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R. Gervais



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    P1.07 - Poster Session with Presenters Present (ID 459)

    • Event: WCLC 2016
    • Type: Poster Presenters Present
    • Track: SCLC/Neuroendocrine Tumors
    • Presentations: 1
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      P1.07-008 - Lomustine Endoxan VP16 as Second or Further Line for Recurrent or Progressive Brain Metastases from SCLC (ID 6153)

      14:30 - 14:30  |  Author(s): R. Gervais

      • Abstract

      Background:
      Up to fifty percent of patients with small-cell lung cancer (SCLC) will experience brain metastases (BM) during the whole course of their disease. The oral regimen Lomustine Cyclophosphamide Etoposide (LCE) has been tested in SCLC as second line treatment and was shown to be equivalent to the intravenous regimen Cyclophosphamide Adriamycin Vincristine (Gervais R et al. Clin Lung Cancer 2015;16:100-5). This retrospective study evaluates the cerebral response rate (CRR) of this oral chemotherapy on brain metastases (BM) from SCLC relapsing after platinum-based chemotherapy.

      Methods:
      Patients with disease progression after one or more prior chemotherapy regimens for SCLC were included if they had at least one measurable BM according to RECIST 1.1, with PS<2. Patients with symptomatic BM were eligible. They were excluded if they had received previous whole brain irradiation before LCE or were receiving concomitant brain irradiation. Patients received the chemotherapy according to modalities described in the GFPC-0501 study (1). The doses were determined by a therapeutic risk level: lomustine, 80 to 120 mg on day 1, cyclophosphamide 100 mg/d, and etoposide 75 mg/d, for 6 to 14 days, every 28 days, until progression or major toxicity. Primary prophylactic granulocyte colony-stimulating factor was recommended. The primary objective was the cerebral response rate (CRR) using RECIST 1.1 .Secondary objectives included the extra-cerebral response rate (ECRR), the overall survival and the safety.

      Results:
      From 2008 to 2014 in Baclesse comprehensive cancer center, 24 patients fulfilled the inclusion criteria. The median age was 57.5 years (interquartile range [IR] 51.5–64.5). CCR was 50% while ECRR was 26% (NS, p=0.135). Interestingly, 8 of the 9 patients with neurological symptoms had symptomatic improvement. Previous treatment (chemotherapy and/or radiotherapy) for BM did not appear to have any effect on CRR (p=1.000). The hematologic toxicities were the most common side effects with neutropenia (grade ¾ : 26%) and thrombocytopenia (grade ¾ : 21%). Median overall survival was 6.3 months.

      Conclusion:
      In our study, Lomustine Cyclophosphamide Endoxan has a high activity on BM from SCLC, with a comparable extra cerebral response rate than others regimen currently used in second line setting. It has a manageable toxicity profile and the oral route allows patients with a short expectancy of life to benefit from a home-delivered treatment. We suggest that this combination should be tested in a prospective study.

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    P3.02a - Poster Session with Presenters Present (ID 470)

    • Event: WCLC 2016
    • Type: Poster Presenters Present
    • Track: Advanced NSCLC
    • Presentations: 1
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      P3.02a-004 - NSCLC Patients Harboring ALK Translocation: Clinical Characteristics and Management in Real World Setting. EXPLORE GFPC 02-14 (ID 5043)

      14:30 - 14:30  |  Author(s): R. Gervais

      • Abstract

      Background:
      ALK (Anaplastic Lymphoma Kinase) translocation is a rare oncogenic driver in NSCLC (Non Small Cell Lung Cancer) (3 to 5%) and few data are published on the management of these patients outside patients included in clinical trial. objective:to investigate clinical characteristics and management of these patients in real world setting.

      Methods:
      inclusion of patients with a diagnosis of NSCLC harboring ALK translocations between January 2012 and December 2014, collection of demographic and clinical characteristics, risk factors, Progression free survival (PFS), Overall Survival (OS), mode of progression and therapeutic management

      Results:
      132 patients recruited in 31 centers: 67(51%) men; age: 60.1 ± 14,5 years; PS 0/1 at diagnosis: 89%; non smokers:79%, adenocarcinoma: 93%; Stage at diagnosis 4/3/2-1:74%/19%/7%: co-mutations EGFR n=2, BRAF n=2, KRAS = 1, HER2 = 1. Outcomes of stage IV (n=97): first line treatment: chemotherapy: 75%, Best supportive care (BSC): 1 %, anti ALK: 24 %; response rate, disease control rate (DCR) and PFS to first line treatment: 42 %,64% and 7.5 months (CI 5.9 ;9.5), second line treatment (n=60): chemotherapy: 25%, anti BRAF 72%, BSC 3 %; response rate, DCR and PFS to second line treatment: 43.4%,70% and 4,7 months (CI 4.0; 8.1); 2 years-OS: 56.7% (CI 45.5 ;70.4), mediane OS was not reach.

      Conclusion:
      In this real world analysis, the majority of NSCLC patients with ALK translocation were non smokers,adenocarcinoma and appears to have a better survival to NSCLC pts without oncogenic driver. Clinical trial information: Supported by an academic grant from Lilly, Astra Zeneca, boehringer ingelheim

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    P3.02b - Poster Session with Presenters Present (ID 494)

    • Event: WCLC 2016
    • Type: Poster Presenters Present
    • Track: Advanced NSCLC
    • Presentations: 2
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      P3.02b-013 - Evaluation of Lung Specific GPA Score in Adenocarcinoma Patients with Brain Metastasis and EGFR Activating Mutation (ID 6178)

      14:30 - 14:30  |  Author(s): R. Gervais

      • Abstract

      Background:
      The lung specific GPA score is an index, commonly used for patients with non-small cell lung carcinoma (NSCLC) and brain metastasis (BM) in order to predict overall survival (OS) with the help of four easy-to-use items: age at the diagnosis of the brain metastasis; Karnofsky Performance Status (KPS), presence of extra cranial metastasis (ECM) and number of brain metastasis (Sperduto PW et al. J Clin Oncol 2012; 30:419‑25). However, this tool might not be appropriate to patients harboring EGFR activating mutations, which are known to have better prognosis than those with no activating mutations. The goal of our study was to determine if the Lung specific GPA score is adapted to population with these mutations.

      Methods:
      We retrospectively analyzed 108 Caucasians patients diagnosed with NSCLC between 2000 and 2014. Clinical features, systemic treatments (chemotherapy or EGFR tyrosine kinase inhibitors) and local brain treatment (Whole Brain Radiotherapy (WBRT) or surgery or Stereotactic Radiosurgery (SRS) were examined. OS were compared to the expected OS according to the lung specific GPA score as described by Sperduto.

      Results:
      Ninety-eight patients (91%) had EGFR activating mutations, whereas 10 (9%) were undetermined. 69% of them were nonsmokers. 77/108 patients (71.3%) were woman. 53/108 patients (49%) had BM: 30 patients had synchronous BM whereas 23 patients had metachronous BM. 20/53 patients (38%) were treated with WBRT. BM is still a burden for NSCLC patients harbouring EGFR activating mutations, (median OS 42 vs 25.5 months, p = 0.0052). OS from BM diagnosis was significantly superior in patients with EGFR activating mutations, compared to the expected OS in accordance with Sperduto’s GPA score (1): group 0-1 (11.5 months IC 95% [8.5-25.7] vs 3.02 months IC 95% [2.63-3.84]); group 1.5-2 (28 months IC 95% [24.3-NR] vs 5.49 months IC 95% [4.83-6.40]) (p = 0.026). Among EGFR activating mutations, OS were also significantly longer in group 1.5-2 than in group 0-1 (28 vs 11.5 months) (p = 0.026)

      Conclusion:
      Currently, Lung specific GPA is not accurate enough to estimate survival time for EGFR mutant patients. However, this tool is still reliable to distinguish different prognosis for patient with EGFR activating mutations, according to their GPA score. In conclusion, EGFR status modifies OS of patients and should be integrated in the items of the GPA score. These results should be validated in further prospective studies.

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      P3.02b-064 - Time to EGFR-TKI Treatment for Patients with Advanced NSCLC and EGFR Activating Mutation in a Tertiary Cancer Center (ID 6197)

      14:30 - 14:30  |  Author(s): R. Gervais

      • Abstract

      Background:
      IPASS was the first study to demonstrate that EGFR-TKI was a valuable option as first line treatment for patients with advanced NSCLC and EGFR activating mutations (Mok TS et al, N Engl J Med 2009, 361 :947-57). To apply this strategy, it is essential that the results of the molecular analysis are quickly available. The objective of our study is first to determine which proportion of patients started EGFR-TKI as first line treatment during the last ten years in our institute, and secondly to calculate the time interval from the initial biopsy to the start of EGFR-TKI treatment.

      Methods:
      All patients with advanced stage NSCLC positive for EGFR activating mutation treated in our Comprehensive cancer center (Centre Francois Baclesse, Caen, France) from March 2006 to Decembre 2015 were retrospectively included. Patients may have been directly referred by their general practionner or by pulmonary physicians who had usually performed the diagnostic biopsy. In such a situation, the histological analysis was performed outside of our hospital. Molecular analysis was performed in both cases in our hospital. Demographic data were collected, the place where the histological analysis was performed, and time from biopsy to the start of first systemic treatment (EGFR-TKI or chemotherapy).

      Results:
      Eighty-six patients were included. Sixty-nine (80%) patients received EGFR-TKI as first line treatment (80%) and 17 (20%) did not. Reasons will be presented at meeting. The median time from initial biopsy to EGFR-TKI treatment was 26 days. The median time from initial biopsy to EGFR-TKI treatment was different according to the place where patients had their biopsy performed: 18 days when the biopsy was performed in our center vs 36 days when it was performed outside.

      Conclusion:
      A high proportion of patients could start EGFR-TKI as first line treatment (80%). Median time to treatment was longer in our center than what has been reported in a recent national survey (Barlesi F et al, Lancet 2016, 387 :1415-26). However, when the biopsy was performed in our hospital, the time to treatment was identical (18 days). Therefore, our collective efforts have now to focus on shortening the time to perform the molecular analysis when the histological analysis is performed outside of our hospital.