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Joseph Friedberg



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    MA05 - Update on Clinical Trials and Treatments (ID 123)

    • Event: WCLC 2019
    • Type: Mini Oral Session
    • Track: Mesothelioma
    • Presentations: 1
    • Now Available
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      MA05.10 - Pembrolizumab in the Treatment of Patients with Malignant Pleural Mesothelioma Following Progression After Initial Chemotherapy (Now Available) (ID 2788)

      13:30 - 15:00  |  Author(s): Joseph Friedberg

      • Abstract
      • Presentation
      • Slides

      Background

      Checkpoint inhibitor (CPI) therapies have demonstrated clinical benefit in patients (pts) with malignant pleural mesothelioma (MPM) and are now included in the NCCN guidelines as an acceptable treatment option. Herein, we report our initial experience treating pts with MPM in the palliative second line or greater setting.

      Method

      Between January 2016 and November 2018, 74 pts with biopsy proven MPM were treated with pembrolizumab every three weeks until confirmed disease progression or unacceptable toxicity. Progression-free survival (PFS) and OS were defined as the time from first pembrolizumab dose to recurrence and death, respectively, or to last contact. Response rates (RR) were measured by a dedicated thoracic radiologist using modified RECIST 1.1 criteria. Adverse events were routinely recorded/scored at each follow up visit. according to CTCAE 4.0 with level of attribution to pembrolizumab.

      Result

      Demographics of the 74 pt cohort are shown in table 1. Twently-nine (39%) of pts experienceda total of 39 grade 1-2 adverse events, possibly or definitely related to therapy (Table 2). There was one grade 4pneumonitis that resulted in new requirement for oxygen, which resolved with steroids; and one patient experienced leukoencephalopathy that resulted in death. The overall response rate (including only partial responses by modified RECIST 1.1) for the entire cohort was 26%. Median progression free survival and overall survival for the entire cohort were 2.8 months and 7.9 months, respectively.

      Table 2: Adverse Events

      CTCAE 4.0 Grade

      AE Description

      1-2

      3-4

      5

      hypothroid

      5

      arthralgias

      8

      colitis

      3

      diarrhea

      2

      lip lesion

      1

      pneumonitis

      2

      1

      SICCA syndrome

      1

      thrombocytopenia

      1

      dermatitis

      1

      hypopigmentation

      1

      nephritis

      1

      fatigue

      1

      abdominal pain

      1

      uveitis

      1

      transaminitis

      1

      elvated alk phos

      1

      leukoencephalopathy

      1

      pruritis

      3

      hypercalcemia

      3

      rash

      2

      Table 1: Demographics

      Age in Years

      median (range)

      Min

      73

      (52-92)

      Gender

      Patients (N=74)

      Female

      29

      39%

      Male

      55

      74%

      Histology

      Epithelial

      58

      78%

      Sarcomatoid

      6

      8%

      Biphasic

      10

      14%

      # of chemotherapy courses

      0

      3

      4%

      1

      42

      57%

      2

      22

      30%

      3-4

      7

      9%

      # of radiotherapy courses

      0

      42

      57%

      1

      30

      41%

      2-3

      6

      8%

      Surgical Resection

      Have EPD

      24

      32%

      Did not have EPD

      50

      68%

      PDL1

      Negative

      21

      28%

      Positive

      12

      16%

      Not Determined

      42

      57%

      Conclusion

      Pembrolizumab in the Tx of MPM was reasonably well tolerated in this large, single institution experience. RR, PFS and OS appear remarkably similar to recent published data from a registry study of off-label use of pembrolizumab in pts with MPM in Switzerland and Australia (include reference). Ongoing studies include analysis of PDL-1 and other potential immunotherapy response biomarkers.

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    P1.06 - Mesothelioma (ID 169)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Mesothelioma
    • Presentations: 2
    • Now Available
    • Moderators:
    • Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
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      P1.06-14 - Posterior Intercostal Lymph Node Positivity as a Prognostic Indicator of Overall Survival in Resectable Malignant Pleural Mesothelioma  (Now Available) (ID 838)

      09:45 - 18:00  |  Author(s): Joseph Friedberg

      • Abstract
      • Slides

      Background

      Posterior intercostal lymph nodes (PICLN), located between posterior ribs and near the spine, are characterized as N1 disease and not typically sampled in resectable malignant pleural mesothelioma (MPM). It has been noted that positive PICLN were associated with decreased overall survival (OS), suggesting their proposed characterization as N2 disease. We seek to validate their significance in an independent patient cohort.

      Method

      This single institution retrospective study included 43 MPM patients who underwent surgery, largely extended pleurectomy/decortication, from March 2015 to February 2019. During surgery, accessible PICLN were sampled for pathologic testing. Patients’ demographic information, clinical history, and surgical pathology were collected via review of medical records after IRB approval. To examine associations between OS and number of PICLN, Pearson correlation coefficients were performed. Survival analysis was performed using log-rank test and Cox regression model.

      Result

      Patient demographics and clinical characteristics are described in Table 1. Pathologic positivity of PICLN was significantly associated with stage (Fisher exact P=0.006). 11.6% of patients demonstrated disease in all sampled PICLN (all positive PICLN) and 4.6% of patients presented with solely PICLN involvement. Compared to patients with no nodal involvement, patients with all positive PICLN were associated with a shorter overall survival (p=0.08). In a Cox regression model that adjusted for stage, all positive PICLN were associated with an increased risk of death (HR=3.13, P=.048), while the presence of any positive PICLN was not significant (HR=2.03, p=0.23).

      table 1_final .jpg

      km curve_final .jpg

      Conclusion

      In addition to validating the negative prognostic impact of PICN, our analysis suggests that survival may be more so dependent on the degree of PICLN involvement than positivity itself. However, given the limited number of patients with solely PICLN positive lymph nodes, the role of PICLN as an independent prognosticator cannot be confidently determined and larger studies are needed.

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      P1.06-20 - Malignant Pleural Mesothelioma: Survival Meta-Analysis from 15 Years of a Standard Systemic Therapy (ID 2848)

      09:45 - 18:00  |  Presenting Author(s): Joseph Friedberg

      • Abstract
      • Slides

      Background

      Malignant pleural mesothelioma is a rare malignancy with an annual incidence of 3,000 cases in the US and is still considered incurable. The standard of care for this cancer, a combination of pemetrexed and a platinum drug, was established in 2003 as the result of a landmark study that reported a median overall survival of 12.1 months for this combination in patients not eligible for surgery. The aim of the current analysis was to determine if there has been a change in the outcome for this population in the past 15 years.

      Method

      A PubMed search was performed and 9 prospective, randomized or single arm (minimum n=50), trials were selected. All studies included patients treated using pemetrexed in combination with platimun as front line therapy in unresectable mesothelioma patients. Average and weighted average OS were calculated and also corrected per the reported odds ratio for survival between the epithelioid and non-epithelioid histologies.

      Result

      The average OS was 12.9 months and the weighted average OS was 13.3 months (range: 8.5 – 16.1 months). The two studies showing the highest median OS (MAPS and LUME-meso) had a higher percentage of tumors with epithelioid histology, which could explain their favorable outcome. Adjusting the average OS using the reported odds ratios for survival between epithelioid and non-epithelioid histologies eliminated the superior outcome in these studies. Furthermore, correcting average survival per the original ratio between tumor histologies for all studies included in the meta-analysis showed an average and weighted average OS lower than 13 months.

      Conclusion

      This analysis strongly supports the contention that survival results for nonoperative patients with mesothelioma should be stratified by histology, epithelioid versus nonepithelioid, similar to the trend in the surgical mesothelioma literature. When factoring in histology, it appears that overall advances in patient care and additional treatments have not significantly changed the overall survival for nonoperative mesothelioma patients in the last 15 years. This meta-analysis underscores the desperate need for new and innovative treatments for this cancer.

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    WS02 - Mesothelioma Workshop (Ticketed Session) (ID 102)

    • Event: WCLC 2019
    • Type: Workshop
    • Track: Mesothelioma
    • Presentations: 1
    • Now Available
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      WS02.06 - Surgery Section: A Proposed System Toward Standardizing Surgery-Based Treatments for Malignant Pleural Mesothelioma, From the Joint NCI-IASLC-MARF Taskforce (Now Available) (ID 3835)

      08:00 - 11:30  |  Presenting Author(s): Joseph Friedberg

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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