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Regine Lamy
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MA08 - Clinical Trials in Brain Metastases (ID 906)
- Event: WCLC 2018
- Type: Mini Oral Abstract Session
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/24/2018, 15:15 - 16:45, Room 203 BD
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MA08.10 - Real-Life Intracerebral Efficacy of Nivolumab in Non-Small Cell Lung Cancer Patients with Brain Metastases (ID 14201)
16:15 - 16:20 | Author(s): Regine Lamy
- Abstract
- Presentation
Background
Data regarding intracerebral efficacy of nivolumab in advanced non-small cell lung cancer (NSCLC) are lacking because of routinely exclusion of patients with active brain metastases (BMs) from clinical trials. We aimed at assessing intracranial activity of nivolumab in patients with BMs in a real-life setting and determining the potential role of prior radiotherapy.
a9ded1e5ce5d75814730bb4caaf49419 Method
Between 01/09/2015 and 30/09/2016, all consecutive advanced NSCLC patients treated with nivolumab after failure of at least one line of chemotherapy were included. Nivolumab was administered at a dose of 3 mg/kg q2w until progression or unacceptable toxicity. Primary endpoint was intracerebral objective response rate (IORR) assessed by brain magnetic resonance imaging or brain computed-tomography scans. Secondary endpoints were overall response rate (ORR) and median duration of intracerebral response.
4c3880bb027f159e801041b1021e88e8 Result
259 patients were treated with nivolumab in 9 centers. Among them, 77 patients who presented BMs before nivolumab initiation were enrolled: 53 (20.5%) at diagnosis and 24 (9.3%) during the course of treatments. Median age at diagnosis was 57 years [29-78]. Most patients were males (72.7%) with smoking history (90.9%) and had adenocarcinoma (72.7%). 23 patients harbored a KRAS mutation. PD-L1 status was unknown. The median of prior lines was 1 [1-6]. BMs were pretreated in 48 (62.3%) patients: 16 received prior SBRT, 32 WBRT. Median time between prior radiotherapy and nivolumab initiation was 4 months [1-;27]. IORR and ORR were 10.4% and 20.8%, respectively. Among the 8 patients with intracerebral response, 5 (6.5%) had pretreated BMs, 3 (3.9%) had radiotherapy-naïve BMs. Median duration of intracerebral response was 11.5 months. No neurological adverse events occurred during nivolumab treatment. Among 259 patients, 36 (13.8%) developed BMs during nivolumab treatment.
8eea62084ca7e541d918e823422bd82e Conclusion
Nivolumab intracerebral response achieved 10.4% in real-life with a satisfactory neurological safety profile. If prior radiotherapy improves IORR must be determined by further investigations.
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P1.04 - Immunooncology (Not CME Accredited Session) (ID 936)
- Event: WCLC 2018
- Type: Poster Viewing in the Exhibit Hall
- Track:
- Presentations: 2
- Moderators:
- Coordinates: 9/24/2018, 16:45 - 18:00, Exhibit Hall
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P1.04-31 - Efficacy and Tolerance of Immune-Checkpoint Inhibitors in EGFR, ALK/ROS 1 Non-Small-Cell-Lung-Cancer (NSCLC): GFPC 03-2016 IMAD Study (ID 11166)
16:45 - 18:00 | Author(s): Regine Lamy
- Abstract
Background
Patients with molecular alterations are considered to be poor candidates for immune- checkpoint inhibitors (ICI) on the second-line phase III trials. Here, we analyze the efficacy of ICI in EGFR /ALK/ROS1 NSCLC patients in real world setting
a9ded1e5ce5d75814730bb4caaf49419 Method
This retrospective, multicentric study in EGFR, ALK and ROS1 NSCLC treated by ICI, analyzed clinical characteristics and outcomes (progression free survival (PFS), duration of ICI treatment and overall survival (OS), since initiation of ICI .
4c3880bb027f159e801041b1021e88e8 Result
51 patients were included from 20 centers in France: 100% adenocarcinoma, 60.7% never smokers, 58.8% female, 58 ± 8.8 years age at diagnosis (36-83), 82.3% EGFR mutated, 15.7 % and 2% ALK and ROS 1 translocated respectively. ICI was a third line treatment in 35,3% of cases, a fourth and more lines treatment in 64,7% of cases. Median PFS was 2.1. [95% CI: 1.5-3.2] months for the whole population, 2.15 [95% CI: 1.4-3;2], for EGFR patients and 2.4 [95% CI: 2.1; NR] for ALK tranlocated patients; 3 months-PFS were 37,3% [95% CI: 26.1; 53.2]; 8 weeks ORR were 19.6% (10 pts with partial response). The median OS for the whole population was 14.7.[95%CI: 12.1-19.2] months, 13.9 [95% CI: 8.8-20] for EGFR patients, 19.2. [95% CI: 13.1-NR] for ALK translocated; 7 (13.7%) patients were treated more than 9 months by ICI; 21.6% (11/51) of patients reported toxicities, all < grade3.
8eea62084ca7e541d918e823422bd82e Conclusion
In this real-world setting analysis, efficacy of ICI in EGFR, ALK, ROS1 NSCLC patients appears close to the efficacy observed in pretreated unselected NSCLC patients. Large prospective studies are needed in these populations
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P1.04-35 - Quick Progression (QP) in Patients Treated by Nivolumab (IO) in 2nd Line or More for Non-Small Cell Lung Cancer: ERORECI Study (GFPC 2016-04) (ID 11936)
16:45 - 18:00 | Author(s): Regine Lamy
- Abstract
Background
Nivolumab has been approved in 2nd line for advanced non-small cell lung cancer (NSCLC). However, more than half of the patients had progressive disease at 16 weeks, without any response and sometimes with deleterious progressions. This descriptive prospective study aimed to assess the characteristics of non responders with QP after IO and the following treatments.
a9ded1e5ce5d75814730bb4caaf49419 Method
From September 1st, 2016 to August 31th, 2017, patients (pts) treated by IO (second line or more) with QP<16 weeks were included by 20 GFPC centers. NSCLC characteristics at the diagnosis, at the IO initiation, treatments (before IO, IO and after IO) and outcomes responses, progression free survival (PFS) according to lines of treatments were recorded.
4c3880bb027f159e801041b1021e88e8 Result
The sample included 319 pts: 64,3y± 9,6, smokers/ex-smokers: 48.0%-42.9%, male: 70.8%, PS01/2: 92.8%-7.2%, stage IV at diagnosis: 71.8%; adenocarcinoma: 63.9%. K-Ras mutated: 25.7%. Only 29% of patients had a PDL1 determination. 93% of pts received first line therapy, 32% second line, 10.3% third line before IO. First line PFS (PFS1) was 6.9m [6.43-7.8], PFS2: 9.33m [1.2-19], PFS3: 4.1m [1.56-12.43]. PFS for IO was 1.7m [0.76-4.16]. 229 (71,8%) patients had a IO PFS<2m; 14.7% of these patients stopped the treatment for toxicity. Among the 146 pts evaluable for response, PR was found in 23% of cases, SD in 30%, and PD in 47%.The table describe a comparison between two groups of QP during IO.
8eea62084ca7e541d918e823422bd82e Conclusion
In real life, QP during IO remains a challenge in NSCLC. Multivariate analyses will be presented to characterize these patients.
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In collaboration with the GFPC* team and supported by an academic grant from Pierre-Fabre pharmaceuticals.
*GFPC: French Lung Cancer Group
6f8b794f3246b0c1e1780bb4d4d5dc53
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P1.09 - Pathology (Not CME Accredited Session) (ID 941)
- Event: WCLC 2018
- Type: Poster Viewing in the Exhibit Hall
- Track:
- Presentations: 1
- Moderators:
- Coordinates: 9/24/2018, 16:45 - 18:00, Exhibit Hall
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P1.09-02 - PD-L1 Expression Pattern in Large Cell Neuroendocrine Carcinoma of the Lung: The GFPC 03-2017 "EPNEC" Study. (ID 11945)
16:45 - 18:00 | Author(s): Regine Lamy
- Abstract
Background
Large cell neuroendocrine carcinomas of the lung (LCNECs) are rare neoplasms with few therapeutics options especially for stage IV diseases. Pathological diagnostic of LCNECs may be difficult with low interobserver reproducibility and need immunohistochemical (IHC) staining. Immune checkpoint inhibitors targeting tumoral and immune cells interaction have revolutionized the treatment of NSCLC, but few data's are available on LCNECs immune environment and particulary the expression of PD-L1 on both tumors (TC) and immune infiltrating (IC) cells. The objective of the present study is to determine the pattern of PD-L1 staining in a cohort of LCNECs patients.
a9ded1e5ce5d75814730bb4caaf49419 Method
Clinical files and tumors biopsies of patients (pts) with a LCNEC diagnosed between 01.01.2014 and 31.12.2016 were retrospectively collected (GFPC 03-2017). All histological samples were centrally reviewed by a panel of six independent pathologists, according to the WHO 2015 classification. LCNEC was confirmed and PD-L1 expression was determined both in TC and IC, using the anti-PD-L1 antibody 22C3 (kit and automat Dako). PD-L1 expression was scored on TC as the percentage of PD-L1 positive cells (0 to 100%). PD-L1 expression on IC was determined as follows: IC0: positive IC representing<1% of the tumor surface; IC1: positive IC representing>=1% but<5% of the tumor surface; IC2: positive IC representing>=5% but<10% of the tumor surface; and IC3: positive IC representing>10% of the tumor surface.
4c3880bb027f159e801041b1021e88e8 Result
Eighty-six pts were initially included in the study.Twenty-eight (32%) of them were excluded for non-LCNEC diagnosis after review. Among the 58 remaining pts with confirmed LCNEC, five (8%) had a mixed histology with a NSCLC component.The mean age of the population was 65 years, mainly mens (86%) and former or current heavy smokers (93%). Fifty-five and 51 tumors samples were respectively available for TC and IC PD-L1 IHC expression. PD-L1 expression on TC was found in only 12% of the samples (7/55), while 76% (39/51) of the samples shows IC PD-L1 positive, with respectively 18 (35%) IC3, 8 (14%) IC 2, and 13 (25%) IC1.
8eea62084ca7e541d918e823422bd82e Conclusion
Histological diagnosis of LCNEC remains difficult, and prospective studies concerning patients with LCNEC should include a centrally pathological review of tumors.The PD-L1 expression pattern looks different for LCNEC in comparison to other lung carcinomas, as few TC were found positive although IC were frequently positive, half of the tumors having high PD-L1 IC infiltration (IC3/2). This PD-L1 pattern may suggest a potential effectiveness of therapeutic anti PD-L1 antibodies and this hypothesis have to be adressed in clinical trials.
6f8b794f3246b0c1e1780bb4d4d5dc53
