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M.Á. Artal Cortés



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    MA06 - Locally Advanced NSCLC: Risk Groups, Biological Factors and Treatment Choices (ID 379)

    • Event: WCLC 2016
    • Type: Mini Oral Session
    • Track: Locally Advanced NSCLC
    • Presentations: 1
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      MA06.09 - Efficacy RENO Study Results of Oral Vinorelbine or Etoposide with Cisplatin & Chemo-Radiation in Stage III NSCLC. SLCG 10/02 (ID 4238)

      17:00 - 17:06  |  Author(s): M.Á. Artal Cortés

      • Abstract
      • Presentation
      • Slides

      Background:
      This study aims to compare efficacy and safety of two widely used combinations of cisplatin (P) in this setting: as etoposide (E) and vinorelbine. This last, in its oral formulation (oV) which has achieved comparable results as the IV formulation and patients (pts) prefer it.

      Methods:
      Pts between 18-75years, with histologically proven untreated and unresectable locally-advanced NSCLC (LA-NSCLC), adequate respiratory function, V20≤35% and ECOG-PS 0-1, were randomized 1:1 to oV-P arm: 2 induction cycles (cy) of oV-P followed by 2 cy more with RT; or to E-P arm: 2 cy of E-P concomitants to RT. Both arms with a total radiation dose of 66Gy administered 2 Gys daily. Primary endpoint was progression free survival (PFS) by RECIST 1.1. Secondary endpoints: overall response rate (ORR), overall survival (OS) and safety. With α-error of 0.05 (one-tailed test) and 0.1 β-error, median PFS unacceptable for the oV-P arm of 10 months (m) (p0) and a very acceptable of 15 m (p1), 122 eligible pts were required.

      Results:
      140 pts from 23 institutions of SLCG were randomized between 08/2011-12/2014. 134 pts were treated (66 in oV-P and 68 in E-P arms). Results based on this 134 pts are presented. Median age 62 years [39-76]; PS 0/1, 45%/55%; current smoker 51%; squamous cell 51%; stage IIIB 54%. 244 and 131 cy were given in the oV-P and E-P arms, respectively. All irradiated pts in oV-P arm received at least 60Gy, 7 pts in the E-P arm received less than 60Gy (4 due to toxicity). 1 pt (1.5%) in oV-P arm and 12 pts (17.6%) in E-P arm presented esophagitis G3/4 (p=0.002). 121 confirmed eligibility for efficacy analysis. ORR were 39 (64%) and 40 pts (67%) in the oV-P and E-P arms, respectively (p=0.889). After 16 m [1-43] of follow-up, 66% pts progressed and 43% pts died. Median PFS is 11.4 m (IC95%; 6-17) in oV-P arm and 11.8 m (IC95%; 7-16) in E-P arm (p=0.374).

      Conclusion:
      Both regimens achieve similar efficacy however oV-P has less toxicity, especially esophagitis G3/4. Further follow-up is needed for the survival analysis.

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    P1.05 - Poster Session with Presenters Present (ID 457)

    • Event: WCLC 2016
    • Type: Poster Presenters Present
    • Track: Early Stage NSCLC
    • Presentations: 1
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      P1.05-005 - Programmed Death-Ligand 1 (PD-L1) in Resected Lung Adenocarcinomas (LA) in a University Hospital (ID 6101)

      14:30 - 14:30  |  Author(s): M.Á. Artal Cortés

      • Abstract

      Background:
      The role of monoclonal antibodies inhibiting of the Programmed Death-1 and its ligand (PD-1/ PD-L1) pathway have been described in advanced disease. The knowledge of the role of this pathway in early stages of lung cancer is still limited. We assessed the incidence of PD-L1 expression in tumour cells of samples of resected lung adenocarcinomas and its prognostic role.

      Methods:
      A retrospective analysis of patients (p) with lung adenocarcinomas radically resected at our Institution between 2004 and 2011 has been conducted. PD-L1 was determined by Immunohistochemistry (SP263, Ventana® assay). A cut-off value of 5% of positive tumour cell was chosen.

      Results:
      112 tumours from 107 p were included. Median age was 62 years. 81% were male, 88% had exposure smoking, baseline performance status was 0 – I – II (62,5% - 26,8% - 10,7%) and pathological stage was I – II – III – IV (49,1% - 26,8% - 23,2% - 0,9%). Fourteen p (12%) expressed PD-L1>5%. They were mostly male (71%), smokers (93%), baseline performance status was 0 – 1 – 2 (64% - 29% - 7%), the most common histological subtype was poorly differentiated adenocarcinoma (64%) and pathological stage was I – II – III (28% - 21% - 50%). One p (7,7%) harboured EGFR mutation, none (0%) were ALK positive and 6 p (46,2%) had a K-RAS mutation. With a follow-up of 52 months median disease free survival (DFS) was 49 months and overall survival (OS) 58 months. Median DFS was shorter in p with expression of PD-L1 (27 months) that in negative tumours (49 months) (p=0,45). Median OS showed a similar pattern (32 vs 66 months respectively) also favouring PD-L1 negative p (p=0,05).

      Conclusion:
      In our series, patients with resected adenocarcinomas expressing PD-L1 in >5% of cells showed a worse disease free and overall survival than patients without such expression.