Surgery Following Immune Checkpoint Inhibitions for Controlled Disease in Recurrent or Metastatic dMMR/MSI-H Colorectal Cancer

Sun Yat-sen University40 enrolled

Overview

Surgical resection for residual lesions could significantly improve the prognosis in metastatic colorectal cancers (CRCs) after systemic treatments, yet the necessity of resecting residual lesions after immune checkpoint inhibitions (ICIs) remains controversial in mismatch repair-deficient (dMMR) or microsatellite instability-high (MSI-H) diseases. We retrospectively enrolled recurrent or metastatic dMMR/MSI-H CRCs who received surgerys from Sun Yat-sen University Cancer Center. Patients without disease progression after at least 2 cycles of ICIs were included. Demographic and clinicopathological data were collected and analyzed. Relapse-free survival (RFS) after surgery were analyzed.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Colorectal Cancer

Eligibility

Sex: ALLMin age: 16 YearsMax age: 74 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. pathologically confirmed CRC with measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1)20; 2. definite pathological or radiological evidence of recurrent or distant metastasis; 3. received at least 2 courses of ICIs; 4. confirmed as dMMR by immunohistochemical method or MSI-H by polymerase chain reaction or next-generation sequencing; 5. receiving therapeutic surgical treatment for residual lesions or tumor sites and achieving no evidence of disease (NED) ; 6. no progression within the duration of preoperative ICIs Exclusion Criteria: \-

Locations (1)

Outcomes

Primary Outcomes

Disease-free Survival

defined as the time from randomization to the first appearance of one of the following: primary tumor recurrence, or death without cancer event; or censored at date of last follow-up

Time frame: up to 5 years

Overall Survival

defined as the time from randomization to death from any cause. Participants who were alive or lost to follow-up at the time of the analysis were censored at the date they were last known to be alive

Time frame: up to 5 years