Safety and Effectiveness of Aflibercept + Fluorouracil, Leucovorin, and Irinotecan (FOLFIRI) for the Treatment of Patients with Metastatic Colorectal Cancer (mCRC) in Current Clinical Practice: OZONE Study

Cancers

Marwan Fakih¹  Pilar García-Alfonso²  Ana Ruiz Casado³  Pascaline Picard⁴  EduardoPolo Marques⁵  Thomas Cartwright⁶  Marina Celanovic⁷  Ian Chau⁸  Zdenĕk Linke⁹ 

[1] City of Hope Comprehensive Cancer Center, Duarte, CA 91010, USA;Hospital General Universitario Gregorio Marañón, 28003 Madrid, Spain;Hospital Universitario Puerta de Hierro-Majadahonda, 28222 Majadahonda, Spain;Ividata, 92300 Levallois Perret, France;Miguel Servet University Hospital, 50009 Zaragoza, Spain;Ocala Oncology, Ocala, FL 34474, USA;Sanofi, Cambridge, MA 02139, USA;The Royal Marsden NHS Foundation Trust, London and Surrey, Sutton SM2 5PT, UK;University Hospital Motol, 150 06 Prague 5, Czech Republic;

关键词: aflibercept;    antiangiogenic;    clinical practice;    folfiri;    metastatic colorectal cancer;    observational;   

DOI  :  10.3390/cancers12030657

来源: DOAJ

【 摘 要 】

For patients with metastatic colorectal cancer (mCRC) that have failed a first-line oxaliplatin-based regimen, the preferred treatment option is an irinotecan-based regimen. This prospective, observational, noncomparative, post-authorization safety study (OZONE) evaluated the safety and effectiveness of aflibercept plus fluorouracil, leucovorin, and irinotecan (FOLFIRI) in patients with mCRC treated in daily practice after failure of an oxaliplatin-based regimen. Patients were grouped by age, renal impairment, hepatic impairment, race, number, and type of prior anticancer therapy. Of 766 treated patients enrolled, 59.5% were male, 94.8% had an Eastern Cooperative Oncology Group performance status of 0−1, all received previous chemotherapy (97.8% including oxaliplatin), and 58.6% had prior exposure to bevacizumab. At least one grade ≥ 3 treatment-emergent adverse event (TEAE) was reported in 68.3% of patients. Neutropenia, hypertension, diarrhea, and asthenia were the most frequently occurring grade ≥ 3 TEAEs. Antivascular endothelial growth factor class events were infrequent. Subgroup analyses did not reveal major differences in the safety profile according to age, renal and hepatic status, race, or prior anticancer therapy. For the total population, median overall survival was 12.5 months, median progression-free survival was 6.1 months, and overall response rate was 16.3%. Aflibercept in combination with FOLFIRI is a safe and efficacious regimen administered in current clinical practice to patients with mCRC previously treated with oxaliplatin. The study results, conducted in real-world clinical practice with a less selected patient population, are aligned with the VELOUR (NCT00561470) trial and no new safety issues were identified.

【 授权许可】

Unknown