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Virginia Calvo



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    OA01 - Improving Outcomes in Locoregional NSCLC I (ID 892)

    • Event: WCLC 2018
    • Type: Oral Abstract Session
    • Track: Treatment of Locoregional Disease - NSCLC
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/24/2018, 10:30 - 12:00, Room 107
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      OA01.05 - Phase II Study of Neo-Adjuvant Chemo/Immunotherapy for Resectable Stages IIIA Non-Small Cell Lung Cancer- Nadim Study-SLCG (ID 12907)

      11:15 - 11:25  |  Author(s): Virginia Calvo

      • Abstract
      • Presentation
      • Slides

      Background

      The combination of chemotherapy and immunotherapy (CT-IO) has a high response rate and longer survival in unselected patients (pts) with metastatic non-small cell lung cancer (NSCLC). There are no data about this combination in the neoadjuvant setting.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      A Phase II, single-arm, open-label multicenter study of local-advanced resectable stage IIIA N2-NSCLC adult patients with CT plus IO (nivolumab (NV)) followed by adjuvant treatment for 1 year. Neoadjuvant treatment: Three cycles of NV 360mg IV Q3W + paclitaxel 200mg/m2 + carboplatin AUC 6 IV Q3W. After completing neoadjuvant therapy, tumor assessment is performed in patients prior to surgery. Surgery is performed in the 3rd or 4th week after day 21 of the third cycle of neoadjuvant treatment. Adjuvant treatment: NV 240mg IV Q2W for 4 months and NV 480mg IV Q4W for 8 months (total one year) after surgical resection. The study aims to recruit 46 pts. The primary endpoint is Progression-Free Survival (PFS) at 24 months. Efficacy is explored using objective pathologic response criteria. We present preliminary data on patients that completed 3 cycles and underwent surgical resection.

      4c3880bb027f159e801041b1021e88e8 Result

      At the time of submission, 46 pts had been included and 20 underwent surgery. CT-IO was well-tolerated and surgery was not delayed in any patient. None of the pts was withdrawn from the study preoperatively due to progression or toxicity.

      Twenty surgeries had been performed and all tumors were deemed resectable. The overall clinical response rate was 5% complete (CR) and 65% PR. The pathological response evaluated after surgery: 13 cases (65.0%) achieved CR (CPR) (95% CI 40.8-84.6%), and 3 (15.0%) had a major pathologic response (MPR), defined as <10% viable tumor cells in the resection specimen. Considering both CPR and MPR, the overall response rate was 80.0% (95% CI 56.3-94.3%) and 60% of complete responses were unsuspected

      8eea62084ca7e541d918e823422bd82e Conclusion

      This is the first multicentric study testing CT-IO in the neoadjuvant setting with promising antitumor activity in locally advanced, potentially resectable NSCLC yields an unprecedented complete pathologic response rate. The data will be updated at the time of the congress. EudraCT Number: 2016-003732-20

      6f8b794f3246b0c1e1780bb4d4d5dc53

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    P1.15 - Treatment in the Real World - Support, Survivorship, Systems Research (Not CME Accredited Session) (ID 947)

    • Event: WCLC 2018
    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/24/2018, 16:45 - 18:00, Exhibit Hall
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      P1.15-24 - Small Cell Lung Cancer: Clinical Characteristics and Survival of a Spanish Cohort of 221 Patients (ID 13200)

      16:45 - 18:00  |  Presenting Author(s): Virginia Calvo

      • Abstract
      • Slides

      Background

      Lung cancer is the leading cause of death from cancer, of which 15% corresponds with small cell lung cancer (SCLC) subtype, directly related with tobacco. SCLC is the most aggressive subtype with an elevated percentage of metastatic patients at diagnosis and a poor prognosis.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      A cohort of 221 patients diagnosed of SCLC were retrospectively analyzed in our center between 2008-2016.

      Patient data was analyzed for baseline demographics and stage at diagnosis.

      Progression free survival (PFS) and overall survival (OS) analysis were made comparing SCLC stage at diagnosis.

      4c3880bb027f159e801041b1021e88e8 Result

      The median age at diagnosis was 64 years and 74% were male, of whom 33% were older than 70 years. Only 0.5 % were never smokers and 16% had history of other malignancies, mostly related with tobacco. At diagnosis, 67% were metastatic and 88% symptomatic.

      Complete baseline characteristics shown at Table 1.

      PFS was 13.5 versus 6.83 months in located versus metastatic disease (p = 0.000) and median OS was 21.2 versus 8.5 months comparing located and metastatic stage (p = 0.000).

      Kaplan-Meier curves shown at Image 1.

      Table 1. Complete baseline characteristics.
      BASELINE CHARACTERISTICS ALL PATIENTS (n=221)
      SEX 164 (74%) male; 57 (26%) female
      AGE AT DIAGNOSIS 64 years (IQR 58-71); 65 years (IQR 59-73) male; 61 years (IQR 55-68) female.
      PATIENTS OLDER THAN 70 YEARS 72 (33%); 60 males and 12 females
      SMOKING HABIT

      Smoker --> 137 (61.9%)

      Former smoker --> (> 365 days without smoking) à 81 (36.65%)

      Never smoker --> 1 (0.45%)

      Unknown --> 2 (0.9%)
      SMOKING PACK YEAR 58 pack/year; 60 pack/year male and 50 pack/year female

      AGE AT THE BEGINNING OF TOBACCO HABIT

      16 years
      STAGE

      Stage I --> 10 (5%)

      Stage II --> 8 (4%)

      Stage III --> 53 (24%)

      Stage IV --> 150 (67%)

      ECOG

      0-1--> 191 (86.4%)

      2--> 23 (10.4%)

      3--> 7 (3.2%)

      CARDIOPULMONARY DISEASE

      COPD 23%

      HBP 47%

      DM 25%

      DL 43%

      Cardiopathy 19%
      HISTORY OF OTHER MALIGNANCIES 16%, most frequent: bladder cancer 7 (20.6%); head and neck cancer 6 (17.7%); lung cancer 4 (11.8%)
      FAMILIAR HISTORY OF LUNG CANCER 39%
      SYMPTOMS AT DIAGNOSIS Cough 42%; weight loss 30%; pain 28%; dyspnoea 27%; asthenia 21%
      TREATMENT

      8.2% palliative treatment

      91.8% active treatment (98.8% standard treatment with platinum-based chemotherapy and 1.2% clinical trial)
      PROGRESSION FREE SURVIVAL

      13.5 (IQR 7.4-40.8) months in located and 6.8 (IQR 4.8-10.2) in metastatic disease compared with (p = 0.000)

      OVERALL SURVIVAL

      21.2 (IQR 10.8-39.6) months in located and 8.5 (IQR 3.9-15.5) in metastatic disease with (p = 0.000)

      12 AND 24-MONTHS OVERALL SURVIVAL

      Located: 73% and 42% respectively

      Metastatic: 33% and 15% respectively

      overall survival.png

      8eea62084ca7e541d918e823422bd82e Conclusion

      SCLC is mostly diagnosed at metastatic stage, but even in located disease prognosis is poor, so investigation is needed to improve PFS and OS.

      6f8b794f3246b0c1e1780bb4d4d5dc53

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