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Giovanni Luca Ceresoli



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    Lunch & Poster Display session (ID 58)

    • Event: ELCC 2019
    • Type: Poster Display session
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 4/11/2019, 12:30 - 13:00, Hall 1
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      199P - Safety meta-analysis of clinical trials delivering TTFields to the upper torso (ID 554)

      12:30 - 13:00  |  Presenting Author(s): Giovanni Luca Ceresoli

      • Abstract
      • Slides

      Background

      Tumor Treating Fields (TTFields), a non-invasive, loco-regional, antimitotic treatment approved for glioblastoma (GBM), are delivered via transducer arrays to tumor region. Localized dermatitis underneath the arrays were main adverse events (AEs) reported in phase 3 GBM trials. The safety of TTFields was analyzed in two phase I-II studies in non-small-cell lung cancer (NSCLC) [EF-15, NCT00749346] and malignant pleural mesothelioma (MPM) [STELLAR, NCT02397928].

      a9ded1e5ce5d75814730bb4caaf49419 Methods

      TTFields studies in this pooled analysis were EF-15 (n=41, advanced NSCLC; plus pemetrexed) and STELLAR (n=80, MPM; plus platinum and pemetrexed). TTFields were applied 12 - 18 hours/day at a frequency of 150 kHz. All patients received standard of care systemic chemotherapy for their disease in addition to TTFields. Severity and frequency of AEs, and association with TTFields treatment were evaluated (CTCAE criteria version 4.0).

      20c51b5f4e9aeb5334c90ff072e6f928 Results

      Patients were aged 27-78 years: STELLAR: 67 (27-78) and EF-15: 63 (44-78), ECOG 0-1; 7 patients in EF-15 had ECOG 2. The incidence of grade 1-2 gastrointestinal (GI) toxicities was 35%. The most common low grade GI toxicities were: nausea (17%), vomiting (6%), constipation (10%) and diarrhea (6%). Grade 1-2 general disorders (16% fatigue and 11% asthenia) were common. Dyspnea Grade 1-2 (12%) and Grade 3-4 (5%) were considered related to standard chemotherapy or underlying disease. Grade 1-2 cardiovascular AEs were 7%; one case of severe arrhythmia (atrial flutter) was unrelated to TTFields. The only common TTFields-related adverse event was dermatitis below the transducer arrays. 59% patients had dermatological AEs: 53% Grade 1-2 dermatitis, 4% grade 3 dermatitis and 11% Grade 1-2 pruritus.

      fd69c5cf902969e6fb71d043085ddee6 Conclusions

      Treatment of solid tumors with TTFields 150 kHz to the thorax did not result in serious AEs or treatment-related pulmonary, cardiac, hematological or gastrointestinal toxicities. Expected dermatological toxicity beneath the device transducer arrays was seen in 59% patients, and resolved after a short treatment break or termination of treatment. These safety results and encouraging survival outcomes support the potential use of TTFields therapy in NSCLC and mesothelioma.

      b651e8a99c4375feb982b7c2cad376e9 Clinical trial identification

      NCT00749346 and NCT02397928.

      7a6a3ffa2dadc03a6151ee2c4d6fa383 Legal entity responsible for the study

      Novocure.

      213f68309caaa4ccc14d5f99789640ad Funding

      Novocure.

      682889d0a1d3b50267a69346a750433d Disclosure

      G.L. Ceresoli: Travel support: Novocure. All other authors have declared no conflicts of interest.

      cffcb1a185b2d7d5c44e9dc785b6bb25

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    Mini Oral session I (ID 60)

    • Event: ELCC 2019
    • Type: Mini Oral session
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 4/11/2019, 08:00 - 08:50, Room A
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      196O - STELLAR: Final updated results of a phase II trial of TTFields with chemotherapy for unresectable malignant pleural mesothelioma (ID 567)

      08:00 - 08:50  |  Presenting Author(s): Giovanni Luca Ceresoli

      • Abstract
      • Presentation
      • Slides

      Background

      Tumor Treating Fields (TTFields), an anti-mitotic, regional treatment approved for glioblastoma utilizes low intensity, alternating electric fields delivered non-invasively to the tumor using a portable medical device. In-vitro, human mesothelioma cells were highly susceptible to TTFields.

      a9ded1e5ce5d75814730bb4caaf49419 Methods

      The trial accrued 80 patients with unresectable, previously untreated mesothelioma. Patients were treated with continuous 150 kHz TTFields (>18h/day) in combination with pemetrexed and cisplatin or carboplatin. Inclusion criteria included ECOG PS of 0-1 and pathologically proven mesothelioma. The primary endpoint was overall survival (OS). A visual analog scale was used to assess EOCG performance status and cancer-related pain assessed until disease progression. The sample size provided 80% power with two-sided alpha of 0.05 to detect an increase in median OS of 5.5 months compared to historical controls (Vogelzang, JCO 2003).

      20c51b5f4e9aeb5334c90ff072e6f928 Results

      All 80 patients had a minimum follow up of 12 months. Median age was 67 (range 27-78), 84% were male and 44% (35 patients) had an ECOG PS of 1. 66% (53 patients) had epithelioid histology, similar to the Vogelzang study. Median OS was 18.2 months (95% CI 12.1-25.8) versus 12.1 months in the historical control. Median OS for epithelioid patients was 21.2 months (95% CI 13.2-25.8). ECOG score was stable during the first year of follow up. Median time to deterioration in performance status was 13.1 months. Average score of pain was lower compared to baseline during the first 7 months of the treatment and was higher later on the study, with a median time to a clinical significant 33% increase in pain of 8.4 months. No device-related serious adverse events (AEs) were reported. Expected TTFields-related dermatitis was reported in 46% (37 patients). Four patients (5%) had grade 3 dermatitis.

      fd69c5cf902969e6fb71d043085ddee6 Conclusions

      The study met primary endpoint of significant extension of overall survival in previously untreated mesothelioma patients. TTFields was not associated with a decrease in performance status or an increase in pain for the duration of TTFields use. TTFields in combination with chemotherapy is efficacious in malignant pleural mesothelioma compared to historical data.

      b651e8a99c4375feb982b7c2cad376e9 Clinical trial identification

      NCT02397928.

      7a6a3ffa2dadc03a6151ee2c4d6fa383 Legal entity responsible for the study

      Novocure.

      213f68309caaa4ccc14d5f99789640ad Funding

      Novocure.

      682889d0a1d3b50267a69346a750433d Disclosure

      G.L. Ceresoli, F. Grosso: Travel funds: Novocure. All other authors have declared no conflicts of interest.

      cffcb1a185b2d7d5c44e9dc785b6bb25

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