Chemotherapy Alone Versus Chemotherapy Plus Targeted Therapy as Adjuvant Therapy for Initially Unresectable Colorectal Cancer Liver Metastases
Study Details
Study Description
Brief Summary
Chemotharapy plus targeted therapy regimen, as an adjuvant therapy, can effectively reduce the rate of both intrahepatic and extrahepatic recurrence in initially unresectable CRLM patients. Those with KRAS/NRAS/BRAF mutated tumors or cycle of conversion therapy ≤ 4 can benefit more from chemotharapy plus targeted therapyrather than from chemotharapy alone, with a tolerable toxicity profile.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
This multi-center study enrolled consecutive patients with initially unresectable CRLM who underwent conversion therapy or radiofrequency ablation (RFA) and achieved no NED status between June 1, 2013, and June 30, 2020, from Zhongshan Hospital of Shanghai, Zhongshan Hospital of Xiamen, Cancer Hospital of Beijing. The inclusion criteria were as follows: (1) with histologically confirmed CRC; (2) with initially unresectable synchronous liver metastases (LMs); (3) accepted conversion therapy and successfully converted into resectable status; (4) underwent R0 intestinal and hepatic resection; (5) accepted adjuvant therapy. The exclusion criteria were as follows: (1) R1/R2 resection; (2) extrahepatic metastases; (3) accepted postoperative monotherapy; (4) lack of follow-up data. According to the adjuvant therapy regimen (with or without targeted therapy), the cohorts were divided into CA cohort and CT cohort. The study was approved by the ethics committee of three medical centers and was adhered to Good Clinical Practice guidelines and the Declaration of Helsinki. Written informed consent was obtained from all participants.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Chemotherapy plus Targeted therapy (CT) The treatment decisions and evaluation of treatment outcomes, such as the assessment of metastases resectability and tumor response, were carried out by the multi-disciplinary team (MDT) comprising experts from each medical centers. In this cohort, initially unresectable colorectal cancer liver metastasis (CRLM) patients who were successfully converted and achieved no evidence of disease status were treated with chemotherapy plus targeted therapy, as adjuvant therapy. |
Drug: Targeted agent
The two cohorts received different adjuvant therapy regimens, with the CT group receiving chemotherapy plus targeted therapy; the CA group received chemotherapy alone.
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| Chemotherapy Alone (CA) In this cohort, initially unresectable colorectal cancer liver metastasis (CRLM) patients who were successfully converted and achieved no evidence of disease status were treated with chemotherapy, as adjuvant therapy. |
Outcome Measures
Primary Outcome Measures
- relapse-free survival [3 years]
The relapse-free survival (PFS) was defined as the period from the start of initial liver resection to the date of tumor relapse or death
Secondary Outcome Measures
- overall survival [5 years]
The overall survival (OS) was defined as the period from the start of initial liver resection until death from any cause, at which point the data was censored.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥ 18 and ≤ 75 years;
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Histologically confirmed CRC;
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Initially unresectable synchronous liver metastases (LMs);
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Accepted conversion therapy and successfully converted into resectable status;
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Underwent R0 intestinal and hepatic resection;
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Accepted adjuvant therapy.
Exclusion Criteria:
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R1/R2 resection;
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Extrahepatic metastases;
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Accepted postoperative monotherapy;
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Lack of follow-up data.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Fudan University
Investigators
- Principal Investigator: Jianmin Xu, MD, Fudan University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CAPTIUM