CANCER PULMON: ESTADIOS INICIALES POSTMUNDIAL PULMON DENVER Manuel Cobo Dols S. Oncología Médica HU Málaga Regional y VV

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1 CANCER PULMON: ESTADIOS INICIALES POSTMUNDIAL PULMON DENVER Manuel Cobo Dols S. Oncología Médica HU Málaga Regional y VV

2 Meta-analisis LACE: adyuvancia vs no adyuvancia Pignon JP, et al. JCO 2008

3 Lancet 2014

4 Meta-analisis adyuvancia Pulmón. Pignon JP, et al. JCO 2008

5 SG > 4 cm SG < 4 cm Strauss GM. CALGB adyuvante. JCO 2008

6 Estadio IB. Adyuvancia Analisis a largo plazo ANITA: No beneficio estadio I CALGB 9333.Analisis SG a 9 años (Strauss ASCO 2011) < 4 cm HR 0.92, p = > 4 cm HR 0.78, p =0.087 JBR-10. Subanálisis estadio I > 4 cm, HR 0.66, p=1.14 < 4 cm, HR p = El tamaño tumoral es un factor relevante en el antiguo Estadio I, pero no se ha validado prospectivamente

7 Estadiaje: Intención, enfoque tratamiento vc

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10 Conclusiones estadios precoces Estándar: Cirugía completa. Si no se puede cirugía completa: SBRT Quimioterapia adyuvante: 4 ciclos CDDP- NVB NO en estadios IA (< 3 cm). SI en IIB: T3 ( >7 cm u otros criterios T3) SI en N + SI /? en IIA: T2b ( 5-7 cm). SI / NO en IB : T2a ( 4-5 cm). Casos seleccionados NO en PS 2-3. SI en > 70 sin comorbilidades importantes

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32 ORAL04.01: Final Results of Phase III Trial of Adjuvant Chemo-Immunotherapy in Lung Cancer Kimura H et al Key results Subgroup analysis identified those who were male, had adenocarcinoma, were stage III or had no preoperative chemotherapy to have poorer prognosis with lower HRs CD8/CD4 ratio was significantly elevated in survivors Conclusions The use immunotherapy in adjuvant treatment of patients with NSCLC was shown to improve survival A large-scale multi-institutional trial is required to validate these findings Chemo-immunotherapy Chemotherapy 2-year OS, % year OS, % OS, HR (95%CI); p-value (1.64, 0.631); p= year RFS, % year RFS, % RFS, HR (95%CI); p-value (0.253, 0.749); p= Kimura et al. J Thorac Oncol 2015; 10 (suppl 2): ORAL04.01

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34 Study of Pembrolizumab (MK-3475) vs Placebo for Participants With Non-small Cell Lung Cancer After Resection With or Without Standard Adjuvant Therapy (MK /KEYNOTE-091) (PEARLS) IB with T 4 cm, II-IIIA 4 cycles of adjuvant CT Completely resected disease Available tumor sample obtained at surgical resection for PD-L1 Immunohistochemistry (IHC) expression assessment R A N D O M I Z E N= 1380 Pembolizumab 200 mg, intravenously (IV), every 3 weeks, for one year (expected maximum 18 doses). Placebo Main endpoint: PFS

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52 JTO 2015, abstrct 2219

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60 RT adyuvante en N2 resecados

61 Base datos SEER Lally B E et al. JCO 2006;24:

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65 Phase III Study Comparing Post-Operative Conformal Radiotherapy to No Post-Operative Radiotherapy in Patients With Completely Resected Non-Small Cell Lung Cancer and Mediastinal N2 Involvement [Lung ART] N2 mediastinal nodal involvement prior to neoadjuvant chemotherapy OR at the time of surgery in the absence of neoadjuvant chemotherapy Completely resected disease by lobectomy, bilobectomy, or pneumonectomy (absence of positive margins or extracapsular extension in a node removed separately) Mediastinal lymph node exploration (lymph node sampling or systematic dissection of lymph nodes at stations 2, 4 and 7 in case of upper/middle right-sided lung cancer; 4, 7, 8 and 9 in case of lower right-sided lung cancer; 5, 6 and 7 in case of upper left -sided lung cancer; 7, 8 and 9 in case of lower left-sided lung cancer is recommended) R A N D O M I Z E N=700 PORT post-operative Clinical stage IIIA= N2 postcx observation Main endpoint: PFS

66 ORAL05.02: Quality of Resection in Pathological N2 NSCLC in the Phase 3 Lung Adjuvant Radiotherapy Trial (Lung ART): An Important Factor Edwards J et al Study objective To explore the impact of post-operative conformal radiotherapy on disease-free survival in patients with completely resected pathologically proven N2 NSCLC with/without induction or adjuvant chemotherapy Key patient inclusion criteria Completely resected NSCLC Histologically or cytologically proven N2 nodal involvement No metastasis No previous RT Age >18 years WHO PS 1 (n=116) Primary endpoint DFS R Post-operative conformal RT (54 Gy) Stratification factors Institution, adjuvant chemotherapy, histology, mediastinal lymph node involvement, pretreatment PET-scan Control PD PD Edwards et al. J Thorac Oncol 2015; 10 (suppl 2): ORAL05.02

67 Nodal evaluation n (%) Sampling 18 (16) Selective dissection 26 (22) Systematic dissection 72 (62) Key results Nodal dissection was performed in 71% of the patients as per the recommendations More than 80% of patients had >2 mediastinal stations explored; station 7 was explored in 106/116 (91%)