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J.C. Pardo Ruiz



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    P3.02c - Poster Session with Presenters Present (ID 472)

    • Event: WCLC 2016
    • Type: Poster Presenters Present
    • Track: Advanced NSCLC
    • Presentations: 1
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      P3.02c-045 - Experience with Nivolumab in Compassionate Use in Non-Small Lung Carcinoma Patients Who Have Progressed to One or More Prior Lines of Chemotherapy (ID 6062)

      14:30 - 14:30  |  Author(s): J.C. Pardo Ruiz

      • Abstract

      Background:
      Treatment options for patients with stage IIIB and IV NSCLC who progress to first line chemotherapy are limited. Immunotherapy represents a promising alternative for NSCLC patients. The aim of our study is to analyze nivolumab in compassionate use in our centre.

      Methods:
      A retrospective study of patients with stage IIIB and IV NSCLC that progress to chemotherapy and receive Nivolumab in compassionate use. A descriptive analysis using chi-square test and survival analysis using Kaplan-Meier estimates. The radiological response was assessed by RECIST 1.1 and immune-related adverse events (irAEs).

      Results:
      Thirty-two patients were included between July 2015 and March 2016, 87.5% men, 12.5%women, 75% adenocarcinoma and 25% squamous, from which 71% received nivolumab in second line and 29 % in third line or more; 12.5 % had PS 2 and 25 % brain metastases. The response rate observed was 17.4 % in the second line and 20 % in third line or more, with a progression-free survival (PFS) of 4 months (95% CI: 2.3-5.4) and 10 months (95% CI 2.9-18), respectively. The average number of administered cycles was 6: 1 in PS2 and 18 when there was pseudoprogression (n=5). The observed irAEs was: grade GI 11 (34 %), GII 4 (12 %) and GIII 1 (3 %), 6% pneumonitis (with previous radiotherapy), 3% autoimmune hepatopathy, 3% pemphigoid and 3% hypothryroidism. Global survival (GS) in PS0 was 6.5 months (95% CI: 4.6-8.3), PS1 of 7.4 (95% CI: 6-8.7) and PS2 of 1 (95% CI: 0, 67-0), with p0.001. The GS with brain metastasis was 3 months (95% CI: 1.7-4.2) vs. 7.9 months (CI 95%6-8.7), with p 0.001, in patients without brain metastasis.

      Conclusion:
      In our series, nivolumab was well tolerated and demonstrated clinical benefit both in second and in third line, except in patients with PS2 and/or brain metastases. Patients that present pseudoprogression obtain major benefit and more occurrence incidence of irAEs (possible indicator of response). External validity is limited by the small number of patients and this is not a randomized study