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Nava Siegelmann-Danieli



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    EP1.01 - Advanced NSCLC (ID 150)

    • Event: WCLC 2019
    • Type: E-Poster Viewing in the Exhibit Hall
    • Track: Advanced NSCLC
    • Presentations: 1
    • Now Available
    • Moderators:
    • Coordinates: 9/08/2019, 08:00 - 18:00, Exhibit Hall
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      EP1.01-21 - Time on Treatment of First-Line PD-1 Inhibitor Monotherapy for Metastatic Non-Small Cell Lung Cancer Patients: Real-World Experience Data (Now Available) (ID 764)

      08:00 - 18:00  |  Presenting Author(s): Nava Siegelmann-Danieli

      • Abstract
      • Slides

      Background

      Clinical trials have established the role of immune checkpoint inhibitors for metastatic NSCLC treatment, but real-world data are limited. We describe the first report of a prospective study on real-world time on treatment (rwTOT) for first-line (1L) anti-PD-1 monotherapy in metastatic NSCLC in a 2.3 million member public health provider in Israel.

      Method

      Newly diagnosed stage IV NSCLC patients who initiated 1L anti-PD-1 therapy in 2017 were identified from the national cancer registry. rwTOT was defined as the length of time between first and last administration date of anti-PD-1 therapy. Patients were considered discontinued if they had a record of next line of therapy, or death, or whose last activity date was ≥120 days from the last administration date; others were censored. The Kaplan-Meier (KM) median and restricted mean (rMean) rwToT were estimated. Jun 2018 data cutoff was utilized to allow minimum 6 months follow-up.

      Result

      A total of 63 patients initiated 1L anti-PD-1 monotherapy; of these, 59 were PD-L1 TPS≥50%, one was TPS<50% and 3 unknown. This cohort comprised of 97% pembrolizumab monotherapy, 65% males, median age=59 yrs, 76% ever smokers, 71% adenocarcinomas, 11% brain metastases, and 62%/14%/24% with 0-1/2-4/unknown ECOG status. The median rwToT was 4.6 (95% CI 2.8-12.8) mo and estimated rMean at 24 months using parametric extrapolation was 10.9 mo (4.3-16.8). Patients with ECOG 0-1, n=39, had a median rwTOT of 10.6 mo (1.9-19.2).

      Time on treatment for anti-PD-1 monotherapy

      1L anti-PD-1 Monotherapy

      N=63

      1L Pembrolizumab Monotherapy

      N=61

      N discontinued (%)

      38 (60.3)

      36 (59.0)

      KM Median rwToT (95% CI)

      4.6 (2.8-12.8)

      5.0 (3.5-NE)

      rMean rwToT @ 12 months (95% CI)

      6.5 (5.3-7.7)

      6.7 (5.4-7.9)

      Parametric (extrapolated) rMean rwToT @ 24 months (95% CI)

      10.9 (4.3-16.8)

      [Gompertz]

      11.2 (4.4-17.1)

      [Gompertz]

      6 months on treatment rate, % (95% CI)

      44.1 (31.6-55.9)

      45.5 (32.7-57.5)

      12 months on treatment rate, % (95% CI)

      39.7 (27.3-51.9)

      41.0 (28.3-53.4)

      Conclusion

      The results of this unselected real-world cohort of metastatic NSCLC patients treated with 1L anti PD-1 monotherapy show that rwTOT rates compare favorably with published data from clinical trials and other real-world studies.

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    EP1.12 - Small Cell Lung Cancer/NET (ID 202)

    • Event: WCLC 2019
    • Type: E-Poster Viewing in the Exhibit Hall
    • Track: Small Cell Lung Cancer/NET
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/08/2019, 08:00 - 18:00, Exhibit Hall
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      EP1.12-21 - Treatment Patterns and Prognostic Factors in Small-Cell Lung Cancer Patients in Israel – Real World Analysis of a Health Services Database (ID 769)

      08:00 - 18:00  |  Presenting Author(s): Nava Siegelmann-Danieli

      • Abstract
      • Slides

      Background

      Small-Cell Lung Cancer (SCLC) is an aggressive smoking-associated malignancy, with rapid growth and early metastatic dissemination that accounts for 10-15% of all lung cancers. Data on current epidemiology and clinical aspects of the disease in Israel are lacking.

      In this observational study, we analyzed treatment patterns and prognostic factors in patients with SCLC in Maccabi Healthcare Services (MHS), a public integrated care organization in Israel.

      Method

      Patients with newly diagnosed, histologically confirmed SCLC who initiated systemic anti-cancer treatment between 2011 to 2017 were identified from the MHS cancer registry. Their demographic, clinical and treatment data were retrospectively analyzed.

      Result

      235 SCLC patients were identified; 61% male, median age 64 years (IQR: 58, 70), 95% ever smokers, 62% had extensive stage disease (ES), 11% had brain metastases and 60% had 0-1 ECOG performance status (PS), all at treatment initiation.

      First-line treatment was platinum-etoposide regimen for the whole cohort. 107 of 235 patients (46%) continued to 2nd-line therapy and 29 patients (12%) received 3rd-line regimen.

      Median overall survival (OS) for the study population was 11.8 months. Patients with limited stage disease (LS) had a significant longer survival than those with ES (23.5 vs 9.1 months, P<0.001). In a multivariable model for all-cause mortality, males had a HR of 1.59 (95% CI 1.14-2.21, P=0.006) compared to females, and patients with ES had a HR of 4.76 (95% CI 1.37-16.49, P=0.014) compared to LS. Additionally, risk of death increased significantly with ECOG PS at presentation (ECOG PS 2 vs 0-1, HR=1.49 (95% CI 0.93, 2.40), ECOG PS 3-4 vs 0-1, HR=3.29 (95% CI 1.10, 9.84)).

      For LS disease, female sex and concurrent chemo-radiation were associated with significantly longer survival.

      Median survival after initiation of 2nd line was significantly longer for those re-challenged with platinum-based regimen compared with those switched to topotecan: 9.1(95% CI 6.1-12.1) vs. 4.5 months (95% CI 3.3-5.7), P=0.001. Results were not affected by platinum sensitivity (i.e. interval from end of first-line to beginning of second line ≥3 months). A multivariable model considering 2nd line patients and incorporating age, sex, stage, PS and brain metastasis at diagnosis confirmed these results.

      Conclusion

      Overall survival for SCLC patients in a real world setting was found to be similar to those reported in clinical trials. Extent of disease, sex and PS were significantly associated with prognosis. Re-challenge of platinum-based doublet was associated with longer OS compared to switching to topotecan treatment.

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