74115117/01/2022Validated04/02/2022Camille Bachothttp://epidemiologie-france.aviesan.fr/en/content/view/full/90996http://epidemiologie-france.aviesan.fr/en/ccontent/xml/(NodeId)/90996A cohort study of patients with advanced, unresectable (stage IIIB) metastatic (stage IV) non-squamous non-small cell lung cancer (NSCLC) or in relapse starting treatment with Avastin® in combination with chemotherapy as first line treatment of metastatic diseaseEOLEML22991Cancer researchNoNon-squamous non-small cell lung cancerMedicineBevacizumabMedical data centerdata_sharing_france@roche.comRoche SASNoPrivateRoche SASPrivateYesStudy databasesCohort studyA selection of health institutions and servicesNoThis observational study will evaluate modality, efficacy and safety of Avastin (bevacizumab) as first-line treatment in combination with chemotherapy in patients with inoperable advanced, metastatic or recurrent non-squamous non-small cell lung cancer in clinical practice
1. To describe characteristics of patients treated with Avastin®: demographic and clinical characteristics, history of the disease, and previous disorders and conditions,
2. To describe methods of use of Avastin® in follow-up: doses and durations of treatment with Avastin® (number of cycles); chemotherapy treatments used in combination with treatment with Avastin®; discontinuation of treatment with Avastin® (temporary and permanent) and reasons; treatment strategies set up after discontinuation of treatment with Avastin®,
3. To describe overall survival of patients treated with Avastin®,
4. To describe the safety profile of treatment with Avastin®: serious and non-serious adverse events and targeted adverse events,
5. To describe quality of life: Spitzer's quality of life questionnaire,
6. To describe therapeutic management of patients with non-squamous cell NSCLC in first-line chemotherapy of metastatic disease not receiving Avastin®: compilation of an anonymous registry over a 3-month period starting with time of scientific set up by the investigator.Prospective cohort :
- Adult, man or woman patient (age >= 18 years),
- With unresectable locally advanced (stage IIIB), metastatic (stage IV) or recurrent non squamous (whenever the histology is not predominantly of squamous cell type) non-small cell lung cancer (NSCLC), and treated in first line setting
- Patient starting for the first time a treatment with bevacizumab in first line setting,
- Patient having received oral and written information on the study and having no objection to the fact that his (her) personal data will be subjected to data processing.
Registry :
- Patients with unresectable locally advanced (stage IIIB), metastatic (stage IV) or recurrent non squamous non-small cell lung cancer (NSCLC), and treated in first line setting,
- Patients for whom the multidisciplinary committee decided to not initiate a treatment with bevacizumab,
- Inclusion in the registry had to be consecutive during the first three months of study participation for each investigator.Adulthood (19 to 24 years)Adulthood (25 to 44 years)Adulthood (45 to 64 years)Elderly (65 to 79 years)Great age (80 years and more)Sick populationC00-C75 - Malignant neoplasms, stated or presumed to be primary, of specified sites, except of lymphoid, haematopoietic and related tissueMaleWomanNational20112013< 500 individuals418Data collection completedClinical dataNoHealth event/morbidityHealth event/mortalityGCP/GVPYesMonitoring by contact with the referring doctorC00-C75 - Malignant neoplasms, stated or presumed to be primary, of specified sites, except of lymphoid, haematopoietic and related tissueNohttp://epidemiologie-france.aviesan.fr/enhttps://www.roche.fr/fr/innovation-recherche-medicale/data-sharing-portail-d-information-partage-des-donnees.htmlAccess on specific project onlyAccess on specific project only