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T. Morán



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    P1.01 - Advanced NSCLC (ID 757)

    • Event: WCLC 2017
    • Type: Poster Session with Presenters Present
    • Track: Advanced NSCLC
    • Presentations: 1
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      P1.01-062 - KRAS Mutations (KRAS-Mut) and antiPD1/PDL1 Therapy in a Cohort of Lung Cancer (LC) Patients (P). Experience from a Single Institution (ID 9548)

      09:30 - 16:00  |  Author(s): T. Morán

      • Abstract
      • Slides

      Background:
      AntiPD1/antiPDL1-based immunotherapy has changed dramatically the prognosis of LC p with a substantial improvement of overall survival (OS) and even presenting long lasting responses in a subset of p. Several factors have been associated with the likelihood of better survival, which include the smoking exposure and the presence of KRAS-mut according to data from randomized clinical trials that compared chemotherapy to these immunotherapeutic agents.

      Method:
      By reviewing the clinical records of all stage IV LC p treated with antiPD1/antiPDL1 agents, we identified p with KRAS-mut and evaluated their clinical outocomes.

      Result:
      129 p with advanced NSCLC were treated with nivolumab, pembrolizumab or atezolizumab (65.1%, 17.1% and 17.8 %, respectively) from November 2013 to April 2017. 14 p were identified as adenocarcinomas with KRAS-mut (20.3%) of all non-squamous NSCLC (60p), once squamous cell carcinoma (39 p), p with Kras status unknown (15p), other reasons (6p) were excluded. KRAS-mut subgroup include 28.5% of female, median (m) age of 62.3 years, 92.8% of ever smokers, and PS0-1. The immunotherapy consisted of nivolumab (71.4%) and pembrolizumab and atezolizumab (14.3% each) and was administered as 1[st], 2[nd] and >3[rd] therapy in 7.1,78.6 and 14.3% of p, respectively. 71.4% of p responded to therapy (64.3% partial response) and in 42.8% of p this response lasted >12 months (range 12-32). For this cohort of p m progression-free survival was 7.65 months and OS was 58 months. At the time of analysis 57.1% were still receiving treatment.

      Conclusion:
      Although the number of p is small, KRAS-mut p represent a subgroup of p that seem to substantially benefit from antiPD1/PDL1 agents in terms of both response and survival.

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    P1.05 - Early Stage NSCLC (ID 691)

    • Event: WCLC 2017
    • Type: Poster Session with Presenters Present
    • Track: Early Stage NSCLC
    • Presentations: 1
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      P1.05-015 - Major Pathological Response as a Predictive Value of Survival in Early-Stage NSCLC  After Chemotherapy: Cohort of NATCH Phase III Trial (ID 9893)

      09:30 - 16:00  |  Author(s): T. Morán

      • Abstract

      Background:
      In early-stage non-small cell lung cancer (NSCLC) patients, randomized phase III NATCH trial reported no statistically differences in disease-free survival (DFS) or overall survival (OS) with the addition of preoperative or adjuvant chemotherapy to surgery. In pre-operative arm, those patients who achieved a complete response obtained a benefit in 5-year DFS rate (59% vs. 38%). Recently, major pathological response (MPR) to preoperative therapy (10% or less of residual viable tumor after preoperative chemotherapy) has reported as surrogate marker of OS. We assess to validate this prognostic factor in a cohort of patients included the NATCH trial.

      Method:
      Retrospectively MPR was collected in a cohort of 57 early-stage NSCLC patients treated in the preoperative arm into NATCH trial from 2 institutions. OS according to MPR was analysed (long-rank test) in the whole population and by histologic subtype

      Result:
      In this cohort, median age was 67 years (47-78), 48 (84%) were males, 26 (46%) squamous subtype. By stage according to 6[th] TNM: 9 (16%) stage IA, 35 (61%) stage IB, 12 (21%) stage IIB and 1 (2%) stage IIIA. All except 3 completed 3 cycles of preoperative treatment. Surgical procedures: 81% lobectomies or bi-lobectomies, 14% pneumonectomies, 5% no surgery. In the whole population, there was a trend toward 5-year OS benefit among those patients with MPR (84.6% vs. 58.5%, p=0.106). According to histologic subtype, squamous tumours with MPR had significantly better 5-year OS (100% vs. 47.1%, p=0.026), but not in adenocarcinoma subtype (66.7% vs. 66.7%, p=0.586).

      Conclusion:
      MPR is a prognostic value in squamous NSCLC patients who receive preoperative chemotherapy. Validation in extended cohort merits further evaluation.

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    P2.07 - Immunology and Immunotherapy (ID 708)

    • Event: WCLC 2017
    • Type: Poster Session with Presenters Present
    • Track: Immunology and Immunotherapy
    • Presentations: 1
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      P2.07-041 - Immuno-Related Cutaneous Adverse Events (IRcutAEs) in Patients (P) with Advanced NSCLC: A Single-Institution Prospective Study (ID 9828)

      09:30 - 16:00  |  Author(s): T. Morán

      • Abstract
      • Slides

      Background:
      Despite the impressive benefits of the immune checkpoint blockade in NSCLC, its use can be hampered by the occurrence of serious adverse events. IRcutAEs are underestimated and poorly described according to data from the clinical trials.

      Method:
      Before starting immunotherapy, all NSCLC p were prospectively referred to the Dermatology Department. Periodic monitoring visits were also scheduled for each p, in order to describe the IRcutAEs and their treatments. The study included data from all consecutive NSCLC p treated with immunotherapy in our institution.

      Result:
      Since May 2016, 50 p were recruited for the present study. According to clinical characteristics; 18 p had squamous histology, 43 p received treatment as second line or further, and 36 p were treated with nivolumab. During the follow-up period, 15 p (30%) developed IRcutAEs. Lichenoid reactions were the most common AE (9 p, 60%), but some specific conditions were also observed, such as a cutaneous lupus (1 p, 6.6%) or an eruptive pseudoangiomatosis (1 p, 6.6%).

      Conclusion:
      IRcutAEs are common during antiPD1-PDL1 therapy. By offering a dermatological follow-up, the diagnosis and management of this type of toxicity can be provided to NSCLC p initiating immunotherapy.

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    PL 02 - Presidential Symposium including Top 3 Abstracts and James Cox Lectureship Award Presentation (ID 585)

    • Event: WCLC 2017
    • Type: Plenary Session
    • Track: Early Stage NSCLC
    • Presentations: 1
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      PL 02.04 - SCAT Ph III Trial: Adjuvant CT Based on BRCA1 Levels in NSCLC N+ Resected Patients. Final Survival Results a Spanish Lung Cancer Group Trial (ID 9523)

      08:15 - 09:45  |  Author(s): T. Morán

      • Abstract
      • Presentation
      • Slides

      Background:
      Postop platinum-based CT is considered standard of care in resected NSCLC with lymph node involvement. BRCA1 and BRCA2 are important DNA repair factors primarily involved in the repair of double strand DNA breaks. BRCA-1 functions may act as a differential regulator of response to cisplatin (Cis) and antimicrotubule agents. BRCA1 defficiency enhances Cis resistance and loss of BRCA1 function is associated to sensitivity to DNA-damaging CT and may also be associated with resistance to spindle poisons.

      Method:
      SCAT randomized phase III multicenter trial tests individualized optimal CT based on expression of BRCA1. After surgery patients (p) with St II and Iii NCSLC were random 1:3 to control arm (3 cycles Cis-Docetaxel) or to experimental arm with treatment assigned according BRCA1 expression levels (low levels: Cis-Gemcitabine; intermediate levels: Cis-Doc; high levels: Docetaxel alone). Stratification factors: N1 vs N2; age < or > 65 y; non-Squamous vs Squamous (Sq) histology; lobectomy vs pneumonectomy). Planned PORT in N2. Primary end-point OS. Secondary end-points DFS, toxicity profile (CTCAE v 3.0) /compliance, recurrence pattern. Statistical hypothesis: 5y survival rate control group (45%) could be increase 20% in experimental arm.

      Result:
      From June/2007 to May/2013, a total of 591 p were screened and 500 of them were randomized in the study, 108 in control arm, 392 in experimental arm. In experimental arm 110 p received Cis-Gem, 127 Cis-Doc and 110 Doc alone. There were no significant differences between arm for known prognostic factors: Median age 64 y; 79% males, 21% females; 43% Sq, 49% Adenoca, 8% others; 57% former smokers, 32% current smokers, 11% never smokers; pneumonectomy 26%; N1 58%, N2 48%. Median tumor size 4.4 cm (0.8-15.5 cm). Median mRNA BRCA1 levels 15.78 (0.73-132). Mean BRCA1 levels 6.95 in Adenoca vs 20.29 in Sq (p<0.001). Compliance of CT was better in experimental arm with less dose-reductions and without differences according extent of surgery. CT compliance was lower in patients older 70 y. Median PFS: 38.7 m (control), 32.2 m Cis-Gem, 34.3 m Cis-Doc and 41 m Doc. At 5 years, event-free rate is 54% in control arm and 56% in experimental arm and median OS 73.3 m (control) vs 77.5 m (exp) (p=0.75). In experimental arm: Docetaxel alone 80.2 m, Cis-Doc 80.5 m and Cis-Gem 74 m.

      Conclusion:
      Higher survival than expected in patients with lymph node involvement. No significant difference in survival achieved with the experimental arm. In case of high levels BRCA CT treatment without cisplatin is not detrimental. (Eudract:2007-000067-15; NCTgov: 00478699)

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