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Margarita Majem



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    P2.15 - Treatment in the Real World - Support, Survivorship, Systems Research (Not CME Accredited Session) (ID 964)

    • Event: WCLC 2018
    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/25/2018, 16:45 - 18:00, Exhibit Hall
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      P2.15-25 - NIVEX TRIAL (GECP 1605): Nivolumab in the Real World: Spanish Expanded Access Program Experience in Pretreated Advanced NSCLC Patients (ID 13030)

      16:45 - 18:00  |  Author(s): Margarita Majem

      • Abstract

      Background

      Nivolumab is a standard treatment for pretreated patients with advanced non-small cell lung cancer (NSCLC). Real world data about toxicity and efficacy of nivolumab is needed.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      We have analyzed patients from the Expanded Access Program in Spain that included patients with advanced pretreated NSCLC. We have retrospectively analyzed 665 patients that had received at least 1 dose of nivolumab 3mg/kg q2w from 01/2015 for squamous Sq﴿ and 06/2015 for non‐Sq NSCLC, to 11/2017.

      4c3880bb027f159e801041b1021e88e8 Result

      Median age was 61 (32-85) years, 73% were men, 85% had ECOG 0-1, 88% were current or former smokers and 15% presented brain metastases. 128 (19,2%) patients presented Sq NSCLC and 537 (80,8%) patients Non‐Sq NSCLC. 7% of patients presented EGFR mutation. PD-L1 was ≥ 1% in 32,9% of analyzed patients.

      Best response was complete response 1,7%, partial response 22,4%, stable disease 24,1%, and progressive disease 37,1%, and was not assessed in 14,7% of patients. No differences in response rate were observed according to histology.

      After a median follow‐up of 8,2 months, the median OS was 8,97 (95%CI 7,69-10,24) months, and the median PFS was 3,23 (95%CI 2,77-3,70) months. Estimated 1-year OS was 42,4% (95%CI 38,5-42,8%) and estimated 1-year PFS was 22,2% (95%CI 19,1-25,3%). No differences in OS or PFS according to histologies were observed.

      296 (44,5%) patients presented toxicity related to Nivolumab, that was grade ≥3 in 69 (10,4%) patients. Grade ≥3 diarrhea was reported in 1,2% of patients and pneumonitis occurred in 1,2% of patients (1 patient presented a grade 5 pneumonitis). According to the presence of grade ≥3 toxicity, the median OS was 14,57 (CI95% 8,45-20,68) months for patients with grade ≥3 toxicity and 8,73 (CI95% 7,50-9,96) months for patients without grade ≥3 toxicity (p= 0,074).

      Additional efficacy data including treatment lines, presence of immune-related adverse events, PS2, brain metastasis, response to first line, or post-nivolumab treatment will be presented.

      8eea62084ca7e541d918e823422bd82e Conclusion

      Efficacy and safety of nivolumab was in line with previously shown data. There was a trend to a better OS for those patients experiencing grade ≥3 toxicity.

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    P2.17 - Treatment of Locoregional Disease - NSCLC (Not CME Accredited Session) (ID 966)

    • Event: WCLC 2018
    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/25/2018, 16:45 - 18:00, Exhibit Hall
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      P2.17-17 - Multimodal Treatment in Pathologically Confirmed Single-Station Resectable IIIA-N2 Non-Small Cell Lung Cancer: A Single Center Experience (ID 13747)

      16:45 - 18:00  |  Presenting Author(s): Margarita Majem

      • Abstract

      Background

      The management of patients with resectable stage IIIA-N2 (7th Edition) non-small cell lung cancer (NSCLC) is controversial. Multimodal treatment with neoadjuvant chemotherapy (CT) and radiotherapy (RT) followed by surgery may be recommended for a selected group of patients.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      We have retrospectively analyzed 21 patients with single-station resectable stage IIIA-N2 NSCLC treated in our center from April 2011 to June 2017. N2 was confirmed by EBUS or mediastinoscopy. Patients received CT with cisplatin (70 mg/m2)/carboplatin (5AUC) + vinorelbine (25 mg/m2 C1, 15 mg/m2 C2-3) concurrent RT with the 2nd cycle of CT with a total dose of 60Gy. PET-CT and mediastinoscopy was performed after induction treatment, and only those patients with mediastinal downstaging disease were proposed for surgery (lobectomy + systematic lymph node dissection). Kaplan-meier analysis was used to evaluate local control (LC), Overall survival (OS), Cause-specific-survival (CSS) and Disease-free-survival (DFS).

      4c3880bb027f159e801041b1021e88e8 Result

      13 patients were males (62%) and 8 females (38%), median age was 63 (52-75). Histology was: 10(48%) adenocarcinoma, 6(28%) squamous and 5 (24%) NOS NSCLC. Surgery was not performed in 5 patients (24%): 1 presented progressive disease, 2 had persistent mediastinum disease and 2 were excluded due to comorbidities. No severe postoperative complications were observed in patients who underwent surgery. Table 1 shows the results.

      With a median follow up of 49 (10-84) months, significant differences in terms of OS (p=0,002) and in CSS (p=0,006) were observed between patients with/without surgery, with no difference in LC and DFS. In patients who underwent surgery, there was a trend to a better LC, OS, CSS, DFS when complete pathological response was achieved.

      table 1.jpg

      8eea62084ca7e541d918e823422bd82e Conclusion

      In patients with pathologically confirmed single-station resectable stage IIIA-N2 NSCLC multimodal treatment with high dose

      radiotherapy is feasible and with a trend to better outcome in patients with complete pathological response.

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