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Maria Eugenia Olmedo



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    P1.12 - Small Cell Lung Cancer/NET (Not CME Accredited Session) (ID 944)

    • 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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      P1.12-20 - Overall Survival with Lurbinectedin Plus Doxorubicin in Relapsed SCLC. Results from an Expansion Cohort of a Phase Ib Trial. (ID 13245)

      16:45 - 18:00  |  Author(s): Maria Eugenia Olmedo

      • Abstract
      • Slides

      Background

      Lurbinectedin (PM01183, L) is a new anticancer drug that binds to DNA, inhibits transactivated transcription and modulates tumor microenvironment. Preclinical evidence of synergism was observed for PM01183 in combination with doxorubicin (DOX).

      a9ded1e5ce5d75814730bb4caaf49419 Method

      This multicenter, phase Ib clinical trial found impressive activity in second-line SCLC patients (ORR 67%). An expansion cohort with reduced dose (L 2mg/m2+ DOX 40mg/m2) was implemented to improve safety. SCLC patients <75 years with ECOG PS 0-1 and with no more than one prior chemotherapy line and stable brain metastases were included. DOX was interrupted after 10 cycles continuing with PM01183 alone. Primary G-CSF prophylaxis was not mandatory.

      4c3880bb027f159e801041b1021e88e8 Result

      27 patients treated. Males: 75%; median age: 64 (49-77) years; ECOG PS 0-1: 32%-68%; CNS involvement: 4%; bulky disease (>50 mm): 75%. 88% responded to 1st line (CR in 4%). Median chemotherapy-free interval (CTFI) was 3.5 months (m). 22% refractory (CTFI <30 days) 15% resistant (R) (CTFI 30-90 days) and 63% sensitive (S) (CTFI>90 days). Overall confirmed ORR was 37% (CR in 4%), and 53% (CR in 6%) in S patients. Overall median PFS was 3.4 m (95% CI, 1.5-6.2), being 1.5 m (95%CI, 0.8-3.4) in R pts, and 5.7 m in S patients. Overall survival (OS) data are summarized in the following table.

      OS

      Overall

      Resistant

      Sensitive

      Overall (n=27)

      7.9 m

      (95% CI: 4.9-11.5)

      4.9 m

      (95% CI: 2.3-6.7)

      11.5 m

      (95% CI: 6.0-16.6)

      Excluding CTFI<30days (n= 21)

      10.2 m

      (95% CI: 6.0-12.1)

      6.7 m

      (95% CI: 5.1-8.4)

      11.5 m

      (95% CI: 6.0-16.6)

      Data shown are median and 95% CI.

      Grade 4 neutropenia, anemia or thrombocytopenia appeared in 64%/0%/7% of patients, respectively, and febrile neutropenia (G3/4) occurred in 10%. Non-hematological toxicity was mild and mainly due to fatigue (G3=18%) and nausea (G3=7%).

      8eea62084ca7e541d918e823422bd82e Conclusion

      Lurbinectedin/DOX combination showed remarkable activity as second line in SCLC, especially in sensitive patients (CTFI>90 days). Activity is higher than that reported for CAV or topotecan. OS shows an outstanding improvement in this second-line setting, especially when excluding refractory pts. A phase III clinical trial (ATLANTIS, NCT02566993) is currently ongoing evaluating this combination in relapsed SCLC patients

      6f8b794f3246b0c1e1780bb4d4d5dc53

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    P3.01 - Advanced NSCLC (Not CME Accredited Session) (ID 967)

    • Event: WCLC 2018
    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/26/2018, 12:00 - 13:30, Exhibit Hall
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      P3.01-88 - Clinical and Molecular Analysis of Long-Term Survivors with Advanced Non-Small Cell Lung Cancer: A Multicenter Experience in Madrid (ID 12571)

      12:00 - 13:30  |  Author(s): Maria Eugenia Olmedo

      • Abstract
      • Slides

      Background

      Long survivors (LS) in non-small-cell lung cancer (NSCLC), defined as an overall survival (OS) greater than 2 years, are less than 10% in most series. Classical prognosis factors include stage, weight loss and ECOG, but there are other factors whose influence on the evolution of these patients is uncertain. Recently, different drugs targeted against EGFR, ALK and ROS 1 reach OS longer than 2 years in a limited number of patients (less than 20%). Immunotherapy in NSCLC has demonstrated very promising results with more LS compared to chemotherapy in first and second line setting. In this study, we have focused in the analysis of LS patients with advanced NSCLC EGFR wt (wild type) and ALK nt (non-translocated), defined as those with OS greater than 36 months, in 8 hospitals in Madrid.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      In this serie, first of all, we will try to make a clinical, histopathological and immunological characterization collecting data from clinical reports according to a previously defined information. In a second step, we will carry out a genetic analysis of these patient samples comparing to an opposite extreme short survivors (SS) samples (OS less than 9 months) from same centers. We used a NGS method of RNA-seq technology with the idea of identify differentiating profiles of gene expression between the two opposite populations with a later confirmation by RT-PCR in the rest of the tissue samples and liquid biopsy.

      4c3880bb027f159e801041b1021e88e8 Result

      We have obtained a differential transcriptome expression between samples from 6 LS and 6 SS, resulting 13 overexpressed and 42 under-expressed genes in LS comparing to SS transcriptome expression. Some of the genes involved in this profile belong to different families and cellular pathways: Secretin receptor, Surfactant Protein, Trefoil Factor 1, Serpin Family, Ca bindings protein channel and Toll like Receptor family. A further confirmation of this profile is carrying on by RT-PCR in the rest of the samples and liquid biopsy from the rest of the patients included in the study.

      8eea62084ca7e541d918e823422bd82e Conclusion

      We present the first data from a genetic analysis of a LS population with NSCLC EGFR wt (wild type) and ALK nt (non-translocated), obtaining a differential RNA profile

      6f8b794f3246b0c1e1780bb4d4d5dc53

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