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In Europe, few data regarding the characteristics of EGFR exon 20 insertion (20ins) mutations in non-small cell lung cancer (NSCLC) are available. Using a large real-world cohort, we assessed the incidence, characteristics, and outcomes of patients with non-squamous (nsq) NSCLC harboring EGFR exon 20ins. The Epidemio-Strategy and Medical Economics advanced and metastatic lung cancer data platform including advanced/metastatic nsqNSCLC patients from January 2015 was analyzed (cut-off date: June 30, 2020). Characteristics, epidermal growth factor receptor (EGFR) mutation and other mutations, treatment patterns, and clinical outcomes were assessed for patients harboring EGFR exon 20ins, common EGFR mutations, other EGFR mutations, and wild-type EGFR. Survival parameters were estimated by the Kaplan-Meier method in these four groups. Out of 9435 nsqNSCLC patients tested for EGFR, 1549 (16.4%) had a mutation, including 61 with EGFR exon 20ins (3.9% of all mutated EGFR). These 61 patients had a mean age of 63.6 years, were mostly female (68.9%) and non-smokers (55.7%), with de novo stage IV disease (73.8%) and performance status 0–1 (76.9%). Almost all patients (95.1%) with exon 20ins received systemic therapy (median, three lines). First-line systemic treatments consisted mainly of combination chemotherapy (70.7%), single-agent EGFR tyrosine kinase inhibitors (10.3%), and single-agent immunotherapy (5.2%). After a median follow-up of 25.0 (95% confidence interval [CI] 22.3–32.4) months, the median real-world overall survival was 24.3 (19.1–32.6) months in patients with exon 20ins compared to 35.4 (95% CI 32.6–37.5) in patients with common EGFR mutation (n = 1049) (p = 0.049) and 19.6 (95% CI 18.6–20.5) in patients with wild-type EGFR (n = 7866) (p = 0.2). This large national study in nsqNSCLC patients confirms that EGFR exon 20ins is a rare condition (0.6%). The prognosis associated with exon 20ins appears to be in line with that of wild-type EGFR, but worse than common EGFR mutations, highlighting the need for advancements for this rare population.

Purpose: Double inhibition of epidermal growth factor receptor (EGFR) using a tyrosine kinase inhibitor plus a monoclonal antibody may be a novel treatment strategy for non–small cell lung cancer (NSCLC). We assessed the efficacy and toxicity of afatinib + cetuximab versus afatinib alone in the first-line treatment of advanced EGFR-mutant NSCLC. Patients and Methods: In this phase II, randomized, open-label study, patients with stage III/IV EGFR-positive NSCLC were randomly assigned (1:1) to receive afatinib (group A) or afatinib + cetuximab (group A + C). Oral afatinib 40 mg was given once daily; cetuximab 250 mg/m² was administered intravenously on day 15 of cycle 1, then every 2 weeks at 500 mg/m² for 6 months. The primary endpoint was time to treatment failure (TTF) rate at 9 months. Exploratory analysis of EGFR circulating tumor DNA in plasma was performed. Results: Between June 2016 and November 2018, 59 patients were included in group A and 58 in group A + C. The study was ended early after a futility analysis was performed. The percentage of patients without treatment failure at 9 months was similar for both groups (59.3% for group A vs. 64.9% for group A + C), and median TTF was 11.1 (95% CI, 8.5–14.1) and 12.9 (9.2–14.5) months, respectively. Other endpoints, including progression-free survival and overall survival, also showed no improvement with the combination versus afatinib alone. There was a slight numerical increase in grade ≥3 adverse events in group A + C. Allele frequency of the EGFR gene mutation in circulating tumor DNA at baseline was associated with shorter PFS, regardless of the treatment received. Conclusions: These results suggest that addition of cetuximab to afatinib does not warrant further investigation in treatment-naïve advanced EGFR-mutant NSCLC.

Background Antiangiogenic agents have improved the prognosis of non-squamous non-small-cell lung cancers (NSCLCs), even though all the patients are not eligible to receive them because of counterindications linked to the tumor's characteristics or comorbidities. Much less information is available about the eligibility of patients with squamous non-small-cell lung cancers (SQ-NSCLCs) to receive antivascular endothelial growth-factor (VEGF) treatments, even though such molecules are being developed for this histology. This study was undertaken to determine the percentage of advanced SQ-NSCLC patients who would be eligible to receive an antiVEGF agent as second-line systemic therapy. Methods This observational, multicenter, prospective study evaluated advanced SQ-NSCLC patients' criteria for ineligibility to receive an antiVEGF during a multidisciplinary meeting to choose their standard second-line systemic therapy. Results Among the 317 patients included, 53.6% had at least one ineligibility criterion, and ~20% had at least two, with disease extension to large vessels (39.8%), tumor cavitation (20.5%), cardiovascular disease (11%) and/or hemoptysis (7.2%) being the most frequent. Patients with an ECOG performance score of 1/2 had more cardiovascular contraindications that those with scores of 0. Conclusion Almost half of the SQ-NSCLC patients included in this study would have been eligible to receive an antiVEGF agent. The development of these molecules for these indications should be encouraged.

Background: The role and timing of whole or stereotaxic brain radiotherapy (BR) in patients with advanced non-small cell lung cancer (aNSCLC) and asymptomatic brain metastases (aBMs) are not well established. This study investigates whether deferring BR until cerebral progression was superior to upfront BR for patients with aNSCLC and aBM. Methods: This open-label, multicenter, phase III trial, randomized (1:1) aNSCLC patients with aBMs to receive upfront BR and chemotherapy: platin–pemetrexed and bevacizumab in eligible patients, followed by maintenance pemetrexed with or without bevacizumab, BR arm, or the same chemotherapy with BR only at cerebral progression, chemotherapy (ChT) arm. Primary endpoint was progression-free survival (PFS), secondary endpoints were overall survival (OS), global, extra-cerebral and cerebral objective response rate (ORR), toxicity, and quality of life [ClinicalTrials.gov identifier: NCT02162537]. Results: The trial was stopped early because of slow recruitment. Among 95 included patients, 91 were randomized in 24 centers: 45 to BR and 46 to ChT arms (age: 60 ± 8.1, men: 79%, PS 0/1: 51.7%/48.3%; adenocarcinomas: 92.2%, extra-cerebral metastases: 57.8%, without differences between arms.) Significantly more patients in the BR-arm received BR compare with those in the ChT arm (87% versus 20%; p Conclusion: The significant BR rate difference between the two arms suggests that upfront BR is not mandatory in aNSCLC with aBM but this trial failed to show that deferring BR for aBM is superior in terms of PFS from upfront BR.

Purpose: The incidence of lung cancer has dramatically increased in women. Preclinical data have suggested that combining EGFR–tyrosine kinase inhibitor (TKI) with an antiestrogen may overcome resistance to EGFR-TKI. Patients and Methods: The IFCT-1003 LADIE trial was a 2 × 2 arms parallel open-label randomized phase II trial. EGFR-TKI–naïve postmenopausal women with advanced lung cancer were treated with gefitinib (G) versus gefitinib + fulvestrant (G+F) in the EGFR-mutated group (EGFR+) or with erlotinib (E) versus erlotinib + fulvestrant (E+F) in the EGFR wild-type group (EGFR-WT). The primary objective was progression-free survival (PFS) at 3 and 9 months for EGFR-WT and EGFR+ patients. Results: Overall, 204 patients (gefitinib 104 and G+F 100) and 175 patients (erlotinib 87 and E+F 88) were enrolled in the EGFR+ and EGFR-WT cohorts. In the EGFR+ cohort, the primary endpoint was reached, with 58% of the G+F group patients being nonprogressive at 9 months. Adding fulvestrant to gefitinib was not associated with improved PFS (9.9 vs 9.4 months) or overall survival (OS; 22.1 vs 28.6 months). In the EGFR-WT cohort, the primary endpoint was also achieved (33.7% of the patients were nonprogressive at 3 months). Adding fulvestrant to erlotinib was not associated with improved outcome (PFS 1.8 vs 2.0 and OS 10.3 vs 7.3 months). No PFS difference was observed regarding estrogen receptor alpha expression. The tolerance was as expected with no treatment-related death. Conclusions: Adding fulvestrant to EGFR-TKI is feasible, but not associated with prolonged PFS regardless of EGFR status. The lack of benefits while combining fulvestrant to EGFR-TKI does not support its future development in an unselected population.

9062 Background: In Europe, 10-15% of non-squamous non-small cell lung cancer (nsqNSCLC) have EGFR mutations of which 5-12% are an Exon 20 insertion (20ins). Methods: Analysis of Epidemio-Strategy and Medical Economics (ESME) Advanced and Metastatic Lung cancer (AMLC) Data Platform (NCT03848052), a multicenter real-life database using a supervised, retrospective data collection process. The database includes 13737 advanced nsqNSCLC treated from January 2015 at participating centres. The cut-off date for patient follow-up for this analysis was June 30, 2020. The aim of the study was to assess real-world patient characteristics, treatment patterns and clinical outcomes of advanced nsqNSCLC EGFR 20ins. Overall survival (OS) of EGFR cohorts (20ins, 19del/L858R without 20ins, other EGFR mutations) and EGFR wild-type/not tested cohort were assessed. Results: 1549 (11.3%) nsqNSCLC had an EGFR mutation, 61 (3.9%) of whom being an EGFR 20ins. These 61 patients (pts) are mainly female (68.9%), non-smoker (55.7%), with de novo stage IIIB/IV disease (78.6%), PS 0-1 (76.9%). Median age was 68.0 years (q1-q3: 54-74). PD-L1 status was assessed in 34 (55.7%) pts, mainly (n = 20) before first line and 22 (64.7%) had negative result. Most (63.9%) pts had EGFR 20ins positive result available before first line. Almost all pts (95.1%, n = 58) received a systemic therapy with a median number of 3 (q1-q3: 1-4) lines. In first line setting, 74% of the pts received chemotherapy (mainly chemotherapy combination), 13.7% received EGFR TKI (mainly as monotherapy) and 8.6% received immunotherapy only. Median treatment duration for pts treated with CarboPem (n = 19), CisplatinPem (n = 16) and CarboTaxol (n = 6) were 4.7 (q1-q3: 2.6-6.6), 7.4 (q1-q3: 5.0-12.8) and 3.3 (q1-q3: 2.8-3.8) months, respectively. For afatinib (n = 3), erlotinib (n = 2) and gefitinib (n = 1), median treatment durations were 1.6 (q1-q3: 0.5-2.8); 1.8 (q1-q3: 1.4-2.1) and 2.3 months, respectively. After a median follow up of 36.3 (95%CI: 34.1-39.8) months, median OS was 24.3 (95%CI: 19.1-32.6) months; 1 and 2-years OS rates were 82.5% (95%CI: 69.7-90.2) and 52.6% (95%CI: 37.3-65.9), respectively. For pts with 19del/L858R without 20ins (n = 1049) and those with other EGFR mutations (n = 439) median OS were 35.4 (95%CI: 32.6-37.5) and 41.7 (95%CI: 31.9-53.5), respectively compared to 20.7 (95%CI: 20.0-21.8] months for pts EGFR wild type/not tested (n = 12188). Conclusions: This large, national real-world analysis based on medical chart data’s confirm that EGFR 20ins is a rare disease (0.4% of advanced nsqNSCLC). Currently available EGFR TKIs appear to have low efficacy and response to chemotherapy seems identical to that of EGFR wild-type/not tested pts. Prognosis for NSCLC pts with EGFR 20ins mutations was in line with that of EGFR wild type/not tested but worse than common EGFR mutations highlighting the need for advancements for this rare population.

9561 Background: Medical treatment of lung cancer has irreversibly changed since the development of immune checkpoint inhibitors (ICI). However, immune biomarkers of efficacy are still lacking. Preliminary data in leukemia and pancreatic cancer showed that soluble immune checkpoints are associated with a reduced overall survival (OS). This led us to explore the prognostic and predictive value of soluble immune checkpoints in non-small cell lung cancer (NSCLC) patients treated with chemotherapy or ICI. Methods: We analyzed 90 advanced NSCLC patients. The pilot cohort (Rennes University Hospital, France), included 48 patients treated with platinum doublets (n = 33) or ICI (n = 15) (LOC/11-16 protocol). The confirmation cohort (Paoli-Calmettes Institute) included 42 patients treated with ICI (nivolumab or pembrolizumab) in a longitudinal prospective setting (Immunosup trial, NCT03595813). In both cohorts, enzyme-linked immunosorbent assays (ELISA) were performed in baseline plasma samples for soluble forms of PD-1, PD-L1, global BTN3, BTLA, BTN3-A1 and BTN2A1. Soluble ICI levels were linked to clinical data using Kaplan-Meier, log-rank and Cox proportional-hazards models. Cut-points were determined using maxstat package for survival, R software R 3.6.2. Results: Five soluble immune checkpoints correlated and clustered together in unsupervised analysis (PD-1, PD-L1, global BTN3, BTLA, BTN3-A1), but were not associated with ICI efficacy. In patients treated with ICI, in the pilot and confirmation cohort, a high baseline plasmatic concentration of soluble BTN2A1 was significantly associated with an improved OS (confirmation cohort with a BTN2A1 cut-point of 3.55 ng/ml: HR = 0.30, 95%CI = 0.12-0.74, p = 0.0057, median OS in BTN2A1low = 7.6 months and median OS in BTN2A1hi = 19.5 months). On the contrary, in patients treated with chemotherapy, soluble BTN2A1 concentration was not associated with overall survival. Conclusions: In advanced NSCLC patients, a high baseline plasmatic concentration of soluble BTN2A1 was correlated with improved outcomes for ICI, but not for chemotherapy, suggesting that baseline soluble BTN2A1 level is a potential predictive biomarker of ICI efficacy. Additional studies are ongoing to confirm this finding.

Background: Nivolumab is approved worldwide as second-line treatment for metastatic non-small cell lung cancer (NSCLC). Despite the fact that most of these cancers are being diagnosed in the older patients, few of the patients were included in pivotal trials. We aimed to describe efficacy and safety in a ``real-world'' older population. Patients and Methods: We retrospectively collected data from older patients (>= 70 years old) with advanced or metastatic NSCLC treated with Nivolumab in our institution. We analyzed safety (CTCAE v4.0 criteria), efficacy (clinical benefit rate, progression-free survival, and overall survival), and correlated these features to geriatric parameters and PD-L1 expression. Along with this cohort, we assessed safety at a national level by retrieving all cases of Nivolumab (prescribed for NSCLC) induced adverse events analyzed by the French pharmacovigilance network during the inclusion period. Results: From July 2015 to September 2016, 30 patients were enrolled with a median age of 752. Clinical benefit rate was 30.6%. Median progression-free survival and overall survival were 33 and 7.1 months, respectively. Fifteen patients (50%) presented an immune-related adverse event (IrAE) of any grade, including four high grade IrAEs. Two hundred and eighty IrAEs had been notified to the French pharmacovigilance network including 91 (35.2%) concerning older patients. Frequency and pattern of IrAEs were similar for older patients and younger subjects. Conclusions: Even though frequency and patterns of IrAEs are different from pivotal studies, these results don't seem specific to older patients. Further prospective investigations are needed to better characterize and predict the impact of Nivolumab on older patients with NSCLC. (C) 2018 Elsevier Ltd. All rights reserved.

Background/aim Radiological evaluation after stereotactic-body-radiotherapy (SBRT) for non-small-cell lung carcinoma (NSCLC) is often difficult due to lung radiation-induced image modifications on computed tomographic (CT) scan. The aim of this study was to evaluate positron-emission tomography-computed tomography (PET-CT) using fluorodeoxyglucose after SBRT in primary lung cancer. Patients and methods Eighteen patients with histologically proven NSCLC were treated with SBRT. All had PET-CT evaluations before treatment, at 2 to 3 months and at 1 year post SBRT during the follow-up. Results Early PET-CT in 12/18 patients who did not experience local failure did not show any progression. No conclusion could be drawn in four cases because early PET-CT was disturbed by inflammatory reaction. Early PET-CT was not predictive of late outcome for two patients, as it showed a significant response followed by disease progression on late evaluation. Conclusion Early PET response appears to correlate with local control at 1 year post SBRT.

// Michael Duruisseaux 1 , Benjamin Besse 2 , Jacques Cadranel 3 , Maurice Perol 4 , Bertrand Mennecier 5 , Laurence Bigay-Game 6 , Renaud Descourt 7 , Eric Dansin 8 , Clarisse Audigier-Valette 9 , Lionel Moreau 10 , Jose Hureaux 11 , Remi Veillon 12 , Josiane Otto 13 , Anne Madroszyk-Flandin 14 , Alexis Cortot 15 , Francois Guichard 16 , Pascaline Boudou-Rouquette 17 , Alexandra Langlais 18 , Pascale Missy 19 , Franck Morin 19 , Denis Moro-Sibilot 1 1 Centre Hospitalier Universitaire Grenoble Alpes, Thoracic Oncology Unit, Chest Department, Grenoble, France 2 Medical Oncology Department, Gustave Roussy, Villejuif, France 3 Assistance Publique Hopitaux de Paris, Tenon Hospital, Chest Department, Paris, France 4 Leon-Berard Cancer Center, Lyon, France 5 Centre Hospitalier Universitaire de Strasbourg, Chest Department, Strasbourg, France 6 Larrey Hospital, Chest Department, Toulouse, France 7 Centre Hospitalier Universitaire de Brest, Brest, France 8 Oscar Lambret Cancer Center, Medical Oncology Department, Lille, France 9 Centre Hospitalier Sainte Musse, Chest Department, Toulon, France 10 Centre Hospitalier General de Colmar, Louis Pasteur Hospital, Chest Department, Colmar, France 11 Centre Hospitalier Universitaire d’Angers, Chest Department, Angers, France 12 Centre Hospitalier Universitaire de Bordeaux, Respiratory Disease Department, Pessac, France 13 Antoine Lacassagne Cancer Center, Nice, France 14 Paoli Calmettes Institute, Marseille, France 15 Centre Hospitalier Universitaire de Lille, Thoracic Oncology Unit, Lille, France 16 Medical Oncology Department, Polyclinique Bordeaux Nord Aquitaine, Bordeaux, France 17 Assistance Publique Hopitaux de Paris, Cochin-Port Royal Hospital, Medical Oncology Department, Paris, France 18 French Cooperative Thoracic Intergroup, Department of Biostatistics, Paris, France 19 French Cooperative Thoracic Intergroup, Clinical Research Unit, Paris, France Correspondence to: Denis Moro-Sibilot, email: DMoro-Sibilot@chu-grenoble.fr Keywords: lung cancer, ALK, crizotinib, ceritinib, alectinib Received: September 28, 2016 Accepted: January 10, 2017 Published: February 26, 2017 ABSTRACT Overall survival (OS) with the anaplastic lymphoma kinase (ALK) inhibitor (ALKi) crizotinib in a large population of unselected patients with ALK -positive non-small-cell lung cancer (NSCLC) is not documented. We sought to assess OS with crizotinib in unselected ALK -positive NSCLC patients and whether post-progression systemic treatments affect survival outcomes. ALK -positive NSCLC patients receiving crizotinib in French expanded access programs or as approved drug were enrolled. We collected clinical and survival data, RECIST-defined progressive disease (PD) and post-PD systemic treatment efficacy. We performed multivariable analysis of OS from crizotinib initiation and PD under crizotinib. At time of analysis, 209 (65.7%) of the 318 included patients had died. Median OS with crizotinib was 16.6 months. The line of crizotinib therapy did not impact survival outcomes. Of the 263 patients with PD, 105 received best supportive care, 74 subsequent drugs other than next-generation ALKi and 84 next-generation ALKi. Next-generation ALKi treatment correlated with better survival outcomes in multivariate analysis. These patients had a median post-PD survival of 25.0 months and median OS from metastatic disease diagnosis of 89.6 months. Unselected ALK -positive NSCLC patients achieve good survival outcomes with crizotinib therapy. Next-generation ALKi may provide survival improvement after PD under crizotinib.

9097Background: The incidence of lung cancer is increasing dramatically in women with recent findings as the preferential involvement of the EGFR pathway and the potential impact of hormonal factor...

International audience; Incidence of non-small cell lung cancer is increasing especially among elderly with about 40% arising in patients over 70 years old. Most of these elderly patients are under treated. Seventy-one patients with lung cancer over 70 years old were treated in Institut Paoli-Calmettes from January 2000 until December 2003 (male/female: 57/14). Median age was 75.5 years (70-92). OMS 0-1-2-3=4.2-60.6-25.4-4.2%, respectively. Comorbidities were represented by arterial hypertension, coronaropathy, cardiac failure, thrombo-embolism, respiratory failure, diabetes, vascular cerebral dysfunction, and renal failure. 29.6% of patients were without comorbidity, and 14.1% had at least three comorbidities. The averages of the Charlson comorbidity score and the Age-Charlson comorbidity score were 3.4 and 6.6, respectively. Histological characteristics: epidermoïd/adenocarcinoma/undifferentiated/small cells: 39.4%/26.8%/15.5%/9.9%. Most of them were advanced lung cancer: St IIIB=14 (19.7%) and St IV=37 (52.1%). Forty-six patients received chemotherapy (64.8%) with 40 patients (86.9%) with platin (carboplatin or cisplatin). The median number of treatment cycles was 4.1 (range 1-7). Two patients achieved complete response and 15 had partial response. The response rate was 39.6%. The 1-year survival rate was 48.5% and the estimated median survival time was 11 months (95%; 7-18 months) for all patients. The 1-year survival rate was 75% and 21.6% and the estimated median survival time was 25.9 months (95%; 12.6, ND) and 5.7 months (95%; 4.2-9.6) for stage IIIB and IV, respectively. Toxicities were judged acceptable with 19 hospitalizations after chemotherapy, for 16 patients who represent 34.8% of patients who received chemotherapy.Conclusions: Chemotherapy is feasible in elderly patients with lung cancer. Patients should be evaluated for chemotherapy based on their performance status and comorbidities especially with geriatric assessment rather than age alone. The chemotherapy with platinum seems to be tolerable and effective.

Background The phase II, open-label BRAIN study (ML21823; NCT00800202) is the first to assess the efficacy/safety of bevacizumab combined with chemotherapy in patients (pts) with ns-NSCLC and untreated CNS metastases. Investigation of CEC, CEP or CTC levels as potential markers of response to bevacizumab was undertaken. Methods In the B + CP arm, blood samples were taken before treatment on day 1 (d1) of cycle 1 (C1) (and 6 hrs after [C1 + 6h] treatment at one centre only), and on d1 of C2 and C3, i.e. 4 samples in total. Samples were taken for the B + E arm on d1 of C1, C2 and C3 (3 samples total). CEC and CTC levels were measured with CellSearch (Immunicon, Veridex). CEP were measured using four-colour flow cytometry after enrichment of progenitor cells using Miltenyi Biotec EPC enumeration and enrichment kit. Cut-offs were 15 cells/4mL for CEC, 2 cells/7.5mL for CTC and median for CEP. Relation between marker levels and 6-month progression-free rate (PFR) and best overall response (BOR) was examined. Results CEC and CTC were analysed in 69/91 (76%) pts, and CEP in 32/91 (35%) pts; baseline (BL) characteristics were similar to the overall population. CEC, CTC and CEP were detected at BL in 94%, 94% and 100% of these pts. In the B + CP group, CEC levels were increased at C1 + 6h, possibly reflecting the antivascular effect of chemotherapy. Furthermore, in the B + CP group, pts with higher BL CTC and no peak in CEC levels at C1 + 6h progressed at 6 months. Analysis of association of markers with BOR and PFR for the two regimens is ongoing. Conclusions Measuring CEC, CTC and CEP is feasible in NSCLC. Detailed analyses will be presented. The clinical value of these markers for predicting response to bevacizumab in advanced ns-NSCLC patients warrants further investigation. B + CP B + E Progression/death at 6 months Progression/death at 6 months CEC (cells/4mL) Median (range) No (n = 28) Yes (n = 19) No (n = 13) Yes (n = 8) C1 cells/4mL (n = 27) 24 (4–464) (n = 18) 32 (0–184) (n = 12) 28 (8–108) (n = 8) 44 (4–96) C1 + 6h cells/4mL change from BL (n = 9) 104 (12–632) 36 (-336–72) (n = 7) 28 (0–120) -16 (-172–100) – – C2 cells/4mL change from BL (n = 24) 24 (8–308) (n = 23) 0 (-376–268) (n = 15) 20 (0–216) (n = 14) -4 (-176–196) (n = 12) 34 (4–180) (n = 11) -4 (-72–160) (n = 8) 34 (0–356) (n = 8) -4 (-76–316) C3 cells/4mL change from BL (n = 26) 34 (0–228) (n = 25) 4 (-440–208) (n = 10) 30 (0–464) (n = 10) 10 (-172–444) (n = 11) 28 (0–76) (n = 10) 0 (-100–52) (n = 7) 76 (0–244) (n = 7) 28 (-20–192) CTC (cells/7.5mL) n (%) No (n = 28) Yes (n = 19) No (n = 13) Yes (n = 8) C1 ≥ 2 cells/7.5mL (n = 28) 24 (85.7%) 4 (14.3%) (n = 17) 8 (47.1%) 9 (52.9%) (n = 12) 10 (83.3%) 2 (16.7%) (n = 8) 7 (87.5%) 1 (12.5%) C2 ≥ 2 cells/7.5mL (n = 24) 21 (87.5%) 3 (12.5%) (n = 16) 10 (62.5%) 6 (37.5%) (n = 11) 9 (81.8%) 2 (18.2%) (n = 8) 5 (62.5%) 3 (37.5%) C3 ≥ 2 cells/7.5mL (n = 25) 22 (88.0%) 3 (12.0%) (n = 11) 7 (63.6%) 4 (36.4%) (n = 12) 12 (100%) 0 (0%) (n = 6) 4 (66.7%) 2 (33.3%) CEP (133+ CEP/1000 CD34+) Median (range) No (n = 12) Yes (n = 9) No (n = 7) Yes (n = 4) C1 (n = 12) 1.8 (0.0–4.3) (n = 9) 1.6 (0.0–5.9) (n = 7) 0.0 (0.0–2.1) (n = 4) 5.0 (0.2–7.1) C1 + 6h (n = 8) 1.5 (0.0–7.8) (n = 6) 0.0 (0.0–0.5) – – C2 (n = 12) 0.3 (0.0–5.8) (n = 7) 0.0 (0.0–3.3) (n = 6) 0.4 (0.0–3.2) (n = 4) 0.3 (0.0–1.1) C3 (n = 12) 1.2 (0.0–8.7) (n = 4) 0.0 (0.0–1.5) (n = 7) 0.7 (0.0–3.7) (n = 3) 1.8 (0.0–3.4) Disclosure H. Senellart: Financial Interest: Advisory Board. E. Dansin: Attended advisory boards for Roche, Lilly and Boehringer-Ingelheim. B. Besse: Received research grants from Roche. All other authors have declared no conflicts of interest.

Aim: In most cancers we do not have clear therapeutic guidelines after the second line of chemotherapy. A score, using 4 criteria, has been built from a multivariate analysis of a cohort of 177 advanced –stage cancers without specific treatment * and was clearly associated with the prognosis. Our aim was to test this score in patients receiving a 3rd or 4th + line in a palliative setting, in order to better define patients who will have a very poor prognosis and should benefit from best supportive care alone. Methods: Were included in this prospective series, patients with solid tumors (except breast cancer) who had received more than 2 chemotherapy lines in a palliative setting and who are planned to receive a third line. The day before the first cycle the 4 parameters were collected and the score calculated (PS 0-1: 0 Points; 2: 2 Pts; 3-4: 4 Pts – metastatic sites: 1: 0 Pts; > 2: 2 Pts - Albumin: 33 g/L - 3 Pts - LDH 600: 1 Pt; score = total + 3 Pts, ranging from 0 to 10) and associated with the outcome (overall survival – comparison by log-rank test ). Results: From August 2013 to March 2014, 64 patients were included. The primary was: sarcoma in 15 Patients, colo-rectal cancer: 14, lung cancer: 11, ovarian cancer : 11, pancreatic cancer: 5, gastric cancer: 4, other: 4.They have previously received: 2 lines in 32 cases, 3 in 17, 4 in 6 and more than 5 lines in 9 cases. Median overall survival (mOS) of the cohort was 4.4 mo, 3 and 6-mo OS were respectively 63 and 46 %. mOS was clearly related with the score. Patients with a good score (0 to 3; n = 27) had a mOS not reached and 3 and 6 mo OS of 100 and 67%; those with a score between 4–6 (n = 15) had a mOS of 3.4 mo, and 3 and 6 mo OS of 52 and 41% while those having a score from 7–10 (m = 22) had a mOS of 1.3 months and 3–6 months OS of 25–0%. Overall survival was significantly (log-rank) different (p Conclusions: Conclusions: this score, very easy to determine, will help medical oncologist to decide which patients should not receive an additional line of chemotherapy due to predicted poor overall survival under treatment. *Barbot AC, et al. J Clin Oncol 2008; 15: 2538-43 Disclosure: All authors have declared no conflicts of interest.

Aim: Lung cancer in patients under 40 years is infrequent and few data are available about the presentation and outcomes of lung cancer in this population. This study aimed to describe the clinical characteristics, the treatments and the outcome of lung cancer occurring in the population of young adults in France. Methods: A prospective observational clinical study was conducted in 37 centers in France. All patients under 40 years diagnosed with lung cancer between November 2010 and December 2013 were enrolled. Results: One hundred and fifty nine patients with lung cancer were included. Intermediate results are currently available for 117 patients. Median age at diagnosis was 38 (20-40). The proportion of men was 58%. Median time between symptoms and diagnosis was 2 months. The distribution of stages I- II, IIIA and IIIB-IV was 9%, 9% and 82% respectively; 66% were diagnosed with metastasis at presentation and the first metastasis site was brain in 47% of patients. Adenocarcinoma was the most common histologic subtype (78%). EGFR screening was performed for 83 patients and 10% of the patients had an activating mutation. Analysis of other driver biomarkers is ongoing. Eighty-four patients (86%) were current or former tobacco smoker with a median of 20 packs -year. Sixty-nine patients (59%) have been exposed to passive smoking essentially in childhood. About half of them (46%) were current or former cannabis smoker (among which 50% regularly). Socioeconomic status was lower comparing to general population, 24% of the patients had no diploma. The first line treatments were 88% chemotherapy, 43% radiotherapy, 21% surgery and 5% best supportive care. Median overall survival was 14.7 months. Conclusions: This study is the first national prospective study dedicated to patients under 40 years diagnosed with lung cancer. Compared to the general population of lung cancer, our preliminary results show a high proportion of women, adenocarcinoma histology, advanced disease at diagnosis and tobacco and cannabis use. Final analysis will be presented at the congress. Disclosure: All authors have declared no conflicts of interest.