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B. Besse



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    MO03 - Thymic Malignancies (ID 123)

    • Event: WCLC 2013
    • Type: Mini Oral Abstract Session
    • Track: Medical Oncology
    • Presentations: 1
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      MO03.03 - RYTHMIC: a nationwide network for thymic malignancies in France (ID 2631)

      10:40 - 10:45  |  Author(s): B. Besse

      • Abstract
      • Presentation
      • Slides

      Background
      RYTHMIC (Réseau tumeurs THYMiques et Cancer) is a nationwide network for thymic malignancies, which was appointed in 2012 by the French National Cancer Institute, as part of its rare cancer program. The objectives of the network include a territorial coverage by regional expert centers, the dissemination of highest standards for the diagnostic and therapeutic management of patients, and the promotion of collaborative research. Registration in RYTHMIC of all patients diagnosed with thymic malignancy is recommended as part of good clinical practice for oncologists.

      Methods
      Starting January 2012, the management of all patients diagnosed with thymic malignancy in France has been discussed on a real-time basis at a reference national multidisciplinary tumor board (MTB), which is organized twice a month using a web-based conferencing system. Decision-making is based on consensual recommendations, that were originally established using available evidence, and are updated and approved each year by all members of the network. A prospective database of all patients is hosted by the French Thoracic Cancer Intergroup. We report the characteristics and treatment modalities of patients included during the first year.

      Results
      From January to December 2012, 257 patients were enrolled in RYTHMIC. There were 126 (49%) men and 131 (51%) women; mean age at diagnosis was 54.5 years. Among 214 cases, histology was thymoma for 146 (56%) patients (11 (5%) type A, 28 (13%) type AB, 22 (10%) type B1, 35 (16%) type B2, 24 (11%) type B3, 26 (12%) mixed type), and thymic carcinoma for 33 (15%) patients, 8 of which were neuroendocrine carcinomas; other histologies were diagnosed for 35 (16%) patients. Among 144 cases, Masaoka-Koga stage was I, IIA, IIB, III, IVA, and IVB in 34 (24%), 19 (13%), 20 (14%), 22 (15%), 35 (24%), and 14 (10%) patients, respectively. 44 (17%) patients presented with autoimmune disorder, consisting of myasthenia gravis in 28 cases. Surgery was performed for 166 patients, mostly using a median sternotomy approach (52% of cases). Postoperative radiotherapy was delivered to 42 patients; 71 patients received perioperative chemotherapy. Exclusive chemotherapy/radiotherapy was administered to 20 and 4 patients, respectively. Mature data will be presented at the meeting.

      Conclusion
      This first analysis of the RYTHMIC prospective cohort demonstrates the feasibility of a national MTB for thymic malignancies, that, besides ensuring all patients an equal access to highly specialized treatment, provides with a comprehensive tool to monitor dedicated actions to improve the management of patients in the future, increase the quality-of-care, and screen patients for future translational research and clinical trials. Supported by Institut National du Cancer

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    MO08 - NSCLC - Early Stage (ID 117)

    • Event: WCLC 2013
    • Type: Mini Oral Abstract Session
    • Track: Medical Oncology
    • Presentations: 1
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      MO08.02 - Adjuvant pazopanib or placebo in resected stage I NSCLC patients: results of the NSCLC adjuvant randomized phase II trial (IFCT-0703) from the French collaborative Intergroup (ID 2274)

      16:20 - 16:25  |  Author(s): B. Besse

      • Abstract
      • Presentation
      • Slides

      Background
      Although UFT is approved in eastern countries, most guidelines do not recommend any adjuvant treatment in resected Stage I NSCLC. Pazopanib (P) is a potent, orally active multi-target receptor tyrosine kinase inhibitor of VEGFR-1, -2, -3, platelet derived growth factor (PDGFR) type-α and –β, approved in metastatic renal cell carcinoma and sarcoma. Neoadjuvant P demonstrated single-agent activity in patients with early stage NSCLC. We report the feasibility and tolerance of adjuvant P in stage I NSCLC.

      Methods
      In this double-blind randomized multicenter phase II/III trial, completely resected patients (pts) with stage I NSCLC (7[th] TNM edition) were randomized to receive either placebo or P 800 mg/d during 6 months. The Fleming’s two stage phase II primary endpoint was compliance (i.e. % of pts able to receive at least 3 months of P, whatever the dose). After 64 pts included (interim analysis), IDMC recommended to start with P 400 mg/d because of initial insufficient compliance. A one-step Fleming design was used with the new dose. Phase II design was not comparative.

      Results
      143 pts were randomized in 29 centers between March 2009 and August 2012, 71 and 72 in the placebo and P arms respectively. Most pts were male (61%) and smokers (91%), median age was 60. Pathological stage was IA in 111 pts (78%) and 16% were squamous cell carcinomas. Compliance for P800 was adequate in 38% (95% confidence interval [21-56]) vs. 87% [71-96] in placebo; for P400 in 69% [50-84] (p=0.01, compared to P800) vs. 93% [77-99] in placebo. Dose modifications were seen in 44% and 34% of P800 and P400 groups. The proportion of patient with at least one grade 3/4 toxicity was 53% [35-71] in P800 (13% [4-29] for placebo) and 38% [21-56] in P400 (27% [12-46] for placebo). No toxic deaths were observed. Only 2 pts has grade 4 toxicities in P800 (fatigue in P arm, GGT in the placebo arm). Most common toxicities G3 in P800 were diarrhea (9%), hypertension (9%), and increased transaminases (16% vs. 0% in P400); in P400 gastro-intestinal disorders (16%, 6% diarrhea) and hypertension (6%).

      Conclusion
      IFCT-0703 is the first feasibility study demonstrating that full dose of P is safe but not feasible in the adjuvant setting in NSCLC. Compliance and tolerance with reduced dose appeared acceptable for adjuvant settings.

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    MO22 - Advanced Disease and Outcomes (ID 103)

    • Event: WCLC 2013
    • Type: Mini Oral Abstract Session
    • Track: Surgery
    • Presentations: 1
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      MO22.08 - Surgical Resection of Stage IIIA-N2 non-small cell lung cancer: Should we still talk about the futile thoracotomy? (ID 825)

      11:15 - 11:20  |  Author(s): B. Besse

      • Abstract
      • Presentation
      • Slides

      Background
      Stage IIIA-N2 non-small cell lung cancer (NSCLC) is currently mainly managed with chemotherapy and radiation therapy with limited outcome. Whether surgical resection should be offered to patients with resectable IIIA-N2 NSCLC as part of a multi-modality approach with adjuvant or neoadjuvant treatment remains unclear. We sought to determine the long-term result of resected IIIA-N2 NSCLC in a single institution.

      Methods
      We reviewed the charts from a consecutive series of 263 patients with a mean age of 62 years (range, 37-68) undergoing lung resection and complete en bloc lymph node dissection for IIIA-N2 NSCLC from 01/2000 to 12/2011. Clinical N2 (cN2) patients were diagnosed preoperatively on chest CT scan and/or PET scan and were histologically proven by mediastinoscopy or EBUS. Patients with cN2 with a single site of mediastinal disease were occasionally treated with surgery upfront followed by adjuvant chemotherapy with or without radiation (cN2 adj, n=70). The remaining patients with cN2 disease were treated with neoadjuvant therapy followed by surgery (cN2 neoadj, n=55). Minimal N2 patients were diagnosed postoperatively on final pathology report and received adjuvant therapy (mN2, n=138).

      Results
      Lung resection was a pneumonectomy in 75 patients and a lobectomy in 188 patients with a post-operative mortality of 1.3% and 3.1%, respectively. Adjuvant chemo- or chemoradiation therapy was administered in 181 patients. The overall 5-year survival was 43.6%, with no significant difference between the type of lung resection (pneumonectomy: 38.9% vs. lobectomy: 45.5%, p=0.18) or the number of mediastinal lymph node site involvement (1 site 44.8% vs. 37,7% for multiple sites, p=0.9). Long-term survival tended to be better for mN2 compared to cN2 (5-year survival of 50.4% vs. 35.9%, respectively; p=0.08). However, survival for cN2 was similar between neoadjuvant and adjuvant therapy (5-year survival of 30.3% vs. 40.2%, respectively; p=0.53). The number of mediastinal lymph node site involvement did not impact survival in patients with cN2 disease (1 site 37.6% vs 27.6% for multiple sites, p=0.59).

      Conclusion
      Surgery for Stage IIIA-N2 NSCLC achieved good long-term survival when combined with chemotherapy or chemo-radiation therapy in well selected patients. Long-term survival was similar in patients with clinical N2 disease whether they received adjuvant or neoadjuvant therapy. Surgery should be considered as part of a multimodality treatment for patients with stage III-N2 NSCLC.

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    O03 - NSCLC - Targeted Therapies I (ID 113)

    • Event: WCLC 2013
    • Type: Oral Abstract Session
    • Track: Medical Oncology
    • Presentations: 1
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      O03.04 - DISCUSSANT (ID 3949)

      11:00 - 11:15  |  Author(s): B. Besse

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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    O21 - SCLC II (ID 119)

    • Event: WCLC 2013
    • Type: Oral Abstract Session
    • Track: Medical Oncology
    • Presentations: 1
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      O21.05 - A multicenter, double-blind, placebo-controlled, randomized phase 2 study of ganitumab or rilotumumab with platinum-based chemotherapy as first-line treatment for extensive-stage small-cell lung cancer (SCLC) (ID 725)

      17:00 - 17:10  |  Author(s): B. Besse

      • Abstract
      • Presentation
      • Slides

      Background
      The type 1 insulin-like growth factor receptor (IGF1R) and MET, the receptor for hepatocyte growth factor (HGF)/scatter factor, appear to play key roles in SCLC. Ganitumab and rilotumumab are investigational, fully human monoclonal antibodies targeting IGF1R and HGF, respectively. A phase 1b/2 study evaluated ganitumab or rilotumumab combined with etoposide plus carboplatin (CE) or cisplatin (PE) in extensive-stage SCLC. The phase 1b results were previously reported (Lorigan et al. Ann Oncol 2010;21[supplement 8]: abstract 444P). Here, the phase 2 results are reported.

      Methods
      Key eligibility criteria: ≥18 years, confirmed SCLC, ECOG performance status ≤1, no prior chemotherapy. Patients were randomized 1:1:1 to receive blinded investigational product (IP) either ganitumab (18 mg/kg IV, day 1) or rilotumumab (15 mg/kg IV, day 1) or placebo, with etoposide (100 mg/m[2] IV, days 1-3) plus, at investigator’s discretion, either carboplatin (AUC=5 mg/mL*minute IV, day 1) or cisplatin (75 mg/m[2] IV, day 1) every three weeks for 4-6 cycles followed by IP monotherapy. Patients were stratified by gender and chemotherapy (CE; PE). Primary endpoint: overall survival (OS). Key secondary endpoints included progression-free survival (PFS), objective response rate (ORR), adverse events (AEs), pharmacokinetics.

      Results
      185 patients (ganitumab/rilotumumab/placebo: 62/62/61) were enrolled between 2 February 2010 and 12 January 2011. Male: 77%/76%/77%. Median age: 60/61/61 years. More patients received carboplatin (41/40/40) than cisplatin (21/22/21). Most common reason for discontinuation of IP was disease progression (69%/61%/74%). Among 179 patients (59/61/59) who received IP, the most frequent any grade AEs (occurring in ≥30% of patients in any arm) were neutropenia (69%/59%/71%), anemia (39%/34%/36%), nausea (41%/30%/22%), alopecia (41%/23%/27%), thrombocytopenia (22%/30%/12%), and vomiting (19%/10%/31%). Grade ≥3 AEs and serious AEs were reported in 69%/72%/80% and 39%/38%/36% of patients, respectively. There were three IP-related grade 5 AEs: cardiac arrest (rilotumumab, n=1), febrile neutropenia (rilotumumab, n=1), gastric ulcer hemorrhage (placebo, n=1). No neutralizing antibodies were observed for either ganitumab or rilotumumab. Efficacy is shown in the table. Ganitumab and rilotumumab combined with chemotherapy showed comparable exposures as those under monotherapy and did not affect the pharmacokinetics of chemotherapy.

      Ganitumab (n=62) Rilotumumab (n=62) Placebo (n=61)
      OS
      Median (95% CI) months 10.7 (8.1–14.1) 12.2 (8.8–14.6) 10.8 (9.4–11.9)
      Adjusted HR[a] (95% CI) 1.01 (0.67–1.52) 0.91 (0.60–1.39)
      PFS
      Median (95% CI) months 5.5 (4.4–5.7) 5.4 (4.4–5.7) 5.4 (4.6–5.8)
      Adjusted HR[a] (95% CI) 1.03 (0.70–1.52) 1.03 (0.69–1.52)
      Objective Response
      Complete response, n (%) 0 (0) 2 (3) 1 (2)
      Partial response, n (%) 39 (63) 40 (65) 35 (57)
      Stable disease, n (%) 13 (21) 12 (19) 16 (26)
      [a]Adjusted for baseline lactate dehydrogenase levels and stratification factors. CI=confidence interval; HR=hazard ratio.

      Conclusion
      In this study of chemonaïve patients with extensive-stage SCLC, the combination of ganitumab or rilotumumab with CE or PE was tolerable; no unexpected toxicities were observed. There were no meaningful improvements in OS, PFS, or ORR with either combination. Survival analyses in biomarker and pharmacokinetic subgroups are ongoing.

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    P1.11 - Poster Session 1 - NSCLC Novel Therapies (ID 208)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 1
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      P1.11-037 - Phase II activity of the HSP90 inhibitor AUY922 in patients with EGFR-mutant advanced non-small cell lung cancer (NSCLC) (ID 2730)

      09:30 - 09:30  |  Author(s): B. Besse

      • Abstract

      Background
      AUY922 is a highly potent, non-geldanamycin, HSP90 inhibitor. HSP90 is a molecular chaperone of oncogenic client proteins relevant in NSCLC pathogenesis, including epidermal growth factor receptor (EGFR), which is mutated in 10% of NSCLC cases in the Western population, and in 30% of NSCLC cases in the Asian population. We report here a subgroup analysis of data from the 2 EGFR mutation strata of a Phase II study of AUY922 in patients with previously treated, advanced NSCLC stratified by molecular status.

      Methods
      Patients with advanced NSCLC who progressed following ≥1 prior line of therapy, received AUY922 (70 mg/m[2]) as a once-weekly, 1-hour infusion. Patients with EGFR-mutant NSCLC were divided into 2 strata: pretreated EGFR-mutant (>2 prior regimens), or less-heavily treated EGFR-mutant (≤2 prior regimens and documented response to an EGFR tyrosine kinase inhibitor [TKI]). The primary endpoint was confirmed response, stable disease at 18 weeks, or no clinical benefit. Secondary endpoints included overall survival (OS), progression-free survival (PFS), and safety/tolerability.

      Results
      At the cut-off date of 14 March 2013, 66 patients with EGFR-mutant NSCLC had been treated (median age 58 years; 67% female; 94% adenocarcinoma; EGFR-initial stratum n=35; less-heavily pretreated EGFR-mutant stratum n=31); all patients had been pretreated with an EGFR TKI. Clinical activity of AUY922 was seen, with any responses (investigator assessed), in 12/66 (18.2%) patients. A total of 34/66 (51.5%) patients had a best overall response of stable disease or non-confirmed partial response; of these patients, 11 (32%) had stable disease for ≥18 weeks. The 18-week PFS rate was 39% in all patients with ≤2 prior lines of therapy (n=43), and 28% in all patients (n=21) who had received >2 lines of therapy. The most frequent adverse events (AEs; any grade, regardless of study drug relationship) were diarrhea (73%), nausea (47%), decreased appetite (38%), fatigue (35%), and headache and night blindness (both 29%). Most AEs were Grade 1 or 2; Grade 3 or 4 AEs included diarrhea (9%), and fatigue, decreased appetite, and hyponatremia (all 6%).

      Conclusion
      AUY922 had an acceptable safety profile. Strong evidence of clinical activity was demonstrated in EGFR TKI-pretreated patients with EGFR-mutant NSCLC. Median PFS, OS and biomarker data for the EGFR-mutant stratum will be presented.

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    P2.11 - Poster Session 2 - NSCLC Novel Therapies (ID 209)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 1
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      P2.11-004 - A Phase Ib, open label, dose escalation study of the safety and pharmacology of PI3-Kinase (PI3K) Inhibitor GDC 0941 in combination with either Paclitaxel (Pac) and Carboplatin (Carbo) with or without Bevacizumab (Bev), or Pemetrexed (Pem), Cisplatin (Cis), and Bev in patients with advanced Non–Small Cell Lung Cancer (NSCLC). (ID 885)

      09:30 - 09:30  |  Author(s): B. Besse

      • Abstract

      Background
      The PI3K pathway has been implicated as a mechanism for cell survival and resistance to chemotherapy. PI3K may be an important target in NSCLC based on genetic alterations such as PIK3CA amplification, PTEN loss and PI3K mutations. Preclinical NSCLC models show that concurrent dosing of GDC-0941 improved activity of taxanes, platinums, and anti-VEGF therapy. This Phase 1b study aims to establish the safety and tolerability of GDC-0941 in combination with four frontline standard of care regimens in patients with advanced NSCLC.

      Methods
      This study contains two Carbo/Pac containing arms: Arm A (GDC-0941 + Carbo + Pac), open to squamous (Sq) patients and Bev-ineligible non-squamous (NSq) patients; and Arm B (GDC-0941 + Carbo + Pac + Bev) for NSq patients. The study also aims to evaluate two Cis/Pem containing arms in NSq patients: Arm C (GDC-0941 + Cis + Pem + Bev); and Arm D (GDC-0941 + Cis + Pem). Study objectives are to evaluate safety and pharmacokinetics (PK), and to determine the maximum tolerated/administered dose (MTD or MAD) of GDC-0941 in combination with chemotherapy regimens in all arms. Patients received GDC-0941 with 4-6 cycles of chemotherapy every 3 weeks (Q3W): Pac (200 mg/m[2]), Carbo (AUC 6 mg/mL·min), Cis (75 mg/m2), Pem (500 mg/m2), and Bev(15 mg/kg) . In all arms, GDC was given PO qd on Days 1-14 of a 21-day cycle. GDC-0941 +/- Bev were given until progression or toxicity.

      Results
      As of 1 February 2013, Arms A, B and C have completed enrollment, with 18, 24 and 13 patients, respectively; no patients have been enrolled in Arm D to date. The most common Grade 3/4 treatment-related adverse events (TAEs) reported in ≥10% of patients were as follows: Arm A: neutropenia (50%), anemia (17%), febrile neutropenia (17%), leukopenia (11%) and thrombocytopenia (11%); Arm B: neutropenia (38%), lymphopenia (13%); Arm C: fatigue (31%), dehydration (15%) and hypertension (15%). The MTD/MAD in Arms A, B and C is 340 mg GDC-0941 in combination with either Carbo + Pac +/- Bev or with Cis + Pem + Bev, respectively. PK characteristics in all Arms were similar to historical profiles for the respective chemotherapy agents, as well as to the single-agent GDC-0941 profile. Confirmed partial responses (PRs) for patients with at least one post-baseline scan are as follows: 6 of 10 (60%) Sq patients; 11 of 28 (39%) NSq (Arms A and B) and 9 of 12 (75%) NSq patients (Arm C).

      Conclusion
      The combinations of GDC-0941 with either Pac + Carbo (+/- Bev), or Cis + Pem + Bev have been well tolerated at doses consistent with target PK exposures based on preclinical activity. Promising responses rates have been observed with all combinations evaluated. Evaluation of GDC-0941 + Cis + Pem is ongoing. A randomized Phase 2 study of GDC-0941 + Pac + Carbo (+/- Bev) in NSq and Sq patients is ongoing.

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    P3.18 - Poster Session 3 - Pathology (ID 177)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Pathology
    • Presentations: 1
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      P3.18-018 - Results of upfront genomic testing in non-small cell lung cancer (NSCLC) patients (MSN study) (ID 3066)

      09:30 - 09:30  |  Author(s): B. Besse

      • Abstract

      Background
      Recent advances in lung cancer have identified potential driver mutations that may be targeted. On the basis of routine screening for EGFR we have initiated a comprehensive large-scale sequencing analysis of genes potentially mutated in NSCLC.

      Methods
      Genomic DNA was extracted prospectively from untreated advanced NSCLC tumors. All materiel was obtained IRB-approved protocols and after patients’ consent (MSN trial "Melanoma – Small-cell lung cancer – Non-small cell lung cancer "). Pathology specimens were macrodissected, after DNA extraction, 106 selected exons from 38 genes were analyzed by Sanger sequencing (EGFR, KRAS, HER2,4, BRAF, PI3KCA, PIK3R1, TP53, CDK4, CDKN2A, cKIT, PDGFRA, MET, FGFR2-4, FCGR2A,3A, FLT3, CTNNB1, GNAS, HRAS, NRAS, KDR, PDPK1, TOP1,2A, ERCC1, FBXW7, TSC2, PTEN, AKT1-3, MAP2K1-2, STK11, ALK). ALK rearrangements and HER2 amplification were detected by FISH. All result therapeutic outcomes were discussed monthly in a molecular thoracic multidisciplinary staff.

      Results
      Thus far (between May 2009 and September 2012), 351 patients (pts) have been included. The median age was 60 years (range 22-87), 212 (60%) were male, 248 (71%) had adenocarcinoma, 286 (81%) were former/current smokers. A complete failure of the analysis was observed in 78 (22%) pts mostly due to insufficient tumor cells in the specimen (<30%) or poor quality DNA. EGFR, KRAS, HER2, BRAF, PI3CA and ALK (“standard biomarkers”), analysis were performed in 235 (67%), 233 (66%), 207(59%), 221(63%), 139 (40%) and 206 (59%) pts respectively. Depending of markers, success rate was between 77% and 86 % (failures include scarce tumor sample). Two hundred and sixty three pts had at least one result for the EGFR, KRAS or ALK, and 176 pts had all three. 107 pts had a whole genomic analysis and 244 had at least one (1-6 biomarkers) standard biomarkers analysis. Ten (3.8%) pts had concurrent oncogenic mutation. The molecular profiles were characterized by 16% EGFR, 26% KRAS, 1% HER2, 0.8% PI3KCA mutated, 7% HER2 amplification and 11% ALK rearrangement. The pts with the while genomic analysis had 12 other genes evaluated for more than 80 pts and 13 pts had mutation (STK11, PDPK1, PTEN, NRAS, MET, KDR, FGFR4, HER4). A personalized targeted therapy was proposed in most of pts with a genomic alteration. Median OS of pts with at least one mutation/translocation for EGFR, KRAS, BRAF or ALK (n=152) was 13 and 17 months (p=0.006) in wild type or mutated pts respectively. In univariate analysis for OS (median follow-up: 19 months), KRAS mutated pts had a poor prognosis (hazard ratio [HR]=1.56, p=0.037), confirmed in multivariate analysis (HR= 1.78, p=0.008), EGFR mutated pts had a good prognosis (HR=0.48, p=0.01), BRAF and ALK mutations/translocation had no prognostic value.

      Conclusion
      Routine mutational profiling of advanced NSCLC is feasible in the vast majority of the pts but an extensive molecular portrait can be performed only in a limited number of pts. The molecular profile may have an impact on pts treatment strategy at our cancer institute. KRAS mutation is associated with poor prognosis. Updated results will be presented.