The CAIRO3 protocol refers to a phase 3 clinical study evaluating the effectiveness of maintenance treatment with capecitabine plus bevacizumab (CAP-B) in patients with metastatic colorectal cancer (mCRC).
CAIRO3 Study: Key Aspects
The CAIRO3 study investigated the use of CAP-B maintenance therapy following initial treatment with six cycles of capecitabine, oxaliplatin, and bevacizumab (CAPOX-B). The primary aim was to determine if CAP-B maintenance could prolong progression-free survival (PFS) without negatively impacting the patient's quality of life. The results indicated that CAP-B maintenance is indeed an effective strategy.
Study Design
The study design typically involved the following:
- Initial Treatment: Patients received six cycles of CAPOX-B (capecitabine, oxaliplatin, and bevacizumab).
- Randomization: Patients who responded to the initial treatment were then randomized to either:
- CAP-B maintenance (capecitabine plus bevacizumab)
- Observation (no further treatment)
- Primary Endpoint: The primary endpoint was progression-free survival (PFS).
- Secondary Endpoints: Secondary endpoints often included overall survival (OS), quality of life, and safety.
Main Findings
The key finding of the CAIRO3 study was the demonstration that maintenance therapy with CAP-B significantly improved progression-free survival compared to observation alone, without compromising the patient's quality of life. This makes it a viable option for patients with mCRC who have responded to initial CAPOX-B treatment.
Implications for Treatment
The CAIRO3 study has had a significant impact on the management of metastatic colorectal cancer. CAP-B maintenance has become a standard of care in many clinical settings, providing an effective way to control the disease and extend the period before it progresses, while maintaining the patient's well-being.