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Margaux Geier
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P2.07 - Immunology and Immunotherapy (ID 708)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Immunology and Immunotherapy
- Presentations: 2
- Moderators:
- Coordinates: 10/17/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P2.07-023 - Safety of Immune Checkpoint Inhibitors in Patients with Preexisting Autoimmune Disease (ID 8646)
09:30 - 09:30 | Presenting Author(s): Margaux Geier
- Abstract
Background:
Immune checkpoint inhibitors (ICIs), by inhibiting immunosuppressive molecules overexpressed in the tumoral environment like CTLA-4 or PD1, increase the anti-tumor immune response and have been approved for an increasing number of cancers. However, they are responsible for immune related adverse effects (IRAEs), and patients with preexisting autoimmune diseases (PAD) have been excluded from clinical trials evaluating those molecules. The aim of this study was to evaluate their safety in routine practice in patients with PAD and the anti-tumoral response in this population.
Method:
Three national expert networks, focusing respectively on skin cancers, thoracic cancers, and inflammatory diseases, participated in the study. All patients who received an ICI despite a PAD were retrospectively included in this nationwide retrospective study.
Result:
31 patients were included in the study (19 men (61%), median age of 66). Most frequent PADs were rheumatoid arthritis (n=9; 29%), psoriasis (n=6; 19%), lupus (n=4; 13%), ulcerative colitis (n=3; 10%), and spondyloarthritis (n=3; 10%). Eleven patients were receiving an immunosuppressive therapy when the ICI was initiated, and 10 had an active disease at that time. Neoplasm types were melanoma (n=16; 52%), non-small-cell lung carcinoma (n=12; 39%), and urologic neoplasms (n=3; 9%), with a median disease duration of 19 months. The majority of the patients (30/31) received an anti-PD1 drug, for a median duration of 4 months. PAD flares were frequent (n=18; 58%) but mostly mild: CTCAE grade 1-2 (n=12; 67%), grade 3-4 (n=3; 17%). 14 patients (78%) received corticosteroids or NSAIDs, and 3 (17%) methotrexate or acitretine for the treatment of these flares. IRAEs not associated with PAD appeared in 10 patients (32%): arthralgia (n=5), colitis (n=2), thyroiditis (n=2), vitiligo (n=2) with mild severity. None of the patients received TNF blockers, neither for a flare nor for an IRAE. 5 patients discontinued the immunotherapy because of an adverse effect. Regarding the cancer response rate, 4 patients over 11 who were taking an immunosuppressive treatment were responders (36%), versus 12 over the 20 other patients (60%).
Conclusion:
PAD flares are frequent during ICI therapy and other IRAEs are also possible, usually easily managed with corticosteroids only. Anti-tumor response could be reduced when an immunosuppressor is ongoing at the beginning of the ICI, within the limit of the number of patients already so far. Overall, the tolerance of ICIs in patients with PAD seems acceptable, but a multidisciplinary follow-up with the PAD referral physician is appropriate to manage frequent PAD flares and/or IRAEs.
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P2.07-030 - Real Life Second-Line Nivolumab in Advanced Non-Small-Cell-Lung Cancer: A French Observational Multicenter Study of 259 Patients (ID 9092)
09:30 - 09:30 | Presenting Author(s): Margaux Geier
- Abstract
Background:
Survival data with nivolumab are based on selected populations and might not reflect outcomes in clinical practice. Overall Survival (OS) and Progression Free Survival (PFS) with anti-PD1 therapy in a large population of unselected patients with advanced Non-Small-Cell-Lung Cancer (NSCLC) are not well documented. We aimed to assess survival data with nivolumab in a large cohort of unselected patients and association of OS with clinical and biological factors.
Method:
Clinical and survival data were collected in a cohort of NSCLC patients treated with nivolumab who experienced confirmed progressive disease (PD) after ≥ 1 line of chemotherapy (CT). Patients received nivolumab at a dose of 3 mg/kg every 2 weeks until PD or unacceptable toxicity. Nivolumab benefit was analyzed according to PFS and OS. The overall response rate (ORR) was analyzed by RECIST 1.1. Age, response to prior CT, eosinophil counts (Ec), prior radiotherapy (RT), lymphocyte counts (Lc), neutrophil counts (Nc), LDH rate were assessed. Kaplan-Meier and Cox regression were performed.
Result:
257 patients treated with nivolumab were enrolled from 9 centers between Sept. 2015 and Oct. 2016. Median age was 62 years [29-85]; 186 patients were males (72%), 93% PS≤1 at the time of the diagnostic; 220 (86%) smokers; 219 (85%) stage IV ; 130 patients (51%) received prior RT. 163 patients (63%) had adenocarcinoma, 70 (27%) squamous cells carcinoma ; 54 (21%) were KRASmut, 11 (4%) EGFRmut, 3 (1%) ALKpositive. PD-L1 expression was unknown (test not required in current practice for nivolumab). The median of prior lines was 1 [1-6]. Median PFS with nivolumab was 3 months [1,9-4]. Median OS was 15 months [1-; NR]. The ORR was 23% (58 patients), the disease control rate was 42% (109 patients). The median duration of response was 6 months [1- ;16]. Age (> or < 70) (p=0.202), response to prior CT (p=0.05) and Ec ≥ 0.5 G/l (p=0.606) were not significantly associated with improved OS. Prior RT was significantly associated with poor OS (p=0.004). Lc < 1 G/l (p=0.019), Nc ≥ 7 G/l (p=0.018), LDH ≥ 500 U/l (p=0.008), were significantly associated with poor OS.
Conclusion:
1) Efficacy of nivolumab in real life is the same as reported in published studies with a median OS of 15 months in clinical practice. 2) In our study neutrophil, lymphocyte and LDH rates predict a poor OS.