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W. Engel-Riedel



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    MO25 - NSCLC - Combined Modality Therapy II (ID 112)

    • Event: WCLC 2013
    • Type: Mini Oral Abstract Session
    • Track: Mesothelioma
    • Presentations: 1
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      MO25.03 - Safety data from a Phase II study of pemetrexed (PEM) and cisplatin (CIS) with concurrent thoracic radiation after PEM+CIS induction in patients with unresectable locally advanced (LA) Non Squamous Non-Small Cell Lung Cancer (NS-NSCLC) (ID 226)

      10:40 - 10:45  |  Author(s): W. Engel-Riedel

      • Abstract
      • Presentation
      • Slides

      Background
      This single-arm multicenter Phase II study investigated the efficacy and safety of PEM+CIS induction chemotherapy (CT) followed by full-dose PEM+CIS with concurrent radiotherapy (RT) in patients with LA NS-NSCLC. The 1-year progression-free survival (PFS) rate (primary endpoint) was 51.3% (ESMO 2013). Here, we report the safety data for induction CT and concurrent CT+RT.

      Methods
      Patients with unresectable Stage IIIA/IIIB NS-NSCLC (AJCC Version 6), ECOG-PS 0-1 and forced expiratory volume (FEV) >50% of predicted normal FEV received 2 cycles of PEM 500mg/m[2] + CIS 75mg/m[2] on Day 1, every 21 days. Patients who did not progress, with no residual neurological toxicity >Grade (G)2, ECOG-PS 0-1 and lung V20<35% were candidates to receive 2 cycles of the same full-dose PEM+CIS regimen with concurrent thoracic RT of 2Gy/fraction, 5d/week for 7wks (66Gy total). All patients received vitamin supplementation/dexamethasone prophylaxis as per PEM-label.

      Results
      90 patients were enrolled in 4 European countries, 75 (83.3%) completed induction CT and started concurrent CT+RT. Characteristics of 90/75 patients starting induction/concurrent therapy: median age 61/62yrs, male 57%/53%, ECOG-PS 0 66%/65%, mean(SD) FEV 2.3(0.62)/2.3(0.59)L, adenocarcinoma 90%/92%, Stage IIIA 36%/37%. 63 of 75 patients starting concurrent CT+RT (84.0%) received all 4 CT cycles and full dose RT. Median PEM+CIS dose intensities were 90-92% during induction and >97% during concurrent CT+RT, median RT dose was 66Gy (only 6 patients <60Gy). One patient died from study-drug-related toxicity (enteritis) during Cycle 4. Four patients discontinued due to non-fatal drug- or radiation-related adverse events (AEs), 1 on induction CT (renal failure), 3 on concurrent CT+RT (hypoacusis, 2 patients with radiation esophagitis). During induction/concurrent therapy, 8 of 90 patients (8.9%)/12 of 75 patients (16.0%) had ≥1 CT dose delay due to AEs, mainly neutropenia (n=5/6). 2/6 patients (2.2%/8.0%) required CT dose reductions. 13 of 75 patients (17.3%) experienced AEs requiring interruption of radiation, mainly radiation esophagitis (9.3%). Common G1-4 toxicities are presented in the table. 41.3% of patients reported ≥1 G3/4 toxicity during concurrent CT+RT, mainly esophagitis (12.0%), neutropenia (10.7%) and leukopenia (9.3%). G3 mucositis, G3 dysphagia and G3 acute pneumonitis were each reported by 1 patient (1.3%); 6 patients (8.0%) required blood-cell transfusions. Figure 1

      Conclusion
      PEM+CIS induction CT followed by full-dose PEM+CIS with concurrent thoracic RT was well tolerated in this study. Incidences of both G3/4 and low-grade toxicities were low, not only during PEM+CIS induction CT, but also during the subsequent 2 cycles of full-dose PEM+CIS CT with concurrent thoracic RT.

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    P1.11 - Poster Session 1 - NSCLC Novel Therapies (ID 208)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 1
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      P1.11-009 - An open label, multicenter, prospective non-interventional (NIS) post-authorization study to monitor the routine clinical practice of Bevacizumab in addition to platinum-based chemotherapy in patients with non-small cell lung cancer (NSCLC) in Germany (ID 1015)

      09:30 - 09:30  |  Author(s): W. Engel-Riedel

      • Abstract

      Background
      The objective of NIS AVAILABLE was the evaluation of safety and efficacy of Bevacizumab plus platinum-based chemotherapy for the first-line treatment of metastatic or locally advanced histologically confirmed NSCLC in routine practice to complement the data that emanates from pre-authorization randomized controlled trials. The trial also collected data on Bevacizumab dosage, combination partner, duration of treatment and causes for modifications or termination.

      Methods
      The NIS AVAILABLE was conducted in Germany from October 2007 until June 2013. Patients were recruited in 200 centers, which included office based and outpatient clinics specialized in oncology and pneumology to be widely representative of the NSCLC population. The study aimed to enroll 900 patients receiving chemotherapy and Bevacizumab according to physician’s decision and label instructions. For each patient baseline characteristics, treatment regime and results on efficacy and safety were documented. Progression-free survival (PFS) was estimated with the Kaplan-Meier-method.

      Results
      Preliminary results of the first interim analysis including 745 patients are presented with focus on baseline characteristics, treatment regimens, dosages and PFS under the perspective of histology and age (≥65/<65 years). The population consisted of 61.3% males, the median age was 62 years (range 29-84), 40.7% of the participants were >65 years of age. At diagnosis 88.6% presented with adenocarcinoma and 82.1% with stage IV disease. 62.0% of the patients had not received any previous treatment (radiation, surgery or chemotherapy) for lung cancer. Bevacizumab was most frequently administered in addition to platinum-based chemotherapy and a third-generation cytotoxic agent. A selection of the most frequently used combination therapies (>6%) and respective PFS values are shown (Table).

      Chemotherapy combinations Patients receiving the combination (%)* Median PFS in months (95% CI)
      Bevacizumab Carboplatin Gemcitabine 9.0 5.9 (4.7-9.8)
      Paclitaxel 35.3 6.7 (5.8-7.4)
      Pemetrexed 10.7 6.5 (4.2-8.5)
      Cisplatin Gemcitabine 12.1 6.0 (4.6-9.9)
      Pemetrexed 9.2 6.8 (3.5-8.4)
      Vinorelbin 6.8 5.9 (4.2-9.1)
      * multiple answers were allowed

      Conclusion
      In the interim analysis of the NIS AVAILABLE Bevacizumab was more frequently combined with carboplatin (64%) than cisplatin (32%) backbone chemotherapy highlighting carboplatin/paclitaxel plus Bevacizumab as the most prominent regime (35.3%). Overall Bevacizumab demonstrated a promising efficacy with a median PFS of 6.7 months in routine practice confirming findings from randomized controlled phase III trials such as E4599 or AVAiL. Although the study was not designed to compare PFS, the results indicate that there might be a difference across regimens.