Drug updated on 9/4/2024
Dosage Form | Injection (intravenous; 100 mg/4 mL [25 mg/mL], 200 mg/8 mL [25 mg/mL]) |
Drug Class | Vascular endothelial growth factor inhibitors |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for use in combination with FOLFIRI (fluorouracil, leucovorin, irinotecan) for the treatment of metastatic colorectal cancer (mCRC) that is resistant to or has progressed following an oxaliplatin regimen.
Latest News
Summary
- Zaltrap (ziv-aflibercept) is indicated for use in combination with FOLFIRI (fluorouracil, leucovorin, irinotecan) for the treatment of metastatic colorectal cancer (mCRC) that is resistant to or has progressed following an oxaliplatin regimen.
- This summary is based on the review of four systematic review(s)/meta-analysis(es). [1-4]
- The pooled prevalence for 12-month Progression-Free Survival (PFS) with aflibercept was 18% (95% CI, 5%-37%) and for 12-month Overall Survival (OS) was 61% (95% CI, 53%-68%) when combined with FOLFIRI.
- Pooled estimate rates for aflibercept in metastatic colorectal cancer (mCRC) included 16.0% for 12-month PFS, 64.4% for 12-month OS, 32.5% for Overall Response Rate (ORR), and 83.5% for Disease Control Rate (DCR).
- Regorafenib demonstrated superior PFS compared to aflibercept in a comparative analysis, with a hazard ratio (HR) of 0.9631 (95% CI, 0.6785-1.367).
- The incidence of antiangiogenic-related adverse events with aflibercept included hypertension (44.2%), proteinuria (31.3%), epistaxis (27.3%), hemorrhage events (22.5%), venous thromboembolic events (8.0%), with Grade III/IV hypertension and proteinuria occurring in 22.6% and 7.4% of cases, respectively.
- Pooled prevalences of grade 3-4 toxicities associated with aflibercept included any grade 3-4 toxicities (69%), diarrhea (10%-16.8%), hypertension (13%-22.3%), neutropenia (29.5%-31%), venous thromboembolic event (5%), proteinuria (7.3%), and oral mucositis (8.6%), indicating significant safety concerns.
- Subgroup analysis revealed no significant differences in primary endpoints when stratified by treatment line (first-line or non-first-line), chemotherapy regime (FOLFIRI or others), or study design (RCTs or single-arm trials). KRAS and BRAF mutated mCRC were identified as subgroups where regorafenib combined with chemotherapy might be a potential alternative to conventional options.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Zaltrap (ziv-aflibercept) Prescribing Information. | 2020 | Sanofi-Aventis U.S. LLC, Bridgewater, NJ |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Rectal cancer, version 2.2022, NCCN clinical practice guidelines in oncology. | 2022 | Journal of the National Comprehensive Cancer Network |
Clinical management of metastatic colorectal cancer in the era of precision medicine. | 2022 | CA: A Cancer Journal for Clinicians |
Treatment of patients with late-stage colorectal cancer: ASCO resource-stratified guideline. | 2020 | Journal of Clinical Oncology |
Treatment sequencing in metastatic colorectal cancer. | 2019 | European Journal of Cancer |