Resumen

Se trata de un estudio prospectivo no intervencional, multinacional, multicéntrico y de múltiples cohortes, con recolección retrospectiva de datos de historia médica y de tratamiento previo a partir de registros médicos, diseñado para evaluar los resultados y la seguridad de atezolizumab en el mundo real para las indicaciones incluidas en la ficha técnica vigente, en el contexto de la práctica clínica habitual.

Descripción detallada

El estudio se dividirá en cohortes separadas según las indicaciones aprobadas para el tratamiento con atezolizumab, excluyendo los participantes no elegibles para cisplatino que reciben atezolizumab como primera línea de tratamiento (LOT1) para cáncer urotelial localmente avanzado/metastásico (CU localmente avanzado/metastásico). El estudio podrá enmendarse para incluir nuevas cohortes a medida que sean aprobadas en los países participantes. Los participantes serán incluidos en cada cohorte según su indicación para recibir atezolizumab.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Patient must have one of the following confirmed diagnoses for which atezolizumab is locally approved in the SmPC: (1) As monotherapy for the treatment of adult patients with locally advanced/metastatic UC after prior platinum-containing chemotherapy (Cohort 1 LOT2+mUC) or (2) As monotherapy for the treatment of adult patients with locally advanced/metastatic NSCLC after prior chemotherapy. Patients with EGFR activating mutations or ALK-positive tumour mutations should also have received targeted therapy before receiving atezolizumab (Cohort 2 LOT2+NSCLC) or (3) In combination with bevacizumab, paclitaxel and carboplatin for the first line treatment of adult patients with metastatic non-squamous NSCLC. Patients with EGFR activating mutations or ALK- positive tumour mutations should also have received targeted therapy (Cohort 3 LOT1 NSCLC) or (4) In combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) (Cohort 4 LOT1 ES-SCLC) or (5) As a monotherapy, for the treatment of metastatic NSCLC with high PD-L1 expression, previously untreated (Cohort 5 LOT1 NSCLC) or (6) In combination with bevacizumab for unresectable locally advanced or metastatic hepatocellular carcinoma previously untreated with systemic therapy (Cohort 6 LOT1 HCC) .
Patient is administered atezolizumab therapy for the first time.
Decision to administer atezolizumab must be made and documented prior to inclusion into the study and must follow local clinical practice.

Criterios de exclusión

Patients not receiving treatment for a disease with atezolizumab according to standard of care and in line with the current summary of product characteristics (SPC) or local labelling. Cisplatin ineligible patients receiving atezolizumab LOT1 for the treatment of locally advanced/metastatic UC patients will be excluded
Concomitant anti-cancer therapy at the time of starting atezolizumab on the index date not part of locally approved combination therapy with atezolizumab.
Treatment with atezolizumab as part of a clinical trial or for compassionate use as part of a pre-approval or compassionate use program.
Patients not receiving atezolizumab, but a biosimilar or non-original biologic.

Ubicaciones

Hospital Universitario Austral

Buenos Aires, Argentina

Lucen S.A.

Buenos Aires, Argentina

Consultorio Privado Korbenfeld

CABA, Argentina

Hospital Italiano de Buenos Aires

Ciudad Autonoma Buenos Aires, Argentina

Sanatorio Allende

Córdoba, Argentina

Sanatorio de la Mujer

Rosario, Argentina

Fundacion Koriza

Santa Rosa, Argentina

Estudio no intervencional, multicéntrico y de múltiples cohortes que investiga los resultados y la seguridad de atezolizumab en condiciones del mundo real en pacientes tratados en la práctica clínica habitual