Long-term Heart-specific Mortality in the Presence of Competing Risks Among Patients With Non-metastatic Gastric Adenocarcinoma Undergoing Resection and Chemotherapy (GaCCoR-01)

Long-term Heart-specific Mortality in the Presence of Competing Risks Among Patients With Non-metastatic Gastric Adenocarcinoma Undergoing Resection and Chemotherapy A Population-based Cohort Study of 21,257 Cases, 2004-2016

In this population-based cohort study, data on patients diagnosed with nmGaC in 2004 through 2016, managed with resection and chemotherapy, followed up until the end of 2016, and surviving ≥1 month were retrieved from the US Surveillance, Epidemiology, and End Results-18 Program. Cumulative mortality functions were calculated. Prognostic factors for heart-specific mortality were evaluated using both multivariable-adjusted Fine-Gray subdistribution and cause-specific hazard functions.

Study Overview

• Status: Completed
• Conditions: Long-term Heart-specific Mortality in the Presence of Competing Risks Among Patients With Gastric Adenocarcinoma Undergoing Resection and Chemotherapy
• Intervention / Treatment: Procedure: Resection and chemotherapy

• Study Type: Observational
• Enrollment (Actual): 21257

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Cases of non-metastatic gastric adenocarcinoma (nmGaC) were defined as patients with microscopically-confirmed first primary invasive adenocarcinoma of the stomach (International Classification of Diseases for Oncology, Third Edition (ICD-O-3) code: C16) without distant metastasis. Only those who underwent resection in January 2004 through December 2016 were included.

Description

Cases of non-metastatic gastric adenocarcinoma (nmGaC) were defined as patients with microscopically-confirmed first primary invasive adenocarcinoma of the stomach (International Classification of Diseases for Oncology, Third Edition (ICD-O-3) code: C16) without distant metastasis. Only those who underwent resection in January 2004 through December 2016 were included. Cancers of other histology types including squamous cell carcinoma, gastrointestinal stromal tumor or sarcoma, neuroendocrine tumor or carcinoid, lymphoma, and germ-cell tumor were ineligible, as were patients with non-gastric cancers involving the stomach, with benign or in situ tumors, or with other malignancies before gastric cancer. We further excluded patients with diagnosis based on death certificate only or autopsy, with missing follow-up period, survival status, or cause of death, or with unknown metastasis status. Cancers with distant metastasis were excluded since resection is not routinely recommended for them. Data before 2004 were not included, as the TNM stage information was unavailable. To minimize the effect of perioperative events on survival, we excluded patients surviving <1 month. No restrictions were applied to age, and patients ≥80 years only comprised 5% of those receiving both resection and chemotherapy.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative mortality	Cumulative incidence functions (CIFs), which, unlike the standard Kaplan-Meier method, allow for estimation of the incidence of the occurrence of an event while taking competing risks from other causes of death into account, were computed and plotted for cause-specific mortalities.	Jan 12, 2020-Mar 5, 2021
Prognostic factors for disease-specific mortalities	Evaluated using both multivariable-adjusted Fine-Gray subdistribution and cause-specific hazard functions.	Jan 12, 2020-Mar 5, 2021

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Anhui Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2004
• Primary Completion (Actual): December 31, 2016
• Study Completion (Actual): December 31, 2016

Study Registration Dates

• First Submitted: March 25, 2021
• First Submitted That Met QC Criteria: March 25, 2021
• First Posted (Actual): March 29, 2021

Study Record Updates

• Last Update Posted (Actual): March 29, 2021
• Last Update Submitted That Met QC Criteria: March 25, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma
• Other Study ID Numbers: GaCCoR-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The Surveillance, Epidemiology, and End Results Program data are available upon reasonable request and with permission of the registry.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No