha B, Eloubeidi M. Improving the inaccuracies of clinical staging of patients with NSCLC: a prospective trial. The Annals of thoracic surgery. 2005;80(4):1207-13; discussion 1213-4.
16. Harders SW. LUCIS: lung cancer imaging studies. Danish medical journal. 2012;59(11):B4542.
17. Al-Sarraf N, Gately K, Lucey J, Wilson L, McGovern E, Young V. Lymph node staging by means of positron emission tomography is less accurate in non-small cell lung cancer patients with enlarged lymph nodes: analysis of 1,145 lymph nodes. Lung cancer (Amsterdam, Netherlands). 2008;60(1):62-8.
18. Ceylan N, Doğan S, Kocaçelebi K, Savaş R, Çakan A, Çağrici U. Contrast enhanced CT versus integrated PET-CT in pre-operative nodal staging of non-small cell lung cancer. Diagnostic and interventional radiology (Ankara, Turkey). 2012;18(5):435-40.
19. Hu M, Yu JM, Liu NB, Liu LP, Guo HB, Yang GR, Zhang PL, Xu XQ. [Significance of dual-time-point 18F-FDG PET imaging in evaluation of hilar and mediastinal lymph node metastasis in non-small-cell lung cancer]. Zhonghua zhong liu za zhi [Chinese journal of oncology]. 2008;30(4):306-9.
20. Tasci E, Tezel C, Orki A, Akin O, Falay O, Kutlu CA. The role of integrated positron emission tomography and computed tomography in the assessment of nodal spread in cases with non-small cell lung cancer. Interactive cardiovascular and thoracic surgery. 2010;10(2):200-3.
21. Ohnishi R, Yasuda I, Kato T, Tanaka T, Kaneko Y, Suzuki T, Yasuda S, Sano K, Doi S, Nakashima M, Hara T, Tsurumi H, Murakami N, Moriwaki H. Combined endobronchial and endoscopic ultrasound-guided fine needle aspiration for mediastinal nodal staging of lung cancer. Endoscopy. 2011;43(12):1082-9.
22. Jeon TY, Lee KS, Yi CA, Chung MP, Kwon OJ, Kim BT, Shim YM. Incremental value of PET/CT Over CT for mediastinal nodal staging of non-small cell lung cancer: Comparison between patients with and without idiopathic pulmonary fibrosis. AJR. American journal of roentgenology. 2010;195(2):370-6.
23. Lee BE, von Haag D, Lown T, Lau D, Calhoun R, Follette D. Advances in positron emission tomography technology have increased the need for surgical staging in non-small cell lung cancer. The Journal of thoracic and cardiovascular surgery. 2007;133(3):746-52.
24. Carnochan FM, Walker WS. Positron emission tomography may underestimate the extent of thoracic disease in lung cancer patients. European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery. 2009;35(5):781-4; discussion 784-5.
25. Xu N, Wang M, Zhu Z, Zhang Y, Jiao Y, Fang W. Integrated positron emission tomography and computed tomography in preoperative lymph node staging of non-small cell lung cancer. Chinese medical journal. 2014;127(4):607-13.
26. Lee AY, Choi SJ, Jung KP, Park JS, Lee SM, Bae SK. Characteristics of Metastatic Mediastinal Lymph Nodes of Non-Small Cell Lung Cancer on Preoperative F-18 FDG PET/CT. Nuclear medicine and molecular imaging. 2014;48(1):41-6.
27. Uesaka D, Demura Y, Ishizaki T, Ameshima S, Miyamori I, Sasaki M, Fujibayashi Y, Okazawa H. Evaluation of dual-time-point 18F-FDG PET for staging in patients with lung cancer. Journal of nuclear medicine : official publication, Society of Nuclear Medicine. 2008;49(10):1606-12.
28. Ventura E, Islam T, Gee MS, Mahmood U, Braschi M, Harisinghani MG. Detection of nodal metastatic disease in patients with non-small cell lung cancer: comparison of positron emission tomography (PET), contrast-enhanced computed tomography (CT), and combined PET-CT. Clinical imaging. 2010;34(1):20-8.
29. Halpern BS, Schiepers C, Weber WA, Crawford TL, Fueger BJ, Phelps ME, Czernin J. Presurgical staging of non-small cell lung cancer: positron emission tomography, integrated positron emission tomography/CT, and software image fusion. Chest. 2005;128(4):2289-97.
30. Kasai T, Motoori K, Horikoshi T, Uchiyama K, Yasufuku K, Takiguchi Y, Takahashi F, Kuniyasu Y, Ito H. Dual-time point scanning of integrated FDG PET/CT for the evaluation of mediastinal and hilar lymph nodes in non-small cell lung cancer diagnosed as operable by contrast-enhanced CT. European journal of radiology. 2010;75(2):143-6.
31. Kim DW, Kim WH, Kim CG. Dual-time-point FDG PET/CT: Is It Useful for Lymph Node Staging in Patients with Non-Small-Cell Lung Cancer?. Nuclear medicine and molecular imaging. 2012;46(3):196-200.
32. An YS, Sun JS, Park KJ, Hwang SC, Park KJ, Sheen SS, Lee S, Lee KB, Yoon JK. Diagnostic performance of (18)F-FDG PET/CT for lymph node staging in patients with operable non-small-cell lung cancer and inflammatory lung disease. Lung. 2008;186(5):327-36.
33. Yang W, Zhang Y, Fu Z, Yu J, Sun X, Mu D, Han A. Imaging of proliferation with 18F-FLT PET/CT versus 18F-FDG PET/CT in non-small-cell lung cancer. European journal of nuclear medicine and molecular imaging. 2010;37(7):1291-9.
34. Shinya T, Rai K, Okumura Y, Fujiwara K, Matsuo K, Yonei T, Sato T, Watanabe K, Kawai H, Sato S, Kanazawa S. Dual-time-point F-18 FDG PET/CT for evaluation of intrathoracic lymph nodes in patients with non-small cell lung cancer. Clinical nuclear medicine. 2009;34(4):216-21.
35. Lee JW, Kim BS, Lee DS, Chung JK, Lee MC, Kim S, Kang WJ. 18F-FDG PET/CT in mediastinal lymph node staging of non-small-cell lung cancer in a tuberculosis-endemic country: consideration of lymph node calcification and distribution pattern to improve specificity. European journal of nuclear medicine and molecular imaging. 2009;36(11):1794-802.
36. Kuo WH, Wu YC, Wu CY, Ho KC, Chiu PH, Wang CW, Chang CJ, Yu CT, Yen TC, Lin C. Node/aorta and node/liver SUV ratios from (18)F-FDG PET/CT may improve the detection of occult mediastinal lymph node metastases in patients with non-small cell lung carcinoma. Academic radiology. 2012;19(6):685-92.
37. Sanli M, Isik AF, Zincirkeser S, Elbek O, Mete A, Tuncozgur B, Elbeyli L. Reliability of positron emission tomography-computed tomography in identification of mediastinal lymph node status in patients with non-small cell lung cancer. The Journal of thoracic and cardiovascular surgery. 2009;138(5):1200-5.
38. Perigaud C, Bridji B, Roussel JC, Sagan C, Mugniot A, Duveau D, Baron O, Despins P. Prospective preoperative mediastinal lymph node staging by integrated positron emission tomography-computerised tomography in patients with non-small-cell lung cancer. European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery. 2009;36(4):731-6.
39. Sit AK, Sihoe AD, Suen WS, Cheng LC. Positron-emission tomography for lung cancer in a tuberculosis-endemic region. Asian cardiovascular & thoracic annals. 2010;18(1):33-8.
40. Zhou Y, Xia J.. Clinical value of 18F-FDG PET-CT imaging in the preoperative diagnosis and staging of regional lymph nodes in non-small cell lung cancer. Chin J CT& MRI. 2014;12:70-74.
41. Shim SS, Lee KS, Kim BT, Chung MJ, Lee EJ, Han J, Choi JY, Kwon OJ, Shim YM, Kim S. Non-small cell lung cancer: prospective comparison of integrated FDG PET/CT and CT alone for preoperative staging. Radiology. 2005;236(3):1011-9.
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Búsqueda y Síntesis de Evidencia
Búsqueda y síntesis de evidencia de efectos deseables e indeseables
4.- ¿Qué tan significativos son los efectos indeseables anticipados?
| Grandes | Moderados | Pequeños | Triviales | Varía | No lo sé |
|---|
Moderados: El panel de expertos de la Guía estimó que los efectos indeseables de «realizar un PET/CT» en comparación a «no realizarlo» son moderados, considerando la evidencia, experiencia clínica, conocimiento de gestión o experiencia de las personas con la condición o problema de salud. El panel destaca que en el grupo de falsos negativos, los pacientes con un elevado riesgo de tener adenopatía mediastínicas positivas y que tengan resultado negativo en el PET/CT, de todos modos podrían ir a otra intervención.
Evidencia de investigación
Se estima que en una población compuesta de 300 pacientes con compromiso mediastínico y 700 personas sin compromiso mediastínico:
– La etapificación mediastínica mediante PET/CT podría clasificar equivocadamente a 69 de 700 pacientes sin compromiso mediastínico, pero la certeza de la evidencia es baja.
– La etapificación mediastínica mediante PET/CT podría no detectar a 68 de 300 pacientes con compromiso mediastínico, pero la certeza de la evidencia es baja.
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53. Yi CA, Shin KM, Lee KS, Kim BT, Kim H, Kwon OJ, Choi JY, Chung MJ. Non-small cell lung cancer staging: efficacy comparison of integrated PET/CT versus 3.0-T whole-body MR imaging. Radiology. 2008;248(2):632-42.
54. Nishiyama Y, Yamamoto Y, Kimura N, Ishikawa S, Sasakawa Y, Ohkawa M. Dual-time-point FDG-PET for evaluation of lymph node metastasis in patients with non-small-cell lung cancer. Annals of nuclear medicine. 2008;22(4):245-50.
55. Lin WY, Hsu WH, Lin KH, Wang SJ. Role of preoperative PET-CT in assessing mediastinal and hilar lymph node status in early stage lung cancer. Journal of the Chinese Medical Association : JCMA. 2012;75(5):203-8.
56. Saydam O, Gokce M, Kilicgun A, Tanriverdi O. Accuracy of positron emission tomography in mediastinal node assessment in coal workers with lung cancer. Medical oncology (Northwood, London, England). 2012;29(2):589-94.
57. Subedi N, Scarsbrook A, Darby M, Korde K, Mc Shane P, Muers MF. The clinical impact of integrated FDG PET-CT on management decisions in patients with lung cancer. Lung cancer (Amsterdam, Netherlands). 2009;64(3):301-7.
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59. Liu BJ, Dong JC, Xu CQ, Zuo CT, Le JJ, Guan YH, Zhao J, Wu JF, Duan XH, Cao YX. Accuracy of 18F-FDG PET/CT for lymph node staging in non-small-cell lung cancers. Chinese medical journal. 2009;122(15):1749-54.
60. Kim YN, Yi CA, Lee KS, Kwon OJ, Lee HY, Kim BT, Choi JY, Kim SW, Chung MP, Han J, Kim TS, Chung MJ, Shim YM. A proposal for combined MRI and PET/CT interpretation criteria for preoperative nodal staging in non-small-cell lung cancer. European radiology. 2012;22(7):1537-46.
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62. Tournoy KG, Maddens S, Gosselin R, Van Maele G, van Meerbeeck JP, Kelles A. Integrated FDG-PET/CT does not make invasive staging of the intrathoracic lymph nodes in non-small cell lung cancer redundant: a prospective study. Thorax. 2007;62(8):696-701.
63. Shin KM, Lee KS, Shim YM, Kim J, Kim BT, Kwon OJ, Park K. FDG PET/CT and mediastinal nodal metastasis detection in stage T1 non-small cell lung cancer: prognostic implications. Korean journal of radiology : official journal of the Korean Radiological Society. 2008;9(6):481-9.
64. Booth K, Hanna GG, McGonigle N, McManus KG, McGuigan J, O’Sullivan J, Lynch T, McAleese J. The mediastinal staging accuracy of 18F-Fluorodeoxyglycose positron emission tomography/computed tomography in non-small cell lung cancer with variable time intervals to surgery. The Ulster medical journal. 2013;82(2):75-81.
65. Mona A, El-Hariri GKG, Ali M. Refat. ntegrated PET/CT in the preoperative staging of lung cancer: a prospective comparison of CT, PET and integrated PET/CT. Egypt J Radiol Nucl Med.. 2012;43:613-21.
66. Plathow C, Aschoff P, Lichy MP, Eschmann S, Hehr T, Brink I, Claussen CD, Pfannenberg C, Schlemmer HP. Positron emission tomography/computed tomography and whole-body magnetic resonance imaging in staging of advanced nonsmall cell lung cancer–initial results. Investigative radiology. 2008;43(5):290-7.
67. Morikawa M, Demura Y, Ishizaki T, Ameshima S, Miyamori I, Sasaki M, Tsuchida T, Kimura H, Fujibayashi Y, Okazawa H. The effectiveness of 18F-FDG PET/CT combined with STIR MRI for diagnosing nodal involvement in the thorax. Journal of nuclear medicine : official publication, Society of Nuclear Medicine. 2009;50(1):81-7.
68. Lee SM, Park CM, Paeng JC, Im HJ, Goo JM, Lee HJ, Kang CH, Kim YW, Kim JI. Accuracy and predictive features of FDG-PET/CT and CT for diagnosis of lymph node metastasis of T1 non-small-cell lung cancer manifesting as a subsolid nodule. European radiology. 2012;22(7):1556-63.
69. Yen RF, Chen KC, Lee JM, Chang YC, Wang J, Cheng MF, Wu YW, Lee YC. 18F-FDG PET for the lymph node staging of non-small cell lung cancer in a tuberculosis-endemic country: is dual time point imaging worth the effort?. European journal of nuclear medicine and molecular imaging. 2008;35(7):1305-15.
70. Czepczynski R, Zielinski P, Stangierski A, Gabryel P, Kasprzak W, Dyszkiewicz W. The value of 18F‐FDG PET/CT scan in the evaluation lymph node status in patients with non‐small cell lung carcinoma. European Journal of Nuclear Medicine and Molecular Imaging. 2011;Conference:S282.
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53. Yi CA, Shin KM, Lee KS, Kim BT, Kim H, Kwon OJ, Choi JY, Chung MJ. Non-small cell lung cancer staging: efficacy comparison of integrated PET/CT versus 3.0-T whole-body MR imaging. Radiology. 2008;248(2):632-42.
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55. Lin WY, Hsu WH, Lin KH, Wang SJ. Role of preoperative PET-CT in assessing mediastinal and hilar lymph node status in early stage lung cancer. Journal of the Chinese Medical Association : JCMA. 2012;75(5):203-8.
56. Saydam O, Gokce M, Kilicgun A, Tanriverdi O. Accuracy of positron emission tomography in mediastinal node assessment in coal workers with lung cancer. Medical oncology (Northwood, London, England). 2012;29(2):589-94.
57. Subedi N, Scarsbrook A, Darby M, Korde K, Mc Shane P, Muers MF. The clinical impact of integrated FDG PET-CT on management decisions in patients with lung cancer. Lung cancer (Amsterdam, Netherlands). 2009;64(3):301-7.
58. Li X, Zhang H, Xing L, Ma H, Xie P, Zhang L, Xu X, Yue J, Sun X, Hu X, Chen M, Xu W, Chen L, Yu J. Mediastinal lymph nodes staging by 18F-FDG PET/CT for early stage non-small cell lung cancer: a multicenter study. Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology. 2012;102(2):246-50.
59. Liu BJ, Dong JC, Xu CQ, Zuo CT, Le JJ, Guan YH, Zhao J, Wu JF, Duan XH, Cao YX. Accuracy of 18F-FDG PET/CT for lymph node staging in non-small-cell lung cancers. Chinese medical journal. 2009;122(15):1749-54.
60. Kim YN, Yi CA, Lee KS, Kwon OJ, Lee HY, Kim BT, Choi JY, Kim SW, Chung MP, Han J, Kim TS, Chung MJ, Shim YM. A proposal for combined MRI and PET/CT interpretation criteria for preoperative nodal staging in non-small-cell lung cancer. European radiology. 2012;22(7):1537-46.
61. Li M, Wu N, Liu Y, Zheng R, Liang Y, Zhang W, Zhao P. Regional nodal staging with 18F-FDG PET-CT in non-small cell lung cancer: Additional diagnostic value of CT attenuation and dual-time-point imaging. European journal of radiology. 2012;81(8):1886-90.
62. Tournoy KG, Maddens S, Gosselin R, Van Maele G, van Meerbeeck JP, Kelles A. Integrated FDG-PET/CT does not make invasive staging of the intrathoracic lymph nodes in non-small cell lung cancer redundant: a prospective study. Thorax. 2007;62(8):696-701.
63. Shin KM, Lee KS, Shim YM, Kim J, Kim BT, Kwon OJ, Park K. FDG PET/CT and mediastinal nodal metastasis detection in stage T1 non-small cell lung cancer: prognostic implications. Korean journal of radiology : official journal of the Korean Radiological Society. 2008;9(6):481-9.
64. Booth K, Hanna GG, McGonigle N, McManus KG, McGuigan J, O’Sullivan J, Lynch T, McAleese J. The mediastinal staging accuracy of 18F-Fluorodeoxyglycose positron emission tomography/computed tomography in non-small cell lung cancer with variable time intervals to surgery. The Ulster medical journal. 2013;82(2):75-81.
65. Mona A, El-Hariri GKG, Ali M. Refat. ntegrated PET/CT in the preoperative staging of lung cancer: a prospective comparison of CT, PET and integrated PET/CT. Egypt J Radiol Nucl Med.. 2012;43:613-21.
66. Plathow C, Aschoff P, Lichy MP, Eschmann S, Hehr T, Brink I, Claussen CD, Pfannenberg C, Schlemmer HP. Positron emission tomography/computed tomography and whole-body magnetic resonance imaging in staging of advanced nonsmall cell lung cancer–initial results. Investigative radiology. 2008;43(5):290-7.
67. Morikawa M, Demura Y, Ishizaki T, Ameshima S, Miyamori I, Sasaki M, Tsuchida T, Kimura H, Fujibayashi Y, Okazawa H. The effectiveness of 18F-FDG PET/CT combined with STIR MRI for diagnosing nodal involvement in the thorax. Journal of nuclear medicine : official publication, Society of Nuclear Medicine. 2009;50(1):81-7.
68. Lee SM, Park CM, Paeng JC, Im HJ, Goo JM, Lee HJ, Kang CH, Kim YW, Kim JI. Accuracy and predictive features of FDG-PET/CT and CT for diagnosis of lymph node metastasis of T1 non-small-cell lung cancer manifesting as a subsolid nodule. European radiology. 2012;22(7):1556-63.
69. Yen RF, Chen KC, Lee JM, Chang YC, Wang J, Cheng MF, Wu YW, Lee YC. 18F-FDG PET for the lymph node staging of non-small cell lung cancer in a tuberculosis-endemic country: is dual time point imaging worth the effort?. European journal of nuclear medicine and molecular imaging. 2008;35(7):1305-15.
70. Czepczynski R, Zielinski P, Stangierski A, Gabryel P, Kasprzak W, Dyszkiewicz W. The value of 18F‐FDG PET/CT scan in the evaluation lymph node status in patients with non‐small cell lung carcinoma. European Journal of Nuclear Medicine and Molecular Imaging. 2011;Conference:S282.
71. Ozkan EA, Araz M, Soydal C, Aras G. A retrospective analysis of 18F‐FDG PET/CT in the primary staging of non‐small cell lung cancer (NSCLC). European Journal of Nuclear Medicine and Molecular Imaging. 2011;Conference:S125.
72. El‐Hariri MA, Gouhar GK, Refat AM. Integrated PET/CT in the preoperative staging of lung cancer: a prospective comparison of CT, PETand integrated PET/CT. The Egyptian Journal of Radiology and Nuclear Medicine. 2012;43(4):613‐21.
73. Üskül BT, Baysungur V, Aksoy F, Turan FE, Sevilgen G, Turker H. Combined use of transbronchial needle aspiration and PET/CT in mediastinal nodal staging of non small cell lung cancer. Multidisciplinary Respiratory Medicine. 2009;4(1):8-14.
74. Uruga H. PET/CT for mediastinal lymph node staging in non‐small‐cell lung cancer with interstitial pneumonia. American Journal of Respiratory and Critical Care Medicine. 2011;Conference:1.
75. Chen W, Jian W, Li HT, Li C, Zhang YK, Xie B, Zhou DQ, Dai YM, Lin Y, Lu M, Huang XQ, Xu CX, Chen L. Whole-body diffusion-weighted imaging vs. FDG-PET for the detection of non-small-cell lung cancer. How do they measure up?. Magnetic resonance imaging. 2010;28(5):613-20
76. Lee SH, Min JW, Lee CH, Park CM, Goo JM, Chung DH, Kang CH, Kim YT, Kim YW, Han SK, Shim YS, Yim JJ. Impact of parenchymal tuberculosis sequelae on mediastinal lymph node staging in patients with lung cancer. Journal of Korean medical science. 2011;26(1):67-70.
Búsqueda y Síntesis de Evidencia
Búsqueda y síntesis de evidencia de efectos deseables e indeseables
5.- ¿Cuál es la certeza general de la evidencia sobre la precisión de la prueba?
| Muy baja | Baja | Moderada | Alta | Ningún estudio incluido |
|---|
Baja: Existe cierta incertidumbre respecto del efecto de «realizar un PET/CT» en comparación a «no realizarlo».
Evidencia de investigación
|
Desenlaces |
Diseño de estudio |
Certeza de la evidencia (GRADE)** |
|
verdaderos positivos |
Estudio de exactitud de casos y controles |
⊕⊕◯◯1,2,3 Baja |
|
verdaderos negativos |
⊕⊕◯◯1,2,3 Baja |
|
|
falsos positivos |
⊕⊕◯◯1,2,3 Baja |
|
|
falsos negativos |
⊕⊕◯◯1,2,3 Baja |
1. Se decidió no disminuir la certeza de la evidencia por inconsistencia, ya que existen razones clínicas que la justifican (Diferentes estadios clínicos o tipo histológico).
2. Se disminuyó un nivel de certeza de evidencia por riesgo de sesgo, ya que la selección de pacientes en 11 estudios [9, 14, 16, 23, 33, 35, 48, 58, 63, 66, 75] era dudosa, en seis estudios no estaba claro si la interpretación del test fue ciega del gold standard [16, 23, 48, 58, 66, 75], en un estudio no está claro si el gold standard fue aplicado a todos los pacientes [75] y en 7 estudios [11, 16, 35, 52, 53, 63, 75] el seguimiento era insuficiente.
3. Se disminuyó un nivel de certeza por imprecisión debido al intervalo de confianza amplio.
6.- ¿Cuál es certeza general de la evidencia sobre efectos de la prueba?
| Muy baja | Baja | Moderada | Alta | Ningún estudio incluido |
|---|
Muy Baja: Existe considerable incertidumbre respecto del efecto de «realizar un PET/CT» en comparación a «no realizarlo». Se baja un nivel de certeza de la evidencia respecto al ítem 5, dado que no se identificaron estudios que evaluaran el efecto de la etapificación mediastínica mediante PET/CT en los desenlaces de salud para los pacientes con cáncer de pulmón (impacto diagnóstico).
7.- ¿Hay incertidumbre importante o variabilidad sobre qué tanto valora la gente los desenlaces principales?
| Incertidumbre o variabilidad importantes | Posiblemente hay incertidumbre o variabilidad importantes | Probablemente no hay incertidumbre ni variabilidad importantes | No hay variabilidad o incertidumbre importante |
|---|
No hay variabilidad o incertidumbre importante: En función de la evidencia de investigación, experiencia clínica, conocimiento de gestión o experiencia de las personas con la condición o problema de salud, el panel de expertos de la Guía consideró que no existe incertidumbre o variabilidad importante respecto a lo que escogería una persona informada de los efectos deseables e indeseables de «realizar un PET/CT» y «no realizarlo». Todas o casi todas las personas escogerían realizarse un PET/CT.
Evidencia de investigación
Se identificó un estudio inglés del 2018 que evaluó la angustia emocional, recuperación, satisfacción y aceptabilidad de realizarse el PET-CT en 51 pacientes con cáncer de pulmón. El 98.2% consideró la prueba aceptable y el 82,3% indicó que el tiempo de recuperación fue inmediato o menor a 30 minutos. En general hubo baja preocupación e incomodad y alta satisfacción promedio (1).
Referencias
1. Evans RE, Taylor SA, Beare S, Halligan S, Morton A, Oliver A, et al. Perceived patient burden and acceptability of whole body MRI for staging lung and colorectal cancer; comparison with standard staging investigations. Br J Radiol [Internet]. 2018 Mar 20 [cited 2018 Aug 9];20170731. Available from: http://www.birpublications.org/doi/10.1259/bjr.20170731
Búsqueda y Síntesis de Evidencia
Búsqueda y síntesis de evidencia de valores y preferencias de los pacientes
8.- El balance entre efectos deseables e indeseables favorece la intervención o la comparación?
| Favorece la comparación | Probablemente favorece la comparación | No favorece la intervención ni la comparación | Probablemente favorece la intervención | Favorece la intervención | Varía | No lo sé |
|---|
Favorece la intervención: Considerando que la intervención es «realizar un PET/CT» y la comparación es «no realizarlo», el panel de expertos de la Guía opinó que el balance entre efectos deseables e indeseables claramente favorece «realizar un PET/CT». Sobre todo, considerando que el PEC/CT podría diagnosticar correctamente a 232 de 300 pacientes con compromiso mediastínico y descartar correctamente a 631 de 700 pacientes sin compromiso mediastínico.
9.- ¿Qué tan grandes son los recursos necesarios (costos)?
| Costos Extensos | Costos moderados | Costos y ahorros despreciables | Ahorros moderados | Ahorros extensos | Varía | No lo sé |
|---|
Costos extensos: El panel de expertos de la Guía consideró que los costos de «realizar un PET/CT» son grandes.
Evidencia de investigación
A continuación se muestran los costos referenciales, es preciso considerar que estos costos fueron recogidos con el único objetivo de constituir un antecedente aproximado.
|
Ítem |
Intervención: PET/CT |
|
Examen y estudio PET-CT (incluye contraste y radiofármaco) PET-CT 1 |
$ 605.180 |
|
Total |
$ 605.180 |
* Costos referenciales por cada vez.
Referencias:
1. Precio total para prestador nivel 1, 2 y 3 de la base de datos Modalidad de Libre Elección 2018 (MLE). FONASA.
Búsqueda y Síntesis de Evidencia
Búsqueda de costos
10.- ¿La costo-efectividad de la intervención beneficia la intervención o la comparación?
| Favorece la comparación | Probablemente favorece la comparación | No favorece la intervención ni la comparación | Probablemente favorece la intervención | Favorece la intervención | Varía | Ningún estudio incluido |
|---|
Probablemente favorece la intervención: Considerando que la intervención es «realizar un PET/CT» y la comparación es «no realizarlo», el panel de expertos de la Guía opinó que probablemente la alternativa más costo-efectiva es «realizar un PET/CT», dado que mejora el diagnóstico y evita tratamientos quirúrgicos innecesarios.
Evidencia de investigación
Se identificó una revisión sistemática cuyo objetivo era proporcionar un análisis de costo efectividad de realizar tomografía por emisión de positrones (PET) para la etapificación y consecuente manejo del cáncer de pulmón de células no pequeñas, la cual señala que la mayoría de los estudios concluyen que la información adicional obtenida de la PET con indicaciones adecuadas y diferentes puntos de equilibrio, compensa el costo de realizarla, sin embargo los estudios no pudieron sintetizarse por variabilidad de las estructuras de costos y fallas metodológicas (1).
Referencias
1. Cao JQ, Rodrigues GB, Louie A V., Zaric GS. Systematic Review of the Cost-Effectiveness of Positron-Emission Tomography in Staging of Non–Small-Cell Lung Cancer and Management of Solitary Pulmonary Nodules. Clin Lung Cancer [Internet]. 2012 May [cited 2018 Sep 20];13(3):161–70. Available from: http://www.ncbi.nlm.nih.gov/pubmed/22133290
Búsqueda y Síntesis de Evidencia
Informe de Búsqueda y síntesis de costo-efectividad
11.- ¿Cuál sería el impacto en equidad en salud?
| Reducido | Probablemente reducido | Probablemente ningún impacto | Probablemente aumentado | Aumentado | Varía | No lo sé |
|---|
Probablemente reducida: El panel de expertos de la Guía consideró que la equidad en salud se probablemente se reduciría si se recomendase «realizar un PET/CT», dado los costos extensos y disponibilidad que PEC/CT en la red asistencial.
12.- ¿La intervención es aceptable para las partes interesadas?
| No | Probablemente no | Probablemente sí | Sí | Varía | No lo sé |
|---|
Probablemente sí: El panel de expertos de la Guía consideró que «realizar un PET/CT» probablemente SÍ es aceptable para las partes interesadas (profesionales de la salud, gestores de centros de salud, directivos de centros de salud, pacientes, cuidadores, seguros de salud, otros).
13.- ¿Es factible implementar la intervención?
| No | Probablemente no | Probablemente sí | Sí | Varía | No lo sé |
|---|
Probablemente sí: El panel de expertos de la Guía consideró que «realizar un PET/CT» probablemente SÍ es factible implementar, contemplando la capacidad de la red asistencial, los recursos humanos disponibles a nivel país, recursos financieros, etc.