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C. Locher



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    MO07 - NSCLC - Targeted Therapies II (ID 114)

    • Event: WCLC 2013
    • Type: Mini Oral Abstract Session
    • Track: Medical Oncology
    • Presentations: 1
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      MO07.09 - Feasibility and clinical impact of re-biopsy in advanced non-small cell lung cancer: a prospective multicentric study in real world setting (GFPC study 12-01) (ID 1045)

      16:15 - 17:45  |  Author(s): C. Locher

      • Abstract
      • Presentation
      • Slides

      Background
      In case of progression under initial treatment, repeat biopsy is a new option procedure in advanced non-small cell lung cancer (NSCLC). Its justification is based on the assessment of biological markers (comparison to the initial status, emergence of resistance to chemotherapy or new biomarkers). The aim of this pragmatic prospective multicenter study was to assess feasibility and clinical utility of re-biopsy in real world setting in advanced NSCLC.

      Methods
      Patient’s main inclusion criteria was advanced NSCLC with an indication of repeat biopsy by the referent clinician. The primary outcome was the percentage of successful procedures; secondary outcomes were localization of the new biopsy, type of procedure, new biological status (comparison to initial status, new biomarkers, resistance biomarkers) and tolerance of the procedure.

      Results
      From May 2012 to May 2013, 18 centers included 102 patients. The characteristics of the 67 first patients were: male: 40%; age: 64.8 ± 10.9 years; PS 0/1: 87%; adenocarcinoma: 85%; EGFR mutated: 46.2%; no biological available assessment: 16.4%; controlled disease as best response to first line: 70%. Repeat biopsy was possible in 80.6%. The main failure reasons were: inaccessible lesion: 4.5%, medical contraindications: 14.9%. Main procedures were: bronchial endoscopy: 48.1%, trans thoracic needle biopsy: 24.1%. The procedure permits to find, in EGFR wild type population, 3 patients with a driver oncogene (1 HER2, 1 Ros1, 1 EML4 ALK); in EGFR mutated patients, 2 T790M mutations and to obtain in 3 patients with no biological data’s at the diagnosis, a biological profile. Complications were very low: 2 cases of moderate bleeding and 1 case of pneumothorax.

      Conclusion
      Repeat biopsy is a feasible procedure with acceptable adverse events. Recommendations should be realized on the indications of re-biopsy, the timing and the recommended site (primary versus metastasis, progressive target versus no progressive). Analysis of the complete population (n=102) will be presented at the meeting. Supported by an academic grant from Boehringer Ingelheim Company and Hoffmann-La Roche Company.

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    P2.09 - Poster Session 2 - Combined Modality (ID 213)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Combined Modality
    • Presentations: 1
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      P2.09-001 - Phase II study of concurrent chemo-radiotherapy (CRT) with weekly cisplatinum plus oral vinorelbine in fit elderly patients with nonresectable locally advanced non-small-cell lung cancer (NSCLC) assessed by Standardized Geriatric Assessment (RACCOSA, GFPC 08-06 study): interim analysis. (ID 233)

      09:30 - 16:30  |  Author(s): C. Locher

      • Abstract

      Background
      Few studies are dedicated to elderly patients with unresectable stage IIIA/B. We used a Standardized Geriatric Assessment (SGA) to select fit elderly patients and assess if this population can benefit from standard of care, namely concurrent CRT.

      Methods
      The aim of this multicentric phase II opened-study was to assess CRT in patients older 70 years with locally advanced NSCLC, evaluated as “fit” according to SGA.CRT associated oral vinorelbine (30 mg/m²/week) and IV cisplatinum (30 mg/m²/week) during 6 weeks concurrently with radiotherapy (66 Gy, 33 fractions, 6,5 weeks). Main inclusion criterias were : PS ≤ 1, weight loss < 10%, creatinine clearance ³ 50 ml/mn abreviated, VEMS ³ 40%, PaO2 ³ 60 mm Hg, KCO ³ 60% and patient classified as fit according to SGA. The principal end-point was early treatment tolerance (number of patients with adverse event grade ³ 3 (except nausea and vomiting) or grade 4 for hematologic toxicity and asthenia. Secondary end-points were RECIST response 4 weeks after treatment, quality of life, tolerance, progression-free survival and overall survival. Using a Simon's optimal plan in 2 steps, the total number of patients to be included was 59 with an intermediate analysis after 19 patients. Toxicities and serious adverse events were monitored by an independent peer committee.

      Results
      Interim analysis was done after 23 inclusions in 19 evaluable patients: males 84% , mean age 74.6 (70 to 83) years, 3 patients didn’t end the treatment (1 disease progression, 1 cons-indication for radiotherapy, 1 patient choice). Four patients had adverse event ≥ 3 (except nausea and vomiting) or grade 4 hematologic toxicity and asthenia. Treatment efficacy was: 1 RC, 10 RP, 5 SD, 1 PD. Two patients were not evaluable (1 early death, 1 patient’s refusal to further treatment). The independent peer committee judged that toxicities were acceptable and consistent with what was expected. Study is ongoing with 44 enroled patients currently.

      Conclusion
      The interim analysis of a phase II study of CRT in fit elderly patients with no resecable locally advanced NSCLC assessed by SGA showed an acceptable toxicity. Results will be upgraded for the congress.

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    P2.10 - Poster Session 2 - Chemotherapy (ID 207)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 1
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      P2.10-013 - Randomized non comparative multicenter phase II study of sequential erlotinib with docetaxel versus docetaxel alone in patients with non small cell lung cancer (NSCLC) after failure of first line chemotherapy (TARSEQ): a GFPC 10.02 study. (ID 972)

      09:30 - 16:30  |  Author(s): C. Locher

      • Abstract

      Background
      Erlotinib and docetaxel are approved in second line treatment of advanced NSCLC. Concomitant administration of a tyrosine kinase inhibitor (TKi) of EGFR with standard chemotherapy in first line did not improve survival compared to chemotherapy alone. Preliminary studies support a possible efficacy of sequential administration of EGFR TKi and chemotherapy. Objective: This open randomized phase II trial (Tarseq) was designed to assess the efficacy and tolerability of second-line sequential erlotinib plus docetaxel in advanced NSCLC.

      Methods
      Patients were randomized (1/1, stratified by center, disease status: recurrent or refractory (no response observed after 4 cycles of first-line chemotherapy))between sequential erlotinib 150 mg/d (day 2-16) + docetaxel (75 mg /m2 d1- 21) (arm A) versus docetaxel (75mg/m2 d1) alone (arm B) until disease progression or unacceptable toxicity. Primary endpoint was the rate of patients with progression-free survival at 15 weeks (PFS15) ; second endpoints included progression-free survival (PFS), overall survival (OS), overall response rate (ORR), and tolerability. Main eligibility criteria were advanced NSCLC, EGFR wild type or unknown, performance status 0 to 2, failure of first line cisplatin based chemotherapy; main exclusion criteria were more than 2 lines of treatment, previous anti-EGFR or docetaxel treatment. Statistical analysis was based on a Simon’s optimal two stage design . The primary endpoint is rejected if the number of efficacy is less 33 over 66 pts (25+ 41) at the end of the two stages.

      Results
      147 patients were randomized by 33 centers: median age: 60 ± 8 years, PS 0/1/2 (44/83/20 pts) ; male: 78%, EGFR status: wild type 66%, unknown: 34%; recurrent patients: 65% (arms A/B :66%/65%), nonsquamous: 86% (arms A/B : 84%/90%), smoking status: smokers 35%, formers 57,5%, never 7,5%. Baseline characteristics were balanced between 2 arms. In ITT, the primary objective was not meet with 18/66 pts without progression at 15 weeks in arm A, 17 /66 pts in arm B. In arm A and B, median PFS was 2,2 (CI95% 1,6-2,8) and 2,5 (CI 95% 1,7-2,8) months and median OS was 6,6 (CI 95% 4,3-10,3) and 8,4 (CI 95% 4,5-11,3) months respectively. Toxicity was acceptable in both arms with 60.2 % and 54% of G3/4 toxicity in arms A and B, respectively.

      Conclusion
      The sequential combination of erlotinib with docetaxel did not demonstrate any benefit in second-line treatment of EGFR wild type or unknown advanced NSCLC, despite acceptable toxicity. The Pharmacological hypothesis of synergism between erlotinib given sequentially and standard chemotherapy is not confirmed in the present study. Clinical trial information: NCT01350817 / Supported by an academic grant from Roche, Chugai, Sanofi Aventis,with the help of clinical research direction ( Limoges University Hospital)

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    P2.22 - Poster Session 2 - Epidemiology, Etiology (ID 167)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Prevention & Epidemiology
    • Presentations: 1
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      P2.22-004 - Survival improvement in primary lung cancer patients in a 10-year period: results of the French KBP-2000-CPHG and KBP-2010-CPHG cohorts (ID 1361)

      09:30 - 16:30  |  Author(s): C. Locher

      • Abstract

      Background
      Due to its high incidence and bad prognosis, lung cancer is a major health problem. In the 2000s, several social and scientific changes (such as decreased smoking, improved diagnosis methods, or the development of new drugs and therapeutic strategies) may have changed the epidemiology and prognosis of this cancer. The objective of the present study was to compare 1-year mortality in adult patients with primary lung cancer at a 10-year interval.

      Methods
      In 2000 and 2010, the French College of General Hospital Respiratory Physicians (CPHG) performed 2 prospective multicenter cohort studies collecting information on all new cases of lung cancer diagnosed histologically or cytologically from 01 January 2000 to 31 December 2000, and from 01 January 2010 to 31 December 2010, and managed in the respiratory department of one of the participating general hospitals. A standardized form was completed for each patient. A steering committee checked recruitment exhaustiveness.

      Results
      137 hospitals in 2000 and 104 hospitals in 2010 included respectively 5667 and 7051 patients. The 2 cohorts represented about 1 in 5 lung cancers diagnosed in France in 2000 and 2010. The characteristics of patients and lung cancer changed during the 10-year period in France. In 2010, compared to 2000, patients were older (mean (SD): 65.5 (11.3) years vs. 64.3 (11.5) years; p<0.0001), more frequently women (24.3% vs. 16.0%; p<0.0001) and more frequently never-smokers (10.9% vs. 7.2%; p<0.0001); they had a lower performance status score (PS) at diagnosis (PS 3 or 4: 12.7% vs. 17.7%; p<0.0001); their tumor was more frequently an adenocarcinoma (45.4% vs. 29.0%; p<0.0001). One-year mortality also changed, decreasing from 61.8% in 2000 to 56.4% in 2010. Multivariate analysis showed that the year of diagnosis was an independent risk-factor for death. Other independent risk-factors were older age, male sex, higher PS, active smoking, and small cell lung cancer (please see the table hereafter).

      Odds ratio 95% CI p-value
      Year of diagnosis
      2000 1 (Ref)
      2010 0.84 0.77-0.91 <0.0001
      Age (years)
      <60 1 (Ref)
      60-75 1.03 0.94-1.13 0.55
      >75 1.53 1.35-1.42 <0.0001
      Sex
      Female 1 (Ref)
      Male 1.28 1.15-1.42 <0.0001
      Smoking status
      Never-smoker 1 (Ref)
      Former-smoker 1.02 0.87-1.19 0.84
      Active-smoker 1.23 1.05-1.44 0.01
      Performance status
      0- Asymptomatic 1 (Ref)
      1- Symptomatic but completely ambulatory 2.45 2.23-2.69 <0.0001
      2- Symptomatic, < 50% in bed 6.49 5.73-7.36 <0.0001
      3- Symptomatic, > 50% in bed 15.2 12.6-18.3 <0.0001
      4- Bedbound 39.0 23.5-64.8 <0.0001
      Small cell lung cancer
      Yes 1 (Ref)
      No 0.83 0.74-0.93 0.002

      Conclusion
      In 10 years, 1-year mortality decreased in patients with primary lung cancer. The improvement in survival was not solely due to epidemiological changes in patient characteristics (age, sex, smoking habits, or PS) and tumor characteristics (histological type) over the 10-year period. This supports the hypothesis of improved management of lung cancer in patients followed up in French general hospitals.

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    P3.10 - Poster Session 3 - Chemotherapy (ID 210)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 1
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      P3.10-041 - Impact of a Comprehensive Geriatric Assessment on management strategies in elderly patients with advanced no small cell lung cancer (NSCLC): a polled analysis of two phase 2 prospective study of the GFPC group. (ID 2418)

      09:30 - 16:30  |  Author(s): C. Locher

      • Abstract

      Background
      The impact of a systematic use of a Comprehensive Geriatric Assessment (CGA) on management strategies in elderly patients with no small cell lung cancer (NSCLC) is not well established. The objective of this study was to analyze if items of CGA may predict overall survival of elderly patients with NSCLC treated by chemotherapy or erlotinib in first or second lines setting.

      Methods
      Individuals data’s of GFPC 0504 study (population of fit elderly patients) and GFPC 0505 study (population of frail elderly patients) were pooled. The aim of these two prospective phase 2 trials were to compare a strategy using chemotherapy (doublet in fit patients, monotherapy in frail patients) in first line followed by erlotinib in second line to the reverse strategy (erlotinib in first line, followed by chemotherapy), in terms of progression-free survival (PFS) in second line period. Secondary outcomes were to compare first-line PFS, overall survival (OS), tolerance and costs. All patients had a complete comprehensive geriatric assessment, evaluating diverse areas as functional status, nutritional status, cognition, psychological functioning, and social support, at randomization. Predictive factors associated with OS were searched using Kaplan-Meier curves and logrank tests in the univariate analysis. A Cox model was used for the multivariate analysis.

      Results
      195 patients were included. Mean age was 77 years. 135 (70%) patients were males, 172 (89%) were stage IV and 109 (56%) were no or ex-smokers. At CGA assessment, 176 patients (70%) had an IADLD score of 3 or 4, 129 pts (66%) had a 0 or 1Charlson score, 167 pts (86%) had a simplified Charlson score < 8, 19 pts had a MMS score < 30, 146 pts (75%) had a situational score >10, 33 (17%) had a nutritional score <8. Factors predicting OS in the univariate analysis were 1-3 PS scores (1.5 [1.1 – 2.0], p=0.01); no or ex-smoker (0.70 [0.52–0.95], p = 0.02); 2-4 Charlson score (2.0 [1.4 – 2.7], p<0.0001, Simplified Charlson score ≥ 8 (1.50 [1.10–2.07],p=0.03), nutritional score>8 (0.60 [0.42 – 0.91], p= 0.01); 2 level mobility score (0.15 [0.04 – 0.62], p = 0.009). In the multivariate analysis, remained 1-3 PS (1.4 [1.02 – 1.9], p = 0.04), 2-4 Charlson score (1.46 [1.07 – 1.99], p=0.02), >8 nutritional score (0.69 [0.46 – 1.04], p= 0.07), level 2 mobility score level (0.25 [0.06 – 1.01], p = 0.06)

      Conclusion
      Comorbidities, nutritional and mobility scores, in this specific elderly population are predictive of OS. Prospective studies using large prospective cohort are needed to better select the more relevant management for elderly with advance NSCLC.