Colorectal Cancer
Conditions
Keywords
Fruquintinib, PD-1, pMMR/MSS
Brief summary
The survival of the refractory CRC is dismal and therapy options are limited ，the researchers aim to investigate the efficacy, safety, and predictors of fruquintinib plus PD-1 in refractory MSS metastatic colorectal cancer in a real-world setting.
Detailed description
The invesgators conducted a retrospective single arm, single-center study in which patients with MSS/pMMR mCRC were received fruquintinib combined with anti-PD-1 antibodies after progressed at least two lines of standard chemotherapy with or without targeted drugs such as bevacizumab and cetuximab at the Hunan Cancer Hospital from 1th January 2019 to 30th June 2022. Eligible patients were aged 18 years or older and had histologically or cytologically confirmed adenocarcinoma of the colon or rectum; with patients who have at least one non-resectable measurable lesion to evaluate by response evaluation criteria in solid tumors (RECIST version 1.1).The primary endpoint was overall survival (OS).
Interventions
DRUGFruquintinib combined with anti-PD-1 antibodies
Fruquintinib (3-5mg once daily for 21 days on/7 days off) anti-PD-1 antibodies (including sintilimab, toripalimab, pembrolizumab, tislelizumab, and nivolumab).
Sponsors
Hunan Cancer Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. patients with MSS/pMMR mCRC who have been received Fruquintinib combined with anti-PD-1 antibodies after progressed at least two lines of standard chemotherapy with or without targeted drugs such as bevacizumab and cetuximab at the Hunan Cancer Hospital from 1th January 2019 to 30th June 2022; 2. Eligible patients were aged 18 years or older 3. had histologically or cytologically confirmed adenocarcinoma of the colon or rectum; 4. patients who have at least one non-resectable measurable lesion to evaluate by response evaluation criteria in solid tumors (RECIST version 1.1). 5. an Eastern Cooperative Oncology Group performance status of 0-2;
Exclusion criteria
1. Pregnancy, lactating female or possibility of becoming pregnant during the study. 2. Has not recovered from clinically relevant non-hematologic CTCAE grade ≥ 3 toxicity of previous anticancer therapy (excluding alopecia, and skin pigmentation). 3. Has symptomatic central nervous system metastases that are neurologically unstable or requiring increasing doses of steroids to control CNS disease. 4. Has severe or uncontrolled active acute or chronic infection. 5.Known carriers of HIV antibodies. 6.Confirmed uncontrolled arterial hypertension or uncontrolled or symptomatic arrhythmia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| overall survival (OS) | assessed up to 2 year | Overall survival defined as the observed time from the treatment of the study until death due to any cause |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| progress-free survival (PFS) | assessed up to 1 year | the time from treatment initiation to the disease progression according to RECIST version 1.1 by investigator's judgement or death from any cause, whichever comes first. |
Other
| Measure | Time frame | Description |
|---|---|---|
| objective response rate (ORR) | assessed up to 1 year | The ORR was calculated as the sum of the proportion of complete responses (CRs) and partial responses (PRs) according to RECIST version 1.1 criteria and using investigator's tumor assessment |
| disease control rate (DCR) | assessed up to 1 year | Disease control rate has been defined as the addition of (CR + PR) rate and also stable disease (SD) rate, according to RECIST v 1.1 |
| Treatment-Related Adverse Events (TRAE) | assessed up to 1 year | Treatment-Related Adverse Events (TRAE) as assessed by CTCAE v5.0, including serious adverse events (SAEs) |
Countries
China
Outcome results
None listed