Abstract
SummaryObjective. To evaluate the efficacy and safety of apatinib combined with FOLFIRI in the first-line treatment of advanced metastatic colorectal cancer (mCRC) and explore potential factors of efficacy. Methods. Twenty mCRC patients treated at Affiliated Cancer Hospital of Shanxi Medical University from March 2017 to March 2019 were included according to the enrolment criteria. They provided informed consent and were treated with apatinib combined with FOLFIRI according to the scheduled regimen until disease progression or unacceptable toxicity occurred. The primary endpoint was OS. The secondary endpoints included PFS, ORR, DCRand safety. OS and PFS were calculated using Kaplan–Meier curves. Univariate and multivariate Cox regression analyses were used to evaluate independent prognostic factors of OS and PFS. R was used to determine cut-off values for biochemical indicators. Forest maps were drawn for Cox univariate results and the relationships between NLR and ECOG, which were significant in univariate analysis, and OS were represented by Kaplan–Meier curves. Results. The median OS and PFS were 16.135 months (95% CI: 9.211–22.929) and 6 months (95% CI: 5.425–6.525). Multivariate Cox analysis showed that NLR and CEA were independent prognostic factors. The most common grade 3–4 adverse events were hypertension, diarrhoea, increased alkaline phosphatase, decreased leukocytes and decreased neutrophils. Conclusion. Apatinib combined with FOLFIRI for the first-line treatment of advanced unresectable mCRC showed good efficacy and safety. The baseline NLR was predictive of efficacy, and a low baseline NLR (HR: 0.2895, P = 0.0084) was associated with improved OS.Clinical Research Registration Number: ChiCTR1800015308.
Highlights
The incidence and mortality of colorectal cancer (CRC) rank third among all malignant tumours worldwide [1]
Investigational New Drugs monoclonal antibodies are currently recognized as targeted therapeutic options for advanced CRC [7], but the antiEGFR monoclonal antibodies panitumumab and cetuximab have significant effects on patients with wild-type RAS and BRAF, while they have poor effects on patients with mutant RAS and BRAF
The efficacy of apatinib in first-line treatment is not yet clear. The objective of this open exploratory clinical trial was to evaluate the efficacy and safety of apatinib in combination with FOLFIRI in patients with advanced unresectable metastatic CRC and to explore clinical factors associated with prognosis
Summary
The incidence and mortality of colorectal cancer (CRC) rank third among all malignant tumours worldwide [1]. Investigational New Drugs monoclonal antibodies are currently recognized as targeted therapeutic options for advanced CRC [7], but the antiEGFR monoclonal antibodies panitumumab and cetuximab have significant effects on patients with wild-type RAS and BRAF, while they have poor effects on patients with mutant RAS and BRAF. It is necessary to explore new therapeutic modes to improve the survival of patients with advanced CRC. Current exploratory studies of apatinib in advanced CRC focus on later-line treatments. The efficacy of apatinib in first-line treatment is not yet clear The objective of this open exploratory clinical trial was to evaluate the efficacy and safety of apatinib in combination with FOLFIRI in patients with advanced unresectable metastatic CRC and to explore clinical factors associated with prognosis
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