The purpose of this study is to collect real-world data to describe the effectiveness and tolerability of first line (1L) zanidatamab-containing therapies and describe the subsequent lines of treatment in participants with unresectable, locally advanced, recurrent or metastatic HER2-positive gastroesophageal adenocarcinoma (GEA) (HER2+ la/m GEA).
Histologically confirmed HER2-positive (defined as IHC3+ or IHC2+ with ISH positivity) locally advanced or metastatic GEA
Documented plan to initiate a zanidatamab-containing therapy as 1L treatment
Sufficient cognitive capacity and language proficiency to complete patient-reported outcomes (PRO) questions
18 years of age or older on the date of initiating 1L zanidatamab-containing therapy
Receiving a zanidatamab-containing therapy as part of a clinical trial or expanded access program
Received zanidatamab prior to the approval date by the FDA for HER2+ la/m GEA
Received the first infusion of zanidatamab prior to providing study consent
For patients initiating chemotherapy backbone first, more than 2 months have elapsed before the first dose of zanidatamab
The study will enroll approximately 300 male and female participants, aged 18 years or older in the United States, diagnosed with HER2-positive locally advanced or metastatic GEA with a plan to initiate a 1L zanidatamab-containing therapy.
Cohort
Prospective
Zanidatamab
DrugAdministered via intravenous (IV) infusion
Average age of participants
Patient demographics
The number of participants at each demographic category: sex, race and ethnicity
Clinical characteristics
Number of participants at each Eastern Cooperative Oncology Group (ECOG) performance status, comorbidities, and gastrointestinal symptoms
Average BMI
Participants' average body mass index (BMI) in kilogram per square meters
Incidence of AESI
Incidence of adverse events of special interest (AESI), including diarrhea, associated with programmed cell death protein 1 (PD-1) antagonists
Duration of the AESI
Duration of the AESI, including the first and subsequent incidence of diarrhea
Time (by treatment cycle) for the onset of AESI
Time (by treatment cycle) where the onset of AESI and the first and following incidences of diarrhea occurred
Time (by treatment cycle) of dose adjustment
Time (by treatment cycle) adjustment for chemotherapy, immunotherapy agent or zanidatamab due to diarrhea and AESI
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