Gastric Cancer
Conditions
Keywords
Gastric Cancer, Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma
Brief summary
This study will be conducted to understand real-world treatment patterns, participant characteristics (demographic and clinico-pathological characteristics), clinical outcomes and safety of different treatment regimens, and healthcare resource utilization in East Asia for HER2-positive locally advanced or metastatic gastric or gastroesophageal adenocarcinoma (de novo advanced disease, relapsed/progressed) in a real-world setting.
Interventions
None listed
Sponsors
Daiichi Sankyo Co., Ltd.
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult participants at the time of 1st LOT (Index Date 1e) initiation - Adult patients ≥18 years old. (Please follow local regulatory requirements if the legal age of consent for study participation is \>18 years old.) * Participants or next of kin/legal representatives who are willing to provide written informed consent as per the local regulations (if IRB/IEC/EC grants a permission to waive informed consent, it is not necessary). * Participants who were pathologically and/or clinically diagnosed with locally advanced or metastatic gastric or gastroesophageal adenocarcinoma (de novo advanced disease, relapsed/progressed) since January 1, 2016, and its record is available at the study participating site. * Participants whose HER2 status were pathologically confirmed HER2-positive (IHC3+ or IHC2+/ISH-positive) before/at the Index Date 2f based on the most recent archived tumor tissue sample to the Date of Diagnosisg, and its record is available at the study participating site. * Participants who received at least 1 LOT for HER2-positive locally advanced or mGC/GEJC in an advanced setting, and its record is available at study participating site. Trastuzumab or its biosimilar use is not required. °Progression on or within 6 months post neoadjuvant or adjuvant therapy is counted as rapid progressor in a neo-adjuvant/adjuvant setting, and thus equivalent to advanced/metastatic disease failing 1 LOT. * Participants who have at least 6 months of follow-up data from the date of 2nd LOT initiation (Index Date 2f) unless participant died within the first 6 months from the Index Date 2, and its record is available at the study participating site. * For rapid progressor participants in a neo-adjuvant/adjuvant setting, Index Date 1 will be the date of neo-adjuvant treatment initiation or adjuvant treatment initiation.
Exclusion criteria
* Participants with a change in HER2 status from positive to negative at progression from early-stage to advanced-stage disease (change from HER2-positive to HER2-negative on repeat biopsy during treatment for advanced stage can be participated). However, if HER2-positive was confirmed before the Date of Diagnosis (or if HER2-positive was confirmed using an archived tumor tissue sample collected during early stage) and the result was followed to make the decision for the 1st LOT, this is not the case. * Participants who had multiple cancer within 3 years of 1st LOT initiation (Index Date 1), except adequately resected melanoma skin cancer, curatively treated in-situ disease, other solid tumors curatively treated. * Participants who are participating or have participated in an interventional study that remains blinded at time of informed consent (IC) or at the time of data collection for participants whose IC is waived by the local IRB/EC/IEC.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Receiving Each Regimen in Each Line of Treatment (LOT) | From the date of 1st line of treatment initiation to the end of follow-up, approximately 12 months | Percentage of participants receiving each regimen in each line of treatment (LOT) since 1st LOT initiation will be assessed. LOT is defined as one regimen, possibly a combination of several drugs, given from the date of initiation of each LOT until the treatment failed to control the disease, is not tolerated by the participant, at the time of disease relapse/progression or death. |
| Duration of Therapy for Each Regimen | From the date of 1st line of treatment initiation to the end of follow-up, approximately 12 months | Duration of Therapy (DoT) is defined as the length of time from initiation of each LOT to permanent discontinuation of the treatment. |
| Reasons for Stopping Treatments in Each Line of Treatment (LOT) | From the date of 1st line of treatment initiation to the end of follow-up, approximately 12 months | Reasons for stopping treatments will be ascertained by patient charts and assessed by frequency and percentage. |
| Treatment Sequencing Pathways | From the date of 1st line of treatment initiation to the end of follow-up, approximately 12 months | Treatment sequencing from 1st LOT to 2nd LOT and to the subsequent LOT will be assessed. |
| Percentage of Participants Receiving Locoregional Treatment for Localized Disease and Metastasis (Radiotherapy and/or Surgery) | From the date of 1st line of treatment initiation to the end of follow-up, approximately 12 months | Percentage of participants receiving locoregional treatment for localized disease and locoregional treatment for metastasis (radiotherapy and/or surgery) since 1st LOT initiation will be assessed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Real-world Time to Next Treatment | From the date of 1st line of treatment initiation to the end of follow-up, approximately 12 months | Length of time from the date the participant initiates the LOT to the date the participant initiates next LOT or death from any cause, whichever occurs first. |
| Real Word Objective Response Rate | From the date of 1st line of treatment initiation to the end of follow-up, approximately 12 months | Proportion of participants who achieved real-world complete response or real-world partial response to treatment for each LOT. |
| Cause of Death in Each Line of Treatment | From the date of 1st line of treatment initiation to the end of follow-up, approximately 12 months | — |
| Number of Deaths in Each Line of Treatment | From the date of 1st line of treatment initiation to the end of follow-up, approximately 12 months | — |
| Number of Participants with Adverse Events of Special Interest (AESI) In Each Line of Treatment | From the date of 1st line of treatment initiation to the end of follow-up, approximately 12 months | — |
| Real World Disease Control Rate | From the date of 1st line of treatment initiation to the end of follow-up, approximately 12 months | Proportion of participants with real-world complete response, real-world partial response and real-world stable disease during treatment for each LOT. |
| Real World Progression Free Survival | From the date of 1st line of treatment initiation to the end of follow-up, approximately 12 months | Length of time from the date of initiation of LOT to the date of real-world disease progression or death due to any cause, whichever comes first. |
| Real Word Overall Survival | From the date of 1st line of treatment initiation to the end of follow-up, approximately 12 months | Length of time from the date of initiation of LOT to death due to any cause. |
| Real World Time to Treatment Failure | From the date of 1st line of treatment initiation to the end of follow-up, approximately 12 months | Length of time from the initiation of LOT to the date of real-world disease progression, treatment discontinuation, or death due to any cause, whichever occurs first. |
| Real World Time to Discontinuation | From the date of 1st line of treatment initiation to the end of follow-up, approximately 12 months | Length of time from the date the participant initiates the LOT to the date the participant discontinues that LOT or death due to any cause, whichever occurs first. |
Countries
China, Hong Kong, South Korea, Taiwan
Outcome results
None listed