Abstract
Routine clinical practice data often differ from clinical trials. This study describes real-world treatment patterns and effectiveness among patients with metastatic colorectal cancer (mCRC) receiving ziv-aflibercept in non-academic, community oncology practices in the USA. De-identified electronic medical records from Vector Oncology and Altos Solutions databases were analysed. We identified 218 patients diagnosed with mCRC who had received prior oxaliplatin therapy and initiated ziv-aflibercept as part of second-line or later-line therapy. Overall survival (OS) and progression-free survival (PFS) were estimated using Kaplan–Meier analysis. Mean age was 62.8 years at ziv-aflibercept initiation. Most patients (91.7%) received bevacizumab before ziv-aflibercept, 95.4% initiated ziv-aflibercept with FOLFIRI or another irinotecan-based regimen, and 59.6% had received prior irinotecan. Overall, 24.8% of patients initiated ziv-aflibercept in second line, 31.7% in third line, 21.6% in fourth line and 22.0% in later lines of therapy. Mean duration of ziv-aflibercept treatment was 5.3 months. For patients initiating ziv-aflibercept in second-, third- and fourth-line therapy, median OS was 11.9 (95% confidence interval 5.1–16.2), 11.1 (6.9–16.7) and 8.1 (5.2–11.4) months, respectively, and median PFS was 4.4 (2.8–6.5), 4.3 (2.9–6.3) and 3.4 (2.2–5.2) months, respectively. Common adverse events (AEs) (any grade) included gastrointestinal disorders (64.7%) and asthenia/fatigue (63.3%). In routine clinical practice, ziv-aflibercept was frequently initiated in third line or later lines of therapy. Although patients receiving ziv-aflibercept were more heavily pretreated and potentially less robust compared with the VELOUR trial, median OS for patients receiving second-line ziv-aflibercept was comparable. AE rates were similar to or lower than the VELOUR trial.
Highlights
Colorectal cancer (CRC) is the fourth most common cancer in the USA, with 132,700 new cases and 49,700 deaths estimated to occur in 2015 [1]
Chemotherapies used to treat metastatic colorectal cancer (mCRC) are commonly based on fluoropyrimidines, combining infusional fluorouracil and leucovorin with either oxaliplatin (FOLFOX regimen) or irinotecan (FOLFIRI regimen) [4]
The objectives of this study were to assess real-world characteristics, treatment patterns, effectiveness and adverse events (AEs) in patients with mCRC who have initiated ziv-aflibercept treatment as second-line or later-line therapy following a prior oxaliplatin-based regimen. This retrospective cohort study aimed to assess patients with mCRC included in the Vector Oncology Data Warehouse and Altos Solutions Inc
Summary
Colorectal cancer (CRC) is the fourth most common cancer in the USA, with 132,700 new cases and 49,700 deaths estimated to occur in 2015 [1]. One-quarter of CRC patients present with metastases at diagnosis, and nearly 50% will develop metastases during the course of their disease [2]. While the estimated CRC-related 5-year survival rate approaches 60% overall, 5-year survival for metastatic disease (mCRC) remains only 12% [2, 3]. Systemic therapy remains the principal treatment option for mCRC. Chemotherapies used to treat mCRC are commonly based on fluoropyrimidines, combining infusional fluorouracil and leucovorin with either oxaliplatin (FOLFOX regimen) or irinotecan (FOLFIRI regimen) [4].
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