The mCRC Patients With pMMR/MSS or dMMR/MSI-H Status Received Palliative Chemotherapy Efficacy and Survival

NCT ID: NCT04482608

Last Updated: 2020-07-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 671 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2020-06-08

Brief Summary

Deficient mismatch repair (dMMR) or microsatellite instability high (MSI-H) accounts for 4-5% in metastatic colorectal cancer (mCRC). The efficacy and survival of patients with dMMR/MSI-H status received palliative chemotherapy have not clear yet. In this study, the investigators observed the efficacy and survival of dMMR/MSI-H status mCRC patients received palliative first-line chemotherapy.

Detailed Description

Colorectal cancer (CRC) is the one of most common cancer in the world. Loss of function of DNA mismatch repair (MMR) is an important mechanism of CRC development. Mutation or modification of MMR genes result in MMR protein deficient (dMMR) and microsatellite instability (MSI). It has been reported that the dMMR or MSI high (MSI-H) phenotype is present in approximately 15-18% of CRC patients. Most dMMR/MSI-H tumors are sporadic CRC, and only approximately 3% of dMMR/MSI-H tumors are Lynch syndrome (LS) or hereditary nonpolyposis colorectal carcinoma (HNPCC).

The dMMR/MSI-H status was reported to be a predictive marker for adjuvant chemotherapy. Multiple retrospective studies showed that dMMR/MSI-H is correlated with a favorable prognosis in stage II/III CRC. Previous studies suggested that dMMR/MSI status may be a predictive marker of decreased benefit form adjuvant monotherapy of 5-fluorouracil (5-FU) in patients with stage II disease, but not in those with stage III disease. For metastatic colorectal cancer (mCRC), the relationship of the MMR/MSI phenotype and prognosis is unclear. Some researchers found that CRC patients with the dMMR/MSI-H phenotype have a worse prognosis. But other researchers thought the dMMR/MSI-H phenotype is no associate to efficacy and survival of palliative chemotherapy, even is benefit for efficacy and survival.Therefore, the aim of this study was to clarify whether the status of dMMR/MSI-H affected progression-free survival (PFS) in mCRC patients who received first-line palliative chemotherapy.

Conditions

Colorectal Cancer Metastatic; Mismatch Repair Deficiency; Microsatellite Instability High

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

pMMR/MSS mCRC patients

The metastatic colorectal cancer patients with proficient mismatch repair or microsatellite stable status.

No interventions assigned to this group

dMMR/MSI-H mCRC patients

The metastatic colorectal cancer patients with deficient mismatch repair or microsatellite instability high status.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 18 years old

2. Histologically confirmed Metastatic colorectal adenocarcinoma;

3. Immunohistochemistry confirmed mismatch repair status or polymerase chain reaction (pCR) / next-generation sequencing (NGS) confirmed microsatellite status

4. Received palliative chemotherapy and have complete information of treatment

Exclusion Criteria

1. Patients have not tested for mismatch repair or microsatellite

2. Patients have not received palliative chemotherapy or received palliative chemotherapy but treatment information incomplete

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Second Affiliated Hospital of Kunming Medical University

OTHER

Sponsor Role: collaborator

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Ruihua Xu

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ying Jin, MD.,PhD

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

Sun yat-sen university cancer center

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

dMMR/MSI-H and chemotherapy

Identifier Type: -

Identifier Source: org_study_id