Author of

• 10801

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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
  • Moderators:
  • Coordinates: 10/28/2013, 09:30 - 16:30, Exhibit Hall, Ground Level

  • 10810

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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): H. Metze
    • 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.