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P1.01 - Poster Session with Presenters Present (ID 453)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Epidemiology/Tobacco Control and Cessation/Prevention
- Presentations: 1
- Coordinates: 12/05/2016, 14:30 - 15:45, Hall B (Poster Area)
P1.01-017 - The Dramatic Shift of Lung Cancer toward Young in Prisons (ID 5149)
14:30 - 15:45 | Author(s): J. Mazières
Although prisoners could be at higher risk for lung cancers, very few studies focused on that particular population. In a previous cohort study (Carbonnaux et al. Oncology 2013;85:370–377), we found an early onset of lung cancer in imprisoned patients. The aim of the CARCAN study was to assess epidemiological characteristics, management, prognosis and incidence of lung cancer among prisoners compared to general population.
We designed a multi-centric observational case-control study. Cases were lung cancer diagnosed in prison in 3 penitentiary medical units (PMU) of France from 2005 to 2013 (Lyon / Marseille / Toulouse). Up to 3 controls were selected for each case from hospital databases. Controls were randomly matched to cases for center, sex, and year of diagnosis. Overall and age-specific cumulated incidences were calculated in the penitentiary area covered by the 3 participating PMU and in the French population using national statistics.
Overall, 170 controls and 72 cases met the inclusion criteria and were analyzed. Cases were mainly men (99%). Mean age at diagnosis was 52.9 (±11.0) in prisoners and 64.3 (±10.1) in controls patients (P<10-4). Most of prisoners were current smokers compared to controls (83% vs 53%; P<10-4). We did not find significant difference in histologic type or TNM stage at diagnosis between the two groups. Also, there was no significant difference in first-line treatment type in both groups; especially there was no difference in the rate of patient undergoing supportive care only. Median time from first symptoms to first treatment was 3.3 months [2.7-3.9] in controls compared to 3.6 months [2.7-4.4] in prisoners (P=0.947). We found no significant difference in progression free and overall survival between the two groups. Cumulated incidence (2008-2013) in men was dramatically increased in prisons in each age category compared to the French incidence. Incidence was 4.5 fold higher in prisons than in the general population among 30-40 years old peoples; 3.4 fold higher in 40-50 yo and 1.4 fold higher in 50-60 and 60+ yo categories.
There is a dramatic shift of lung cancer toward young peoples in prisons. However, presentation, management and prognosis are similar in prisoners compared to controls. These finding should justify a specific screening policy in that high-risk population.
PL04a - Plenary Session: Immune Checkpoint Inhibitors in Advanced NSCLC (ID 430)
- Event: WCLC 2016
- Type: Plenary
- Track: Chemotherapy/Targeted Therapy/Immunotherapy
- Presentations: 1
PL04a.03 - Durvalumab in ≥3rd-Line Locally Advanced or Metastatic, EGFR/ALK Wild-Type NSCLC: Results from the Phase 2 ATLANTIC Study (Abstract under Embargo until December 7, 7:00 CET) (ID 5336)
08:45 - 09:40 | Author(s): J. Mazières
Treatment with anti-PD-1/PD-L1 antibodies has demonstrated meaningful clinical benefit in patients with advanced NSCLC. Patients that progress after 2 lines of chemotherapy have few treatment options and poor outcomes. Durvalumab is an engineered human IgG1 mAb targeting programmed cell death ligand-1 (PD-L1).
ATLANTIC (NCT02087423) is a Phase 2, open-label, single-arm trial in patients with locally advanced or metastatic Stage IIIB–IV NSCLC (WHO PS 0 or 1; ≥2 prior systemic treatment regimens, including one platinum-based). There was no maximum number of prior treatments. The study initially enrolled all-comers and then was restricted to patients with PD-L1 high tumours (≥25% of tumour cells with membrane staining). The study includes three cohorts; here we report final results in Cohorts 2 and 3 that had EGFR/ALK wild-type or unknown status. Patients enrolled in Cohort 3 had ≥90% of tumour cells with PD-L1 staining. The primary endpoint is ORR (RECIST v1.1), based on independent central review. Secondary endpoints include DCR, DoR, PFS, OS, and safety (CTCAE v4.03).
As of 3 June 2016, in Cohorts 2/3, 265/68 patients (median age 62/61 years, 67/72% PS 1, 21/29% squamous histology; mean of 3.2/2.6 prior therapies) had received durvalumab (10 mg/kg i.v. q2w). Responses were durable; in Cohort 2, patients with PD-L1 ≥25%, the ORR was similar in patients with squamous and non-squamous histology.
Most AEs were low grade and resolved with treatment delay and/or immunosuppressive interventions. Overall, 10.2% of patients had Grade ≥3 treatment-related AEs and 2.7% had treatment-related AEs leading to discontinuation.
Cohort 2 Cohort 3 PD-L1 high (≥25%) PD-L1 low/negative (<25%) PD-L1 ≥90% n=146 n=93 n=68 ORR,* %(95%CI) 16.4(10.8-23.5) 7.5(3.1-14.9) 30.9(20.2-43.3) DCR, %(95%CI) 28.8(21.6-36.8) 20.4(12.8-30.1) 38.2(26.7-50.8) mDoR, months(25[th], 75[th] percentile) 12.3(7.5-NR) NR(7.2-NR) NR; 18/21 responders progression free at DCO n=149 n=94 n=67 mPFS, months(95%CI) 3.3(1.9-3.7) 1.9(1.8-1.9) 2.4(1.8-5.5) mOS, months(95%CI) 10.9(8.6-13.6) 9.3(5.9-10.8) NR(5.9-NC) 1-year OS, %(95%CI) 47.7(39.3-55.5) 34.5(25.0-44.1) 50.8(36.9-63.2) mFollow-up for OS, months 9.4 9.3 7.0 *Confirmed response per independent central review. DCO=data cutoff; DCR=disease control rate (complete response, partial response or stable disease ≥24 weeks); DoR=duration of response; m=median; NC=not calculated; NR=not reached; ORR=objective response rate; OS=overall survival; PFS=progression-free survival
Durvalumab was active and led to durable responses in a heavily pretreated metastatic NSCLC population; activity was numerically greater for patients whose tumours exceeded the 25% PD-L1 cutoff. The tolerability profile was manageable. Results are consistent with other anti-PD-1/PD-L1 therapies in metastatic, relapsed NSCLC and support further development of durvalumab.
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