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

Sun Yat-sen University671 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

671

Conditions

Colorectal Cancer Metastatic Mismatch Repair Deficiency Microsatellite Instability High

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Sun yat-sen university cancer center

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

Progression-Free Survival (PFS)

PFS as measured in accordance with the Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1

Time frame: up to 24-36 months

Secondary Outcomes

Response rate

Based on Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1)

Time frame: From first patient first visit to 6 month after last patient first visit

Disease Control Rate (DCR)

Based on Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1)

Time frame: From first patient first visit to 6 month after last patient first visit

Overall survival

The time from registration to death due to any cause, or censored at date last known alive.

Time frame: up to approximately 9 year

Data from ClinicalTrials.gov

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